| Source Page | TATOBA:SEND specifications |
|---|---|
| Valid Tables | 33 |
| Destination | Library |
| Options |
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| Output Format | Table |
| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core | Dataset Name | Variable Name (no prefix) | Seq. for Order | Observation Class | Domain Prefix |
|---|---|---|---|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | CO | STUDYID | 1 | SEND Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | CO | Identifier | Two-character abbreviation for the domain. | Req | CO | DOMAIN | 2 | SEND Special-Purpose | |
| RDOMAIN | Related Domain Abbreviation | Char | Record Qualifier | Domain abbreviation of the parent record(s). Null for comments collected as a general comment or additional information. | Exp | CO | RDOMAIN | 3 | SEND Special-Purpose | ||
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID. | Exp | CO | USUBJID | 4 | SEND Special-Purpose | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooled subjects to assign a single result to multiple subjects. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID. | Perm | CO | POOLID | 5 | SEND Special-Purpose | ||
| COSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | CO | SEQ | 6 | SEND Special-Purpose | CO | |
| IDVAR | Identifying Variable | Char | Record Qualifier | Variable in the parent dataset that identifies the record(s) to which the comment applies, which is contained in IDVAR. Examples: BWSEQ or CLGRPID. Used only when individual comments are related to domain records. | Exp | CO | IDVAR | 7 | SEND Special-Purpose | ||
| IDVARVAL | Identifying Variable Value | Char | Record Qualifier | Value of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. | Exp | CO | IDVARVAL | 8 | SEND Special-Purpose | ||
| COREF | Comment Reference | Char | Record Qualifier | Applicant-defined reference associated with the comment. May be the logbook page number, name (e.g., Logbook), or a combination of information that identifies the reference (e.g., Logbook, page 650, Day 28, morning). | Perm | CO | REF | 9 | SEND Special-Purpose | CO | |
| COVAL | Comment | Char | Topic | The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. | Req | CO | VAL | 10 | SEND Special-Purpose | CO | |
| COEVAL | Evaluator | Char | Record Qualifier | Used to describe the originator of the comment. Examples: TECHNICIAN, STUDY DIRECTOR, VET. | Perm | CO | EVAL | 11 | SEND Special-Purpose | CO | |
| CODTC | Date/Time of Comment | Char | ISO 8601 datetime or interval | Timing | Date/Time of the comment, in ISO 8601 format. May be null if this is a child record of another domain or if the comment date was not collected. In all other cases, this represents the date/time of the comment in ISO 8601 format. | Exp | CO | DTC | 12 | SEND Special-Purpose | CO |
| CODY | Study Day of Comment | Num | Timing | Study day of the comment, in integer days. May be null if this is a child record of another domain or if the comment date was not collected. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | CO | DY | 13 | SEND Special-Purpose | CO | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DM | STUDYID | 1 | SEND Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | DM | Identifier | Two-character abbreviation for the domain. | Req | DM | DOMAIN | 2 | SEND Special-Purpose | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | DM | USUBJID | 3 | SEND Special-Purpose | ||
| SUBJID | Subject Identifier for the Study | Char | Topic | Subject (i.e., Animal) identifier used within the study. | Req | DM | SUBJID | 4 | SEND Special-Purpose | ||
| RFSTDTC | Subject Reference Start Date/Time | Char | ISO 8601 datetime or interval | Record Qualifier | Reference start date/time for the subject in ISO 8601 format. Usually equivalent to date/time when subject was first exposed to study product. Study day calculation (the --DY variable) in all domains will be based on this date. The collected date used to populate RFSTDTC must be defined in the data definition file. | Req | DM | RFSTDTC | 5 | SEND Special-Purpose | |
| RFENDTC | Subject Reference End Date/Time | Char | ISO 8601 datetime or interval | Record Qualifier | Reference end date/time for the subject in ISO 8601 format. Usually equivalent to the date/time when the subject was determined to have left the study. The collected date used to populate RFSTDTC must be defined in the data definition file. | Exp | DM | RFENDTC | 6 | SEND Special-Purpose | |
| RFXSTDTC | Date/Time of First Study Exposure | Char | ISO 8601 datetime or interval | Record Qualifier | First date/time of exposure to any protocol-specified product exposure, equal to the earliest value of EXSTDTC. Note: Absolute first. | Perm | DM | RFXSTDTC | 7 | SEND Special-Purpose | |
| RFXENDTC | Date/Time of Last Study Exposure | Char | ISO 8601 datetime or interval | Record Qualifier | Last date/time of exposure to any protocol-specified product, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing). Note: Absolute last. | Perm | DM | RFXENDTC | 8 | SEND Special-Purpose | |
| SITEID | Study Site Identifier | Char | Record Qualifier | Unique identifier for a study site within a submission. Use only if subjects are housed at different sites. | Perm | DM | SITEID | 9 | SEND Special-Purpose | ||
| BRTHDTC | Date/Time of Birth | Char | ISO 8601 datetime or interval | Record Qualifier | Date/Time of birth of the subject, in ISO 8601 format. | Perm | DM | BRTHDTC | 10 | SEND Special-Purpose | |
| AGE | Age | Num | Record Qualifier | May be derived (RFSTDTC - BRTHDTC), but BRTHDTC may not be available in all cases. Age may also be collected. | Perm | DM | AGE | 11 | SEND Special-Purpose | ||
| AGETXT | Age Range | Char | number-number | Record Qualifier | Used when the age is a range and the exact birthdate is not known. This variable is a character field for the purposes of defining age ranges, e.g., if the information available for the age of the subject is 6-8 and AGEU is WEEKS. Populate only when BRTHDTC or AGE is not specified. The format for AGETXT is "number-number" (e.g., 6-8). | Perm | DM | AGETXT | 12 | SEND Special-Purpose | |
| AGEU | Age Unit | Char | (AGEU) | Variable Qualifier | Units associated with AGE and AGETXT. | Exp | DM | AGEU | 13 | SEND Special-Purpose | |
| SEX | Sex | Char | (SEX) | Record Qualifier | The sex of the subject. | Req | DM | SEX | 14 | SEND Special-Purpose | |
| SPECIES | Species | Char | (SPECIES) | Record Qualifier | If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). | Perm | DM | SPECIES | 15 | SEND Special-Purpose | |
| STRAIN | Strain/Substrain | Char | (STRAIN) | Record Qualifier | Used to identify the vendor-supplied strain, substrain, or breed designation for the test system under study. It may combine the background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, and CHIMPANZEE). The SEND Controlled Terminology codelist consists of commonly used wild type strains. It is extensible to accommodate strains not listed and genetically modified substrains. If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). Country of origin for non-human primates should not go into STRAIN. In general, details related to coat color (e.g., White and Red designations for New Zealand Rabbits) should not go into STRAIN. | Perm | DM | STRAIN | 16 | SEND Special-Purpose | |
| SBSTRAIN | Strain/Substrain Details | Char | Record Qualifier | Free-text field that allows the to enter further details qualifiying the SPECIES and/or STRAIN, depending on the level to which these variables were defined. Examples include the description of a specific genetic alteration, country of origin for non-human primates, details related to coat color (e.g., White and Red designations for New Zealand Rabbits), and important animal husbandry information (e.g., SPF, BR, VAF). | Perm | DM | SBSTRAIN | 17 | SEND Special-Purpose | ||
| ARMCD | Planned Arm Code | Char | Record Qualifier | Short name for ARM (may be up to 20 characters) used for sorting and programming. Should be populated when Arms have been defined in the TA domain. | Exp | DM | ARMCD | 18 | SEND Special-Purpose | ||
| ARM | Description of Planned Arm | Char | Synonym Qualifier | Descriptive name given to a specific Trial Arm to which the subject was assigned. | Perm | DM | ARM | 19 | SEND Special-Purpose | ||
| SETCD | Set Code | Char | Record Qualifier | Short name of a specific Trial Set to which the subject was assigned, as defined by the applicant. Maximum of 8 characters. This represents the Trial Set for which parameters are being submitted. | Req | DM | SETCD | 20 | SEND Special-Purpose | ||
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | SE | STUDYID | 1 | SEND Special-Purpose | ||
| DOMAIN | Domain Abbreviation | Char | SE | Identifier | Two-character abbreviation for the domain. | Req | SE | DOMAIN | 2 | SEND Special-Purpose | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | SE | USUBJID | 3 | SEND Special-Purpose | ||
| SESEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a USUBJID within a domain. May be any valid number. | Req | SE | SEQ | 4 | SEND Special-Purpose | SE | |
| ETCD | Element Code | Char | Topic | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. | Req | SE | ETCD | 5 | SEND Special-Purpose | ||
| ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the Element.. | Perm | SE | ELEMENT | 6 | SEND Special-Purpose | ||
| SESTDTC | Start Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | Start date/time for an Element for each subject, in ISO 8601 format. | Req | SE | STDTC | 7 | SEND Special-Purpose | SE |
| SEENDTC | End Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | End date/time for an Element for each subject, in ISO 8601 format. | Exp | SE | ENDTC | 8 | SEND Special-Purpose | SE |
| SEUPDES | Description of Unplanned Element | Char | Synonym Qualifier | Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of UNPLAN. | Perm | SE | UPDES | 9 | SEND Special-Purpose | SE | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | EX | STUDYID | 1 | SEND Interventions | ||
| DOMAIN | Domain Abbreviation | Char | EX | Identifier | Two-character abbreviation for the domain. | Req | EX | DOMAIN | 2 | SEND Interventions | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | EX | USUBJID | 3 | SEND Interventions | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | EX | POOLID | 4 | SEND Interventions | ||
| FOCID | Focus of Study-Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol for which a measurement, test, or examination was performed, such as a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | EX | FOCID | 5 | SEND Interventions | ||
| EXSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | EX | SEQ | 6 | SEND Interventions | EX | |
| EXTRT | Name of Actual Product | Char | Topic | Name of the product, as defined by the protocol. | Req | EX | TRT | 7 | SEND Interventions | EX | |
| EXDOSE | Dose per Administration | Num | Record Qualifier | Amount of product administered. | Exp | EX | DOSE | 8 | SEND Interventions | EX | |
| EXDOSTXT | Dose Description | Char | Record Qualifier | If the amount of product administered cannot be represented as a number and populated in EXDOSE, this field is used to describe the amount of product administered. Example: 200-400. | Perm | EX | DOSTXT | 9 | SEND Interventions | EX | |
| EXDOSU | Dose Units | Char | (UNIT) | Variable Qualifier | Units for EXDOSE or EXDOSTXT. Examples: ng, mg, or mg/kg. | Exp | EX | DOSU | 10 | SEND Interventions | EX |
| EXDOSFRM | Dose Form | Char | (FRM) | Variable Qualifier | Dose form for product (form administered). Examples: TABLET, LOTION. | Exp | EX | DOSFRM | 11 | SEND Interventions | EX |
| EXDOSFRQ | Dosing Frequency Per Interval | Char | (FREQ) | Variable Qualifier | Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: QD (once daily), BID (2x daily). | Req | EX | DOSFRQ | 12 | SEND Interventions | EX |
| EXROUTE | Route of Administration | Char | (ROUTE) | Variable Qualifier | Route of administration for EXTRT. Examples: ORAL GAVAGE, DERMAL, INTRAVENOUS. | Req | EX | ROUTE | 13 | SEND Interventions | EX |
| EXLOT | Lot Number | Char | Record Qualifier | Lot Number(s) or Batch Number(s) of the EXTRT test article. If mixed lots of the test article are administered during the same constant dosing interval, this should be represented as "Lot A;Lot B." Mixed lots are produced by the mixing of Lots a and B of the test article into one solution, suspension, or dietary food concentration. If no test article was administered, EXLOT should be null. | Exp | EX | LOT | 14 | SEND Interventions | EX | |
| EXLOC | Location of Dose Administration | Char | Record Qualifier | Specifies anatomical location (site) of administration. Example: LEFT HINDLIMB for a topical application or an injection site number. Each administration will require its own record. | Perm | EX | LOC | 15 | SEND Interventions | EX | |
| EXMETHOD | Method of Administration | Char | Record Qualifier | Method of the dose administration. Example: INFUSION. | Perm | EX | METHOD | 16 | SEND Interventions | EX | |
| EXTRTV | Product Vehicle | Char | Record Qualifier | Describes vehicle used for exposure. Example: SALINE. | Exp | EX | TRTV | 17 | SEND Interventions | EX | |
| EXVAMT | Amount Administered | Num | Record Qualifier | The amount (volume or weight) of the product plus vehicle administered in a single dose. This is not to be confused with EXDOSE. EXDOSE refers to the amount of test material administered to the subject. | Perm | EX | VAMT | 18 | SEND Interventions | EX | |
| EXVAMTU | Amount Administered Units | Char | (UNIT) | Variable Qualifier | Units for EXVAMT (per dose administration). | Perm | EX | VAMTU | 19 | SEND Interventions | EX |
| EXADJ | Reason for Dose Adjustment | Char | Record Qualifier | Describes reason or explanation of why a dose is adjusted - used only when an adjustment is represented in EX. May be used for variations from protocol-specified doses or changes from expected doses (e.g., when dose is adjusted due to toxicity). | Perm | EX | ADJ | 20 | SEND Interventions | EX | |
| EXSTDTC | Start Date/Time of Exposure | Char | ISO 8601 datetime or interval | Timing | Date/Time when administration of the product indicated by EXTRT and EXDOSE began, in ISO 8601 format. | Exp | EX | STDTC | 21 | SEND Interventions | EX |
| EXENDTC | End Date/Time of Exposure | Char | ISO 8601 datetime or interval | Timing | Date/Time when administration of the product indicated by EXTRT and EXDOSE ended, in ISO 8601 format. | Perm | EX | ENDTC | 22 | SEND Interventions | EX |
| EXSTDY | Study Day of Start of Exposure | Num | Timing | Study day when administration of the product began, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | EX | STDY | 23 | SEND Interventions | EX | |
| EXENDY | Study Day of End of Exposure | Num | Timing | Study day when administration of the product ended, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | EX | ENDY | 24 | SEND Interventions | EX | |
| EXDUR | Duration of Exposure | Char | ISO 8601 duration | Timing | Duration and unit of time for a continuous exposure. This may be used to denote the length of an infusion (e.g., PT10M to indicate 10 minutes). | Perm | EX | DUR | 25 | SEND Interventions | EX |
| EXTPT | Planned Time Point Name | Char | Timing | Text description of time when a dose should be given. Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EXTPTNUM and EXTPTREF. | Perm | EX | TPT | 26 | SEND Interventions | EX | |
| EXTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EXTPT to aid in sorting. | Perm | EX | TPTNUM | 27 | SEND Interventions | EX | |
| EXELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601 format) relative to the planned fixed reference (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- PT15M" to represent the period of 15 minutes prior to the reference point indicated by EXTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by EXTPTREF. | Perm | EX | ELTM | 28 | SEND Interventions | EX |
| EXTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EXELTM, if used for EXTPTNUM, and EXTPT. It is recommended that EXTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: Previous dose, previous feed. | Perm | EX | TPTREF | 29 | SEND Interventions | EX | |
| EXRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, EXTPTREF. | Perm | EX | RFTDTC | 30 | SEND Interventions | EX |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DS | STUDYID | 1 | SEND Events | ||
| DOMAIN | Domain Abbreviation | Char | DS | Identifier | Two-character abbreviation for the domain. | Req | DS | DOMAIN | 2 | SEND Events | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | DS | USUBJID | 3 | SEND Events | ||
| DSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | DS | SEQ | 4 | SEND Events | DS | |
