SDTM v1.5 scraping for specifications

Role,Variable Name,Variable Label,Type,Description,noname0,Position,Domain,CDISC Notes
Topic,--TRT,Name of Treatment,Char,"The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation.",,,,
Synonym Qualifier of --TRT,--MODIFY,Modified Treatment Name,Char,"If the value for --TRT is modified for coding purposes, then the modified text is placed here.",1,,,
Synonym Qualifier of --TRT,--DECOD,Standardized Treatment Name,Char,"Standardized or dictionary-derived name of the topic variable, --TRT, or the modified topic variable (--MODIFY), if applicable. Equivalent to the generic drug name in WHO Drug, or a term in SNOMED, ICD9, or other published or sponsor-defined dictionaries.",2,,,
Record Qualifier,--MOOD,Mood,Char,"Mode or condition of the record (e.g., SCHEDULED, PERFORMED).",3,,,
Grouping Qualifier,--CAT,Category,Char,Used to define a category of topic-variable values.,4,,,
Grouping Qualifier,--SCAT,Subcategory,Char,Used to define a further categorization of --CAT values.,5,,,
Variable Qualifier of --TRT,--PRESP,Pre-specified,Char,Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.,6,,,
Record Qualifier,--OCCUR,Occurrence,Char,Used to record whether a pre-specified intervention occurred when information about the occurrence of a specific intervention is solicited.,7,,,
Record Qualifier,--STAT,Completion Status,Char,Used to indicate when a question about the occurrence of a pre-specified intervention was not answered. Should be null or have a value of NOT DONE.,8,,,
Record Qualifier,--REASND,Reason Not Done,Char,Reason not done. Used in conjunction with --STAT when value is NOT DONE.,9,,,
Record Qualifier,--INDC,Indication,Char,"Denotes the indication for the intervention (e.g., why the therapy was taken or administered).",10,,,
Variable Qualifier of --TRT,--CLAS,Class,Char,"Class for a medication or treatment, often obtained from a coding dictionary.",11,,,
Variable Qualifier of --TRT,--CLASCD,Class Code,Char,Used to represent code for --CLAS.,12,,,
Record Qualifier,--DOSE,Dose,Num,Amount of --TRT given. Not populated when --DOSTXT is populated.,13,,,
Record Qualifier,--DOSTXT,Dose Description,Char,"Dosing information collected in text form. Examples: <1 per day, 200-400. Not populated when --DOSE is populated.",14,,,
"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT",--DOSU,Dose Units,Char,"Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg).",15,,,
"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT",--DOSFRM,Dose Form,Char,"Dose form for the treatment. Examples: TABLET, CAPSULE.",16,,,
"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT",--DOSFRQ,Dosing Frequency per Interval,Char,"Usually expressed as the number of doses given per a specific interval. Examples: Q2H, QD, PRN.",17,,,
Record Qualifier,--DOSTOT,Total Daily Dose,Num,Total daily dose of --TRT using the units in --DOSU. Used when dosing is collected as Total Daily Dose.,18,,,
"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT",--DOSRGM,Intended Dose Regimen,Char,"Text description of the (intended) schedule or regimen for the Intervention. Example: TWO WEEKS ON, TWO WEEKS OFF.",19,,,
Variable Qualifier of --TRT,--ROUTE,Route of Administration,Char,"Route of administration for the intervention. Examples: ORAL, INTRAVENOUS.",20,,,
Record Qualifier,--LOT,Lot Number,Char,Lot number for the intervention described in --TRT.,21,,,
Record Qualifier,--LOC,Location of Dose Administration,Char,"Anatomical location of an intervention, such as an injection site. Example: ARM for an injection.",22,,,
Variable Qualifier of --LOC,--LAT,Laterality,Char,"Qualifier for anatomical location further detailing laterality of intervention administration. Examples: RIGHT, LEFT, BILATERAL",23,,,
Variable Qualifier of --LOC,--DIR,Directionality,Char,"Qualifier for anatomical location further detailing directionality of intervention administration. Examples: ANTERIOR, LOWER, PROXIMAL",24,,,
Variable Qualifier of --LOC,--PORTOT,Portion or Totality,Char,"Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of the intervention administration. Examples: ENTIRE, SINGLE, SEGMENT, MANY.",25,,,
Record Qualifier,--FAST,Fasting Status,Char,"Indicator used to identify fasting status. Valid values include Y, N, U or null if not relevant.",26,,,
Variable Qualifier,--PSTRG,Pharmaceutical Strength,Num,"Amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form. Example: 50 mg/TABLET, 300 mg/L",27,,,
