Copy of SENDIG 3.1.1 Metadata

Role,Dataset Name,Variable Name,Variable Label,Type,Variable Name (no prefix),CDISC Notes,Seq. for Order,Observation Class,Core,"Controlled Terms, Codelist, or Format",Domain Prefix
Identifier,CO,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Special-Purpose,Req,,
Identifier,CO,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Special-Purpose,Req,CO,
Record Qualifier,CO,RDOMAIN,Related Domain Abbreviation,Char,RDOMAIN,Domain abbreviation of the parent record(s). Null for comments collected as a general comment or additional information.,3,Special-Purpose,Exp,,
Identifier,CO,USUBJID,Unique Subject Identifier,Char,USUBJID,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.,4,Special-Purpose,Exp,,
Identifier,CO,POOLID,Pool Identifier,Char,POOLID,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.,5,Special-Purpose,Perm,,
Identifier,CO,COSEQ,Sequence Number,Num,SEQ,"The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.",6,Special-Purpose,Req,,CO
Record Qualifier,CO,IDVAR,Identifying Variable,Char,IDVAR,"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.",7,Special-Purpose,Exp,,
Record Qualifier,CO,IDVARVAL,Identifying Variable Value,Char,IDVARVAL,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.,8,Special-Purpose,Exp,,
Record Qualifier,CO,COREF,Comment Reference,Char,REF,"Sponsor-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).",9,Special-Purpose,Perm,,CO
Topic,CO,COVAL,Comment,Char,VAL,The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. See Assumption 4 in Section 5.2.1.1.,10,Special-Purpose,Req,,CO
Record Qualifier,CO,COEVAL,Evaluator,Char,EVAL,"Used to describe the originator of the comment. Examples: TECHNICIAN, STUDY DIRECTOR, VET.",11,Special-Purpose,Perm,,CO
Timing,CO,CODTC,Date/Time of Comment,Char,DTC,"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.",12,Special-Purpose,Exp,ISO 8601,CO
Timing,CO,CODY,Study Day of Comment,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",13,Special-Purpose,Perm,,CO
Identifier,DM,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Special-Purpose,Req,,
Identifier,DM,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Special-Purpose,Req,DM,
Identifier,DM,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Special-Purpose,Req,,
Topic,DM,SUBJID,Subject Identifier for the Study,Char,SUBJID,"Subject (i.e., Animal) identifier used within the study.",4,Special-Purpose,Req,,
Record Qualifier,DM,RFSTDTC,Subject Reference Start Date/Time,Char,RFSTDTC,Reference start date/time for the subject in ISO 8601 format. Usually equivalent to date/time when subject was first exposed to study treatment. Study day calculation (the --DY variable) in all domains will be based on this date. The sponsor must define what collected date is used to populate RFSTDTC in the data definition file.,5,Special-Purpose,Req,ISO 8601,
Record Qualifier,DM,RFENDTC,Subject Reference End Date/Time,Char,RFENDTC,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 sponsor must define what collected date is used to populate RFENDTC in the data definition file.,6,Special-Purpose,Exp,ISO 8601,
Record Qualifier,DM,RFXSTDTC,Date/Time of First Study Treatment,Char,RFXSTDTC,"First date/time of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC. Note: Absolute first.",7,Special-Purpose,Perm,ISO 8601,
Record Qualifier,DM,RFXENDTC,Date/Time of Last Study Treatment,Char,RFXENDTC,"Last date/time of exposure to any protocol-specified treatment or therapy, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing). Note: Absolute last",8,Special-Purpose,Perm,ISO 8601,
Record Qualifier,DM,SITEID,Study Site Identifier,Char,SITEID,Unique identifier for a study site within a submission. Use only if subjects are housed at different sites.,9,Special-Purpose,Perm,,
Record Qualifier,DM,BRTHDTC,Date/Time of Birth,Char,BRTHDTC,"Date/Time of birth of the subject, in ISO 8601 format.",10,Special-Purpose,Perm,ISO 8601,
Record Qualifier,DM,AGE,Age,Num,AGE,"May be derived (RFSTDTC – BRTHDTC), but BRTHDTC may not be available in all cases. Age may also be collected.",11,Special-Purpose,Perm,,
Record Qualifier,DM,AGETXT,Age Range,Char,AGETXT,"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).",12,Special-Purpose,Perm,number-number,
Variable Qualifier,DM,AGEU,Age Unit,Char,AGEU,Units associated with AGE and AGETXT.,13,Special-Purpose,Exp,(AGEU),
Record Qualifier,DM,SEX,Sex,Char,SEX,The sex of the subject.,14,Special-Purpose,Req,(SEX),
Record Qualifier,DM,SPECIES,Species,Char,SPECIES,"If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary).",15,Special-Purpose,Perm,(SPECIES),
Record Qualifier,DM,STRAIN,Strain/Substrain,Char,STRAIN,"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.",16,Special-Purpose,Perm,(STRAIN),
Record Qualifier,DM,SBSTRAIN,Strain/Substrain Details,Char,SBSTRAIN,"Free-text field that allows the sponsor 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).",17,Special-Purpose,Perm,,
Record Qualifier,DM,ARMCD,Planned Arm Code,Char,ARMCD,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.,18,Special-Purpose,Exp,,
Synonym Qualifier,DM,ARM,Description of Planned Arm,Char,ARM,"Descriptive name given to a specific Trial Arm (e.g., Low Dose, Mid Dose, 10 mg/kg/day dose, Third Arm) to which the subject was assigned.",19,Special-Purpose,Perm,,
Record Qualifier,DM,SETCD,Set Code,Char,SETCD,"Short name of a specific Trial Set to which the subject was assigned, as defined by the sponsor. Maximum of 8 characters. This represents the Trial Set for which parameters are being submitted.",20,Special-Purpose,Req,,
Identifier,SE,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Special-Purpose,Req,,
Identifier,SE,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Special-Purpose,Req,SE,
Identifier,SE,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Special-Purpose,Req,,
Identifier,SE,SESEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a USUBJID within a domain. May be any valid number.,4,Special-Purpose,Req,,SE
Topic,SE,ETCD,Element Code,Char,ETCD,ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions.,5,Special-Purpose,Req,,
Synonym Qualifier,SE,ELEMENT,Description of Element,Char,ELEMENT,The name of the Element..,6,Special-Purpose,Perm,,
Timing,SE,SESTDTC,Start Date/Time of Element,Char,STDTC,"Start date/time for an Element for each subject, in ISO 8601 format.",7,Special-Purpose,Req,ISO 8601,SE
Timing,SE,SEENDTC,End Date/Time of Element,Char,ENDTC,"End date/time for an Element for each subject, in ISO 8601 format.",8,Special-Purpose,Exp,ISO 8601,SE
Synonym Qualifier,SE,SEUPDES,Description of Unplanned Element,Char,UPDES,Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of UNPLAN.,9,Special-Purpose,Perm,,SE
Identifier,EX,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Interventions,Req,,
Identifier,EX,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Interventions,Req,EX,
Identifier,EX,USUBJID,Unique Subject Identifier,Char,USUBJID,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.,3,Interventions,Exp,,
Identifier,EX,POOLID,Pool Identifier,Char,POOLID,"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.",4,Interventions,Perm,,
Identifier,EX,FOCID,Focus of Study-Specific Interest,Char,FOCID,"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.",5,Interventions,Perm,,
Identifier,EX,EXSEQ,Sequence Number,Num,SEQ,"The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.",6,Interventions,Req,,EX
Topic,EX,EXTRT,Name of Actual Treatment,Char,TRT,"Name of the treatment, as defined by the protocol.",7,Interventions,Req,,EX
Record Qualifier,EX,EXDOSE,Dose per Administration,Num,DOSE,Amount of treatment administered.,8,Interventions,Exp,,EX
Record Qualifier,EX,EXDOSTXT,Dose Description,Char,DOSTXT,"If the amount of treatment administered cannot be represented as a number and populated in EXDOSE, this field is used to describe the amount of treatment administered. Example: 200-400.",9,Interventions,Perm,,EX
Variable Qualifier,EX,EXDOSU,Dose Units,Char,DOSU,"Units for EXDOSE or EXDOSTXT. Examples: ng, mg, or mg/kg.",10,Interventions,Exp,(UNIT),EX
Variable Qualifier,EX,EXDOSFRM,Dose Form,Char,DOSFRM,"Dose form for treatment (form administered). Examples: TABLET, LOTION.",11,Interventions,Exp,(FRM),EX
Variable Qualifier,EX,EXDOSFRQ,Dosing Frequency Per Interval,Char,DOSFRQ,"Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: QD (once daily), BID (2x daily).",12,Interventions,Req,(FREQ),EX
Variable Qualifier,EX,EXROUTE,Route of Administration,Char,ROUTE,"Route of administration for EXTRT. Examples: ORAL GAVAGE, DERMAL, INTRAVENOUS.",13,Interventions,Req,(ROUTE),EX
Record Qualifier,EX,EXLOT,Lot Number,Char,LOT,"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.",14,Interventions,Exp,,EX
Record Qualifier,EX,EXLOC,Location of Dose Administration,Char,LOC,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.,15,Interventions,Perm,,EX
Record Qualifier,EX,EXMETHOD,Method of Administration,Char,METHOD,Method of the dose administration. Example: INFUSION.,16,Interventions,Perm,,EX
Record Qualifier,EX,EXTRTV,Treatment Vehicle,Char,TRTV,Describes vehicle used for treatment. Example: SALINE.,17,Interventions,Exp,,EX
Record Qualifier,EX,EXVAMT,Amount Administered,Num,VAMT,The amount (volume or weight) of the treatment compound 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.,18,Interventions,Perm,,EX
Variable Qualifier,EX,EXVAMTU,Amount Administered Units,Char,VAMTU,Units for EXVAMT (per dose administration).,19,Interventions,Perm,(UNIT),EX
Record Qualifier,EX,EXADJ,Reason for Dose Adjustment,Char,ADJ,"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).",20,Interventions,Perm,,EX
Timing,EX,EXSTDTC,Start Date/Time of Treatment,Char,STDTC,"Date/Time when administration of the treatment indicated by EXTRT and EXDOSE began, in ISO 8601 format.",21,Interventions,Exp,ISO 8601,EX
Timing,EX,EXENDTC,End Date/Time of Treatment,Char,ENDTC,"Date/Time when administration of the treatment indicated by EXTRT and EXDOSE ended, in ISO 8601 format.",22,Interventions,Perm,ISO 8601,EX
Timing,EX,EXSTDY,Study Day of Start of Treatment,Num,STDY,"Study day when administration of the treatment began, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",23,Interventions,Perm,,EX
Timing,EX,EXENDY,Study Day of End of Treatment,Num,ENDY,"Study day when administration of the treatment ended, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",24,Interventions,Perm,,EX
Timing,EX,EXDUR,Duration of Treatment,Char,DUR,"Duration and unit of time for a continuous treatment. This may be used to denote the length of an infusion (e.g., PT10M to indicate 10 minutes).",25,Interventions,Perm,ISO 8601,EX
Timing,EX,EXTPT,Planned Time Point Name,Char,TPT,"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.",26,Interventions,Perm,,EX
Timing,EX,EXTPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of EXTPT to aid in sorting.,27,Interventions,Perm,,EX
Timing,EX,EXELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,"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.",28,Interventions,Perm,ISO 8601,EX
Timing,EX,EXTPTREF,Time Point Reference,Char,TPTREF,"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.",29,Interventions,Perm,,EX
Timing,EX,EXRFTDTC,Date/Time of Reference Time Point,Char,RFTDTC,"Date/Time of the reference time point, EXTPTREF.",30,Interventions,Perm,ISO 8601,EX
Identifier,DS,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Events,Req,,
Identifier,DS,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Events,Req,DS,
Identifier,DS,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Events,Req,,
Identifier,DS,DSSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Events,Req,,DS
Topic,DS,DSTERM,Reported Term for the Disposition Event,Char,TERM,"DSTERM is the original term recorded for subject disposition. DSTERM is not under controlled terminology, but should be mapped to DSDECOD.",5,Events,Req,,DS