| DSTERM | Reported Term for the Disposition Event | Char | Topic | DSTERM is the original term recorded for subject disposition. DSTERM is not under controlled terminology, but should be mapped to DSDECOD. | Req | DS | TERM | 5 | SEND Events | DS | |
| DSDECOD | Standardized Disposition Term | Char | (DSDECOD) | Synonym Qualifier | Contains the result in a standard format. | Req | DS | DECOD | 6 | SEND Events | DS |
| DSUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the subject's disposition was unscheduled. If the subject's disposition was based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Exp | DS | USCHFL | 7 | SEND Events | DS |
| VISITDY | Planned Study Day of Disposition | Num | Timing | Planned study day of collection. Should be an integer. VISITDY should be populated only when DSTERM represents a scheduled activity. | Perm | DS | VISITDY | 8 | SEND Events | ||
| DSSTDTC | Date/Time of Disposition | Char | ISO 8601 datetime or interval | Timing | Date/Time of the disposition event, in ISO 8601 format. | Req | DS | STDTC | 9 | SEND Events | DS |
| DSSTDY | Study Day of Disposition | Num | Timing | Study day of the disposition event, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | DS | STDY | 10 | SEND Events | DS | |
| DSNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | DS | NOMDY | 11 | SEND Events | DS | |
| DSNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac. | Perm | DS | NOMLBL | 12 | SEND Events | DS | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | BW | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | BW | Identifier | Two-character abbreviation for the domain. | Req | BW | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | BW | USUBJID | 3 | SEND Findings | ||
| BWSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | BW | SEQ | 4 | SEND Findings | BW | |
| BWTESTCD | Test Short Name | Char | (BWTESTCD) | Topic | Short name of the measurement, test, or examination described in BWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in BWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). BWTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | BW | TESTCD | 5 | SEND Findings | BW |
| BWTEST | Test Name | Char | (BWTEST) | Synonym Qualifier | Long name for BWTESTCD. The value in BWTEST cannot be longer than 40 characters. | Req | BW | TEST | 6 | SEND Findings | BW |
| BWORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | BW | ORRES | 7 | SEND Findings | BW | |
| BWORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | BW | ORRESU | 8 | SEND Findings | BW |
| BWSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from BWORRES in a standard format or standard units. BWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in BWSTRESN. | Exp | BW | STRESC | 9 | SEND Findings | BW | |
| BWSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of BWSTRESC. BWSTRESN should store all numeric test results or findings. | Exp | BW | STRESN | 10 | SEND Findings | BW | |
| BWSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for BWSTRESC and BWSTRESN. | Exp | BW | STRESU | 11 | SEND Findings | BW |
| BWSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in BWORRES. | Perm | BW | STAT | 12 | SEND Findings | BW |
| BWREASND | Reason Not Done | Char | Record Qualifier | Describes why BWSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT. | Perm | BW | REASND | 13 | SEND Findings | BW | |
| BWBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp | BW | BLFL | 14 | SEND Findings | BW |
| BWFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. The value should by Y or null. | Perm | BW | FAST | 15 | SEND Findings | BW |
| BWEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | BW | EXCLFL | 16 | SEND Findings | BW |
| BWREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when BWEXCLFL is Y. | Perm | BW | REASEX | 17 | SEND Findings | BW | |
| BWUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | BW | USCHFL | 18 | SEND Findings | BW |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | BW | VISITDY | 19 | SEND Findings | ||
| BWDTC | Date/Time Animal Weighed | Char | ISO 8601 datetime or interval | Timing | Date/Time of body weight collection in ISO 8601 format. | Exp | BW | DTC | 20 | SEND Findings | BW |
| BWDY | Study Day Animal Weighed | Num | Timing | Study day of body weight collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | BW | DY | 21 | SEND Findings | BW | |
| BWNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | BW | NOMDY | 22 | SEND Findings | BW | |
| BWNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of BWNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac". | Perm | BW | NOMLBL | 23 | SEND Findings | BW | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | CL | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | CL | Identifier | Two-character abbreviation for the domain. | Req | CL | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | CL | USUBJID | 3 | SEND Findings | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | CL | POOLID | 4 | SEND Findings | ||
| FOCID | Focus of Study-Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol, for which a measurement, test, or examination was performed. An example could be a drug application site, e.g. "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | CL | FOCID | 5 | SEND Findings | ||
| CLSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | CL | SEQ | 6 | SEND Findings | CL | |
| CLGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the product exposure group number. | Perm | CL | GRPID | 7 | SEND Findings | CL | |
| CLSPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase and assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Perm | CL | SPID | 8 | SEND Findings | CL | |
| CLTESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in CLTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CLTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CLTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | CL | TESTCD | 9 | SEND Findings | CL | |
| CLTEST | Test Name | Char | Synonym Qualifier | Long name for CLTESTCD. The value in CLTEST cannot be longer than 40 characters. | Req | CL | TEST | 10 | SEND Findings | CL | |
| CLCAT | Category for Clinical Observations | Char | (CLCAT) | Grouping Qualifier | Used to define a category of the clinical observation. | Req | CL | CAT | 11 | SEND Findings | CL |
| CLSCAT | Subcategory for Clinical Observations | Char | Grouping Qualifier | Used to further categorize a group of clinical observations within a category. For example "Whole Body Appearance" and "Sensory Organ Appearance" may be subcategories within Clinical Signs. | Perm | CL | SCAT | 12 | SEND Findings | CL | |
| CLBODSYS | Body System or Organ Class | Char | (BODSYS) | Record Qualifier | Body system or organ class associated with the measurement performed. | Perm | CL | BODSYS | 13 | SEND Findings | CL |
| CLORRES | Result or Findings as Collected | Char | Result Qualifier | Text description of the finding as originally received or collected. If the examination was not performed on a particular body system, or at the subject level, then the value should be null, and NOT DONE should appear in CLSTAT. | Exp | CL | ORRES | 14 | SEND Findings | CL | |
| CLSTRESC | Standardized Result in Character Format | Char | Result Qualifier | The base finding from CLORRES without modifiers. If the examination was completed and there were no abnormal findings, the value must be NORMAL. | Exp | CL | STRESC | 15 | SEND Findings | CL | |
| CLRESCAT | Result Category | Char | Variable Qualifier | Used to categorize the result of a finding post collection. Examples: Color or Facial. | Perm | CL | RESCAT | 16 | SEND Findings | CL | |
| CLSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate examination not done or result is missing. Should be null if a result exists in CLORRES. | Perm | CL | STAT | 17 | SEND Findings | CL |
| CLREASND | Reason Not Done | Char | Record Qualifier | Describes why CLSTAT is NOT DONE, such as SUBJECT MORIBUND. | Perm | CL | REASND | 18 | SEND Findings | CL | |
| CLLOC | Location of a Finding | Char | Record Qualifier | Can be used to specify where a clinical sign occurred. Example: LEFT EAR for skin rash. | Exp | CL | LOC | 19 | SEND Findings | CL | |
| CLEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Example: TOX TECHNICIAN, OPHTHALMOLOGIST, VETERINARIAN. | Perm | CL | EVAL | 20 | SEND Findings | CL | |
| CLSEV | Severity | Char | Record Qualifier | Describes the severity or intensity of a particular finding. | Perm | CL | SEV | 21 | SEND Findings | CL | |
| CLEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | CL | EXCLFL | 22 | SEND Findings | CL |
| CLREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when CLEXCLFL is Y. | Perm | CL | REASEX | 23 | SEND Findings | CL | |
| CLUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | CL | USCHFL | 24 | SEND Findings | CL |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | CL | VISITDY | 25 | SEND Findings | ||
| CLDTC | Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Date/Time of the clinical observation in ISO 8601 format. For measurements related to a continuous evaluation interval, CLDTC should be used to indicate the start date/time of that interval. | Exp | CL | DTC | 26 | SEND Findings | CL |
| CLENDTC | End Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Date/Time of end of observation interval, in ISO 8601 format. Should be populated when CLDTC represents the start date/time of a continuous evaluation interval. | Perm | CL | ENDTC | 27 | SEND Findings | CL |
| CLDY | Study Day of Observation | Num | Timing | Study day of observation, in integer days. For measurements related to a continuous evaluation interval, CLDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | CL | DY | 28 | SEND Findings | CL | |
| CLENDY | Study Day of End of Observation | Num | Timing | Study day of the end of observation, in integer days. Can be populated when CLDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | CL | ENDY | 29 | SEND Findings | CL | |
| CLNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | CL | NOMDY | 30 | SEND Findings | CL | |
| CLNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of CLNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac". | Perm | CL | NOMLBL | 31 | SEND Findings | CL | |
| CLTPT | Planned Time Point Name | Char | Timing | Text description of time when an observation should be taken, as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time postdose. | Perm | CL | TPT | 32 | SEND Findings | CL | |
| CLTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of CLTPT to aid in sorting. | Perm | CL | TPTNUM | 33 | SEND Findings | CL | |
| CLELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned Elapsed time (in ISO 8601 format) relative to a planned reference (CLTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- PT15M" to represent the period of 15 minutes prior to the reference point indicated by CLTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by CLTPTREF. | Perm | CL | ELTM | 34 | SEND Findings | CL |
| CLTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by CLELTM, if used for CLTPTNUM, and CLTPT. It is recommended that CLTPTREF be as descriptive as possible, so the reference time point can be inferred without looking at other variables. Examples: PREVIOUS DOSE, PREVIOUS MEAL. | Perm | CL | TPTREF | 35 | SEND Findings | CL | |
| CLRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, CLTPTREF. | Perm | CL | RFTDTC | 36 | SEND Findings | CL |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | CV | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | CV | Identifier | Two-character abbreviation for the domain. | Req | CV | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product. | Req | CV | USUBJID | 3 | SEND Findings | ||
| CVSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | CV | SEQ | 4 | SEND Findings | CV | |
| CVGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject and can be used to support relationships within the domain and between domains using RELREC. This is not the dosing group number. | Perm | CV | GRPID | 5 | SEND Findings | CV | |
| CVSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference identifier. | Perm | CV | SPID | 6 | SEND Findings | CV | |
| CVTESTCD | Test Short Name | Char | (SCVTSTCD) | Topic | Short name of the measurement, test, or examination described in CVTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CVTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CVTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: DIABP, HR, MAP, SYSBP. | Req | CV | TESTCD | 7 | SEND Findings | CV |
| CVTEST | Test Name | Char | (SCVTST) | Synonym Qualifier | Long name for CVTESTCD. The value in CVTEST cannot be longer than 40 characters. Examples: Diastolic Blood Pressure, Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure. | Req | CV | TEST | 8 | SEND Findings | CV |
| CVPOS | Position of Subject During Test | Char | (POSITION) | Record Qualifier | Position of the subject during the measurement or examination. If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp | CV | POS | 9 | SEND Findings | CV |
| CVORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | CV | ORRES | 10 | SEND Findings | CV | |
| CVORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | CV | ORRESU | 11 | SEND Findings | CV |
| CVSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from CVORRES in a standard format or standard units. CVSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in CVSTRESN. | Exp | CV | STRESC | 12 | SEND Findings | CV | |
| CVSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; contains the numeric form of CVSTRESC. CVSTRESN should store all numeric test results or findings. | Exp | CV | STRESN | 13 | SEND Findings | CV | |
| CVSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for CVSTRESC and CVSTRESN. | Exp | CV | STRESU | 14 | SEND Findings | CV |
| CVSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in CVORRES. | Perm | CV | STAT | 15 | SEND Findings | CV |
| CVREASND | Reason Not Done | Char | Record Qualifier | Describes why CVSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | CV | REASND | 16 | SEND Findings | CV | |
| CVMETHOD | Method of Test | Char | Record Qualifier | Method of the test or examination. Examples: Intravascular, External Cuff. | Exp | CV | METHOD | 17 | SEND Findings | CV | |
| CVCSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Exp | CV | CSTATE | 18 | SEND Findings | CV |
| CVBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp | CV | BLFL | 19 | SEND Findings | CV |
| CVDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm | CV | DRVFL | 20 | SEND Findings | CV |
| CVEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | CV | EXCLFL | 21 | SEND Findings | CV |
| CVREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when CVEXCLFL is Y. | Perm | CV | REASEX | 22 | SEND Findings | CV | |
| CVUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | CV | USCHFL | 23 | SEND Findings | CV |
| CVDTC | Date/Time of Cardiovascular Test | Char | ISO 8601 datetime or interval | Timing | Date/Time of cardiovascular data collection, in ISO 8601 format. For measurements related to a continuous evaluation interval, CVDTC should be used to indicate the start date/time of that interval. | Exp | CV | DTC | 24 | SEND Findings | CV |
| CVENDTC | End Date/Time of Cardiovascular Test | Char | ISO 8601 datetime or interval | Timing | Date/Time of end of a cardiovascular evaluation interval, in ISO 8601 format. Should be populated when CVDTC represents the start date/time of a continuous evaluation interval. | Perm | CV | ENDTC | 25 | SEND Findings | CV |
| CVDY | Study Day of Cardiovascular Test | Num | Timing | Study day of cardiovascular data collection, in integer days. For measurements related to a continuous evaluation interval, CVDY can be used to indicate start day of that interval. The algorithm for calculating the day must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | CV | DY | 26 | SEND Findings | CV | |
| CVENDY | Study Day of End of Cardiovascular Test | Num | Timing | Study day of the end of a cardiovascular evaluation interval, in integer days. Can be populated when CVDY represents the start day of a continuous evaluation interval. The algorithm for calculating the day must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | CV | ENDY | 27 | SEND Findings | CV | |
| CVNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | CV | NOMDY | 28 | SEND Findings | CV | |
| CVNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of CVNOMDY as presented in the study report Examples: Pretreatment, Week 4, Day 28. | Perm | CV | NOMLBL | 29 | SEND Findings | CV | |