Variable Qualifier,--PSTRGU,Pharmaceutical Strength Units,Char,"Unit for --PSTRG. Example: mg/TABLET, mg/mL",28,,,
Record Qualifier,--TRTV,Treatment Vehicle,Char,"Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE.",29,,,
Record Qualifier,--VAMT,Treatment Vehicle Amount,Num,Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone.,30,,,
Variable Qualifier of --VAMT,--VAMTU,Treatment Vehicle Amount Units,Char,"Units for the prepared product (treatment + vehicle). Examples: mL, mg.",31,,,
Record Qualifier,--ADJ,Reason for Dose Adjustment,Char,"Describes reason or explanation of why a dose is adjusted. Examples ADVERSE EVENT, INSUFFICIENT RESPONSE, NON-MEDICAL REASON.",32,,,
Record Qualifier,--USCHFL,Unscheduled Flag,Char,"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. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used.",33,,,
Topic,--TERM,Reported Term,Char,"Topic variable for an event observation, which is the verbatim or pre-specified name of the event.",,,,
Synonym Qualifier of --TERM,--MODIFY,Modified Reported Term,Char,"If the value for --TERM is modified for coding purposes, then the modified text is placed here.",1,,,
Variable Qualifier of --TERM,--LLT,Lowest Level Term,Char,MedDRA Lowest Level Term.,2,,,
Variable Qualifier of --LLT,--LLTCD,Lowest Level Term Code,Num,MedDRA Lowest Level Term code.,3,,,
Synonym Qualifier of --TERM,--DECOD,Dictionary-Derived Term,Char,"Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA).",4,,,
Variable Qualifier of --DECOD,--PTCD,Preferred Term Code,Num,MedDRA Preferred Term code.,5,,,
Variable Qualifier of --TERM,--HLT,High Level Term,Char,MedDRA High Level Term from the primary path.,6,,,
Variable Qualifier of --HLT,--HLTCD,High Level Term Code,Num,MedDRA High Level Term code from the primary path.,7,,,
Variable Qualifier of --TERM,--HLGT,High Level Group Term,Char,MedDRA High Level Group Term from the primary path.,8,,,
Variable Qualifier of --HLGT,--HLGTCD,High Level Group Term Code,Num,MedDRA High Level Group Term code from the primary path.,9,,,
Grouping Qualifier,--CAT,Category,Char,Used to define a category of topic-variable values.,10,,,
Grouping Qualifier,--SCAT,Subcategory,Char,Used to define a further categorization of --CAT values.,11,,,
Variable Qualifier of --TERM,--PRESP,Pre-specified,Char,"Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.",12,,,
Record Qualifier,--OCCUR,Occurrence,Char,Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited.,13,,,
Record Qualifier,--STAT,Completion Status,Char,Used to indicate when a question about the occurrence of a pre-specified event was not answered. Should be null or have a value of NOT DONE.,14,,,
Record Qualifier,--REASND,Reason Not Done,Char,Reason not done. Used in conjunction with --STAT when its value is NOT DONE.,15,,,
Record Qualifier,--BODSYS,Body System or Organ Class,Char,Body system or system organ class assigned for analysis from a standard hierarchy (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS.,16,,,
Variable Qualifier of --BODSYS,--BDSYCD,Body System or Organ Class Code,Num,MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis.,17,,,
Variable Qualifier of --TERM,--SOC,Primary System Organ Class,Char,MedDRA primary System Organ Class associated with the event.,18,,,
Variable Qualifier of --SOC,--SOCCD,Primary System Organ Class Code,Num,MedDRA primary System Organ Class code.,19,,,
Record Qualifier,--LOC,Location of Event,Char,Describes anatomical location relevant for the event. Example: ARM for skin rash.,20,,,
Variable Qualifier of --LOC,--LAT,Laterality,Char,"Qualifier for anatomical location further detailing laterality. Examples: RIGHT, LEFT, BILATERAL",21,,,
Variable Qualifier of --LOC,--DIR,Directionality,Char,"Qualifier for anatomical location further detailing directionality. Examples: ANTERIOR, LOWER, PROXIMAL",22,,,
Variable Qualifier of --LOC,--PORTOT,Portion or Totality,Char,"Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY.",23,,,
Record Qualifier,--PARTY,Accountable Party,Char,"Party accountable for the transferable object (e.g. device, specimen) as a result of the activity performed in the associated --TERM variable. The party could be an individual (e.g., subject), an organization (e.g., sponsor), or a location that is a proxy for an individual or organization (e.g., site). It is usually a somewhat general term that is further identified in the --PRTYID variable.",24,,,