Synonym Qualifier,DS,DSDECOD,Standardized Disposition Term,Char,DECOD,Contains the result in a standard format.,6,Events,Req,(DSDECOD),DS
Record Qualifier,DS,DSUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",7,Events,Exp,(NY),DS
Timing,DS,VISITDY,Planned Study Day of Disposition,Num,VISITDY,Planned study day of collection. Should be an integer. VISITDY should be populated only when DSTERM represents a scheduled activity.,8,Events,Perm,,
Timing,DS,DSSTDTC,Date/Time of Disposition,Char,STDTC,"Date/Time of the disposition event, in ISO 8601 format.",9,Events,Req,ISO 8601,DS
Timing,DS,DSSTDY,Study Day of Disposition,Num,STDY,"Study day of the disposition event, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",10,Events,Perm,,DS
Timing,DS,DSNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,11,Events,Exp,,DS
Timing,DS,DSNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac.",12,Events,Perm,,DS
Identifier,BG,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,BG,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,BG,
Identifier,BG,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,BG,BGSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,BG
Topic,BG,BGTESTCD,Test Short Name,Char,TESTCD,"Short name of the measurement, test, or examination described in BGTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in BGTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., ""1TEST"" is not valid). BGTESTCD cannot contain characters other than letters, numbers, or underscores.",5,Findings,Req,(BGTESTCD),BG
Synonym Qualifier,BG,BGTEST,Test Name,Char,TEST,Long name for BGTESTCD. The value in BGTEST cannot be longer than 40 characters.,6,Findings,Req,(BGTEST),BG
Result Qualifier,BG,BGORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,7,Findings,Exp,,BG
Variable Qualifier,BG,BGORRESU,Unit of the Original Result,Char,ORRESU,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.,8,Findings,Exp,(UNIT),BG
Result Qualifier,BG,BGSTRESC,Standardized Result in Character Format,Char,STRESC,"Contains the result value for all findings, copied or derived from BGORRES in a standard format or standard units. BGSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in BGSTRESN.",9,Findings,Exp,,BG
Result Qualifier,BG,BGSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of BGSTRESC. BGSTRESN should store all numeric test results or findings.,10,Findings,Exp,,BG
Variable Qualifier,BG,BGSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for BGSTRESC and BGSTRESN.,11,Findings,Exp,(UNIT),BG
Record Qualifier,BG,BGSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in BGORRES.,12,Findings,Perm,(ND),BG
Record Qualifier,BG,BGREASND,Reason Not Done,Char,REASND,"Describes why BGSTAT is NOT DONE, such as MISSING BODY WEIGHT.",13,Findings,Perm,,BG
Record Qualifier,BG,BGEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",14,Findings,Perm,(NY),BG
Record Qualifier,BG,BGREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when BGEXCLFL is Y.,15,Findings,Perm,,BG
Timing,BG,BGDTC,Date/Time Animal Weighed,Char,DTC,"Date/Time of the start of the weight interval, in ISO 8601 format.",16,Findings,Exp,ISO 8601,BG
Timing,BG,BGENDTC,End Date/Time Animal Weighed,Char,ENDTC,"Date/Time of the end of the weight interval, in ISO 8601 format.",17,Findings,Exp,ISO 8601,BG
Timing,BG,BGDY,Study Day of Start of Interval,Num,DY,"Study day of the start of the weight interval, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",18,Findings,Perm,,BG
Timing,BG,BGENDY,Study Day of End of Weight Interval,Num,ENDY,"Study day of the end of the weight interval, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",19,Findings,Perm,,BG
Identifier,BW,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,BW,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,BW,
Identifier,BW,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,BW,BWSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,BW
Topic,BW,BWTESTCD,Test Short Name,Char,TESTCD,"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.",5,Findings,Req,(BWTESTCD),BW
Synonym Qualifier,BW,BWTEST,Test Name,Char,TEST,Long name for BWTESTCD. The value in BWTEST cannot be longer than 40 characters.,6,Findings,Req,(BWTEST),BW
Result Qualifier,BW,BWORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,7,Findings,Exp,,BW
Variable Qualifier,BW,BWORRESU,Unit of the Original Result,Char,ORRESU,The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list.,8,Findings,Exp,(UNIT),BW
Result Qualifier,BW,BWSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",9,Findings,Exp,,BW
Result Qualifier,BW,BWSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of BWSTRESC. BWSTRESN should store all numeric test results or findings.,10,Findings,Exp,,BW
Variable Qualifier,BW,BWSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for BWSTRESC and BWSTRESN.,11,Findings,Exp,(UNIT),BW
Record Qualifier,BW,BWSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in BWORRES.,12,Findings,Perm,(ND),BW
Record Qualifier,BW,BWREASND,Reason Not Done,Char,REASND,"Describes why BWSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT.",13,Findings,Perm,,BW
Record Qualifier,BW,BWBLFL,Baseline Flag,Char,BLFL,A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined.,14,Findings,Exp,(NY),BW
Record Qualifier,BW,BWFAST,Fasting Status,Char,FAST,Indicator used to identify fasting status. The value should by Y or null.,15,Findings,Perm,(NY),BW
Record Qualifier,BW,BWEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",16,Findings,Perm,(NY),BW
Record Qualifier,BW,BWREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when BWEXCLFL is Y.,17,Findings,Perm,,BW
Record Qualifier,BW,BWUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",18,Findings,Perm,(NY),BW
Timing,BW,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned study day of collection. Should be an integer.,19,Findings,Perm,,
Timing,BW,BWDTC,Date/Time Animal Weighed,Char,DTC,Date/Time of body weight collection in ISO 8601 format.,20,Findings,Exp,ISO 8601,BW
Timing,BW,BWDY,Study Day Animal Weighed,Num,DY,"Study day of body weight collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",21,Findings,Perm,,BW
Timing,BW,BWNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,22,Findings,Exp,,BW
Timing,BW,BWNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of BWNOMDY as presented in the study report. Examples: ""Week 4,"" ""Day 28,"" ""Terminal Sac"".",23,Findings,Perm,,BW
Identifier,CL,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,CL,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,CL,
Identifier,CL,USUBJID,Unique Subject Identifier,Char,USUBJID,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.,3,Findings,Exp,,
Identifier,CL,POOLID,Pool Identifier,Char,POOLID,"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.",4,Findings,Perm,,
Identifier,CL,FOCID,Focus of Study-Specific Interest,Char,FOCID,"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.",5,Findings,Perm,,
Identifier,CL,CLSEQ,Sequence Number,Num,SEQ,"The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.",6,Findings,Req,,CL
Identifier,CL,CLGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.,7,Findings,Perm,,CL
Identifier,CL,CLSPID,Mass Identifier,Char,SPID,"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.",8,Findings,Perm,,CL
Topic,CL,CLTESTCD,Test Short Name,Char,TESTCD,"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.",9,Findings,Req,,CL
Synonym Qualifier,CL,CLTEST,Test Name,Char,TEST,Long name for CLTESTCD. The value in CLTEST cannot be longer than 40 characters.,10,Findings,Req,,CL
Grouping Qualifier,CL,CLCAT,Category for Clinical Observations,Char,CAT,Used to define a category of the clinical observation.,11,Findings,Req,(CLCAT),CL
Grouping Qualifier,CL,CLSCAT,Subcategory for Clinical Observations,Char,SCAT,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.,12,Findings,Perm,,CL
Record Qualifier,CL,CLBODSYS,Body System or Organ Class,Char,BODSYS,Body system or organ class associated with the measurement performed.,13,Findings,Perm,(BODSYS),CL
Result Qualifier,CL,CLORRES,Result or Findings as Collected,Char,ORRES,"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.",14,Findings,Exp,,CL
Result Qualifier,CL,CLSTRESC,Standardized Result in Character Format,Char,STRESC,"The base finding from CLORRES without modifiers. If the examination was completed and there were no abnormal findings, the value must be NORMAL.",15,Findings,Exp,,CL
Variable Qualifier,CL,CLRESCAT,Result Category,Char,RESCAT,Used to categorize the result of a finding post collection. Examples: Color or Facial.,16,Findings,Perm,,CL
Record Qualifier,CL,CLSTAT,Completion Status,Char,STAT,Used to indicate examination not done or result is missing. Should be null if a result exists in CLORRES.,17,Findings,Perm,(ND),CL
Record Qualifier,CL,CLREASND,Reason Not Done,Char,REASND,"Describes why CLSTAT is NOT DONE, such as SUBJECT MORIBUND.",18,Findings,Perm,,CL
Record Qualifier,CL,CLLOC,Location of a Finding,Char,LOC,Can be used to specify where a clinical sign occurred. Example: LEFT EAR for skin rash.,19,Findings,Exp,,CL
Record Qualifier,CL,CLEVAL,Evaluator,Char,EVAL,"Role of the person who provided the evaluation. Example: TOX TECHNICIAN, OPHTHALMOLOGIST, VETERINARIAN.",20,Findings,Perm,,CL
Record Qualifier,CL,CLSEV,Severity,Char,SEV,Describes the severity or intensity of a particular finding.,21,Findings,Perm,,CL
Record Qualifier,CL,CLEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",22,Findings,Perm,(NY),CL
Record Qualifier,CL,CLREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when CLEXCLFL is Y.,23,Findings,Perm,,CL
Record Qualifier,CL,CLUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",24,Findings,Perm,(NY),CL
Timing,CL,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned study day of collection. Should be an integer.,25,Findings,Perm,,
Timing,CL,CLDTC,Date/Time of Observation,Char,DTC,"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.",26,Findings,Exp,ISO 8601,CL
Timing,CL,CLENDTC,End Date/Time of Observation,Char,ENDTC,"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.",27,Findings,Perm,ISO 8601,CL
Timing,CL,CLDY,Study Day of Observation,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",28,Findings,Perm,,CL
Timing,CL,CLENDY,Study Day of End of Observation,Num,ENDY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",29,Findings,Perm,,CL
Timing,CL,CLNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,30,Findings,Exp,,CL
Timing,CL,CLNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of CLNOMDY as presented in the study report. Examples: ""Week 4,"" ""Day 28,"" ""Terminal Sac"".",31,Findings,Perm,,CL
Timing,CL,CLTPT,Planned Time Point Name,Char,TPT,"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.",32,Findings,Perm,,CL
Timing,CL,CLTPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of CLTPT to aid in sorting.,33,Findings,Perm,,CL
Timing,CL,CLELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,"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.",34,Findings,Perm,ISO 8601,CL
Timing,CL,CLTPTREF,Time Point Reference,Char,TPTREF,"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.",35,Findings,Perm,,CL
Timing,CL,CLRFTDTC,Date/Time of Reference Time Point,Char,RFTDTC,"Date/Time of the reference time point, CLTPTREF.",36,Findings,Perm,ISO 8601,CL
Identifier,CV,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,CV,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,CV,
Identifier,CV,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product.,3,Findings,Req,,
Identifier,CV,CVSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,CV
Identifier,CV,CVGRPID,Group Identifier,Char,GRPID,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 treatment group number.,5,Findings,Perm,,CV
Identifier,CV,CVSPID,Sponsor-Defined Identifier,Char,SPID,Sponsor-defined reference identifier,6,Findings,Perm,,CV