| CVTPT | Planned Time Point Name | Char | Timing | Text description of time when data should be collected. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See CVTPTNUM and CVTPTREF. Examples: Predose, 1 Hour Postdose. | Exp | CV | TPT | 30 | SEND Findings | CV | |
| CVTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of CVTPT to aid in sorting. | Exp | CV | TPTNUM | 31 | SEND Findings | CV | |
| CVELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (CVTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by CVTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by CVTPTREF. | Exp | CV | ELTM | 32 | SEND Findings | CV |
| CVTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by CVELTM, if used for CVTPTNUM, and CVTPT. It is recommended that CVTPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Exp | CV | TPTREF | 33 | SEND Findings | CV | |
| CVRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, CVTPTREF. | Perm | CV | RFTDTC | 34 | SEND Findings | CV |
| CVEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of CVSTINT and CVENINT when CVTPTREF is not available. | Perm | CV | EVLINT | 35 | SEND Findings | CV |
| CVSTINT | Planned Start of Assessment Interval | Char | ISO 8601 duration | Timing | Planned start of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT1H. | Exp | CV | STINT | 36 | SEND Findings | CV |
| CVENINT | Planned End of Assessment Interval | Char | ISO 8601 duration | Timing | Planned end of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT2H. | Exp | CV | ENINT | 37 | SEND Findings | CV |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DD | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | DD | Identifier | Two-character abbreviation for the domain. | Req | DD | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | DD | USUBJID | 3 | SEND Findings | ||
| DDSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | DD | SEQ | 4 | SEND Findings | DD | |
| DDTESTCD | Death Diagnosis Short Name | Char | (DDTESTCD) | Topic | Short name of the measurement, test, or examination described in DDTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DDTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). DDTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | DD | TESTCD | 5 | SEND Findings | DD |
| DDTEST | Death Diagnosis Name | Char | (DDTEST) | Synonym Qualifier | Long name for DDTESTCD. The value in DDTEST cannot be longer than 40 characters. | Req | DD | TEST | 6 | SEND Findings | DD |
| DDORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the diagnosis of the subject's cause of death, as originally received or collected. | Req | DD | ORRES | 7 | SEND Findings | DD | |
| DDSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the diagnosis information, copied or derived from DDORRES in a standard format. Examples: UNKNOWN, GAVAGE ERROR. | Exp | DD | STRESC | 8 | SEND Findings | DD | |
| DDRESCAT | Result Category | Char | Variable Qualifier | Used to categorize the result of a finding. Examples: EXPOSURE RELATED, NON-EXPOSURE RELATED, UNDETERMINED, ACCIDENTAL, etc. | Perm | DD | RESCAT | 9 | SEND Findings | DD | |
| DDEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, VETERINARIAN. | Perm | DD | EVAL | 10 | SEND Findings | DD | |
| DDDTC | Date/Time | Char | ISO 8601 datetime or interval | Timing | The date/time of subject disposition, in ISO 8601 format. | Perm | DD | DTC | 11 | SEND Findings | DD |
| DDDY | Study Day | Num | Timing | Study day of subject disposition, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | DD | DY | 12 | SEND Findings | DD | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DU | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | DU | Identifier | Two-character abbreviation for the domain. | Req | DU | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. \n Expected in this domain as devices may have settings or uses that either may not involve subjects (e.g., diagnostic tools) or devices that are removed from the study prior to contact with a subject (e.g., device has malfunction). | Exp | DU | USUBJID | 3 | SEND Findings | ||
| SPDEVID | Applicant Device Identifier | Char | Identifier | Applicant-defined identifier for the device. The value of SPDEVID may be linked to a nonclinical trial set by a matching value of the parameter APDEVID in the TX dataset. \n It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, or combination of identifiers). | Exp | DU | SPDEVID | 4 | SEND Findings | ||
| DUSEQ | Sequence Number | Num | Identifier | Sequence Number given to ensure uniqueness of device records within subject records within a domain. \n May be any valid number. It should be unique within every subject/device combination. | Req | DU | SEQ | 5 | SEND Findings | DU | |
| DUGRPID | Group ID | Char | Identifier | Identifier for a group or block of related records. \n Used to tie together a block of related records in a single domain for a subject or a group of subject related records (e.g., group records specifying all the settings for a specific imaging scan, such as field strength, repetition time and echo time). | Perm | DU | GRPID | 6 | SEND Findings | DU | |
| DUREFID | Reference ID | Char | Identifier | Internal or external identifier. This could be a scan code or equivalent. \n The value of DUREFID may be linked to a nonclinical trial set by a matching value of the parameter SMKRGM. SMKRGM is an identifier used to represent a smoking regimen in the TX dataset and serves as a link to the Device-In-Use (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine. | Perm | DU | REFID | 7 | SEND Findings | DU | |
| DUSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference number. | Perm | DU | SPID | 8 | SEND Findings | DU | |
| DUTESTCD | Device-In-Use Test Short Name | Char | (DUTESTCD) | Topic | Short name of the measurement, test, or examination described in DUTEST. \n It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DUTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). DUTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "COILSTR", "CNTMEDIA". | Req | DU | TESTCD | 9 | SEND Findings | DU |
| DUTEST | Device-In-Use Test Name | Char | (DUTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. \n The value in DUTEST cannot be longer than 40 characters. Examples: "Coil Strength", "Contrast Media". | Req | DU | TEST | 10 | SEND Findings | DU |
| DUCAT | Category for Device-In-Use | Char | Grouping Qualifier | Defines a category of related records. \n It can be used to define the type of device for which settings are recorded if the DI domain is not used (e.g., if the device is not under study); may also be used to record the type of setting (e.g., "HARDWARE" vs. "SOFTWARE"). | Perm | DU | CAT | 11 | SEND Findings | DU | |
| DUSCAT | Subcategory for Device-In-Use | Char | Grouping Qualifier | A further categorization of a measurement or examination. \n For example, if DUCAT = "SOFTWARE", DUSCAT might be "NOMINAL" or "POST-ADJUSTMENT". | Perm | DU | SCAT | 12 | SEND Findings | DU | |
| DUORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the measurement as originally received or collected. \n DUORRES should contain the setting or other device condition in effect at the time the device was used. | Exp | DU | ORRES | 13 | SEND Findings | DU | |
| DUORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. \n The unit for DUORRES. Examples: Tesla, mm. | Exp | DU | ORRESU | 14 | SEND Findings | DU |
| DUSTRESC | Result or Finding in Standard Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from DUORRES in a standard format or standard units. \n DUSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DUSTRESN. For example, if a test has results "NONE," "NEG," and "NEGATIVE" in DUORRES, and these results effectively have the same meaning, they could be represented in standard format in DUSTRESC as "NEGATIVE". | Exp | DU | STRESC | 15 | SEND Findings | DU | |
| DUSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format. \n Copied in numeric format from DUSTRESC. DUSTRESN should store all numeric test results or findings. | Exp | DU | STRESN | 16 | SEND Findings | DU | |
| DUSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for DUSTRESC and DUSTRESN. \n The unit for standardized results may or may not be the same as for the original results. | Exp | DU | STRESU | 17 | SEND Findings | DU |
| VISITNUM | Visit Number | Num | Timing | A clinical encounter number. \n A Numeric version of VISIT, used for sorting. | Exp | DU | VISITNUM | 18 | SEND Findings | ||
| VISIT | Visit Name | Char | Timing | Protocol-defined description of clinical encounter. \n May be used in addition to VISITNUM and/or VISITDY. | Perm | DU | VISIT | 19 | SEND Findings | ||
| VISITDY | Planned Study Day of Visit | Num | Timing | Planned study day of the visit based upon RFSTDTC in Demographics. \n This value is usually derived. | Perm | DU | VISITDY | 20 | SEND Findings | ||
| DUDTC | Date/Time Device Used with Test/Setting | Char | ISO 8601 datetime or interval | Timing | Date/time that the device was used with this setting. \n This is not the date/time that the setting was set on the device, but rather that date/time that a measurement or test was done using that setting. | Exp | DU | DTC | 21 | SEND Findings | DU |
| DUDY | Study Day of Observation | Num | Timing | Study day of Device-In-Use measurement, measured as integer days. \n Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm | DU | DY | 22 | SEND Findings | DU | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | EG | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | EG | Identifier | Two-character abbreviation for the domain. | Req | EG | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | EG | USUBJID | 3 | SEND Findings | ||
| EGSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | EG | SEQ | 4 | SEND Findings | EG | |
| EGGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number. | Perm | EG | GRPID | 5 | SEND Findings | EG | |
| EGREFID | ECG Reference Identifier | Char | Identifier | Internal or external ECG identifier. Example: UUID. | Perm | EG | REFID | 6 | SEND Findings | EG | |
| EGSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference identifier. | Perm | EG | SPID | 7 | SEND Findings | EG | |
| EGTESTCD | ECG Test Short Name | Char | (EGTESTCD) | Topic | Short name of the measurement, test, or examination described in EGTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in EGTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). EGTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: EGHRMN, QTMAX. | Req | EG | TESTCD | 8 | SEND Findings | EG |
| EGTEST | ECG Test Name | Char | (EGTEST) | Synonym Qualifier | Long name for EGTESTCD. The value in EGTEST cannot be longer than 40 characters. Examples: ECG Mean Heart Rate, Summary (Max) QT Duration. | Req | EG | TEST | 9 | SEND Findings | EG |
| EGCAT | Category for ECG | Char | (EGCATSND) | Grouping Qualifier | Used to define a category of the ECG test performed. Examples: MEASUREMENT, DIAGNOSIS, INTERPRETATION. | Perm | EG | CAT | 10 | SEND Findings | EG |
| EGPOS | ECG Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp | EG | POS | 11 | SEND Findings | EG |
| EGORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the ECG measurement or finding as originally received or collected. | Exp | EG | ORRES | 12 | SEND Findings | EG | |
| EGORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | EG | ORRESU | 13 | SEND Findings | EG |
| EGSTRESC | Standardized Result in Character Format | Char | (EGSTRESC) | Result Qualifier | Contains the result value for all findings, copied or derived from EGORRES, in a standard format or standard units. EGSTRESC should store all results or findings in character format, using controlled terminology, where possible. If results are numeric, they should also be stored in numeric format in EGSTRESN. | Exp | EG | STRESC | 14 | SEND Findings | EG |
| EGSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of EGSTRESC. EGSTRESN should store all numeric test results or findings. | Exp | EG | STRESN | 15 | SEND Findings | EG | |
| EGSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for EGSTRESC and EGSTRESN. | Exp | EG | STRESU | 16 | SEND Findings | EG |
| EGSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in EGORRES. | Perm | EG | STAT | 17 | SEND Findings | EG |
| EGREASND | Reason Not Done | Char | Record Qualifier | Describes why EGSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | EG | REASND | 18 | SEND Findings | EG | |
| EGXFN | ECG External File Name | Char | Record Qualifier | File name and path for the external ECG Waveform file. Would be used if applicant is requested to submit waveform. | Perm | EG | XFN | 19 | SEND Findings | EG | |
| EGNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | EG | NAM | 20 | SEND Findings | EG | |
| EGMETHOD | Method of ECG Test | Char | (EGMETHOD) | Record Qualifier | Method of the test or examination. Examples: 12 LEAD STANDARD, 6 LEAD STANDARD. | Exp | EG | METHOD | 21 | SEND Findings | EG |
| EGLEAD | Lead Used for Measurement | Char | (EGLEAD) | Record Qualifier | Lead identified to capture the measurement. | Exp | EG | LEAD | 22 | SEND Findings | EG |
| EGCSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Exp | EG | CSTATE | 23 | SEND Findings | EG |
| EGBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp | EG | BLFL | 24 | SEND Findings | EG |
| EGDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. Records that represent the average of other records, or that are not as originally received or collected, are examples of records that might be derived for the submission datasets. | Perm | EG | DRVFL | 25 | SEND Findings | EG |
| EGEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Should be null for records that contain collected or derived data. Examples: RESPONSIBLE SCIENTIST, PRINCIPAL INVESTIGATOR, PEER REVIEWER. | Perm | EG | EVAL | 26 | SEND Findings | EG | |
| EGEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | EG | EXCLFL | 27 | SEND Findings | EG |
| EGREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when EGEXCLFL is Y. | Perm | EG | REASEX | 28 | SEND Findings | EG | |
| EGUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | EG | USCHFL | 29 | SEND Findings | EG |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | EG | VISITDY | 30 | SEND Findings | ||
| EGDTC | Date/Time of ECG Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of ECG data collection, in ISO 8601 format. For indicating measurement over a continuous period, DTC should be used to indicate start date/time of collection. | Exp | EG | DTC | 31 | SEND Findings | EG |
| EGENDTC | End Date/Time of ECG Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of end of the ECG data collection, in ISO 8601 format. Should be populated for measurement over a continuous period only. | Perm | EG | ENDTC | 32 | SEND Findings | EG |
| EGDY | Study Day of ECG Collection | Num | Timing | Study day of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | EG | DY | 33 | SEND Findings | EG | |
| EGENDY | Study Day of End of ECG Collection | Num | Timing | Study day of the end of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | EG | ENDY | 34 | SEND Findings | EG | |
| EGNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | EG | NOMDY | 35 | SEND Findings | EG | |
| EGNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of EGNOMDY as presented in the study report. Examples: Pre-Exposure, Week 4, Day 28. | Perm | EG | NOMLBL | 36 | SEND Findings | EG | |
| EGTPT | Planned Time Point Name | Char | Timing | Text description of time when ECG data should be collected. Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EGTPTNUM and EGTPTREF. Examples: Predose, 1 Hour Postdose. | Perm | EG | TPT | 37 | SEND Findings | EG | |
| EGTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EGTPT to aid in sorting. | Perm | EG | TPTNUM | 38 | SEND Findings | EG | |
| EGELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (EGTPTREF). This variable is useful where there are repetitive measures. Not a clock-time or a date-time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by EGTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by EGTPTREF. | Perm | EG | ELTM | 39 | SEND Findings | EG |
| EGTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EGELTM, if used for EGTPTNUM, and EGTPT. It is recommended that EGTPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Perm | EG | TPTREF | 40 | SEND Findings | EG | |
| EGRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, EGTPTREF. | Perm | EG | RFTDTC | 41 | SEND Findings | EG |
| EGEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of EGSTINT and EGENINT when EGTPTREF is not available. | Perm | EG | EVLINT | 42 | SEND Findings | EG |
| EGSTINT | Planned Start of Assessment Interval | Char | ISO 8601 duration | Timing | Planned Start of an asessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | Perm | EG | STINT | 43 | SEND Findings | EG |