Record Qualifier,--PRTYID,Identification of Accountable Party,Char,"Identification of the specific party accountable for the transferable object (e.g. device, specimen) after the action in --TERM is taken. Used in conjunction with --PARTY.",25,,,
Record Qualifier,--SEV,Severity/Intensity,Char,"The severity or intensity of the event. Examples: MILD, MODERATE, SEVERE.",26,,,
Record Qualifier,--SER,Serious Event,Char,Is this is a serious event? Valid values are "Y" and "N".,27,,,
Record Qualifier,--ACN,Action Taken with Study Treatment,Char,"Describes changes made to the study treatment as a result of the event. Examples: DOSE INCREASED, DOSE NOT CHANGED.",28,,,
Record Qualifier,--ACNOTH,Other Action Taken,Char,Describes other actions taken as a result of the event that are unrelated to dose adjustments of study treatment.,29,,,
Record Qualifier,--ACNDEV,Action Taken with Device,Char,"Action taken with respect to a device in a study, which may or may not be the device under study",30,,,
Record Qualifier,--REL,Causality,Char,"Records the investigator's opinion as to the causality of the event to the treatment. ICH E2A and E2B examples include NOT RELATED, UNLIKELY RELATED, POSSIBLY RELATED, RELATED.",31,,,
Record Qualifier,--RELNST,Relationship to Non-Study Treatment,Char,An opinion as to whether the event may have been due to a treatment other than study drug. Example: "MORE LIKELY RELATED TO ASPIRIN USE.",32,,,
Record Qualifier,--PATT,Pattern of Event,Char,"Used to indicate the pattern of the event over time. Examples: INTERMITTENT, CONTINUOUS, SINGLE EVENT.",33,,,
Record Qualifier,--OUT,Outcome of Event,Char,"Description of the outcome of an event. Examples: RECOVERED/RESOLVED, FATAL.",34,,,
Record Qualifier,--SCAN,Involves Cancer,Char,Was the event associated with the development of cancer? Valid values are "Y" and "N".,35,,,
Record Qualifier,--SCONG,Congenital Anomaly or Birth Defect,Char,Was the event associated with congenital anomaly or birth defect? Valid values are "Y" and "N".,36,,,
Record Qualifier,--SDISAB,Persist or Signif Disability/Incapacity,Char,Did the event result in persistent or significant disability/incapacity? Valid values are "Y" and "N".,37,,,
Record Qualifier,--SDTH,Results in Death,Char,Did the event result in death? Valid values are "Y" and "N".,38,,,
Record Qualifier,--SHOSP,Requires or Prolongs Hospitalization,Char,Did the event require or prolong hospitalization? Valid values are "Y" and "N".,39,,,
Record Qualifier,--SLIFE,Is Life Threatening,Char,Was the event life threatening? Valid values are "Y" and "N".,40,,,
Record Qualifier,--SOD,Occurred with Overdose,Char,Did the event occur with an overdose? Valid values are "Y" and "N".,41,,,
Record Qualifier,--SMIE,Other Medically Important Serious Event,Char,Do additional categories for seriousness apply? Valid values are "Y" and "N".,42,,,
Record Qualifier,--CONTRT,Concomitant or Additional Trtmnt Given,Char,Was another treatment given because of the occurrence of the event? Valid values are "Y" and "N".,43,,,
Variable Qualifier of --TOXGR,--TOX,Toxicity,Char,"Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: HYPERCALCEMIA, HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.",44,,,
Record Qualifier,--TOXGR,Toxicity Grade,Char,Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.,45,,,
Record Qualifier,--USCHFL,Unscheduled Flag,Char,"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. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used.",46,,,
Topic,--TESTCD,"Short Name of Measurement, Test or Examination",Char,"Short character value for --TEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. Examples: PLAT, SYSBP, RRMIN, EYEEXAM.",,,,
Synonym Qualifier of --TESTCD,--TEST,"Name of Measurement, Test or Examination",Char,"Long name For --TESTCD. Examples: Platelet, Systolic Blood Pressure, Summary (Min) RR Duration, Eye Examination.",1,,,
Synonym Qualifier of --ORRES,--MODIFY,Modified Term,Char,"If the value of --ORRES is modified for coding purposes, then the modified text is placed here.",2,,,
Variable Qualifier of --TESTCD and --TEST,--TSTDTL,"Measurement, Test or Examination Detail",Char,Further description of --TESTCD and --TEST. Example: "The percentage of cells with +1 intensity of staining" when MITEST = Thyroid Transcription Factor 1.,3,,,