Topic,CV,CVTESTCD,Test Short Name,Char,TESTCD,"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.",7,Findings,Req,(SCVTSTCD),CV
Synonym Qualifier,CV,CVTEST,Test Name,Char,TEST,"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.",8,Findings,Req,(SCVTST),CV
Record Qualifier,CV,CVPOS,Position of Subject During Test,Char,POS,"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.",9,Findings,Exp,(POSITION),CV
Result Qualifier,CV,CVORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,10,Findings,Exp,,CV
Variable Qualifier,CV,CVORRESU,Unit of the Original Result,Char,ORRESU,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.,11,Findings,Exp,(UNIT),CV
Result Qualifier,CV,CVSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",12,Findings,Exp,,CV
Result Qualifier,CV,CVSTRESN,Standardized Result in Numeric Format,Num,STRESN,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.,13,Findings,Exp,,CV
Variable Qualifier,CV,CVSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for CVSTRESC and CVSTRESN.,14,Findings,Exp,(UNIT),CV
Record Qualifier,CV,CVSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in CVORRES.,15,Findings,Perm,(ND),CV
Record Qualifier,CV,CVREASND,Reason Not Done,Char,REASND,"Describes why CVSTAT is NOT DONE, such as BROKEN EQUIPMENT.",16,Findings,Perm,,CV
Record Qualifier,CV,CVMETHOD,Method of Test,Char,METHOD,"Method of the test or examination. Examples: Intravascular, External Cuff.",17,Findings,Exp,,CV
Record Qualifier,CV,CVCSTATE,Consciousness State,Char,CSTATE,"Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS.",18,Findings,Exp,(CSTATE),CV
Record Qualifier,CV,CVBLFL,Baseline Flag,Char,BLFL,A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined.,19,Findings,Exp,(NY),CV
Record Qualifier,CV,CVDRVFL,Derived Flag,Char,DRVFL,Used to indicate a derived record. The value should be Y or null.,20,Findings,Perm,(NY),CV
Record Qualifier,CV,CVEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",21,Findings,Perm,(NY),CV
Record Qualifier,CV,CVREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when CVEXCLFL is Y.,22,Findings,Perm,,CV
Record Qualifier,CV,CVUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",23,Findings,Perm,(NY),CV
Timing,CV,CVDTC,Date/Time of Cardiovascular Test,Char,DTC,"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.",24,Findings,Exp,ISO 8601,CV
Timing,CV,CVENDTC,End Date/Time of Cardiovascular Test,Char,ENDTC,"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.",25,Findings,Perm,ISO 8601,CV
Timing,CV,CVDY,Study Day of Cardiovascular Test,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",26,Findings,Perm,,CV
Timing,CV,CVENDY,Study Day of End of Cardiovascular Test,Num,ENDY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",27,Findings,Perm,,CV
Timing,CV,CVNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,28,Findings,Exp,,CV
Timing,CV,CVNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of CVNOMDY as presented in the study report Examples: Pretreatment, Week 4, Day 28.",29,Findings,Perm,,CV
Timing,CV,CVTPT,Planned Time Point Name,Char,TPT,"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.",30,Findings,Exp,,CV
Timing,CV,CVTPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of CVTPT to aid in sorting.,31,Findings,Exp,,CV
Timing,CV,CVELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,"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.",32,Findings,Exp,ISO 8601,CV
Timing,CV,CVTPTREF,Time Point Reference,Char,TPTREF,"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.",33,Findings,Exp,,CV
Timing,CV,CVRFTDTC,Date/Time of Reference Time Point,Char,RFTDTC,"Date/Time of the reference time point, CVTPTREF.",34,Findings,Perm,ISO 8601,CV
Timing,CV,CVEVLINT,Evaluation Interval,Char,EVLINT,Length of evaluation interval in ISO 8601 duration format. Used in place of CVSTINT and CVENINT when CVTPTREF is not available.,35,Findings,Perm,ISO 8601,CV
Timing,CV,CVSTINT,Planned Start of Assessment Interval,Char,STINT,"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.",36,Findings,Exp,ISO 8601,CV
Timing,CV,CVENINT,Planned End of Assessment Interval,Char,ENINT,"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.",37,Findings,Exp,ISO 8601,CV
Identifier,DD,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,DD,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,DD,
Identifier,DD,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,DD,DDSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,DD
Topic,DD,DDTESTCD,Death Diagnosis Short Name,Char,TESTCD,"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.",5,Findings,Req,(DDTESTCD),DD
Synonym Qualifier,DD,DDTEST,Death Diagnosis Name,Char,TEST,Long name for DDTESTCD. The value in DDTEST cannot be longer than 40 characters.,6,Findings,Req,(DDTEST),DD
Result Qualifier,DD,DDORRES,Result or Findings as Collected,Char,ORRES,"Result of the diagnosis of the subject's cause of death, as originally received or collected.",7,Findings,Req,,DD
Result Qualifier,DD,DDSTRESC,Standardized Result in Character Format,Char,STRESC,"Contains the diagnosis information, copied or derived from DDORRES in a standard format. Examples: UNKNOWN, GAVAGE ERROR.",8,Findings,Exp,,DD
Variable Qualifier,DD,DDRESCAT,Result Category,Char,RESCAT,"Used to categorize the result of a finding. Examples: TREATMENT RELATED, NONTREATMENT RELATED, UNDETERMINED, ACCIDENTAL, etc.",9,Findings,Perm,,DD
Record Qualifier,DD,DDEVAL,Evaluator,Char,EVAL,"Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, SPONSOR, VETERINARIAN.",10,Findings,Perm,,DD
Timing,DD,DDDTC,Date/Time,Char,DTC,"The date/time of subject disposition, in ISO 8601 format.",11,Findings,Perm,ISO 8601,DD
Timing,DD,DDDY,Study Day,Num,DY,"Study day of subject disposition, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",12,Findings,Perm,,DD
Identifier,EG,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,EG,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,EG,
Identifier,EG,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,EG,EGSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,EG
Identifier,EG,EGGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.,5,Findings,Perm,,EG
Identifier,EG,EGREFID,ECG Reference Identifier,Char,REFID,Internal or external ECG identifier. Example: UUID.,6,Findings,Perm,,EG
Identifier,EG,EGSPID,Sponsor-Defined Identifier,Char,SPID,Sponsor-defined reference identifier.,7,Findings,Perm,,EG
Topic,EG,EGTESTCD,ECG Test Short Name,Char,TESTCD,"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.",8,Findings,Req,(EGTESTCD),EG
Synonym Qualifier,EG,EGTEST,ECG Test Name,Char,TEST,"Long name for EGTESTCD. The value in EGTEST cannot be longer than 40 characters. Examples: ECG Mean Heart Rate, Summary (Max) QT Duration.",9,Findings,Req,(EGTEST),EG
Grouping Qualifier,EG,EGCAT,Category for ECG,Char,CAT,"Used to define a category of the ECG test performed. Examples: MEASUREMENT, DIAGNOSIS, INTERPRETATION.",10,Findings,Perm,(EGCATSND),EG
Record Qualifier,EG,EGPOS,ECG Position of Subject,Char,POS,"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.",11,Findings,Exp,(POSITION),EG
Result Qualifier,EG,EGORRES,Result or Findings as Collected,Char,ORRES,Result of the ECG measurement or finding as originally received or collected.,12,Findings,Exp,,EG
Variable Qualifier,EG,EGORRESU,Unit of the Original Result,Char,ORRESU,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.,13,Findings,Exp,(UNIT),EG
Result Qualifier,EG,EGSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",14,Findings,Exp,(EGSTRESC),EG
Result Qualifier,EG,EGSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of EGSTRESC. EGSTRESN should store all numeric test results or findings.,15,Findings,Exp,,EG
Variable Qualifier,EG,EGSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for EGSTRESC and EGSTRESN.,16,Findings,Exp,(UNIT),EG
Record Qualifier,EG,EGSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in EGORRES.,17,Findings,Perm,(ND),EG
Record Qualifier,EG,EGREASND,Reason Not Done,Char,REASND,"Describes why EGSTAT is NOT DONE, such as BROKEN EQUIPMENT.",18,Findings,Perm,,EG
Record Qualifier,EG,EGXFN,ECG External File Name,Char,XFN,File name and path for the external ECG Waveform file. Would be used if sponsor is requested to submit waveform.,19,Findings,Perm,,EG
Record Qualifier,EG,EGNAM,Laboratory Name,Char,NAM,Name or identifier of the laboratory or vendor that provided the test results.,20,Findings,Perm,,EG
Record Qualifier,EG,EGMETHOD,Method of ECG Test,Char,METHOD,"Method of the test or examination. Examples: 12 LEAD STANDARD, 6 LEAD STANDARD.",21,Findings,Exp,(EGMETHOD),EG
Record Qualifier,EG,EGLEAD,Lead Used for Measurement,Char,LEAD,Lead identified to capture the measurement.,22,Findings,Exp,(EGLEAD),EG
Record Qualifier,EG,EGCSTATE,Consciousness State,Char,CSTATE,"Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS.",23,Findings,Exp,(CSTATE),EG
Record Qualifier,EG,EGBLFL,Baseline Flag,Char,BLFL,A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined.,24,Findings,Exp,(NY),EG
Record Qualifier,EG,EGDRVFL,Derived Flag,Char,DRVFL,"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.",25,Findings,Perm,(NY),EG
Record Qualifier,EG,EGEVAL,Evaluator,Char,EVAL,"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.",26,Findings,Perm,,EG
Record Qualifier,EG,EGEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",27,Findings,Perm,(NY),EG
Record Qualifier,EG,EGREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when EGEXCLFL is Y.,28,Findings,Perm,,EG
Record Qualifier,EG,EGUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",29,Findings,Perm,(NY),EG
Timing,EG,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned study day of collection. Should be an integer.,30,Findings,Perm,,
Timing,EG,EGDTC,Date/Time of ECG Collection,Char,DTC,"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.",31,Findings,Exp,ISO 8601,EG
Timing,EG,EGENDTC,End Date/Time of ECG Collection,Char,ENDTC,"Date/Time of end of the ECG data collection, in ISO 8601 format. Should be populated for measurement over a continuous period only.",32,Findings,Perm,ISO 8601,EG
Timing,EG,EGDY,Study Day of ECG Collection,Num,DY,"Study day of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",33,Findings,Perm,,EG
Timing,EG,EGENDY,Study Day of End of ECG Collection,Num,ENDY,"Study day of the end of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",34,Findings,Perm,,EG
Timing,EG,EGNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,35,Findings,Exp,,EG
Timing,EG,EGNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of EGNOMDY as presented in the study report. Examples: Pre-Treatment, Week 4, Day 28.",36,Findings,Perm,,EG
Timing,EG,EGTPT,Planned Time Point Name,Char,TPT,"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.",37,Findings,Perm,,EG
Timing,EG,EGTPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of EGTPT to aid in sorting.,38,Findings,Perm,,EG
Timing,EG,EGELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,"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.",39,Findings,Perm,ISO 8601,EG
Timing,EG,EGTPTREF,Time Point Reference,Char,TPTREF,"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.",40,Findings,Perm,,EG
Timing,EG,EGRFTDTC,Date/Time of Reference Time Point,Char,RFTDTC,"Date/Time of the reference time point, EGTPTREF.",41,Findings,Perm,ISO 8601,EG
Timing,EG,EGEVLINT,Evaluation Interval,Char,EVLINT,Length of evaluation interval in ISO 8601 duration format. Used in place of EGSTINT and EGENINT when EGTPTREF is not available.,42,Findings,Perm,ISO 8601,EG
Timing,EG,EGSTINT,Planned Start of Assessment Interval,Char,STINT,Planned Start of an asessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format.,43,Findings,Perm,ISO 8601,EG
Timing,EG,EGENINT,Planned End of Assessment Interval,Char,ENINT,Planned End of an assessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format.,44,Findings,Perm,ISO 8601,EG