| EGENINT | Planned End of Assessment Interval | Char | ISO 8601 duration | Timing | Planned End of an assessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | Perm | EG | ENINT | 44 | SEND Findings | EG |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | FW | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | FW | Identifier | Two-character abbreviation for the domain. | Req | FW | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | FW | USUBJID | 3 | SEND Findings | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | FW | POOLID | 4 | SEND Findings | ||
| FWSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | FW | SEQ | 5 | SEND Findings | FW | |
| FWGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the dosing group number. | Perm | FW | GRPID | 6 | SEND Findings | FW | |
| FWTESTCD | Food/Water Consumption Short Name | Char | (FWTESTCD) | Topic | Short name of the measurement, test, or examination described in FWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). FWTESTCD cannot contain characters other than letters, numbers, or underscores. Extensible controlled values are FC, FCRELBW, WC, and WCRELBW. | Req | FW | TESTCD | 7 | SEND Findings | FW |
| FWTEST | Food/Water Consumption Name | Char | (FWTEST) | Synonym Qualifier | Long name for FWTESTCD. The value in FWTEST cannot be longer than 40 characters. Extensible controlled values are Food Consumption, Food Consumption Relative to Body Wt, Water Consumption, Water Consumption Relative to Body Wt. | Req | FW | TEST | 8 | SEND Findings | FW |
| FWORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | FW | ORRES | 9 | SEND Findings | FW | |
| FWORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | FW | ORRESU | 10 | SEND Findings | FW |
| FWSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from FWORRES, in a standard format or standard units. FWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in FWSTRESN. | Exp | FW | STRESC | 11 | SEND Findings | FW | |
| FWSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of FWSTRESC. FWSTRESN should store all numeric test results or findings. | Exp | FW | STRESN | 12 | SEND Findings | FW | |
| FWSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for FWSTRESC and FWSTRESN. | Exp | FW | STRESU | 13 | SEND Findings | FW |
| FWSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in FWORRES. | Perm | FW | STAT | 14 | SEND Findings | FW |
| FWREASND | Reason Not Done | Char | Record Qualifier | Describes why FWSTAT is NOT DONE, such as FOOD WET. | Perm | FW | REASND | 15 | SEND Findings | FW | |
| FWEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | FW | EXCLFL | 16 | SEND Findings | FW |
| FWREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when FWEXCLFL is Y. | Perm | FW | REASEX | 17 | SEND Findings | FW | |
| FWDTC | Start Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Date/Time of the start of the observation in IS0 8601 format. | Exp | FW | DTC | 18 | SEND Findings | FW |
| FWENDTC | End Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Date/Time of the end of the observation in IS0 8601 format. | Exp | FW | ENDTC | 19 | SEND Findings | FW |
| FWDY | Study Day of Start of Observation | Num | Timing | Study day of the start of the observation, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | FW | DY | 20 | SEND Findings | FW | |
| FWENDY | Study Day of End of Observation | Num | Timing | Study day of the end of the observation, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | FW | ENDY | 21 | SEND Findings | FW | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | GT | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | GT | Identifier | Two-character abbreviation for the domain. | Req | GT | DOMAIN | 2 | SEND Findings | |
| GTSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a domain. \n Sequence number given to ensure uniqueness of records within a domain. May be any valid number. | Req | GT | SEQ | 3 | SEND Findings | GT | |
| GTREFID | Reference ID | Char | Identifier | A sequence of characters used to uniquely identify a source of information (e.g., lab specimen, petri dish, flask, well, group of petri dishes, group of flasks, an entire assay). | Req | GT | REFID | 4 | SEND Findings | GT | |
| GTTESTCD | Lab Test or Examination Short Name | Char | (GTTESTCD) | Topic | Short name of the measurement, test, or examination described in GTTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in GTTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). GTTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: RVERT, CYTOTOX. | Req | GT | TESTCD | 5 | SEND Findings | GT |
| GTTEST | Lab Test or Examination Name | Char | (GTTEST) | Synonym Qualifier | Long name for GTTESTCD. The value in GTTEST cannot be longer than 40 characters. Examples: Revertants, Cytotoxicity. | Req | GT | TEST | 6 | SEND Findings | GT |
| GTORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | GT | ORRES | 7 | SEND Findings | GT | |
| GTORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | GT | ORRESU | 8 | SEND Findings | GT |
| GTCELLEV | Number of Cells Evaluated | Num | Result Qualifier | The number of cells evaluated. | Perm | GT | CELLEV | 9 | SEND Findings | GT | |
| GTCOLSRT | Collected Summary Result Type | Char | (COLSTYP) | Variable Qualifier | Used to indicate the type of collected summary result. For example, MAXIMUM, MINIMUM, and MEAN. | Perm | GT | COLSRT | 10 | SEND Findings | GT |
| GTSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from GTORRES in a standard format or standard units. GTSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in GTSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in GTORRES and these results effectively have the same meaning, they could be represented in standard format in GTSTRESC as NEGATIVE. For other examples, see general assumptions. | Exp | GT | STRESC | 11 | SEND Findings | GT | |
| GTSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of GTSTRESC. GTSTRESN should store all numeric test results or findings. | Exp | GT | STRESN | 12 | SEND Findings | GT | |
| GTSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for GTSTRESC, GTSTRESN, GTSTRLO, and GTSTRHI. | Exp | GT | STRESU | 13 | SEND Findings | GT |
| GTSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in GTORRES. | Perm | GT | STAT | 14 | SEND Findings | GT |
| GTREASND | Reason Not Done | Char | Record Qualifier | Describes why GTSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST. | Perm | GT | REASND | 15 | SEND Findings | GT | |
| GTSPCCND | Specimen Condition | Char | (SPECCOND) | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: PRECIPITATION PRESENT, CONTAMINATED, etc. If multiple conditions are present on a sample, concatenate the values with a semicolon and no spaces as a separator. | Perm | GT | SPCCND | 16 | SEND Findings | GT |
| GTSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be N if the specimen is not usable; otherwise it should be null. | Perm | GT | SPCUFL | 17 | SEND Findings | GT |
| GTMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. Examples: MANUALLY COUNTED, INSTRUMENT COUNTED. | Perm | GT | METHOD | 18 | SEND Findings | GT | |
| GTRUNID | Run ID | Char | Record Qualifier | A sequence of characters used to uniquely identify a particular run of a test on a particular batch of samples. | Perm | GT | RUNID | 19 | SEND Findings | GT | |
| GTEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | GT | EXCLFL | 20 | SEND Findings | GT |
| GTREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when GTEXCLFL is Y. | Perm | GT | REASEX | 21 | SEND Findings | GT | |
| GTDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | The date or date and time of the assessment or the specimen or data collection, represented in a standardized character format. For an Ames test, this is the date the bacterial culture is plated. | Perm | GT | DTC | 22 | SEND Findings | GT |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | LB | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | LB | Identifier | Two-character abbreviation for the domain. | Req | LB | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | LB | USUBJID | 3 | SEND Findings | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | LB | POOLID | 4 | SEND Findings | ||
| LBSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | LB | SEQ | 5 | SEND Findings | LB | |
| LBGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the dosing group number. | Perm | LB | GRPID | 6 | SEND Findings | LB | |
| LBREFID | Specimen Identifier | Char | Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm | LB | REFID | 7 | SEND Findings | LB | |
| LBSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference identifier. Example: Line number on the Lab page. | Perm | LB | SPID | 8 | SEND Findings | LB | |
| LBTESTCD | Lab Test or Examination Short Name | Char | (LBTESTCD) | Topic | Short name of the measurement, test, or examination described in LBTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in LBTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). LBTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: ALT, LDH. | Req | LB | TESTCD | 9 | SEND Findings | LB |
| LBTEST | Lab Test or Examination Name | Char | (LBTEST) | Synonym Qualifier | Long name for LBTESTCD. The value in LBTEST cannot be longer than 40 characters. Examples: Alanine Aminotransferase, Lactate Dehydrogenase. | Req | LB | TEST | 10 | SEND Findings | LB |
| LBCAT | Category for Lab Test | Char | Grouping Qualifier | Used to define a category of the lab test performed. Examples: URINALYSIS, CLINICAL CHEMISTRY, HEMATOLOGY, etc. | Exp | LB | CAT | 11 | SEND Findings | LB | |
| LBSCAT | Subcategory for Lab Test | Char | Grouping Qualifier | A further categorization of a test category. Examples: DIFFERENTIAL, LIVER FUNCTION, ELECTROLYTES. | Perm | LB | SCAT | 12 | SEND Findings | LB | |
| LBORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | LB | ORRES | 13 | SEND Findings | LB | |
| LBORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | LB | ORRESU | 14 | SEND Findings | LB |
| LBORNRLO | Reference Range Lower Limit-Orig Unit | Char | Variable Qualifier | Lower end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results. | Perm | LB | ORNRLO | 15 | SEND Findings | LB | |
| LBORNRHI | Reference Range Upper Limit-Orig Unit | Char | Variable Qualifier | Upper end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results. | Perm | LB | ORNRHI | 16 | SEND Findings | LB | |
| LBSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from LBORRES, in a standard format or standard units. LBSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in LBSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in LBORRES and these results effectively have the same meaning, they could be represented in standard format in LBSTRESC as NEGATIVE. For other examples, see general assumptions. | Exp | LB | STRESC | 17 | SEND Findings | LB | |
| LBSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of LBSTRESC. LBSTRESN should store all numeric test results or findings. | Exp | LB | STRESN | 18 | SEND Findings | LB | |
| LBSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for LBSTRESC and LBSTRESN. | Exp | LB | STRESU | 19 | SEND Findings | LB |
| LBSTNRLO | Reference Range Lower Limit-Std Unit | Num | Variable Qualifier | Lower end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Perm | LB | STNRLO | 20 | SEND Findings | LB | |
| LBSTNRHI | Reference Range Upper Limit-Std Unit | Num | Variable Qualifier | Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Perm | LB | STNRHI | 21 | SEND Findings | LB | |
| LBSTNRC | Reference Range for Char Rslt-Std Unit | Char | Variable Qualifier | For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., -1 to +1; NEGATIVE TO TRACE). | Perm | LB | STNRC | 22 | SEND Findings | LB | |
| LBNRIND | Reference Range Indicator | Char | Variable Qualifier | Indicates where value falls with respect to reference range defined by LBORNRLO and LBORNRHI, LBSTRNRLO and LBSTNRHI, or by LBSTNRC. Examples: NORMAL, ABNORMAL, HIGH, LOW. \n Applicants should specify in the study metadata (Comments column in the data definition file) whether LBNRIND refers to the original or standard reference ranges and results. Should not be used to indicate biological significance. | Perm | LB | NRIND | 23 | SEND Findings | LB | |
| LBSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in LBORRES. | Perm | LB | STAT | 24 | SEND Findings | LB |
| LBREASND | Reason Not Done | Char | Record Qualifier | Describes why LBSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST. | Perm | LB | REASND | 25 | SEND Findings | LB | |
| LBNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | LB | NAM | 26 | SEND Findings | LB | |
| LBSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of specimen analyzed to obtain the measurement or finding. Examples: WHOLE BLOOD, SERUM, PLASMA, URINE, LIVER, HEART. | Exp | LB | SPEC | 27 | SEND Findings | LB |
| LBANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the LBSPEC variable. If the anatomical region is not included in the specimen description LBSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | LB | ANTREG | 28 | SEND Findings | LB | |
| LBSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC. | Perm | LB | SPCCND | 29 | SEND Findings | LB | |
| LBSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be N if the specimen is not usable; otherwise it should be null. | Perm | LB | SPCUFL | 30 | SEND Findings | LB |
| LBLOC | Specimen Collection Location | Char | Record Qualifier | Location relevant to the collection of specimen for the measurement. | Perm | LB | LOC | 31 | SEND Findings | LB | |
| LBLAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | LB | LAT | 32 | SEND Findings | LB |
| LBDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | LB | DIR | 33 | SEND Findings | LB |
| LBPORTOT | Portion or Totality | Char | (PORTOT) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm | LB | PORTOT | 34 | SEND Findings | LB |
| LBMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK. | Exp | LB | METHOD | 35 | SEND Findings | LB | |
| LBBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp | LB | BLFL | 36 | SEND Findings | LB |
| LBFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. The value should be Y or null. | Perm | LB | FAST | 37 | SEND Findings | LB |
| LBDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. Records that represent the average of other records, or are not as originally received or collected are examples of records that might be derived for the submission datasets. | Perm | LB | DRVFL | 38 | SEND Findings | LB |
| LBTOX | Toxicity | Char | Variable Qualifier | Description of toxicity quantified by LBTOXGR. The applicant is expected to provide the name and version of the scale used to map the terms, utilizing the data definition file external codelist attributes. | Perm | LB | TOX | 39 | SEND Findings | LB | |
| LBTOXGR | Standard Toxicity Grade | Char | Record Qualifier | Records toxicity grade value using a standard toxicity scale (such as the NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not "Grade 2"). The applicant is expected to provide the name of the scale and version used to map the terms, utilizing the data definition file external codelist attributes. | Perm | LB | TOXGR | 40 | SEND Findings | LB | |
| LBEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm | LB | EXCLFL | 41 | SEND Findings | LB |
| LBREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when LBEXCLFL is "Y". | Perm | LB | REASEX | 42 | SEND Findings | LB | |
| LBUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the specimen collection was unscheduled. If a specimen collection was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | Exp | LB | USCHFL | 43 | SEND Findings | LB |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of specimen collection. Should be an integer. | Perm | LB | VISITDY | 44 | SEND Findings | ||
| LBDTC | Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of specimen collection, in IS0 8601 format. | Exp | LB | DTC | 45 | SEND Findings | LB |
| LBENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of the end of specimen collection in ISO 8601 format. Should be populated only for continuous sample collection. | Perm | LB | ENDTC | 46 | SEND Findings | LB |
| LBDY | Study Day of Specimen Collection | Num | Timing | Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | LB | DY | 47 | SEND Findings | LB | |
| LBENDY | Study Day of End of Specimen Collection | Num | Timing | Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | LB | ENDY | 48 | SEND Findings | LB | |
| LBNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp | LB | NOMDY | 49 | SEND Findings | LB | |
| LBNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of LBNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac. | Perm | LB | NOMLBL | 50 | SEND Findings | LB | |
| LBTPT | Planned Time Point Name | Char | Timing | Text Description of time when specimen should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See LBTPTNUM and LBTPTREF. Examples: Start, 5 min post. | Perm | LB | TPT | 51 | SEND Findings | LB | |
| LBTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of LBTPT to aid in sorting. | Perm | LB | TPTNUM | 52 | SEND Findings | LB | |
| LBELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Elapsed time (in ISO 8601 format) relative to a planned fixed reference (LBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- P15M" to represent the period of 15 minutes prior to the reference point indicated by LBTPTREF, or "P8H" to represent the period of 8 hours after the reference point indicated by LBTPTREF. | Perm | LB | ELTM | 53 | SEND Findings | LB |
| LBTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by LBELTM, if used for LBTPTNUM, and LBTPT. It is recommended that LBTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: PREVIOUS DOSE, PREVIOUS MEAL. | Perm | LB | TPTREF | 54 | SEND Findings | LB | |
| LBRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, LBTPTREF. | Perm | LB | RFTDTC | 55 | SEND Findings | LB |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | MA | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | MA | Identifier | Two-character code for the domain. | Req | MA | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | MA | USUBJID | 3 | SEND Findings | ||
| FOCID | Focus of Study-Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol, for which a measurement, test, or examination was performed. An example could be a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | MA | FOCID | 4 | SEND Findings | ||
| MASEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | MA | SEQ | 5 | SEND Findings | MA | |
| MAGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number. | Perm | MA | GRPID | 6 | SEND Findings | MA | |
| MAREFID | Specimen Reference Identifier | Char | Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm | MA | REFID | 7 | SEND Findings | MA | |
| MASPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Perm | MA | SPID | 8 | SEND Findings | MA | |
| MATESTCD | Macroscopic Examination Short Name | Char | (MATESTCD) | Topic | Short name of the measurement, test, or examination described in MATEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MATESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MATESTCD cannot contain characters other than letters, numbers, or underscores. | Req | MA | TESTCD | 9 | SEND Findings | MA |
| MATEST | Macroscopic Examination Name | Char | (MATEST) | Synonym Qualifier | Long name for MATESTCD. The value in MATEST cannot be longer than 40 characters. Extensible controlled values are Gross Pathological Examination, Clinical Signs Follow-up. | Req | MA | TEST | 10 | SEND Findings | MA |
| MABODSYS | Body System or Organ Class | Char | (BODSYS) | Record Qualifier | Body system or organ class associated with the specimen examined. | Perm | MA | BODSYS | 11 | SEND Findings | MA |
| MAORRES | Result or Findings as Collected | Char | Result Qualifier | Text description of the findings as originally received or collected, including the base gross pathological observation and any modifiers, such as severity, origin, classification, size, color, etc. | Exp | MA | ORRES | 12 | SEND Findings | MA | |
| MASTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains only the base gross pathological observation (e.g., ENLARGED) from MAORRES, without any modifiers. If the examination was completed and there were no findings, the value must be UNREMARKABLE. | Exp | MA | STRESC | 13 | SEND Findings | MA | |
| MASTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate examination not done or result is missing. Should be null if a result exists in MAORRES. | Perm | MA | STAT | 14 | SEND Findings | MA |
| MAREASND | Reason Not Done | Char | Record Qualifier | Describes why MASTAT is NOT DONE. Example: Tissue not examined, Tissue Autolyzed. | Perm | MA | REASND | 15 | SEND Findings | MA | |
| MANAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | MA | NAM | 16 | SEND Findings | MA | |
| MASPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, organ, or fluid examined. Examples: GLAND, ADRENAL; KIDNEY; VESSEL, LYMPHATIC. See also Assumption 4.b. | Exp | MA | SPEC | 17 | SEND Findings | MA |
| MAANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the MASPEC variable. If the anatomical region is not included in the specimen description MASPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | MA | ANTREG | 18 | SEND Findings | MA | |
| MASPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Perm | MA | SPCCND | 19 | SEND Findings | MA | |
| MASPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Perm | MA | SPCUFL | 20 | SEND Findings | MA |
| MALAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | MA | LAT | 21 | SEND Findings | MA |
| MADIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | MA | DIR | 22 | SEND Findings | MA |
| MAPORTOT | Portion or Totality | Char | (PORTOT) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm | MA | PORTOT | 23 | SEND Findings | MA |
| MAEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Used only for results that are subjective (i.e., assigned by a person or a group). Examples: PRINCIPAL PATHOLOGIST, PEER REVIEW, Applicant PATHOLOGIST. | Perm | MA | EVAL | 24 | SEND Findings | MA | |
| MASEV | Severity | Char | (SEV) | Record Qualifier | Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE. | Perm | MA | SEV | 25 | SEND Findings | MA |
| MADTHREL | Relationship to Death | Char | (NY) | Record Qualifier | Describes the relationship of a particular finding to the death of a subject ("Y" = caused death, "N" = did not cause death, "U" = unknown). May be left null if not available. | Perm | MA | DTHREL | 26 | SEND Findings | MA |
| MADTC | Date/Time | Char | ISO 8601 datetime or interval | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition in ISO 8601 format. | Perm | MA | DTC | 27 | SEND Findings | MA |
| MADY | Study Day | Num | Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | MA | DY | 28 | SEND Findings | MA | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | MI | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | MI | Identifier | Two-character abbreviation for the domain. | Req | MI | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | MI | USUBJID | 3 | SEND Findings | ||
| FOCID | Focus of Study-Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol for which a measurement, test, or examination was performed. An example could be a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | MI | FOCID | 4 | SEND Findings | ||
| MISEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | MI | SEQ | 5 | SEND Findings | MI | |
| MIGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number. | Perm | MI | GRPID | 6 | SEND Findings | MI | |
| MIREFID | Specimen Reference Identifier | Char | Identifier | Internal or external specimen identifier. Example: Specimen barcode number. | Perm | MI | REFID | 7 | SEND Findings | MI | |
| MISPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Perm | MI | SPID | 8 | SEND Findings | MI | |
| MITESTCD | Microscopic Examination Short Name | Char | (MITESTCD) | Topic | Short name of the measurement, test, or examination described in MITEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MITESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MITESTCD cannot contain characters other than letters, numbers, or underscores. Extensible controlled value is MIEXAM covering an assessment by microscope (e.g., light, elctron, confocal, etc). | Req | MI | TESTCD | 9 | SEND Findings | MI |
| MITEST | Microscopic Examination Name | Char | (MITEST) | Synonym Qualifier | Long name for MITESTCD. The value in MITEST cannot be longer than 40 characters. Extensible controlled value is Microscopic Examination. | Req | MI | TEST | 10 | SEND Findings | MI |
| MIBODSYS | Body System or Organ Class | Char | (BODSYS) | Record Qualifier | Body system or organ class associated with the specimen examined. | Perm | MI | BODSYS | 11 | SEND Findings | MI |
| MIORRES | Result or Findings as Collected | Char | Result Qualifier | Microscopic finding as originally recorded, including all modifiers. | Exp | MI | ORRES | 12 | SEND Findings | MI | |
| MISTRESC | Standardized Result in Character Format | Char | (NONNEO) \n (NEOPLASM) | Result Qualifier | For non-neoplastic findings, contains only the base pathological process (e.g., NECROSIS) without any modifiers such as severity, distribution, chronicity or characteristics. If the examination was completed and there were no findings, the value must be UNREMARKABLE. The base pathological process from MIORRES should be mapped to a synonymous term from the controlled list, NONNEO, where possible. \n Neoplastic findings must be populated using the NEOPLASM controlled list. | Exp | MI | STRESC | 13 | SEND Findings | MI |
| MIRESCAT | Result Category | Char | (MIRESCAT) | Variable Qualifier | Used to categorize the result of a finding. Example: MALIGNANT for tumor findings or NON-NEOPLASTIC for pathology findings. | Perm | MI | RESCAT | 14 | SEND Findings | MI |
| MICHRON | Chronicity of Finding | Char | (CHRNCTY) | Variable Qualifier | Describes the apparent relative duration of a particular finding. Examples: ACUTE, CHRONIC. | Exp | MI | CHRON | 15 | SEND Findings | MI |
| MIDISTR | Distribution Pattern of Finding | Char | (DSTRBN) | Variable Qualifier | Distribution pattern of a particular finding(s) within the examined area. Examples: DIFFUSE, FOCAL, MULTIFOCAL. | Exp | MI | DISTR | 16 | SEND Findings | MI |
| MISTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate a test was not done or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE. | Perm | MI | STAT | 17 | SEND Findings | MI |
| MIREASND | Reason Not Done | Char | Record Qualifier | Describes why MISTAT is NOT DONE, such as SAMPLE AUTOLYZED or SPECIMEN LOST. | Perm | MI | REASND | 18 | SEND Findings | MI | |
| MINAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | MI | NAM | 19 | SEND Findings | MI | |
| MISPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, orgain, or fluid specimen examined. Examples: LIVER, HEART, BONE MARROW. | Req | MI | SPEC | 20 | SEND Findings | MI |
| MIANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | The protocol-defined subregion of the specimen examined. Example: Cortex or Medulla (if the MISPEC is, for example, GLAND, ADRENAL). | Perm | MI | ANTREG | 21 | SEND Findings | MI | |
| MISPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Exp | MI | SPCCND | 22 | SEND Findings | MI | |
| MISPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Exp | MI | SPCUFL | 23 | SEND Findings | MI |
| MILAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | MI | LAT | 24 | SEND Findings | MI |
| MIDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | MI | DIR | 25 | SEND Findings | MI |
| MIMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. This could be different types of staining used for the slides whenever appropriate. Example: H&E. | Perm | MI | METHOD | 26 | SEND Findings | MI | |
| MIEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW. | Perm | MI | EVAL | 27 | SEND Findings | MI | |
| MISEV | Severity | Char | (SEV) | Record Qualifier | Describes the severity of a particular finding. | Exp | MI | SEV | 28 | SEND Findings | MI |
| MIDTHREL | Relationship to Death | Char | (NY) | Record Qualifier | Describes the relationship of a particular finding to the death of a subject ("Y" = caused death, "N" = did not cause death, "U" = unknown). May be left null if not available. | Perm | MI | DTHREL | 29 | SEND Findings | MI |
| MIDTC | Date/Time | Char | ISO 8601 datetime or interval | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format. | Perm | MI | DTC | 30 | SEND Findings | MI |
| MIDY | Study Day | Num | Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | MI | DY | 31 | SEND Findings | MI | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | OM | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | OM | Identifier | Two-character abbreviation for the domain. | Req | OM | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | OM | USUBJID | 3 | SEND Findings | ||
| OMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | OM | SEQ | 4 | SEND Findings | OM | |
| OMTESTCD | Test Short Name | Char | (OMTESTCD) | Topic | Short name of the measurement, test, or examination described in OMTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in OMTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). OMTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | OM | TESTCD | 5 | SEND Findings | OM |
| OMTEST | Test Name | Char | (OMTEST) | Synonym Qualifier | Long name for OMTESTCD. The value in OMTEST cannot be longer than 40 characters. | Req | OM | TEST | 6 | SEND Findings | OM |
| OMORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | OM | ORRES | 7 | SEND Findings | OM | |
| OMORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | OM | ORRESU | 8 | SEND Findings | OM |
| OMSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from OMORRES in a standard format or in standard units. OMSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in OMSTRESN. | Exp | OM | STRESC | 9 | SEND Findings | OM | |
| OMSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of OMSTRESC. OMSTRESN should store all numeric test results or findings. | Exp | OM | STRESN | 10 | SEND Findings | OM | |
| OMSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for OMSTRESC and OMSTRESN. | Exp | OM | STRESU | 11 | SEND Findings | OM |
| OMSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in OMORRES. | Perm | OM | STAT | 12 | SEND Findings | OM |
| OMREASND | Reason Not Done | Char | Record Qualifier | Describes why OMSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT. | Perm | OM | REASND | 13 | SEND Findings | OM | |
| OMSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, organ, or fluid specimen used as the object for the finding. Examples: GLAND, ADRENAL, KIDNEY, VESSEL, LYMPHATIC. | Req | OM | SPEC | 14 | SEND Findings | OM |
| OMANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the OMSPEC variable. If the anatomical region is not included in the specimen description OMSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be blank if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | OM | ANTREG | 15 | SEND Findings | OM | |
| OMSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: FIXED. | Perm | OM | SPCCND | 16 | SEND Findings | OM | |
| OMSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Perm | OM | SPCUFL | 17 | SEND Findings | OM |
| OMLAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | OM | LAT | 18 | SEND Findings | OM |
| OMDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | OM | DIR | 19 | SEND Findings | OM |
| OMPORTOT | Portion or Totality | Char | (PORTOT) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm | OM | PORTOT | 20 | SEND Findings | OM |
| OMEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm | OM | EXCLFL | 21 | SEND Findings | OM |
| OMREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when OMEXCLFL is "Y". | Perm | OM | REASEX | 22 | SEND Findings | OM | |
| OMDTC | Date/Time Organ Measured | Char | ISO 8601 datetime or interval | Timing | Date/Time of specimen/tissue weighing, in ISO 8601 format. | Exp | OM | DTC | 23 | SEND Findings | OM |
| OMDY | Study Day of Measurement | Num | Timing | Study day of specimen/tissue weighing, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | OM | DY | 24 | SEND Findings | OM | |
| OMNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day: Used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | OM | NOMDY | 25 | SEND Findings | OM | |
| OMNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of OMNOMDY as presented in the study report (examples: "Week 4," "Day 28," "Terminal Sac"). | Perm | OM | NOMLBL | 26 | SEND Findings | OM | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | PC | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | PC | Identifier | Two-character abbreviation for the domain. | Req | PC | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | PC | USUBJID | 3 | SEND Findings | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | PC | POOLID | 4 | SEND Findings | ||
| PCSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | PC | SEQ | 5 | SEND Findings | PC | |
| PCGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the dosing group number. | Perm | PC | GRPID | 6 | SEND Findings | PC | |