Grouping Qualifier,--CAT,Category,Char,"Used to define a category of topic-variable values. Examples: HEMATOLOGY, URINALYSIS, CHEMISTRY, HAMILTON DEPRESSION SCALE, SF36, EGFR MUTATION ANALYSIS.",4,,,
Grouping Qualifier,--SCAT,Subcategory,Char,Used to define a further categorization of --CAT values. Example: WBC DIFFERENTIAL.,5,,,
Record Qualifier,--POS,Position of Subject During Observation,Char,"Position of the subject during a measurement or examination. Examples: SUPINE, STANDING, SITTING.",6,,,
Record Qualifier,--BODSYS,Body System or Organ Class,Char,Body System or Organ Class that is involved for a finding from the standard hierarchy for dictionary-coded results. Example: MedDRA SOC.,7,,,
Result Qualifier,--ORRES,Result or Finding in Original Units,Char,"Result of the measurement or finding as originally received or collected. Examples: 120, <1, POS.",8,,,
Variable Qualifier of --ORRES,--ORRESU,Original Units,Char,"Unit for --ORRES. Examples: in, LB, kg/L.",9,,,
Variable Qualifier of --ORRES,--ORNRLO,Normal Range Lower Limit-Original Units,Char,Lower end of normal range or reference range for results stored in --ORRES.,10,,,
Variable Qualifier of --ORRES,--ORNRHI,Normal Range Upper Limit-Original Units,Char,Upper end of normal range or reference range for results stored in --ORRES.,11,,,
Variable Qualifier of --ORRES,--ORREF,Reference Result in Original Units,Char,"Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable. Examples: value from predicted normal value in spirometry tests.",12,,,
Result Qualifier,--STRESC,Result or Finding in Standard Format,Char,"Contains the result value for all findings, copied or derived from --ORRES in a standard format or in standard units. --STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN. For example, if various tests have results ""NONE"", ""NEG"", and ""NEGATIVE"" in --ORRES and these results effectively have the same meaning, they could be represented in standard format in --STRESC as ""NEGATIVE"".",13,,,
Result Qualifier,--STRESN,Numeric Result/Finding in Standard Units,Num,Used for continuous or numeric results or findings in standard format; copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings.,14,,,
Variable Qualifier of --STRESC and --STRESN,--STRESU,Standard Units,Char,Standardized units used for --STRESC and --STRESN. Example: mol/L.,15,,,
Variable Qualifier of --STRESC and --STRESN,--STNRLO,Normal Range Lower Limit-Standard Units,Num,"Lower end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (-STRESU).",16,,,
Variable Qualifier of --STRESC and --STRESN,--STNRHI,Normal Range Upper Limit-Standard Units,Num,"Upper end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (-STRESU).",17,,,
Variable Qualifier of --STRESC,--STNRC,Normal Range for Character Results,Char,Normal range or reference range for results stored in --STRESC that are character in ordinal or categorical scale. Example: Negative to Trace.,18,,,
Variable Qualifier of --STRESC,--STREFC,Reference Result in Standard Format,Char,Reference value for the result or finding copied or derived from --ORREF in a standard format.,19,,,
Variable Qualifier of --STRESN,--STREFN,Numeric Reference Result in Std Units,Num,"Reference value for continuous or numeric results or findings in standard format or in standard units. --STREFN uses the same units as --STRESN, if applicable.",20,,,
Variable Qualifier of --ORRES,--NRIND,Normal/Reference Range Indicator,Char,"Used to indicate the value is outside the normal range or reference range. May be defined by --ORNRLO and --ORNRHI or other objective criteria. Examples: Y, N; HIGH, LOW; NORMAL; ABNORMAL.",21,,,
Variable Qualifier of --ORRES,--RESCAT,Result Category,Char,Used to categorize the result of a finding. Example: MALIGNANT or BENIGN for tumor findings. RESISTANCE VARIANT for genetic variation.,22,,,
Variable Qualifier of --STRESC,--CHRON,Chronicity of Finding,Char,"Characterization of the duration of a biological process resulting in a particular finding. Examples: ACUTE, CHRONIC, SUBACUTE.",23,,,
Variable Qualifier of --STRESC,--DISTR,Distribution Pattern of Finding,Char,"Description of the distribution pattern of a finding within the examined area. Examples: FOCAL, MULTIFOCAL, DIFFUSE, FOCAL MULTIFOCAL.",24,,,
Record Qualifier,--STAT,Completion Status,Char,"Used to indicate that a question was not asked or 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.",25,,,