Identifier,FW,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,FW,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,FW,
Identifier,FW,USUBJID,Unique Subject Identifier,Char,USUBJID,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.,3,Findings,Exp,,
Identifier,FW,POOLID,Pool Identifier,Char,POOLID,"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.",4,Findings,Perm,,
Identifier,FW,FWSEQ,Sequence Number,Num,SEQ,"The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.",5,Findings,Req,,FW
Identifier,FW,FWGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.,6,Findings,Perm,,FW
Topic,FW,FWTESTCD,Food/Water Consumption Short Name,Char,TESTCD,"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.",7,Findings,Req,(FWTESTCD),FW
Synonym Qualifier,FW,FWTEST,Food/Water Consumption Name,Char,TEST,"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.",8,Findings,Req,(FWTEST),FW
Result Qualifier,FW,FWORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,9,Findings,Exp,,FW
Variable Qualifier,FW,FWORRESU,Unit of the Original Result,Char,ORRESU,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.,10,Findings,Exp,(UNIT),FW
Result Qualifier,FW,FWSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",11,Findings,Exp,,FW
Result Qualifier,FW,FWSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of FWSTRESC. FWSTRESN should store all numeric test results or findings.,12,Findings,Exp,,FW
Variable Qualifier,FW,FWSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for FWSTRESC and FWSTRESN.,13,Findings,Exp,(UNIT),FW
Record Qualifier,FW,FWSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in FWORRES.,14,Findings,Perm,(ND),FW
Record Qualifier,FW,FWREASND,Reason Not Done,Char,REASND,"Describes why FWSTAT is NOT DONE, such as FOOD WET.",15,Findings,Perm,,FW
Record Qualifier,FW,FWEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",16,Findings,Perm,(NY),FW
Record Qualifier,FW,FWREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when FWEXCLFL is Y.,17,Findings,Perm,,FW
Timing,FW,FWDTC,Start Date/Time of Observation,Char,DTC,Date/Time of the start of the observation in IS0 8601 format.,18,Findings,Exp,ISO 8601,FW
Timing,FW,FWENDTC,End Date/Time of Observation,Char,ENDTC,Date/Time of the end of the observation in IS0 8601 format.,19,Findings,Exp,ISO 8601,FW
Timing,FW,FWDY,Study Day of Start of Observation,Num,DY,"Study day of the start of the observation, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",20,Findings,Perm,,FW
Timing,FW,FWENDY,Study Day of End of Observation,Num,ENDY,"Study day of the end of the observation, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",21,Findings,Perm,,FW
Identifier,LB,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,LB,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,LB,
Identifier,LB,USUBJID,Unique Subject Identifier,Char,USUBJID,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.,3,Findings,Exp,,
Identifier,LB,POOLID,Pool Identifier,Char,POOLID,"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.",4,Findings,Perm,,
Identifier,LB,LBSEQ,Sequence Number,Num,SEQ,"The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.",5,Findings,Req,,LB
Identifier,LB,LBGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.,6,Findings,Perm,,LB
Identifier,LB,LBREFID,Specimen Identifier,Char,REFID,Internal or external specimen identifier. Example: 1009570101.,7,Findings,Perm,,LB
Identifier,LB,LBSPID,Sponsor-Defined Identifier,Char,SPID,Sponsor-defined reference identifier. Example: Line number on the Lab page.,8,Findings,Perm,,LB
Topic,LB,LBTESTCD,Lab Test or Examination Short Name,Char,TESTCD,"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.",9,Findings,Req,(LBTESTCD),LB
Synonym Qualifier,LB,LBTEST,Lab Test or Examination Name,Char,TEST,"Long name for LBTESTCD. The value in LBTEST cannot be longer than 40 characters. Examples: Alanine Aminotransferase, Lactate Dehydrogenase.",10,Findings,Req,(LBTEST),LB
Grouping Qualifier,LB,LBCAT,Category for Lab Test,Char,CAT,"Used to define a category of the lab test performed. Examples: URINALYSIS, CLINICAL CHEMISTRY, HEMATOLOGY, etc.",11,Findings,Exp,,LB
Grouping Qualifier,LB,LBSCAT,Subcategory for Lab Test,Char,SCAT,"A further categorization of a test category. Examples: DIFFERENTIAL, LIVER FUNCTION, ELECTROLYTES.",12,Findings,Perm,,LB
Result Qualifier,LB,LBORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,13,Findings,Exp,,LB
Variable Qualifier,LB,LBORRESU,Unit of the Original Result,Char,ORRESU,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.,14,Findings,Exp,(UNIT),LB
Variable Qualifier,LB,LBORNRLO,Reference Range Lower Limit-Orig Unit,Char,ORNRLO,Lower end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results.,15,Findings,Perm,,LB
Variable Qualifier,LB,LBORNRHI,Reference Range Upper Limit-Orig Unit,Char,ORNRHI,Upper end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results.,16,Findings,Perm,,LB
Result Qualifier,LB,LBSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",17,Findings,Exp,,LB
Result Qualifier,LB,LBSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of LBSTRESC. LBSTRESN should store all numeric test results or findings.,18,Findings,Exp,,LB
Variable Qualifier,LB,LBSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for LBSTRESC and LBSTRESN.,19,Findings,Exp,(UNIT),LB
Variable Qualifier,LB,LBSTNRLO,Reference Range Lower Limit-Std Unit,Num,STNRLO,Lower end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.,20,Findings,Perm,,LB
Variable Qualifier,LB,LBSTNRHI,Reference Range Upper Limit-Std Unit,Num,STNRHI,Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.,21,Findings,Perm,,LB
Variable Qualifier,LB,LBSTNRC,Reference Range for Char Rslt-Std Unit,Char,STNRC,"For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., -1 to +1; NEGATIVE TO TRACE).",22,Findings,Perm,,LB
Variable Qualifier,LB,LBNRIND,Reference Range Indicator,Char,NRIND,"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 Sponsors 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.",23,Findings,Perm,,LB
Record Qualifier,LB,LBSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in LBORRES.,24,Findings,Perm,(ND),LB
Record Qualifier,LB,LBREASND,Reason Not Done,Char,REASND,"Describes why LBSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST.",25,Findings,Perm,,LB
Record Qualifier,LB,LBNAM,Laboratory Name,Char,NAM,Name or identifier of the laboratory or vendor that provided the test results.,26,Findings,Perm,,LB
Record Qualifier,LB,LBSPEC,Specimen Material Type,Char,SPEC,"Defines the type of specimen analyzed to obtain the measurement or finding. Examples: WHOLE BLOOD, SERUM, PLASMA, URINE, LIVER, HEART.",27,Findings,Exp,(SPEC),LB
Variable Qualifier,LB,LBANTREG,Anatomical Region of Specimen,Char,ANTREG,"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.",28,Findings,Perm,,LB
Record Qualifier,LB,LBSPCCND,Specimen Condition,Char,SPCCND,"Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC",29,Findings,Perm,,LB
Record Qualifier,LB,LBSPCUFL,Specimen Usability for the Test,Char,SPCUFL,Describes the usability of the specimen for the test. Should be N if the specimen is not usable; otherwise it should be null.,30,Findings,Perm,(NY),LB
Record Qualifier,LB,LBLOC,Specimen Collection Location,Char,LOC,Location relevant to the collection of specimen for the measurement.,31,Findings,Perm,,LB
Variable Qualifier,LB,LBLAT,Specimen Laterality within Subject,Char,LAT,"Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.",32,Findings,Perm,(LAT),LB
Variable Qualifier,LB,LBDIR,Specimen Directionality within Subject,Char,DIR,"Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.",33,Findings,Perm,(DIR),LB
Variable Qualifier,LB,LBPORTOT,Portion or Totality,Char,PORTOT,"Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY.",34,Findings,Perm,(PORTOT),LB
Record Qualifier,LB,LBMETHOD,Method of Test or Examination,Char,METHOD,"Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK.",35,Findings,Exp,,LB
Record Qualifier,LB,LBBLFL,Baseline Flag,Char,BLFL,A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined.,36,Findings,Exp,(NY),LB
Record Qualifier,LB,LBFAST,Fasting Status,Char,FAST,Indicator used to identify fasting status. The value should be Y or null,37,Findings,Perm,(NY),LB
Record Qualifier,LB,LBDRVFL,Derived Flag,Char,DRVFL,"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.",38,Findings,Perm,(NY),LB
Variable Qualifier,LB,LBTOX,Toxicity,Char,TOX,"Description of toxicity quantified by LBTOXGR. The sponsor is expected to provide the name and version of the scale used to map the terms, utilizing the data definition file external codelist attributes.",39,Findings,Perm,,LB
Record Qualifier,LB,LBTOXGR,Standard Toxicity Grade,Char,TOXGR,"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 sponsor is expected to provide the name of the scale and version used to map the terms, utilizing the data definition file external codelist attributes.",40,Findings,Perm,,LB
Record Qualifier,LB,LBEXCLFL,Exclusion Flag,Char,EXCLFL,"""Y"" if the result should be excluded from all calculations, otherwise null.",41,Findings,Perm,(NY),LB
Record Qualifier,LB,LBREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when LBEXCLFL is "Y".,42,Findings,Perm,,LB
Record Qualifier,LB,LBUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",43,Findings,Exp,(NY),LB
Timing,LB,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned study day of specimen collection. Should be an integer.,44,Findings,Perm,,
Timing,LB,LBDTC,Date/Time of Specimen Collection,Char,DTC,"Date/Time of specimen collection, in IS0 8601 format.",45,Findings,Exp,ISO 8601,LB
Timing,LB,LBENDTC,End Date/Time of Specimen Collection,Char,ENDTC,Date/Time of the end of specimen collection in ISO 8601 format. Should be populated only for continuous sample collection.,46,Findings,Perm,ISO 8601,LB
Timing,LB,LBDY,Study Day of Specimen Collection,Num,DY,"Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",47,Findings,Perm,,LB
Timing,LB,LBENDY,Study Day of End of Specimen Collection,Num,ENDY,"Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",48,Findings,Perm,,LB
Timing,LB,LBNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,49,Findings,Exp,,LB
Timing,LB,LBNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of LBNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac.",50,Findings,Perm,,LB
Timing,LB,LBTPT,Planned Time Point Name,Char,TPT,"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.",51,Findings,Perm,,LB
Timing,LB,LBTPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of LBTPT to aid in sorting.,52,Findings,Perm,,LB
Timing,LB,LBELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,"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.",53,Findings,Perm,ISO 8601,LB
Timing,LB,LBTPTREF,Time Point Reference,Char,TPTREF,"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.",54,Findings,Perm,,LB
Timing,LB,LBRFTDTC,Date/Time of Reference Time Point,Char,RFTDTC,"Date/Time of the reference time point, LBTPTREF",55,Findings,Perm,ISO 8601,LB
Identifier,MA,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,MA,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character code for the domain.,2,Findings,Req,MA,
Identifier,MA,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,MA,FOCID,Focus of Study-Specific Interest,Char,FOCID,"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.",4,Findings,Perm,,
Identifier,MA,MASEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,5,Findings,Req,,MA
Identifier,MA,MAGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.,6,Findings,Perm,,MA
Identifier,MA,MAREFID,Specimen Reference Identifier,Char,REFID,Internal or external specimen identifier. Example: 1009570101.,7,Findings,Perm,,MA
Identifier,MA,MASPID,Mass Identifier,Char,SPID,"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.",8,Findings,Perm,,MA