| PCREFID | Sample Identifier | Char | Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm | PC | REFID | 7 | SEND Findings | PC | |
| PCSPID | applicant-Defined Identifier | Char | Identifier | Applicant-defined reference identifier. | Perm | PC | SPID | 8 | SEND Findings | PC | |
| PCTESTCD | Test Short Name | Char | Topic | Short name of the analyte (or measurement ) described in PCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PCTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | PC | TESTCD | 9 | SEND Findings | PC | |
| PCTEST | Test Name | Char | Synonym Qualifier | Long name for PCTESTCD, such as the name of the analyte (or measurement). The value in PCTEST cannot be longer than 40 characters. | Req | PC | TEST | 10 | SEND Findings | PC | |
| PCCAT | Test Category | Char | Grouping Qualifier | Used to define a category of the pharmacokinetic test performed. Examples: ANALYTE, METABOLITE , SPECIMEN PROPERTY. | Perm | PC | CAT | 11 | SEND Findings | PC | |
| PCSCAT | Test Subcategory | Char | Grouping Qualifier | A further categorization of a test category. | Perm | PC | SCAT | 12 | SEND Findings | PC | |
| PCORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | PC | ORRES | 13 | SEND Findings | PC | |
| PCORRESU | Unit of the Original Result | Char | (PKUNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | PC | ORRESU | 14 | SEND Findings | PC |
| PCSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from PCORRES in a standard format or standard units. PCSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in PCSTRESN. Results beyond limits of quantitation should be represented with the term "BLQ" for results below the limit and "ALQ" for results above the limit. | Exp | PC | STRESC | 15 | SEND Findings | PC | |
| PCSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of PCSTRESC. PCSTRESN should store all numeric test results or findings. For results beyond limits of quantitation, this variable should be left null (e.g., if PCSTRESC is "BLQ", PCSTRESN would be null). | Exp | PC | STRESN | 16 | SEND Findings | PC | |
| PCSTRESU | Unit of the Standardized Result | Char | (PKUNIT) | Variable Qualifier | Standardized unit used for PCSTRESC and PCSTRESN. | Exp | PC | STRESU | 17 | SEND Findings | PC |
| PCSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in PCORRES. | Perm | PC | STAT | 18 | SEND Findings | PC |
| PCREASND | Reason Not Done | Char | Record Qualifier | Describes why PCSTAT is NOT DONE, such as SPECIMEN LOST. | Perm | PC | REASND | 19 | SEND Findings | PC | |
| PCNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor providing the test results. | Perm | PC | NAM | 20 | SEND Findings | PC | |
| PCSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE. | Req | PC | SPEC | 21 | SEND Findings | PC |
| PCSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC. | Perm | PC | SPCCND | 22 | SEND Findings | PC | |
| PCSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Perm | PC | SPCUFL | 23 | SEND Findings | PC |
| PCMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. Examples: HPLC/MS, ELISA. This should contain sufficient information and granularity to allow differentiation of various methods that might have been used within a study. | Perm | PC | METHOD | 24 | SEND Findings | PC | |
| PCBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be "Y" or null. The baseline flag is applicant-defined. | Perm | PC | BLFL | 25 | SEND Findings | PC |
| PCFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status. The value should be "Y" or null. | Perm | PC | FAST | 26 | SEND Findings | PC |
| PCDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records are examples of records that would be derived for the submission datasets. | Perm | PC | DRVFL | 27 | SEND Findings | PC |
| PCLLOQ | Lower Limit of Quantitation | Num | Variable Qualifier | Indicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU. | Exp | PC | LLOQ | 28 | SEND Findings | PC | |
| PCEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm | PC | EXCLFL | 29 | SEND Findings | PC |
| PCREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when PCEXCLFL is "Y". | Perm | PC | REASEX | 30 | SEND Findings | PC | |
| PCUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the specimen collection was unscheduled. If a specimen collection was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | Perm | PC | USCHFL | 31 | SEND Findings | PC |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned day of collection. Should be an integer. | Perm | PC | VISITDY | 32 | SEND Findings | ||
| PCDTC | Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of specimen collection, in ISO 8601 format. If there is no end time, this will be the collection time. | Perm | PC | DTC | 33 | SEND Findings | PC |
| PCENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 datetime or interval | Timing | End date/time of specimen collection, in ISO 8601 format. If there is no end time, the collection time should be represented in PCDTC, and PCENDTC should be null. | Perm | PC | ENDTC | 34 | SEND Findings | PC |
| PCDY | Study Day of Specimen Collection | Num | Timing | Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics (DM) domain. | Perm | PC | DY | 35 | SEND Findings | PC | |
| PCENDY | Study Day of End of Specimen Collection | Num | Timing | Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in DM domain. | Perm | PC | ENDY | 36 | SEND Findings | PC | |
| PCNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp | PC | NOMDY | 37 | SEND Findings | PC | |
| PCNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of PCNOMDY as presented in the study report. Examples: "Week 4", "Day 28". | Perm | PC | NOMLBL | 38 | SEND Findings | PC | |
| PCTPT | Planned Time Point Name | Char | Timing | Text description of time when specimen should be taken. \n Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See PCTPTNUM and PCTPTREF. Examples: Start, 5 min post. | Perm | PC | TPT | 39 | SEND Findings | PC | |
| PCTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of PCTPT to aid in sorting. | Perm | PC | TPTNUM | 40 | SEND Findings | PC | |
| PCELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601 format) relative to a planned fixed reference (PCTPTREF) such as "Day 1, Dose 1". This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "PT0H" to represent any predose values; "PT8H" to represent the period of 8 hours after the reference point indicated by PCTPTREF. | Exp | PC | ELTM | 41 | SEND Findings | PC |
| PCTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by PCELTM, if used for PCTPTNUM, and PCTPT. It is recommended that PCTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Example: "Day 1, Dose 1". | Exp | PC | TPTREF | 42 | SEND Findings | PC | |
| PCRFTDTC | Date/Time of Reference Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, PCTPTREF. | Exp | PC | RFTDTC | 43 | SEND Findings | PC |
| PCEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | Planned evaluation interval associated with a PCTEST record in ISO 8601 format. Example: "-P2H" to represent a planned interval of collection of 2 hours prior to the time point described in PCTPT. | Perm | PC | EVLINT | 44 | SEND Findings | PC |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | PP | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | PP | Identifier | Two-character abbreviation for the domain. | Req | PP | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | PP | USUBJID | 3 | SEND Findings | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | PP | POOLID | 4 | SEND Findings | ||
| PPSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | PP | SEQ | 5 | SEND Findings | PP | |
| PPGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the dosing group number. | Perm | PP | GRPID | 6 | SEND Findings | PP | |
| PPTESTCD | Parameter Short Name | Char | (PKPARMCD) | Topic | Short name of the measurement, test, or examination described in PPTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PPTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: AUCINT, TMAX, CMAX. | Req | PP | TESTCD | 7 | SEND Findings | PP |
| PPTEST | Parameter Name | Char | (PKPARM) | Synonym Qualifier | Long name for PPTESTCD. The value in PPTEST cannot be longer than 40 characters. Examples: AUC from T1 to T2, Time of CMAX, Max Conc. | Req | PP | TEST | 8 | SEND Findings | PP |
| PPCAT | Parameter Category | Char | Grouping Qualifier | Used to define a category of parameters associated with a specific analyte. This must be the analyte in PCTEST whose profile the parameter is associated with. | Exp | PP | CAT | 9 | SEND Findings | PP | |
| PPSCAT | Parameter Subcategory | Char | Grouping Qualifier | Categorization of the model type used to calculate the pharmacokinetic parameters. Examples include COMPARTMENTAL, NON-COMPARTMENTAL. | Perm | PP | SCAT | 10 | SEND Findings | PP | |
| PPORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as calculated. | Exp | PP | ORRES | 11 | SEND Findings | PP | |
| PPORRESU | Unit of the Original Result | Char | (PKUNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the CDISC Controlled Terminology list. | Exp | PP | ORRESU | 12 | SEND Findings | PP |
| PPSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from PPORRES in a standard format or standard units. PPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PPSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in PPORRES and these results effectively have the same meaning, they could be represented in standard format in PPSTRESC as NEGATIVE. For other examples, see general assumptions. | Exp | PP | STRESC | 13 | SEND Findings | PP | |
| PPSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of PPSTRESC. PPSTRESN should store all numeric test results or findings. | Exp | PP | STRESN | 14 | SEND Findings | PP | |
| PPSTRESU | Unit of the Standardized Result | Char | (PKUNIT) | Variable Qualifier | Standardized unit used for PPSTRESC and PPSTRESN. | Exp | PP | STRESU | 15 | SEND Findings | PP |
| PPSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES. | Perm | PP | STAT | 16 | SEND Findings | PP |
| PPREASND | Reason Not Done | Char | Record Qualifier | Describes why a parameter was not performed, such as INSUFFICIENT DATA. Used in conjunction with PPSTAT when value is NOT DONE. | Perm | PP | REASND | 17 | SEND Findings | PP | |
| PPSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE. \n If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine clearance), refer to TIG guidance on how to populate. | Exp | PP | SPEC | 18 | SEND Findings | PP |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | PP | VISITDY | 19 | SEND Findings | ||
| PPNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp | PP | NOMDY | 20 | SEND Findings | PP | |
| PPNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of PPNOMDY as presented in the study report. Examples: "Week 4", "Day 28". | Perm | PP | NOMLBL | 21 | SEND Findings | PP | |
| PPTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point used as a basis for PPRFTDTC. | Exp | PP | TPTREF | 22 | SEND Findings | PP | |
| PPRFTDTC | Date/Time of Reference Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, PPTPTREF. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records. | Exp | PP | RFTDTC | 23 | SEND Findings | PP |
| PPSTINT | Start of Assessment Interval | Char | ISO 8601 duration | Timing | Start of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT12H. | Perm | PP | STINT | 24 | SEND Findings | PP |
| PPENINT | End of Assessment Interval | Char | ISO 8601 duration | Timing | End of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT24H. | Perm | PP | ENINT | 25 | SEND Findings | PP |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | PM | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | PM | Identifier | Two-character abbreviation for the domain. | Req | PM | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | PM | USUBJID | 3 | SEND Findings | ||
| PMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | PM | SEQ | 4 | SEND Findings | PM | |
| PMGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number. | Perm | PM | GRPID | 5 | SEND Findings | PM | |
| PMSPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Exp | PM | SPID | 6 | SEND Findings | PM | |
| PMTESTCD | Test Short Name | Char | (PHSPRPCD) | Topic | Short name of the measurement, test, or examination described in PMTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PMTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PMTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | PM | TESTCD | 7 | SEND Findings | PM |
| PMTEST | Test Name | Char | (PHSPRP) | Synonym Qualifier | Long name for PMTESTCD. The value in PMTEST cannot be longer than 40 characters. | Req | PM | TEST | 8 | SEND Findings | PM |
| PMORRES | Result or Findings as Collected | Char | Variable Qualifier | Text description of findings as originally received or collected. If the examination was not performed, then the value should be null, and NOT DONE should appear in PMSTAT. | Exp | PM | ORRES | 9 | SEND Findings | PM | |
| PMORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | Units for PMORRES, if available (e.g., for length, width, or depth findings). The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | PM | ORRESU | 10 | SEND Findings | PM |
| PMSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied, or derived from PMORRES in a standard format or standard units. PMSTRESC should store all results or findings (without location of finding) in character format; if results are numeric, they should also be submitted in numeric format in PMSTRESN. | Exp | PM | STRESC | 11 | SEND Findings | PM | |
| PMSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of PMSTRESC. PMSTRESN should store all numeric test results or findings. | Exp | PM | STRESN | 12 | SEND Findings | PM | |
| PMSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for PMSTRESC and PMSTRESN. | Exp | PM | STRESU | 13 | SEND Findings | PM |
| PMSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in PMORRES. | Perm | PM | STAT | 14 | SEND Findings | PM |
| PMREASND | Reason Not Done | Char | Record Qualifier | Describes why PMSTAT is NOT DONE, such as MEASUREMENT IMPOSSIBLE DUE TO EXCESSIVE ULCERATION OF MASS. | Perm | PM | REASND | 15 | SEND Findings | PM | |
| PMLOC | Location of a Finding | Char | Record Qualifier | Specifies the location of the palpable mass finding. Example: LEFT SHOULDER. | Exp | PM | LOC | 16 | SEND Findings | PM | |
| PMEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Example: TECHNICIAN. | Perm | PM | EVAL | 17 | SEND Findings | PM | |
| PMUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | Perm | PM | USCHFL | 18 | SEND Findings | PM |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | PM | VISITDY | 19 | SEND Findings | ||
| PMDTC | Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Date/Time of the observation in ISO 8601 format. | Exp | PM | DTC | 20 | SEND Findings | PM |
| PMDY | Study Day of Observation | Num | Timing | Study day of the observation, measured as integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | PM | DY | 21 | SEND Findings | PM | |
| PMNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | PM | NOMDY | 22 | SEND Findings | PM | |
| PMNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of PMNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac". | Perm | PM | NOMLBL | 23 | SEND Findings | PM | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | RE | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | RE | Identifier | Two-character abbreviation for the domain. | Req | RE | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product. | Req | RE | USUBJID | 3 | SEND Findings | ||
| RESEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | RE | SEQ | 4 | SEND Findings | RE | |
| REGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject and can be used to support relationships within the domain and between domains using RELREC. This is not the dosing group number. | Perm | RE | GRPID | 5 | SEND Findings | RE | |
| RESPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference identifier. | Perm | RE | SPID | 6 | SEND Findings | RE | |
| RETESTCD | Test Short Name | Char | (SRETSTCD) | Topic | Short name of the measurement, test, or examination described in RETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in RETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). RETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: RESPRATE, TIDALVOL, MV. | Req | RE | TESTCD | 7 | SEND Findings | RE |
| RETEST | Test Name | Char | (SRETST) | Synonym Qualifier | Long name for RETESTCD. The value in RETEST cannot be longer than 40 characters. Examples: Respiratory Rate, Tidal Volume, Minute Volume. | Req | RE | TEST | 8 | SEND Findings | RE |