Record Qualifier,--REASND,Reason Not Done,Char,Reason not done. Used in conjunction with --STAT when value is NOT DONE.,26,,,
Record Qualifier,--XFN,External File Path,Char,"Filename for an external file, such as one for an ECG waveform or a medical image.",27,,,
Record Qualifier,--NAM,Laboratory/Vendor Name,Char,"Name or identifier of the vendor (e.g., laboratory) that provided the test results.",28,,,
Synonym Qualifier of --TESTCD,--LOINC,LOINC Code,Char,Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable such as a lab test.,29,,,
Record Qualifier,--SPEC,Specimen Material Type,Char,"Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE, DNA, RNA.",30,,,
Variable Qualifier of --SPEC,--ANTREG,Anatomical Region,Char,"Defines the specific anatomical or biological region of a tissue, organ specimen or the region from which the specimen is obtained, as defined in the protocol, such as a section or part of what is described in the --SPEC variable. Examples: CORTEX, MEDULLA, MUCOSA",31,,,
Record Qualifier,--SPCCND,Specimen Condition,Char,Defines the condition of the specimen. Example: CLOUDY.,32,,,
Record Qualifier,--SPCUFL,Specimen Usability for the Test,Char,"Describes the usability of the specimen for the test. The value will be N if the specimen is not usable, and null if the specimen is usable.",33,,,
Record Qualifier,--LOC,Location Used for the Measurement,Char,"Anatomical location of the subject relevant to the collection of the measurement. Examples: RECTAL for temperature, ARM for blood pressure.",34,,,
Variable Qualifier of --LOC,--LAT,Laterality,Char,"Qualifier for anatomical location or specimen further detailing laterality. Examples: RIGHT, LEFT, BILATERAL",35,,,
Variable Qualifier of --LOC,--DIR,Directionality,Char,"Qualifier for anatomical location or specimen further detailing directionality. Examples: ANTERIOR, LOWER, PROXIMAL",36,,,
Variable Qualifier of --LOC,--PORTOT,Portion or Totality,Char,"Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. . Examples: ENTIRE, SINGLE, SEGMENT, MANY.",37,,,
Record Qualifier,--METHOD,Method of Test or Examination,Char,"Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK",38,,,
Record Qualifier,--RUNID,Run ID,Char,A unique identifier for a particular run of a test on a particular batch of samples.,39,,,
Record Qualifier,--ANMETH,Analysis Method,Char,Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g. an image or a genetic sequence).,40,,,
Record Qualifier,--LEAD,Lead Identified to Collect Measurements,Char,"Lead or leads identified to capture the measurement for a test from an instrument. Examples: LEAD I, LEAD V2, LEAD CM5.",41,,,
Record Qualifier,--CSTATE,Consciousness State,Char,"The consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS",42,,,
Record Qualifier,--LOBXFL,Last Observation Before Exposure Flag,Char,Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be Y or null.,43,,,
Record Qualifier,--BLFL,Baseline Flag,Char,Indicator used to identify a baseline value. Should be Y or null.,44,,,
Record Qualifier,--FAST,Fasting Status,Char,"Indicator used to identify fasting status. Valid values include Y, N, U or null if not relevant.",45,,,
Record Qualifier,--DRVFL,Derived Flag,Char,"Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be Y or null.",46,,,
Record Qualifier,--EVAL,Evaluator,Char,"Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: ADJUDICATION COMMITTEE, INDEPENDENT ASSESSOR, RADIOLOGIST.",47,,,
Variable Qualifier of --EVAL,--EVALID,Evaluator Identifier,Char,"Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST1, RADIOLOGIST2.",48,,,
Record Qualifier,--ACPTFL,Accepted Record Flag,Char,"In cases where more than one assessor provides an evaluation of a result or response, this flag identifies the record that is considered to be the accepted evaluation. Expected values can include Y, N or null. This is not intended to be an analysis flag to indicate acceptability for a given analysis",49,,,
Variable Qualifier of --TOXGR,--TOX,Toxicity,Char,"Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: HYPERCALCEMIA, HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.",50,,,
Record Qualifier,--TOXGR,Toxicity Grade,Char,Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define data definition document. Example: 2.,51,,,
Record Qualifier,--SEV,Severity,Char,"Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE.",52,,,