Topic,MA,MATESTCD,Macroscopic Examination Short Name,Char,TESTCD,"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.",9,Findings,Req,(MATESTCD),MA
Synonym Qualifier,MA,MATEST,Macroscopic Examination Name,Char,TEST,"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.",10,Findings,Req,(MATEST),MA
Record Qualifier,MA,MABODSYS,Body System or Organ Class,Char,BODSYS,Body system or organ class associated with the specimen examined.,11,Findings,Perm,(BODSYS),MA
Result Qualifier,MA,MAORRES,Result or Findings as Collected,Char,ORRES,"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.",12,Findings,Exp,,MA
Result Qualifier,MA,MASTRESC,Standardized Result in Character Format,Char,STRESC,"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.",13,Findings,Exp,,MA
Record Qualifier,MA,MASTAT,Completion Status,Char,STAT,Used to indicate examination not done or result is missing. Should be null if a result exists in MAORRES.,14,Findings,Perm,(ND),MA
Record Qualifier,MA,MAREASND,Reason Not Done,Char,REASND,"Describes why MASTAT is NOT DONE. Example: Tissue not examined, Tissue Autolyzed.",15,Findings,Perm,,MA
Record Qualifier,MA,MANAM,Laboratory Name,Char,NAM,Name or identifier of the laboratory or vendor that provided the test results.,16,Findings,Perm,,MA
Record Qualifier,MA,MASPEC,Specimen Material Type,Char,SPEC,"Defines the type of tissue, organ, or fluid examined. Examples: GLAND, ADRENAL; KIDNEY; VESSEL, LYMPHATIC. See also Assumption 4.b.",17,Findings,Exp,(SPEC),MA
Variable Qualifier,MA,MAANTREG,Anatomical Region of Specimen,Char,ANTREG,"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.",18,Findings,Perm,,MA
Record Qualifier,MA,MASPCCND,Specimen Condition,Char,SPCCND,Free or standardized text describing the condition of the specimen. Example: AUTOLYZED.,19,Findings,Perm,,MA
Record Qualifier,MA,MASPCUFL,Specimen Usability for the Test,Char,SPCUFL,Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null.,20,Findings,Perm,(NY),MA
Variable Qualifier,MA,MALAT,Specimen Laterality within Subject,Char,LAT,"Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.",21,Findings,Perm,(LAT),MA
Variable Qualifier,MA,MADIR,Specimen Directionality within Subject,Char,DIR,"Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.",22,Findings,Perm,(DIR),MA
Variable Qualifier,MA,MAPORTOT,Portion or Totality,Char,PORTOT,"Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY.",23,Findings,Perm,(PORTOT),MA
Record Qualifier,MA,MAEVAL,Evaluator,Char,EVAL,"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, SPONSOR PATHOLOGIST.",24,Findings,Perm,,MA
Record Qualifier,MA,MASEV,Severity,Char,SEV,"Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE.",25,Findings,Perm,(SEV),MA
Record Qualifier,MA,MADTHREL,Relationship to Death,Char,DTHREL,"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.",26,Findings,Perm,(NY),MA
Timing,MA,MADTC,Date/Time,Char,DTC,"For a specimen collected or observed post mortem, this is the date/time of subject disposition in ISO 8601 format.",27,Findings,Perm,ISO 8601,MA
Timing,MA,MADY,Study Day,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",28,Findings,Perm,,MA
Identifier,MI,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,MI,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,MI,
Identifier,MI,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,MI,FOCID,Focus of Study-Specific Interest,Char,FOCID,"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.",4,Findings,Perm,,
Identifier,MI,MISEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,5,Findings,Req,,MI
Identifier,MI,MIGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.,6,Findings,Perm,,MI
Identifier,MI,MIREFID,Specimen Reference Identifier,Char,REFID,Internal or external specimen identifier. Example: Specimen barcode number.,7,Findings,Perm,,MI
Identifier,MI,MISPID,Mass Identifier,Char,SPID,"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.",8,Findings,Perm,,MI
Topic,MI,MITESTCD,Microscopic Examination Short Name,Char,TESTCD,"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).",9,Findings,Req,(MITESTCD),MI
Synonym Qualifier,MI,MITEST,Microscopic Examination Name,Char,TEST,Long name for MITESTCD. The value in MITEST cannot be longer than 40 characters. Extensible controlled value is Microscopic Examination.,10,Findings,Req,(MITEST),MI
Record Qualifier,MI,MIBODSYS,Body System or Organ Class,Char,BODSYS,Body system or organ class associated with the specimen examined.,11,Findings,Perm,(BODSYS),MI
Result Qualifier,MI,MIORRES,Result or Findings as Collected,Char,ORRES,"Microscopic finding as originally recorded, including all modifiers.",12,Findings,Exp,,MI
Result Qualifier,MI,MISTRESC,Standardized Result in Character Format,Char,STRESC,"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.",13,Findings,Exp,(NONNEO) \n (NEOPLASM),MI
Variable Qualifier,MI,MIRESCAT,Result Category,Char,RESCAT,Used to categorize the result of a finding. Example: MALIGNANT for tumor findings or NON-NEOPLASTIC for pathology findings.,14,Findings,Perm,(MIRESCAT),MI
Variable Qualifier,MI,MICHRON,Chronicity of Finding,Char,CHRON,"Describes the apparent relative duration of a particular finding. Examples: ACUTE, CHRONIC.",15,Findings,Exp,(CHRNCTY),MI
Variable Qualifier,MI,MIDISTR,Distribution Pattern of Finding,Char,DISTR,"Distribution pattern of a particular finding(s) within the examined area. Examples: DIFFUSE, FOCAL, MULTIFOCAL.",16,Findings,Exp,(DSTRBN),MI
Record Qualifier,MI,MISTAT,Completion Status,Char,STAT,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.,17,Findings,Perm,(ND),MI
Record Qualifier,MI,MIREASND,Reason Not Done,Char,REASND,"Describes why MISTAT is NOT DONE, such as SAMPLE AUTOLYZED or SPECIMEN LOST.",18,Findings,Perm,,MI
Record Qualifier,MI,MINAM,Laboratory Name,Char,NAM,Name or identifier of the laboratory or vendor that provided the test results.,19,Findings,Perm,,MI
Record Qualifier,MI,MISPEC,Specimen Material Type,Char,SPEC,"Defines the type of tissue, orgain, or fluid specimen examined. Examples: LIVER, HEART, BONE MARROW.",20,Findings,Req,(SPEC),MI
Variable Qualifier,MI,MIANTREG,Anatomical Region of Specimen,Char,ANTREG,"The protocol-defined subregion of the specimen examined. Example: Cortex or Medulla (if the MISPEC is, for example, GLAND, ADRENAL).",21,Findings,Perm,,MI
Record Qualifier,MI,MISPCCND,Specimen Condition,Char,SPCCND,Free or standardized text describing the condition of the specimen. Example: AUTOLYZED.,22,Findings,Exp,,MI
Record Qualifier,MI,MISPCUFL,Specimen Usability for the Test,Char,SPCUFL,Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null.,23,Findings,Exp,(NY),MI
Variable Qualifier,MI,MILAT,Specimen Laterality within Subject,Char,LAT,"Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.",24,Findings,Perm,(LAT),MI
Variable Qualifier,MI,MIDIR,Specimen Directionality within Subject,Char,DIR,"Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.",25,Findings,Perm,(DIR),MI
Record Qualifier,MI,MIMETHOD,Method of Test or Examination,Char,METHOD,Method of the test or examination. This could be different types of staining used for the slides whenever appropriate. Example: H&E.,26,Findings,Perm,,MI
Record Qualifier,MI,MIEVAL,Evaluator,Char,EVAL,"Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST.",27,Findings,Perm,,MI
Record Qualifier,MI,MISEV,Severity,Char,SEV,Describes the severity of a particular finding.,28,Findings,Exp,(SEV),MI
Record Qualifier,MI,MIDTHREL,Relationship to Death,Char,DTHREL,"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.",29,Findings,Perm,(NY),MI
Timing,MI,MIDTC,Date/Time,Char,DTC,"For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format.",30,Findings,Perm,ISO 8601,MI
Timing,MI,MIDY,Study Day,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",31,Findings,Perm,,MI
Identifier,OM,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,OM,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,OM,
Identifier,OM,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,OM,OMSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,OM
Topic,OM,OMTESTCD,Test Short Name,Char,TESTCD,"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.",5,Findings,Req,(OMTESTCD),OM
Synonym Qualifier,OM,OMTEST,Test Name,Char,TEST,Long name for OMTESTCD. The value in OMTEST cannot be longer than 40 characters.,6,Findings,Req,(OMTEST),OM
Result Qualifier,OM,OMORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,7,Findings,Exp,,OM
Variable Qualifier,OM,OMORRESU,Unit of the Original Result,Char,ORRESU,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.,8,Findings,Exp,(UNIT),OM
Result Qualifier,OM,OMSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",9,Findings,Exp,,OM
Result Qualifier,OM,OMSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of OMSTRESC. OMSTRESN should store all numeric test results or findings.,10,Findings,Exp,,OM
Variable Qualifier,OM,OMSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for OMSTRESC and OMSTRESN.,11,Findings,Exp,(UNIT),OM
Record Qualifier,OM,OMSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in OMORRES.,12,Findings,Perm,(ND),OM
Record Qualifier,OM,OMREASND,Reason Not Done,Char,REASND,"Describes why OMSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT.",13,Findings,Perm,,OM
Record Qualifier,OM,OMSPEC,Specimen Material Type,Char,SPEC,"Defines the type of tissue, organ, or fluid specimen used as the object for the finding. Examples: GLAND, ADRENAL, KIDNEY, VESSEL, LYMPHATIC.",14,Findings,Req,(SPEC),OM
Variable Qualifier,OM,OMANTREG,Anatomical Region of Specimen,Char,ANTREG,"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.",15,Findings,Perm,,OM
Record Qualifier,OM,OMSPCCND,Specimen Condition,Char,SPCCND,Free or standardized text describing the condition of the specimen. Example: FIXED.,16,Findings,Perm,,OM
Record Qualifier,OM,OMSPCUFL,Specimen Usability for the Test,Char,SPCUFL,Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null.,17,Findings,Perm,(NY),OM
Variable Qualifier,OM,OMLAT,Specimen Laterality within Subject,Char,LAT,"Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.",18,Findings,Perm,(LAT),OM
Variable Qualifier,OM,OMDIR,Specimen Directionality within Subject,Char,DIR,"Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.",19,Findings,Perm,(DIR),OM
Variable Qualifier,OM,OMPORTOT,Portion or Totality,Char,PORTOT,"Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY.",20,Findings,Perm,(PORTOT),OM
Record Qualifier,OM,OMEXCLFL,Exclusion Flag,Char,EXCLFL,"""Y"" if the result should be excluded from all calculations, otherwise null.",21,Findings,Perm,(NY),OM
Record Qualifier,OM,OMREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when OMEXCLFL is "Y".,22,Findings,Perm,,OM
Timing,OM,OMDTC,Date/Time Organ Measured,Char,DTC,"Date/Time of specimen/tissue weighing, in ISO 8601 format.",23,Findings,Exp,ISO 8601,OM
Timing,OM,OMDY,Study Day of Measurement,Num,DY,"Study day of specimen/tissue weighing, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",24,Findings,Perm,,OM
Timing,OM,OMNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,25,Findings,Exp,,OM
Timing,OM,OMNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of OMNOMDY as presented in the study report (examples: ""Week 4,"" ""Day 28,"" ""Terminal Sac"").",26,Findings,Perm,,OM
Identifier,PC,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,PC,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,PC,
Identifier,PC,USUBJID,Unique Subject Identifier,Char,USUBJID,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.,3,Findings,Exp,,
Identifier,PC,POOLID,Pool Identifier,Char,POOLID,"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.",4,Findings,Perm,,
Identifier,PC,PCSEQ,Sequence Number,Num,SEQ,"The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.",5,Findings,Req,,PC
Identifier,PC,PCGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.,6,Findings,Perm,,PC
Identifier,PC,PCREFID,Sample Identifier,Char,REFID,Internal or external specimen identifier. Example: 1009570101.,7,Findings,Perm,,PC