| REPOS | Position of Subject During Test | Char | (POSITION) | Record Qualifier | Position of the subject during the measurement or examination, If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp | RE | POS | 9 | SEND Findings | RE |
| REORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | RE | ORRES | 10 | SEND Findings | RE | |
| REORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | RE | ORRESU | 11 | SEND Findings | RE |
| RESTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from REORRES in a standard format or standard units. RESTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in RESTRESN. | Exp | RE | STRESC | 12 | SEND Findings | RE | |
| RESTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; contains the numeric form of RESTRESC. RESTRESN should store all numeric test results or findings. | Exp | RE | STRESN | 13 | SEND Findings | RE | |
| RESTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for RESTRESC and RESTRESN. | Exp | RE | STRESU | 14 | SEND Findings | RE |
| RESTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in REORRES. | Perm | RE | STAT | 15 | SEND Findings | RE |
| REREASND | Reason Not Done | Char | Record Qualifier | Describes why RESTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | RE | REASND | 16 | SEND Findings | RE | |
| REMETHOD | Method of Test | Char | Record Qualifier | Method of the test or examination. Examples: Whole body plethysmograph, Head-out plethysmograph, Invasive. | Exp | RE | METHOD | 17 | SEND Findings | RE | |
| RECSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Exp | RE | CSTATE | 18 | SEND Findings | RE |
| REBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp | RE | BLFL | 19 | SEND Findings | RE |
| REDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm | RE | DRVFL | 20 | SEND Findings | RE |
| REEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | RE | EXCLFL | 21 | SEND Findings | RE |
| REREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when REEXCLFL is Y. | Perm | RE | REASEX | 22 | SEND Findings | RE | |
| REUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | RE | USCHFL | 23 | SEND Findings | RE |
| REDTC | Date/Time of Respiratory Measurement | Char | ISO 8601 datetime or interval | Timing | Date/Time of respiratory data collection, in ISO 8601 format. For measurements related to a continuous evaluation interval, REDTC should be used to indicate the start date/time of that interval. | Exp | RE | DTC | 24 | SEND Findings | RE |
| REENDTC | End Date/Time of Respiratory Measurement | Char | ISO 8601 datetime or interval | Timing | Date/Time of end of the respiratory evaluation interval, in ISO 8601 format. Should be populated when REDTC represents the start date/time of a continuous evaluation interval. | Perm | RE | ENDTC | 25 | SEND Findings | RE |
| REDY | Study Day of Respiratory Measurement | Num | Timing | Study day of respiratory data collection, in integer days. For measurements related to a continuous evaluation interval, REDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | RE | DY | 26 | SEND Findings | RE | |
| REENDY | End Study Day of Respiratory Measurement | Num | Timing | Study day of the respiratory data collection, in integer days. Can be populated when REDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | RE | ENDY | 27 | SEND Findings | RE | |
| RENOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | RE | NOMDY | 28 | SEND Findings | RE | |
| RENOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of RENOMDY as presented in the study report. Examples: Pretreatment, Week 4, Day 28. | Perm | RE | NOMLBL | 29 | SEND Findings | RE | |
| RETPT | Planned Time Point Name | Char | Timing | Text description of time when respiratory data should be collected. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See RETPTNUM and RETPTREF. Examples: Predose, 1 Hour Postdose. | Exp | RE | TPT | 30 | SEND Findings | RE | |
| RETPTNUM | Planned Time Point Number | Num | Timing | Numerical version of RETPT to aid in sorting. | Exp | RE | TPTNUM | 31 | SEND Findings | RE | |
| REELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (RETPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by RETPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by RETPTREF. | Exp | RE | ELTM | 32 | SEND Findings | RE |
| RETPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by REELTM, if used for RETPTNUM, and RETPT. It is recommended that RETPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Exp | RE | TPTREF | 33 | SEND Findings | RE | |
| RERFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, RETPTREF. | Perm | RE | RFTDTC | 34 | SEND Findings | RE |
| REEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of RESTINT and REENINT when RETPTREF is not available. | Perm | RE | EVLINT | 35 | SEND Findings | RE |
| RESTINT | Planned Start of Assessment Interval | Char | ISO 8601 duration | Timing | Planned start of an assessment interval relative to Time Point Reference (RETPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT1H. | Exp | RE | STINT | 36 | SEND Findings | RE |
| REENINT | Planned End of Assessment Interval | Char | ISO 8601 duration | Timing | Planned end of an assessment interval relative to Time Point Reference (RETPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT2H. | Exp | RE | ENINT | 37 | SEND Findings | RE |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | SC | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | SC | Identifier | Two-character abbreviation for the domain. | Req | SC | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across a study for all applications or submissions involving the product. | Req | SC | USUBJID | 3 | SEND Findings | ||
| SCSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | SC | SEQ | 4 | SEND Findings | SC | |
| SCGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number. | Perm | SC | GRPID | 5 | SEND Findings | SC | |
| SCTESTCD | Subject Characteristic Short Name | Char | (SBCCDSND) | Topic | Short name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Some extensible controlled values are: SPLRNAM, SPLRLOC, HAIRCOLR. | Req | SC | TESTCD | 6 | SEND Findings | SC |
| SCTEST | Subject Characteristic | Char | (SBCSND) | Synonym Qualifier | Long name for SCTESTCD. The value in SCTEST cannot be longer than 40 characters. Examples: Test Subject Supplier, Test Subject Supplier Site, and Hair Coat Color. | Req | SC | TEST | 7 | SEND Findings | SC |
| SCORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the subject characteristic as originally received or collected. | Exp | SC | ORRES | 8 | SEND Findings | SC | |
| SCORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Perm | SC | ORRESU | 9 | SEND Findings | SC |
| SCSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from SCORRES in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in SCORRES, these results effectively have the same meaning. In this case, they could be represented in standard format in SCSTRESC with a single term NEGATIVE. | Exp | SC | STRESC | 10 | SEND Findings | SC | |
| SCSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of SCSTRESC. SCSTRESN should store all numeric test results or findings. | Perm | SC | STRESN | 11 | SEND Findings | SC | |
| SCSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for SCSTRESC and SCSTRESN. | Perm | SC | STRESU | 12 | SEND Findings | SC |
| SCDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Date/Time of collection of the subject characteristic information, in ISO 8601 format. | Perm | SC | DTC | 13 | SEND Findings | SC |
| SCDY | Study Day of Collection | Num | Timing | Study day of collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | SC | DY | 14 | SEND Findings | SC | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TF | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | TF | Identifier | Two-character abbreviation for the domain. | Req | TF | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product within the submission. | Req | TF | USUBJID | 3 | SEND Findings | ||
| TFSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | TF | SEQ | 4 | SEND Findings | TF | |
| TFGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number. | Perm | TF | GRPID | 5 | SEND Findings | TF | |
| TFREFID | Specimen Identifier | Char | Identifier | Internal or external specimen identifier. Example: Specimen barcode number. | Perm | TF | REFID | 6 | SEND Findings | TF | |
| TFSPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Exp | TF | SPID | 7 | SEND Findings | TF | |
| TFTESTCD | Tumor Examination Short Name | Char | (TFTESTCD) | Topic | Short name of the measurement, test, or examination described in TFTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in TFTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). TFTESTCD cannot contain characters other than letters, numbers, or underscores. Example: TUMEX. | Req | TF | TESTCD | 8 | SEND Findings | TF |
| TFTEST | Tumor Examination Name | Char | (TFTEST) | Synonym Qualifier | Long name for TFTESTCD. The value in TFTEST cannot be longer than 40 characters. Example: Tumor Examination. | Req | TF | TEST | 9 | SEND Findings | TF |
| TFORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the histopathological examination as originally received or collected. | Exp | TF | ORRES | 10 | SEND Findings | TF | |
| TFSTRESC | Standardized Result in Character Format | Char | (NEOPLASM) | Result Qualifier | Contains the tumor name mapped from TFORRES into a standard format from the controlled terms list. | Exp | TF | STRESC | 11 | SEND Findings | TF |
| TFRESCAT | Tumor Malignancy Status | Char | (NEOSTAT) | Variable Qualifier | Used to record the malignancy of the tumor as determined by the pathologist. It may be copied or derived from a description in TFORRES. Examples: BENIGN, MALIGNANT, METASTATIC, and UNDETERMINED. | Req | TF | RESCAT | 12 | SEND Findings | TF |
| TFNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | TF | NAM | 13 | SEND Findings | TF | |
| TFSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, organ, or fluid specimen examined. Examples: LIVER, HEART. | Req | TF | SPEC | 14 | SEND Findings | TF |
| TFANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the TFSPEC variable. If the anatomical region is not included in the specimen description TFSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | TF | ANTREG | 15 | SEND Findings | TF | |
| TFSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Perm | TF | SPCCND | 16 | SEND Findings | TF | |
| TFLAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | TF | LAT | 17 | SEND Findings | TF |
| TFDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | TF | DIR | 18 | SEND Findings | TF |
| TFMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. This could be different types of staining used for the slides. Example: H&E. | Perm | TF | METHOD | 19 | SEND Findings | TF | |
| TFEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Example: TOX PATHOLOGIST, PEER REVIEW. | Perm | TF | EVAL | 20 | SEND Findings | TF | |
| TFDTHREL | Relationship to Death | Char | (NY) | Record Qualifier | Describes the relationship of a particular finding to the death of a subject. Example: Y if the tumor was the cause of death, N if the tumor was not the cause of death, or U for Unknown. Null cannot be used because the variable is required. | Req | TF | DTHREL | 21 | SEND Findings | TF |
| TFDTC | Date/Time | Char | ISO 8601 datetime or interval | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format. | Perm | TF | DTC | 22 | SEND Findings | TF |
| TFDY | Study Day | Num | Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | TF | DY | 23 | SEND Findings | TF | |
| TFDETECT | Time in Days to Detection of Tumor | Num | Timing | The number of days from the start of dosing to the earliest detection of the tumor in the experimental phase. This variable must be populated for every tumor discovered during the experimental phase. | Req | TF | DETECT | 24 | SEND Findings | TF | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | VS | STUDYID | 1 | SEND Findings | ||
| DOMAIN | Domain Abbreviation | Char | VS | Identifier | Two-character abbreviation for the domain. | Req | VS | DOMAIN | 2 | SEND Findings | |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | VS | USUBJID | 3 | SEND Findings | ||
| VSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | VS | SEQ | 4 | SEND Findings | VS | |
| VSGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number. | Perm | VS | GRPID | 5 | SEND Findings | VS | |
| VSSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference identifier. | Perm | VS | SPID | 6 | SEND Findings | VS | |
| VSTESTCD | Vital Signs Test Short Name | Char | (SVSTSTCD) | Topic | Short name of the measurement described in VSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in VSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). VSTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | VS | TESTCD | 7 | SEND Findings | VS |
| VSTEST | Vital Signs Test Name | Char | (SVSTST) | Synonym Qualifier | Long name for VSTESTCD. The value in VSTEST cannot be longer than 40 characters. | Req | VS | TEST | 8 | SEND Findings | VS |
| VSCAT | Category for Vital Signs | Char | Grouping Qualifier | Used to define a category of the vital signs measurement performed. | Perm | VS | CAT | 9 | SEND Findings | VS | |
| VSSCAT | Subcategory for Vital Signs | Char | Grouping Qualifier | A further categorization of the vital signs measurement performed. | Perm | VS | SCAT | 10 | SEND Findings | VS | |
| VSPOS | Vital Signs Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during the measurement. If the subject is restrained, populate with the position (example SITTING or STANDING). | Perm | VS | POS | 11 | SEND Findings | VS |
| VSORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the vital signs measurement as originally received or collected. | Exp | VS | ORRES | 12 | SEND Findings | VS | |
| VSORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | VS | ORRESU | 13 | SEND Findings | VS |
| VSSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from VSORRES in a standard format or standard units. VSSTRESC should store all results in character format; if results are numeric, they should also be submited in numeric format in VSSTRESN. | Exp | VS | STRESC | 14 | SEND Findings | VS | |
| VSSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of VSSTRESC. VSSTRESN should store all numeric test results or findings. | Exp | VS | STRESN | 15 | SEND Findings | VS | |
| VSSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for VSSTRESC and VSSTRESN. | Exp | VS | STRESU | 16 | SEND Findings | VS |
| VSSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in VSORRES. | Perm | VS | STAT | 17 | SEND Findings | VS |
| VSREASND | Reason Not Done | Char | Record Qualifier | Describes why VSSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | VS | REASND | 18 | SEND Findings | VS | |
| VSLOC | Location of Vital Signs Measurement | Char | Record Qualifier | Location relevant to the collection of the vital signs measurement. Example: RECTAL for Temperature. | Perm | VS | LOC | 19 | SEND Findings | VS | |
| VSCSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Perm | VS | CSTATE | 20 | SEND Findings | VS |
| VSBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp | VS | BLFL | 21 | SEND Findings | VS |
| VSDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm | VS | DRVFL | 22 | SEND Findings | VS |
| VSEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | VS | EXCLFL | 23 | SEND Findings | VS |
| VSREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when VSEXCLFL is Y. | Perm | VS | REASEX | 24 | SEND Findings | VS | |
| VSUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | VS | USCHFL | 25 | SEND Findings | VS |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned day of the vital signs measurement. Should be an integer. | Perm | VS | VISITDY | 26 | SEND Findings | ||
| VSDTC | Date/Time of Measurement | Char | ISO 8601 datetime or interval | Timing | Date/Time of the vital sign measurement, in ISO 8601 format. For indicating measurement over a period, DTC should be populated with the start date/time of collection. | Exp | VS | DTC | 27 | SEND Findings | VS |
| VSENDTC | End Date/Time of Measurement | Char | ISO 8601 datetime or interval | Timing | Date/Time of the end of the vital sign measurement, in ISO 8601 format. Should be populated for continuous period only. | Perm | VS | ENDTC | 28 | SEND Findings | VS |
| VSDY | Study Day of Vital Signs Measurement | Num | Timing | Study day of vital signs measurements, in integer days. For indicating measurement over a continuous period, VSDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | VS | DY | 29 | SEND Findings | VS | |