Identifier,PC,PCSPID,Sponsor-Defined Identifier,Char,SPID,Sponsor-defined reference identifier.,8,Findings,Perm,,PC
Topic,PC,PCTESTCD,Test Short Name,Char,TESTCD,"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.",9,Findings,Req,,PC
Synonym Qualifier,PC,PCTEST,Test Name,Char,TEST,"Long name for PCTESTCD, such as the name of the analyte (or measurement). The value in PCTEST cannot be longer than 40 characters.",10,Findings,Req,,PC
Grouping Qualifier,PC,PCCAT,Test Category,Char,CAT,"Used to define a category of the pharmacokinetic test performed. Examples: ANALYTE, METABOLITE, SPECIMEN PROPERTY.",11,Findings,Perm,,PC
Grouping Qualifier,PC,PCSCAT,Test Subcategory,Char,SCAT,A further categorization of a test category.,12,Findings,Perm,,PC
Result Qualifier,PC,PCORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,13,Findings,Exp,,PC
Variable Qualifier,PC,PCORRESU,Unit of the Original Result,Char,ORRESU,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.,14,Findings,Exp,(PKUNIT),PC
Result Qualifier,PC,PCSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",15,Findings,Exp,,PC
Result Qualifier,PC,PCSTRESN,Standardized Result in Numeric Format,Num,STRESN,"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).",16,Findings,Exp,,PC
Variable Qualifier,PC,PCSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for PCSTRESC and PCSTRESN.,17,Findings,Exp,(PKUNIT),PC
Record Qualifier,PC,PCSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in PCORRES.,18,Findings,Perm,(ND),PC
Record Qualifier,PC,PCREASND,Reason Not Done,Char,REASND,"Describes why PCSTAT is NOT DONE, such as SPECIMEN LOST.",19,Findings,Perm,,PC
Record Qualifier,PC,PCNAM,Laboratory Name,Char,NAM,Name or identifier of the laboratory or vendor providing the test results.,20,Findings,Perm,,PC
Record Qualifier,PC,PCSPEC,Specimen Material Type,Char,SPEC,"Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE.",21,Findings,Req,(SPEC),PC
Record Qualifier,PC,PCSPCCND,Specimen Condition,Char,SPCCND,"Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC.",22,Findings,Perm,,PC
Record Qualifier,PC,PCSPCUFL,Specimen Usability for the Test,Char,SPCUFL,Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null.,23,Findings,Perm,(NY),PC
Record Qualifier,PC,PCMETHOD,Method of Test or Examination,Char,METHOD,"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.",24,Findings,Perm,,PC
Record Qualifier,PC,PCBLFL,Baseline Flag,Char,BLFL,A baseline indicator may be used to calculate differences or changes from baseline. Value should be "Y" or null. The baseline flag is sponsor-defined.,25,Findings,Perm,(NY),PC
Record Qualifier,PC,PCFAST,Fasting Status,Char,FAST,Indicator used to identify fasting status. The value should be "Y" or null.,26,Findings,Perm,(NY),PC
Record Qualifier,PC,PCDRVFL,Derived Flag,Char,DRVFL,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.,27,Findings,Perm,(NY),PC
Variable Qualifier,PC,PCLLOQ,Lower Limit of Quantitation,Num,LLOQ,Indicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU.,28,Findings,Exp,,PC
Record Qualifier,PC,PCEXCLFL,Exclusion Flag,Char,EXCLFL,"""Y"" if the result should be excluded from all calculations, otherwise null.",29,Findings,Perm,(NY),PC
Record Qualifier,PC,PCREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when PCEXCLFL is "Y".,30,Findings,Perm,,PC
Record Qualifier,PC,PCUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",31,Findings,Perm,(NY),PC
Timing,PC,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned day of collection. Should be an integer.,32,Findings,Perm,,
Timing,PC,PCDTC,Date/Time of Specimen Collection,Char,DTC,"Date/Time of specimen collection, in ISO 8601 format. If there is no end time, this will be the collection time.",33,Findings,Perm,ISO 8601,PC
Timing,PC,PCENDTC,End Date/Time of Specimen Collection,Char,ENDTC,"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.",34,Findings,Perm,ISO 8601,PC
Timing,PC,PCDY,Study Day of Specimen Collection,Num,DY,"Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics (DM) domain.",35,Findings,Perm,,PC
Timing,PC,PCENDY,Study Day of End of Specimen Collection,Num,ENDY,"Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in DM domain.",36,Findings,Perm,,PC
Timing,PC,PCNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,37,Findings,Exp,,PC
Timing,PC,PCNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of PCNOMDY as presented in the study report. Examples: ""Week 4"", ""Day 28"".",38,Findings,Perm,,PC
Timing,PC,PCTPT,Planned Time Point Name,Char,TPT,"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.",39,Findings,Perm,,PC
Timing,PC,PCTPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of PCTPT to aid in sorting.,40,Findings,Perm,,PC
Timing,PC,PCELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,"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.",41,Findings,Exp,ISO 8601,PC
Timing,PC,PCTPTREF,Time Point Reference,Char,TPTREF,"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"".",42,Findings,Exp,,PC
Timing,PC,PCRFTDTC,Date/Time of Reference Point,Char,RFTDTC,"Date/Time of the reference time point, PCTPTREF.",43,Findings,Exp,ISO 8601,PC
Timing,PC,PCEVLINT,Evaluation Interval,Char,EVLINT,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.,44,Findings,Perm,ISO 8601,PC
Identifier,PP,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,PP,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,PP,
Identifier,PP,USUBJID,Unique Subject Identifier,Char,USUBJID,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.,3,Findings,Exp,,
Identifier,PP,POOLID,Pool Identifier,Char,POOLID,"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.",4,Findings,Perm,,
Identifier,PP,PPSEQ,Sequence Number,Num,SEQ,"The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.",5,Findings,Req,,PP
Identifier,PP,PPGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.,6,Findings,Perm,,PP
Topic,PP,PPTESTCD,Parameter Short Name,Char,TESTCD,"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.",7,Findings,Req,(PKPARMCD),PP
Synonym Qualifier,PP,PPTEST,Parameter Name,Char,TEST,"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.",8,Findings,Req,(PKPARM),PP
Grouping Qualifier,PP,PPCAT,Parameter Category,Char,CAT,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.,9,Findings,Exp,,PP
Grouping Qualifier,PP,PPSCAT,Parameter Subcategory,Char,SCAT,"Categorization of the model type used to calculate the pharmacokinetic parameters. Examples include COMPARTMENTAL, NON-COMPARTMENTAL.",10,Findings,Perm,,PP
Result Qualifier,PP,PPORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as calculated.,11,Findings,Exp,,PP
Variable Qualifier,PP,PPORRESU,Unit of the Original Result,Char,ORRESU,The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the CDISC Controlled Terminology (http://www.cdisc.org/terminology) list.,12,Findings,Exp,(PKUNIT),PP
Result Qualifier,PP,PPSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",13,Findings,Exp,,PP
Result Qualifier,PP,PPSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of PPSTRESC. PPSTRESN should store all numeric test results or findings.,14,Findings,Exp,,PP
Variable Qualifier,PP,PPSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for PPSTRESC and PPSTRESN.,15,Findings,Exp,(PKUNIT),PP
Record Qualifier,PP,PPSTAT,Completion Status,Char,STAT,Used to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES.,16,Findings,Perm,(ND),PP
Record Qualifier,PP,PPREASND,Reason Not Done,Char,REASND,"Describes why a parameter was not performed, such as INSUFFICIENT DATA. Used in conjunction with PPSTAT when value is NOT DONE.",17,Findings,Perm,,PP
Record Qualifier,PP,PPSPEC,Specimen Material Type,Char,SPEC,"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 Section 4.3.6.2 for guidance on how to populate.",18,Findings,Exp,(SPEC),PP
Timing,PP,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned study day of collection. Should be an integer.,19,Findings,Perm,,
Timing,PP,PPNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,20,Findings,Exp,,PP
Timing,PP,PPNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of PPNOMDY as presented in the study report. Examples: ""Week 4"", ""Day 28"".",21,Findings,Perm,,PP
Timing,PP,PPTPTREF,Time Point Reference,Char,TPTREF,Name of the fixed reference point used as a basis for PPRFTDTC.,22,Findings,Exp,,PP
Timing,PP,PPRFTDTC,Date/Time of Reference Point,Char,RFTDTC,"Date/Time of the reference time point, PPTPTREF. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records.",23,Findings,Exp,ISO 8601,PP
Timing,PP,PPSTINT,Start of Assessment Interval,Char,STINT,"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.",24,Findings,Perm,ISO 8601,PP
Timing,PP,PPENINT,End of Assessment Interval,Char,ENINT,"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.",25,Findings,Perm,ISO 8601,PP
Identifier,PM,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,PM,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,PM,
Identifier,PM,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,PM,PMSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,PM
Identifier,PM,PMGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.,5,Findings,Perm,,PM
Identifier,PM,PMSPID,Mass Identifier,Char,SPID,"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.",6,Findings,Exp,,PM
Topic,PM,PMTESTCD,Test Short Name,Char,TESTCD,"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.",7,Findings,Req,(PHSPRPCD),PM
Synonym Qualifier,PM,PMTEST,Test Name,Char,TEST,Long name for PMTESTCD. The value in PMTEST cannot be longer than 40 characters.,8,Findings,Req,(PHSPRP),PM
Variable Qualifier,PM,PMORRES,Result or Findings as Collected,Char,ORRES,"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.",9,Findings,Exp,,PM
Variable Qualifier,PM,PMORRESU,Unit of the Original Result,Char,ORRESU,"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.",10,Findings,Exp,(UNIT),PM
Result Qualifier,PM,PMSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",11,Findings,Exp,,PM
Result Qualifier,PM,PMSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of PMSTRESC. PMSTRESN should store all numeric test results or findings.,12,Findings,Exp,,PM
Variable Qualifier,PM,PMSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for PMSTRESC and PMSTRESN.,13,Findings,Exp,(UNIT),PM
Record Qualifier,PM,PMSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in PMORRES.,14,Findings,Perm,(ND),PM
Record Qualifier,PM,PMREASND,Reason Not Done,Char,REASND,"Describes why PMSTAT is NOT DONE, such as MEASUREMENT IMPOSSIBLE DUE TO EXCESSIVE ULCERATION OF MASS.",15,Findings,Perm,,PM
Record Qualifier,PM,PMLOC,Location of a Finding,Char,LOC,Specifies the location of the palpable mass finding. Example: LEFT SHOULDER.,16,Findings,Exp,,PM
Record Qualifier,PM,PMEVAL,Evaluator,Char,EVAL,Role of the person who provided the evaluation. Example: TECHNICIAN.,17,Findings,Perm,,PM
Record Qualifier,PM,PMUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",18,Findings,Perm,(NY),PM
Timing,PM,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned study day of collection. Should be an integer.,19,Findings,Perm,,
Timing,PM,PMDTC,Date/Time of Observation,Char,DTC,Date/Time of the observation in ISO 8601 format.,20,Findings,Exp,ISO 8601,PM
Timing,PM,PMDY,Study Day of Observation,Num,DY,"Study day of the observation, measured as integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",21,Findings,Perm,,PM
Timing,PM,PMNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,22,Findings,Exp,,PM
Timing,PM,PMNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of PMNOMDY as presented in the study report. Examples: ""Week 4,"" ""Day 28,"" ""Terminal Sac"".",23,Findings,Perm,,PM
Identifier,RE,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,RE,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,RE,
Identifier,RE,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product.,3,Findings,Req,,
Identifier,RE,RESEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,RE
Identifier,RE,REGRPID,Group Identifier,Char,GRPID,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 treatment group number.,5,Findings,Perm,,RE
Identifier,RE,RESPID,Sponsor-Defined Identifier,Char,SPID,Sponsor-defined reference identifier.,6,Findings,Perm,,RE
Topic,RE,RETESTCD,Test Short Name,Char,TESTCD,"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.",7,Findings,Req,(SRETSTCD),RE
Synonym Qualifier,RE,RETEST,Test Name,Char,TEST,"Long name for RETESTCD. The value in RETEST cannot be longer than 40 characters. Examples: Respiratory Rate, Tidal Volume, Minute Volume.",8,Findings,Req,(SRETST),RE
Record Qualifier,RE,REPOS,Position of Subject During Test,Char,POS,"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.",9,Findings,Exp,(POSITION),RE
Result Qualifier,RE,REORRES,Result or Findings as Collected,Char,ORRES,Result of the measurement or finding as originally received or collected.,10,Findings,Exp,,RE
Variable Qualifier,RE,REORRESU,Unit of the Original Result,Char,ORRESU,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.,11,Findings,Exp,(UNIT),RE
Result Qualifier,RE,RESTRESC,Standardized Result in Character Format,Char,STRESC,"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.",12,Findings,Exp,,RE
Result Qualifier,RE,RESTRESN,Standardized Result in Numeric Format,Num,STRESN,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.,13,Findings,Exp,,RE
Variable Qualifier,RE,RESTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for RESTRESC and RESTRESN.,14,Findings,Exp,(UNIT),RE
Record Qualifier,RE,RESTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in REORRES.,15,Findings,Perm,(ND),RE
Record Qualifier,RE,REREASND,Reason Not Done,Char,REASND,"Describes why RESTAT is NOT DONE, such as BROKEN EQUIPMENT.",16,Findings,Perm,,RE
Record Qualifier,RE,REMETHOD,Method of Test,Char,METHOD,"Method of the test or examination. Examples: Whole body plethysmograph, Head-out plethysmograph, Invasive.",17,Findings,Exp,,RE
Record Qualifier,RE,RECSTATE,Consciousness State,Char,CSTATE,"Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS",18,Findings,Exp,(CSTATE),RE
Record Qualifier,RE,REBLFL,Baseline Flag,Char,BLFL,A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined.,19,Findings,Exp,(NY),RE
Record Qualifier,RE,REDRVFL,Derived Flag,Char,DRVFL,Used to indicate a derived record. The value should be Y or null.,20,Findings,Perm,(NY),RE
Record Qualifier,RE,REEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",21,Findings,Perm,(NY),RE
Record Qualifier,RE,REREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when REEXCLFL is Y.,22,Findings,Perm,,RE
Record Qualifier,RE,REUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",23,Findings,Perm,(NY),RE
Timing,RE,REDTC,Date/Time of Respiratory Measurement,Char,DTC,"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.",24,Findings,Exp,ISO 8601,RE
Timing,RE,REENDTC,End Date/Time of Respiratory Measurement,Char,ENDTC,"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.",25,Findings,Perm,ISO 8601,RE
Timing,RE,REDY,Study Day of Respiratory Measurement,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",26,Findings,Perm,,RE
Timing,RE,REENDY,End Study Day of Respiratory Measurement,Num,ENDY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",27,Findings,Perm,,RE
Timing,RE,RENOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,28,Findings,Exp,,RE
Timing,RE,RENOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of RENOMDY as presented in the study report. Examples: Pretreatment, Week 4, Day 28.",29,Findings,Perm,,RE
Timing,RE,RETPT,Planned Time Point Name,Char,TPT,"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.",30,Findings,Exp,,RE
Timing,RE,RETPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of RETPT to aid in sorting.,31,Findings,Exp,,RE
Timing,RE,REELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,"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.",32,Findings,Exp,ISO 8601,RE
Timing,RE,RETPTREF,Time Point Reference,Char,TPTREF,"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.",33,Findings,Exp,,RE
Timing,RE,RERFTDTC,Date/Time of Reference Time Point,Char,RFTDTC,"Date/Time of the reference time point, RETPTREF.",34,Findings,Perm,ISO 8601,RE
Timing,RE,REEVLINT,Evaluation Interval,Char,EVLINT,Length of evaluation interval in ISO 8601 duration format. Used in place of RESTINT and REENINT when RETPTREF is not available.,35,Findings,Perm,ISO 8601,RE
Timing,RE,RESTINT,Planned Start of Assessment Interval,Char,STINT,"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.",36,Findings,Exp,ISO 8601,RE
Timing,RE,REENINT,Planned End of Assessment Interval,Char,ENINT,"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.",37,Findings,Exp,ISO 8601,RE
Identifier,SC,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,SC,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,SC,
Identifier,SC,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across a study for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,SC,SCSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,SC
Identifier,SC,SCGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.,5,Findings,Perm,,SC
Topic,SC,SCTESTCD,Subject Characteristic Short Name,Char,TESTCD,"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.",6,Findings,Req,(SBCCDSND),SC
Synonym Qualifier,SC,SCTEST,Subject Characteristic,Char,TEST,"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.",7,Findings,Req,(SBCSND),SC
Result Qualifier,SC,SCORRES,Result or Findings as Collected,Char,ORRES,Result of the subject characteristic as originally received or collected.,8,Findings,Exp,,SC
Variable Qualifier,SC,SCORRESU,Unit of the Original Result,Char,ORRESU,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.,9,Findings,Perm,(UNIT),SC
Result Qualifier,SC,SCSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",10,Findings,Exp,,SC
Result Qualifier,SC,SCSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of SCSTRESC. SCSTRESN should store all numeric test results or findings.,11,Findings,Perm,,SC
Variable Qualifier,SC,SCSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for SCSTRESC and SCSTRESN.,12,Findings,Perm,(UNIT),SC
Timing,SC,SCDTC,Date/Time of Collection,Char,DTC,"Date/Time of collection of the subject characteristic information, in ISO 8601 format.",13,Findings,Perm,ISO 8601,SC
Timing,SC,SCDY,Study Day of Collection,Num,DY,"Study day of collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",14,Findings,Perm,,SC
Identifier,TF,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,TF,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,TF,
Identifier,TF,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product within the submission,3,Findings,Req,,
Identifier,TF,TFSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,TF
Identifier,TF,TFGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.,5,Findings,Perm,,TF
Identifier,TF,TFREFID,Specimen Identifier,Char,REFID,Internal or external specimen identifier. Example: Specimen barcode number.,6,Findings,Perm,,TF
Identifier,TF,TFSPID,Mass Identifier,Char,SPID,"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.",7,Findings,Exp,,TF
Topic,TF,TFTESTCD,Tumor Examination Short Name,Char,TESTCD,"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.",8,Findings,Req,(TFTESTCD),TF
Synonym Qualifier,TF,TFTEST,Tumor Examination Name,Char,TEST,Long name for TFTESTCD. The value in TFTEST cannot be longer than 40 characters. Example: Tumor Examination.,9,Findings,Req,(TFTEST),TF
Result Qualifier,TF,TFORRES,Result or Findings as Collected,Char,ORRES,Result of the histopathological examination as originally received or collected.,10,Findings,Exp,,TF
Result Qualifier,TF,TFSTRESC,Standardized Result in Character Format,Char,STRESC,Contains the tumor name mapped from TFORRES into a standard format from the controlled terms list.,11,Findings,Exp,(NEOPLASM),TF
Variable Qualifier,TF,TFRESCAT,Tumor Malignancy Status,Char,RESCAT,"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.",12,Findings,Req,(NEOSTAT),TF
Record Qualifier,TF,TFNAM,Laboratory Name,Char,NAM,Name or identifier of the laboratory or vendor that provided the test results.,13,Findings,Perm,,TF
Record Qualifier,TF,TFSPEC,Specimen Material Type,Char,SPEC,"Defines the type of tissue, organ, or fluid specimen examined. Examples: LIVER, HEART.",14,Findings,Req,(SPEC),TF
Variable Qualifier,TF,TFANTREG,Anatomical Region of Specimen,Char,ANTREG,"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.",15,Findings,Perm,,TF
Record Qualifier,TF,TFSPCCND,Specimen Condition,Char,SPCCND,Free or standardized text describing the condition of the specimen. Example: AUTOLYZED.,16,Findings,Perm,,TF
Variable Qualifier,TF,TFLAT,Specimen Laterality within Subject,Char,LAT,"Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.",17,Findings,Perm,(LAT),TF
Variable Qualifier,TF,TFDIR,Specimen Directionality within Subject,Char,DIR,"Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.",18,Findings,Perm,(DIR),TF
Record Qualifier,TF,TFMETHOD,Method of Test or Examination,Char,METHOD,Method of the test or examination. This could be different types of staining used for the slides. Example: H&E.,19,Findings,Perm,,TF
Record Qualifier,TF,TFEVAL,Evaluator,Char,EVAL,"Role of the person who provided the evaluation. Example: TOX PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST.",20,Findings,Perm,,TF
Record Qualifier,TF,TFDTHREL,Relationship to Death,Char,DTHREL,"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.",21,Findings,Req,(NY),TF
Timing,TF,TFDTC,Date/Time,Char,DTC,"For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format.",22,Findings,Perm,ISO 8601,TF
Timing,TF,TFDY,Study Day,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",23,Findings,Perm,,TF
Timing,TF,TFDETECT,Time in Days to Detection of Tumor,Num,DETECT,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.,24,Findings,Req,,TF
Identifier,VS,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Findings,Req,,
Identifier,VS,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Findings,Req,VS,
Identifier,VS,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,Findings,Req,,
Identifier,VS,VSSEQ,Sequence Number,Num,SEQ,Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.,4,Findings,Req,,VS
Identifier,VS,VSGRPID,Group Identifier,Char,GRPID,Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.,5,Findings,Perm,,VS
Identifier,VS,VSSPID,Sponsor-Defined Identifier,Char,SPID,Sponsor-defined reference identifier,6,Findings,Perm,,VS
Topic,VS,VSTESTCD,Vital Signs Test Short Name,Char,TESTCD,"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.",7,Findings,Req,(SVSTSTCD),VS
Synonym Qualifier,VS,VSTEST,Vital Signs Test Name,Char,TEST,Long name for VSTESTCD. The value in VSTEST cannot be longer than 40 characters.,8,Findings,Req,(SVSTST),VS
Grouping Qualifier,VS,VSCAT,Category for Vital Signs,Char,CAT,Used to define a category of the vital signs measurement performed.,9,Findings,Perm,,VS
Grouping Qualifier,VS,VSSCAT,Subcategory for Vital Signs,Char,SCAT,A further categorization of the vital signs measurement performed.,10,Findings,Perm,,VS
Record Qualifier,VS,VSPOS,Vital Signs Position of Subject,Char,POS,"Position of the subject during the measurement. If the subject is restrained, populate with the position (example SITTING or STANDING).",11,Findings,Perm,(POSITION),VS
Result Qualifier,VS,VSORRES,Result or Findings as Collected,Char,ORRES,Result of the vital signs measurement as originally received or collected.,12,Findings,Exp,,VS
Variable Qualifier,VS,VSORRESU,Unit of the Original Result,Char,ORRESU,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.,13,Findings,Exp,(UNIT),VS
Result Qualifier,VS,VSSTRESC,Standardized Result in Character Format,Char,STRESC,"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.",14,Findings,Exp,,VS