| VSENDY | Study Day of End of Measurement | Num | Timing | Study day of the end of the vital signs measurement, in integer days. Can be populated when VSDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | VS | ENDY | 30 | SEND Findings | VS | |
| VSNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | VS | NOMDY | 31 | SEND Findings | VS | |
| VSNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of VSNOMDY as presented in the study report. Examples: Pre-Exposure, Week 4, Day 28. | Perm | VS | NOMLBL | 32 | SEND Findings | VS | |
| VSTPT | Planned Time Point Name | Char | Timing | Text description of time when the vital signs measurement should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See VSTPTNUM and VSTPTREF. Examples: Predose, 1 Hour Postdose. | Perm | VS | TPT | 33 | SEND Findings | VS | |
| VSTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of VSTPT to aid in sorting. | Perm | VS | TPTNUM | 34 | SEND Findings | VS | |
| VSELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned elapsed time (in ISO 8601 format) relative to a planned fixed reference (VSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as a duration in ISO 8601 format. Examples: '-PT15M' to represent the period of 15 minutes prior to the reference point indicated by VSTPTREF or 'PT8H' to represent the period of 8 hours after the reference point indicated by VSTPTREF. | Perm | VS | ELTM | 35 | SEND Findings | VS |
| VSTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by VSELTM, if used for VSTPTNUM, and VSTPT. It is recommended that VSTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: DAY 1 DOSE, DAY 1 MEAL. | Perm | VS | TPTREF | 36 | SEND Findings | VS | |
| VSRFTDTC | Date/Time of Time Point Reference | Char | ISO 8601 datetime or interval | Timing | Date/Time of the reference time point, VSTPTREF. | Perm | VS | RFTDTC | 37 | SEND Findings | VS |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | POOLDEF | STUDYID | 1 | SEND Relationship | ||
| POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. | Req | POOLDEF | POOLID | 2 | SEND Relationship | ||
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify across all studies for all applications or submissions involving the product. | Req | POOLDEF | USUBJID | 3 | SEND Relationship | ||
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | RELREC | STUDYID | 1 | SEND Relationship | ||
| RDOMAIN | Related Domain Abbreviation | Char | Identifier | Two-character abbreviation for the domain of the parent record(s). | Req | RELREC | RDOMAIN | 2 | SEND Relationship | ||
| USUBJID | Unique Subject Identifier | Char | Identifier | Unique Subject Identifier of the Parent record(s). Either USUBJID or POOLID must be populated, except for certain domain-to-domain relationships (see Section 8.2.3). | Exp | RELREC | USUBJID | 3 | SEND Relationship | ||
| POOLID | Pool Identifier | Char | Identifier | Pool Identifier of the Parent record(s). If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | RELREC | POOLID | 4 | SEND Relationship | ||
| IDVAR | Identifying Variable | Char | Identifier | Name of the identifying variable in the general observation class domain that identifies the related record(s). Examples include BWSEQ and BWGRPID. | Req | RELREC | IDVAR | 5 | SEND Relationship | ||
| IDVARVAL | Identifying Variable Value | Char | Identifier | Value of identifying variable described in IDVAR. For example, if BWSEQ is the variable being used to describe this record, then the value of BWSEQ would be entered here. | Exp | RELREC | IDVARVAL | 6 | SEND Relationship | ||
| RELTYPE | Relationship Type | Char | (RELTYPE) | Record Qualifier | Identifies the hierarchical level of the records in the relationship. Values are only necessary when identifying a relationship between domains (as described in Section 2.8.5.2). Values should be either ONE or MANY. | Perm | RELREC | RELTYPE | 7 | SEND Relationship | |
| RELID | Relationship Identifier | Char | Record Qualifier | Unique value within a study that identifies the relationship. RELID can be any value the applicant chooses and is only meaningful within the df dataset to identify the related/associated domain records. | Req | RELREC | RELID | 8 | SEND Relationship | ||
| STUDYID | Study Identifier | Char | Identifier | A sequence of characters used by the applicant to uniquely identify the study. | Req | RELREF | STUDYID | 1 | SEND Relationship | ||
| SETCD | Trial Set Code | Char | Identifier | The short sequence of characters used to represent the trial set. | Req | RELREF | SETCD | 2 | SEND Relationship | ||
| REFID | Reference ID | Char | Identifier | A sequence of characters used to uniquely identify a source of information. | Req | RELREF | REFID | 3 | SEND Relationship | ||
| PARENT | Parent Reference ID | Char | Identifier | The identifier for the immediate progenitor of a source of information. Identifies the REFID of the parent. | Exp | RELREF | PARENT | 4 | SEND Relationship | ||
| LEVEL | Reference ID Generation Level | Num | Variable Qualifier | The generation number of the information source in relation to the first generation of the source of information. Identifies the level number of the reference ID. | Exp | RELREF | LEVEL | 5 | SEND Relationship | ||
| LVLDESC | Reference ID Level Description | Char | (LVLDSCRS) | Variable Qualifier | A description of the generation number of the information source in relation to the first generation of the source of information. Examples: ASSAY, TRIAL SET, EXPERIMENTAL UNIT, OBSERVATIONAL UNIT. | Perm | RELREF | LVLDESC | 6 | SEND Relationship | |
| STUDYID | Study Identifier | Char | Identifier | Unique study identifier of the parent record(s). | Req | SUPP | STUDYID | 1 | SEND Relationship | ||
| RDOMAIN | Related Domain Abbreviation | Char | Identifier | Two-character abbreviation for the domain of the parent record(s). | Req | SUPP | RDOMAIN | 2 | SEND Relationship | ||
| USUBJID | Unique Subject Identifier | Char | Identifier | Unique subject identifier of the parent record(s). Either USUBJID or POOLID must be populated. | Exp | SUPP | USUBJID | 3 | SEND Relationship | ||
| POOLID | Pool Identifier | Char | Identifier | Pool identifier of the Parent record(s).. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | SUPP | POOLID | 4 | SEND Relationship | ||
| IDVAR | Identifying Variable | Char | Identifier | Identifying variable in the dataset that identifies the related record(s). Examples: BWSEQ, CLGRPID. | Exp | SUPP | IDVAR | 5 | SEND Relationship | ||
| IDVARVAL | Identifying Variable Value | Char | Identifier | Value of identifying variable of the parent record(s). | Exp | SUPP | IDVARVAL | 6 | SEND Relationship | ||
| QNAM | Qualifier Variable Name | Char | Topic | The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters nor can it start with a number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the applicant's operational dataset. The value in QNAM may not be the same as any variable name defined in another domain or the SDTM. The QNAM should uniquely correspond to a QLABEL within a single domain. | Req | SUPP | QNAM | 7 | SEND Relationship | ||
| QLABEL | Qualifier Variable Label | Char | Synonym Qualifier | This is the long name or label associated with QNAM. The value in QLABEL should be in title case and cannot be longer than 40 characters. This will often be the column label in the sponsor's operational dataset. | Req | SUPP | QLABEL | 8 | SEND Relationship | ||
| QVAL | Data Value | Char | Result Qualifier | Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in SUPP-- with a null value for QVAL. | Req | SUPP | QVAL | 9 | SEND Relationship | ||
| QORIG | Origin | Char | Record Qualifier | QORIG is used to indicate the origin of the data. Possible values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. | Perm | SUPP | QORIG | 10 | SEND Relationship | ||
| QEVAL | Evaluator | Char | Record Qualifier | Used only for results that are subjective (i.e., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include PATHOLOGIST or VETERINARIAN, etc. | Perm | SUPP | QEVAL | 11 | SEND Relationship | ||
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TA | STUDYID | 1 | SEND Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TA | Identifier | Two-character abbreviation for the domain. | Req | TA | DOMAIN | 2 | SEND Trial Design | |
| ARMCD | Planned Arm Code | Char | Topic | Short name of a specific ARM (may be up to 20 characters) used for sorting and programming. Should be populated in Demographics when Arms have been defined in this domain. | Req | TA | ARMCD | 3 | SEND Trial Design | ||
| ARM | Description of Planned Arm | Char | Synonym Qualifier | Descriptive name given to a specific Trial Arm (e.g., Low Dose, Mid Dose, 10 mg/kg/day dose). | Req | TA | ARM | 4 | SEND Trial Design | ||
| TAETORD | Order of Element within Arm | Num | Timing | Number that provides the order of the planned Element within the Arm. This value should be an integer. | Req | TA | ETORD | 5 | SEND Trial Design | TA | |
| ETCD | Element Code | Char | Record Qualifier | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. | Req | TA | ETCD | 6 | SEND Trial Design | ||
| ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the Element. | Perm | TA | ELEMENT | 7 | SEND Trial Design | ||
| TABRANCH | Branch | Char | Rule | Conditions subjects meet, occurring at the end of an Element, which cause an Arm to branch off from other Arms (e.g., randomization to "PRODUCT X"). | Perm | TA | BRANCH | 8 | SEND Trial Design | TA | |
| TATRANS | Transition Rule | Char | Rule | If the study/trial design allows for a subject to transition to an Element other than the next sequential Element, as defined by TAETORD, then the conditions for transitioning to those other Elements, as well as the alternative Element sequences, are specified in this rule (e.g., TATRANS = 'Subject with Hypoactivity Transitions to Rest Period to Product Exposure 2'). | Perm | TA | TRANS | 9 | SEND Trial Design | TA | |
| EPOCH | Trial Epoch | Char | Timing | Name of the study Epoch with which this Element of the Arm is associated (e.g., Screen). Equivalent to 'Phase' or 'Period'. | Exp | TA | EPOCH | 10 | SEND Trial Design | ||
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TE | STUDYID | 1 | SEND Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TE | Identifier | Two-character abbreviation for the domain. | Req | TE | DOMAIN | 2 | SEND Trial Design | |
| ETCD | Element Code | Char | Topic | ETCD (the short form of ELEMENT) is limited to 8 characters and does not have special character restrictions. | Req | TE | ETCD | 3 | SEND Trial Design | ||
| ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the Element. | Req | TE | ELEMENT | 4 | SEND Trial Design | ||
| TESTRL | Rule for Start of Element | Char | Rule | Expresses rule for beginning Element. | Req | TE | STRL | 5 | SEND Trial Design | TE | |
| TEENRL | Rule for End of Element | Char | Rule | Expresses rule for ending Element. Either TEENRL or TEDUR must be present for each Element; both may be present. | Perm | TE | ENRL | 6 | SEND Trial Design | TE | |
| TEDUR | Planned Duration of Element | Char | ISO 8601 duration | Timing | Planned duration of Element in ISO 8601 format. Use when an Element represents a fixed duration. TEENRL or TEDUR must be present for each Element; both may be present. | Perm | TE | DUR | 7 | SEND Trial Design | TE |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study within the submission. | Req | TS | STUDYID | 1 | SEND Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TS | Identifier | Two-character abbreviation for the domain most relevant to the observation. | Req | TS | DOMAIN | 2 | SEND Trial Design | |
| TSSEQ | Sequence Number | Num | Identifier | Sequence number used to ensure uniqueness within a TSPARMCD. Allows inclusion of multiple records for the same TSPARMCD, and can be used to join related records. | Req | TS | SEQ | 3 | SEND Trial Design | TS | |
| TSGRPID | Group Identifier | Char | Identifier | Used to tie together a group of related records. This is not the applicant-defined protocol group number. | Exp | TS | GRPID | 4 | SEND Trial Design | TS | |
| TSPARMCD | Trial Summary Parameter Short Name | Char | (STSPRMCD) | Topic | Short character value for the trial design characteristic described in TSPARM. Value must be 8 characters or less. | Req | TS | PARMCD | 5 | SEND Trial Design | TS |
| TSPARM | Trial Summary Parameter | Char | (STSPRM) | Synonym Qualifier | Term for the trial parameter. Value must be 40 characters or less. | Req | TS | PARM | 6 | SEND Trial Design | TS |
| TSVAL | Parameter Value | Char | Result Qualifier | Value of the TS parameter (e.g., "FDA" when TSPARM is GLP Type). The values for some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.6.3 that lists all defined parameters. TSVAL can only be null if TSVALNF is populated. | Exp | TS | VAL | 7 | SEND Trial Design | TS | |
| TSVALNF | Parameter Null Flavor | Char | ISO 21090 NullFlavor | Record Qualifier | Null flavor for the value of TSPARM, to be populated only if TSVAL is null. | Perm | TS | VALNF | 8 | SEND Trial Design | TS |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | TX | STUDYID | 1 | SEND Trial Design | ||
| DOMAIN | Domain Abbreviation | Char | TX | Identifier | Two-character abbreviation for the domain. | Req | TX | DOMAIN | 2 | SEND Trial Design | |
| SETCD | Set Code | Char | Identifier | Short name of the Trial Set. The same element may occur more than once within an Arm. Maximum 8 characters. This represents the Trial Set for which parameters are being submitted. | Req | TX | SETCD | 3 | SEND Trial Design | ||
| SET | Set Description | Char | Synonym Qualifier | Long description of a specific Trial Set, as defined by the applicant. | Req | TX | SET | 4 | SEND Trial Design | ||
| TXSEQ | Sequence Number | Num | Identifier | Unique number for this record within this dataset (This sequence should be unique within the entire dataset because there is no USUBJID.). | Req | TX | SEQ | 5 | SEND Trial Design | TX | |
| TXPARMCD | Trial Set Parameter Short Name | Char | (STSPRMCD) | Topic | Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters. | Req | TX | PARMCD | 6 | SEND Trial Design | TX |
| TXPARM | Trial Set Parameter | Char | (STSPRM) | Synonym Qualifier | Term for the Trial Set parameter. Maximum 40 characters. | Req | TX | PARM | 7 | SEND Trial Design | TX |
| TXVAL | Trial Set Parameter Value | Char | Result Qualifier | Value of the Trial Set parameter (e.g., Fed ad libitum or Restricted Feeding when TXPARM is FEEDREG). Some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.4.2 that lists all defined Trial Set parameters. | Req | TX | VAL | 8 | SEND Trial Design | TX | |
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | DI | STUDYID | 1 | SEND Study Reference | ||
| DOMAIN | Domain Abbreviation | Char | DI | Identifier | Two-character abbreviation for the domain. | Req | DI | DOMAIN | 2 | SEND Study Reference | |
| SPDEVID | Applicant Device Identifier | Char | Identifier | Applicant-defined identifier for the device. The value of SPDEVID may be linked to a nonclinical trial set by a matching value of the parameter APDEVID in the TX dataset. \n It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers). | Req | DI | SPDEVID | 3 | SEND Study Reference | ||
| DISEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID) within dataset. \n If there is only one value for DIPARMCD for each value of SPDEVID, then DISEQ will be 1 for all records. DISEQ must be a valid number. | Exp | DI | SEQ | 4 | SEND Study Reference | DI | |
| DIPARMCD | Device Identifier Element Short Name | Char | Topic | Short name of the identifier characteristic of the device (e.g., "SERIAL", "MODEL"). \n A record with DIPARMCD = "DEVTYPE" should be included (see below). | Req | DI | PARMCD | 5 | SEND Study Reference | DI | |
| DIPARM | Device Identifier Element Name | Char | Synonym Qualifier | Name of the identifier characteristic of the device. \n Examples: Serial Number, Model. A record with DIPARM = "DEVTYPE" should be included (see below). | Req | DI | PARM | 6 | SEND Study Reference | DI | |
| DIVAL | Device Identifier Element Value | Char | Result Qualifier | Value for the parameter. Value for the parameter. When DIPARMCD=DEVTYPE it should use controlled terminology defined by FDA in their Preferred Term codelist. FDA has stated a preference for the Global Medical Device Nomenclature (GMDN), but as of the date of this publication, the GMDN is not freely available to the public. In its Unique Device Identification rule, FDA indicated that GMDN will not be required unless it is available to the public at no cost. There is a lookup tool on the FDA website to map GMDN codes to FDA PT codes. | Req | DI | VAL | 7 | SEND Study Reference | DI |
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