Result Qualifier,VS,VSSTRESN,Standardized Result in Numeric Format,Num,STRESN,Used for numeric results or findings in standard format; contains the numeric form of VSSTRESC. VSSTRESN should store all numeric test results or findings.,15,Findings,Exp,,VS
Variable Qualifier,VS,VSSTRESU,Unit of the Standardized Result,Char,STRESU,Standardized unit used for VSSTRESC and VSSTRESN.,16,Findings,Exp,(UNIT),VS
Record Qualifier,VS,VSSTAT,Completion Status,Char,STAT,Used to indicate when a test is not done or result is missing. Should be null if a result exists in VSORRES.,17,Findings,Perm,(ND),VS
Record Qualifier,VS,VSREASND,Reason Not Done,Char,REASND,"Describes why VSSTAT is NOT DONE, such as BROKEN EQUIPMENT.",18,Findings,Perm,,VS
Record Qualifier,VS,VSLOC,Location of Vital Signs Measurement,Char,LOC,Location relevant to the collection of the vital signs measurement. Example: RECTAL for Temperature.,19,Findings,Perm,,VS
Record Qualifier,VS,VSCSTATE,Consciousness State,Char,CSTATE,"Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS.",20,Findings,Perm,(CSTATE),VS
Record Qualifier,VS,VSBLFL,Baseline Flag,Char,BLFL,A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined.,21,Findings,Exp,(NY),VS
Record Qualifier,VS,VSDRVFL,Derived Flag,Char,DRVFL,Used to indicate a derived record. The value should be Y or null.,22,Findings,Perm,(NY),VS
Record Qualifier,VS,VSEXCLFL,Exclusion Flag,Char,EXCLFL,"Y if the result should be excluded from all calculations, otherwise null.",23,Findings,Perm,(NY),VS
Record Qualifier,VS,VSREASEX,Reason for Exclusion,Char,REASEX,The reason the result should be excluded from all calculations. Used only when VSEXCLFL is Y.,24,Findings,Perm,,VS
Record Qualifier,VS,VSUSCHFL,Unscheduled Flag,Char,USCHFL,"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.",25,Findings,Perm,(NY),VS
Timing,VS,VISITDY,Planned Study Day of Collection,Num,VISITDY,Planned day of the vital signs measurement. Should be an integer.,26,Findings,Perm,,
Timing,VS,VSDTC,Date/Time of Measurement,Char,DTC,"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.",27,Findings,Exp,ISO 8601,VS
Timing,VS,VSENDTC,End Date/Time of Measurement,Char,ENDTC,"Date/Time of the end of the vital sign measurement, in ISO 8601 format. Should be populated for continuous period only.",28,Findings,Perm,ISO 8601,VS
Timing,VS,VSDY,Study Day of Vital Signs Measurement,Num,DY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",29,Findings,Perm,,VS
Timing,VS,VSENDY,Study Day of End of Measurement,Num,ENDY,"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 sponsor-defined RFSTDTC variable in the Demographics (DM) domain.",30,Findings,Perm,,VS
Timing,VS,VSNOMDY,Nominal Study Day for Tabulations,Num,NOMDY,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.,31,Findings,Exp,,VS
Timing,VS,VSNOMLBL,Label for Nominal Study Day,Char,NOMLBL,"A label for a given value of VSNOMDY as presented in the study report. Examples: Pre-Treatment, Week 4, Day 28.",32,Findings,Perm,,VS
Timing,VS,VSTPT,Planned Time Point Name,Char,TPT,"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.",33,Findings,Perm,,VS
Timing,VS,VSTPTNUM,Planned Time Point Number,Num,TPTNUM,Numerical version of VSTPT to aid in sorting.,34,Findings,Perm,,VS
Timing,VS,VSELTM,Planned Elapsed Time from Time Point Ref,Char,ELTM,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.,35,Findings,Perm,ISO 8601,VS
Timing,VS,VSTPTREF,Time Point Reference,Char,TPTREF,"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.",36,Findings,Perm,,VS
Timing,VS,VSRFTDTC,Date/Time of Time Point Reference,Char,RFTDTC,"Date/Time of the reference time point, VSTPTREF.",37,Findings,Perm,ISO 8601,VS
Identifier,TA,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Trial Design,Req,,
Identifier,TA,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Trial Design,Req,TA,
Topic,TA,ARMCD,Planned Arm Code,Char,ARMCD,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.,3,Trial Design,Req,,
Synonym Qualifier,TA,ARM,Description of Planned Arm,Char,ARM,"Descriptive name given to a specific Trial Arm (e.g., Low Dose, Mid Dose, 10 mg/kg/day dose).",4,Trial Design,Req,,
Timing,TA,TAETORD,Order of Element within Arm,Num,ETORD,Number that provides the order of the planned Element within the Arm. This value should be an integer.,5,Trial Design,Req,,TA
Record Qualifier,TA,ETCD,Element Code,Char,ETCD,ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions.,6,Trial Design,Req,,
Synonym Qualifier,TA,ELEMENT,Description of Element,Char,ELEMENT,The name of the Element.,7,Trial Design,Perm,,
Rule,TA,TABRANCH,Branch,Char,BRANCH,"Conditions subjects meet, occurring at the end of an Element, which cause an Arm to branch off from other Arms (e.g., randomization to control group).",8,Trial Design,Perm,,TA
Rule,TA,TATRANS,Transition Rule,Char,TRANS,"If the study 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 Treatment 2').",9,Trial Design,Perm,,TA
Timing,TA,EPOCH,Trial Epoch,Char,EPOCH,"Name of the study Epoch with which this Element of the Arm is associated (e.g., Treatment, Screen). Equivalent to 'Phase' or 'Period.'",10,Trial Design,Exp,,
Identifier,TE,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Trial Design,Req,,
Identifier,TE,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Trial Design,Req,TE,
Topic,TE,ETCD,Element Code,Char,ETCD,ETCD (the short form of ELEMENT) is limited to 8 characters and does not have special character restrictions.,3,Trial Design,Req,,
Synonym Qualifier,TE,ELEMENT,Description of Element,Char,ELEMENT,The name of the Element.,4,Trial Design,Req,,
Rule,TE,TESTRL,Rule for Start of Element,Char,STRL,Expresses rule for beginning Element.,5,Trial Design,Req,,TE
Rule,TE,TEENRL,Rule for End of Element,Char,ENRL,Expresses rule for ending Element. Either TEENRL or TEDUR must be present for each Element; both may be present.,6,Trial Design,Perm,,TE
Timing,TE,TEDUR,Planned Duration of Element,Char,DUR,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.,7,Trial Design,Perm,ISO 8601,TE
Identifier,TS,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study within the submission.,1,Trial Design,Req,,
Identifier,TS,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain most relevant to the observation.,2,Trial Design,Req,TS,
Identifier,TS,TSSEQ,Sequence Number,Num,SEQ,"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.",3,Trial Design,Req,,TS
Identifier,TS,TSGRPID,Group Identifier,Char,GRPID,Used to tie together a group of related records. This is not the sponsor-defined protocol group number.,4,Trial Design,Exp,,TS
Topic,TS,TSPARMCD,Trial Summary Parameter Short Name,Char,PARMCD,Short character value for the trial design characteristic described in TSPARM. Value must be 8 characters or less.,5,Trial Design,Req,(STSPRMCD),TS
Synonym Qualifier,TS,TSPARM,Trial Summary Parameter,Char,PARM,Term for the trial parameter. Value must be 40 characters or less.,6,Trial Design,Req,(STSPRM),TS
Result Qualifier,TS,TSVAL,Parameter Value,Char,VAL,"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.",7,Trial Design,Exp,,TS
Record Qualifier,TS,TSVALNF,Parameter Null Flavor,Char,VALNF,"Null flavor for the value of the TSPARMs, which should be included according to the trial summary code table below if and only if TSVAL is null.",8,Trial Design,Perm,(NULLFLAVOR),TS
Identifier,TX,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Trial Design,Req,,
Identifier,TX,DOMAIN,Domain Abbreviation,Char,DOMAIN,Two-character abbreviation for the domain.,2,Trial Design,Req,TX,
Identifier,TX,SETCD,Set Code,Char,SETCD,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.,3,Trial Design,Req,,
Synonym Qualifier,TX,SET,Set Description,Char,SET,"Long description of a specific Trial Set, as defined by the sponsor.",4,Trial Design,Req,,
Identifier,TX,TXSEQ,Sequence Number,Num,SEQ,Unique number for this record within this dataset. (This sequence should be unique within the entire dataset because there is no USUBJID.),5,Trial Design,Req,,TX
Topic,TX,TXPARMCD,Trial Set Parameter Short Name,Char,PARMCD,Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters.,6,Trial Design,Req,(STSPRMCD),TX
Synonym Qualifier,TX,TXPARM,Trial Set Parameter,Char,PARM,Term for the Trial Set parameter. Maximum 40 characters.,7,Trial Design,Req,(STSPRM),TX
Result Qualifier,TX,TXVAL,Trial Set Parameter Value,Char,VAL,"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.",8,Trial Design,Req,,TX
Identifier,POOLDEF,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Relationship,Req,,
Identifier,POOLDEF,POOLID,Pool Identifier,Char,POOLID,Identifier used for pooling subjects to assign a single finding to multiple subjects.,2,Relationship,Req,,
Identifier,POOLDEF,USUBJID,Unique Subject Identifier,Char,USUBJID,Identifier used to uniquely identify across all studies for all applications or submissions involving the product.,3,Relationship,Req,,
,RELREC,STUDYID,Study Identifier,Char,STUDYID,Unique identifier for a study.,1,Relationship,Req,,
,RELREC,RDOMAIN,Related Domain Abbreviation,Char,RDOMAIN,Two-character abbreviation for the domain of the parent record(s).,2,Relationship,Req,,
,RELREC,USUBJID,Unique Subject Identifier,Char,USUBJID,"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).",3,Relationship,Exp,,
,RELREC,POOLID,Pool Identifier,Char,POOLID,"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.",4,Relationship,Perm,,
,RELREC,IDVAR,Identifying Variable,Char,IDVAR,Name of the identifying variable in the general observation class domain that identifies the related record(s). Examples include BWSEQ and BWGRPID.,5,Relationship,Req,,
,RELREC,IDVARVAL,Identifying Variable Value,Char,IDVARVAL,"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.",6,Relationship,Exp,,
,RELREC,RELTYPE,Relationship Type,Char,RELTYPE,Identifies the hierarchical level of the records in the relationship. Values are only necessary when identifying a relationship between domains (as described in Section 8.4). Values should be either ONE or MANY.,7,Relationship,Perm,(RELTYPE),
,RELREC,RELID,Relationship Identifier,Char,RELID,Unique value within a study that identifies the relationship. RELID can be any value the sponsor chooses and is only meaningful within the df dataset to identify the related/associated domain records.,8,Relationship,Req,,
,SUPP,STUDYID,Study Identifier,Char,STUDYID,Unique study identifier of the parent record(s).,1,Relationship,Req,,
,SUPP,RDOMAIN,Related Domain Abbreviation,Char,RDOMAIN,Two-character abbreviation for the domain of the parent record(s).,2,Relationship,Req,,
,SUPP,USUBJID,Unique Subject Identifier,Char,USUBJID,Unique subject identifier of the parent record(s). Either USUBJID or POOLID must be populated.,3,Relationship,Exp,,
,SUPP,POOLID,Pool Identifier,Char,POOLID,"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.",4,Relationship,Perm,,
,SUPP,IDVAR,Identifying Variable,Char,IDVAR,"Identifying variable in the dataset that identifies the related record(s). Examples: BWSEQ, CLGRPID.",5,Relationship,Exp,,
,SUPP,IDVARVAL,Identifying Variable Value,Char,IDVARVAL,Value of identifying variable of the parent record(s).,6,Relationship,Exp,,
,SUPP,QNAM,Qualifier Variable Name,Char,QNAM,"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 sponsor'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.",7,Relationship,Req,,
,SUPP,QLABEL,Qualifier Variable Label,Char,QLABEL,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.,8,Relationship,Req,,
,SUPP,QVAL,Data Value,Char,QVAL,"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.",9,Relationship,Req,,
,SUPP,QORIG,Origin,Char,QORIG,"QORIG is used to indicate the origin of the data. Possible values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. See Section 3.2.2.1.",10,Relationship,Perm,,
,SUPP,QEVAL,Evaluator,Char,QEVAL,"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.",11,Relationship,Perm,,