Record Qualifier,--DTHREL,Relationship to Death,Char,"Describes the relationship of a particular finding to the death of a subject. Examples: Y, N or U. Not to be used with human clinical trials.",53,,,
Variable Qualifier of --STRESC and --STRESN,--LLOQ,Lower Limit of Quantitation,Num,Indicates the lower limit of quantitation for an assay. Units will be those used for --STRESU.,54,,,
Variable Qualifier of --STRESC and --STRESN,--ULOQ,Upper Limit of Quantitation,Num,Indicates the upper limit of quantitation for an assay. Units will be those used for --STRESU.,55,,,
Record Qualifier,--EXCLFL,Exclude from Statistics,Char,"Indicates whether the values in the result variables for this record should be excluded from summary statistical calculations such as Mean, Standard Deviation, and Count (and others). Expected to be Y or null. --EXCLFL should not be used when --STAT is NOT DONE. Not to be used with human clinical trials.",56,,,
Record Qualifier,--REASEX,Reason for Exclusion from Statistics,Char,Reason excluded from statistics. Used in conjunction with --EXCLFL when its value is Y. Not to be used with human clinical trials.,57,,,
Record Qualifier,--USCHFL,Unscheduled Flag,Char,"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. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used.",58,,,
Record Qualifier,--REPNUM,Repetition Number,Num,"The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary, e.g., within a time point or within a visit. For example, multiple measurements of blood pressure or multiple analyses of a sample.",59,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,Two-character abbreviation for the domain most relevant to the observation. The Domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.,2,,,
,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
,APID,Associated Persons Identifier,Char,"Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. (See Section 4.1.3 for Pool Definition Dataset and Section 5 for Associated Persons data).",4,,,
,POOLID,Pool Identifier,Char,An identifier used to identify a result from a group of subjects that is not assignable to a specific subject.,5,,,
,SPDEVID,Sponsor Device Identifier,Char,Sponsor-defined identifier for a device.,6,,,
,FETUSID,Fetus Identifier,Char,Identifier used to identify a fetus from a maternal subject for prenatal evaluations. FETUSID uniquely identifies a fetus within a subject. Not to be used with human clinical trials.,7,,,
,FOCID,Focus of Study-Specific Interest,Char,"Identification of a focus of study-specific interest on or within a subject or specimen as called out 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"", or a more specific focus, e.g., ""OD"" (right eye) or ""Upper left quadrant of the back"". The value in this variable should have inherent semantic meaning.",8,,,
,--SEQ,Sequence Number,Num,"Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1.",9,,,
,--GRPID,Group ID,Char,"Optional group identifier, used to link together a block of related records within a subject in a domain. Also used to link together a block of related records in the Trial Summary dataset (Section 3.4).",10,,,
,--REFID,Reference ID,Char,"Optional internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image.",11,,,
,--RECID,Invariant Record Identifier,Char,"Identifier for a record that is unique within a domain for a study and that remains invariant through subsequent versions of the dataset, even if the content of the record is modified. When a record is deleted, this value must not be reused to identify another record in either the current or future versions of the domain.",12,,,
,--SPID,Sponsor-Defined Identifier,Char,Sponsor-defined identifier. Example: pre-printed line identifier on a Concomitant Medications page.,13,,,
,--LNKID,Link ID,Char,Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. For Example: A single tumor may have multiple measurements/assessments performed at each study visit.,14,,,
,--LNKGRP,Link Group ID,Char,Identifier used to link related records across domains. This will usually be a many-to-one relationship. For example: Multiple tumor measurements/assessments will contribute to a single response to therapy determination record.,15,,,
,VISITNUM,Visit Number,Num,"Clinical encounter number. Numeric version of VISIT, used for sorting.",1,,,
,VISIT,Visit Name,Char,Protocol-defined description of a clinical encounter.,2,,,
,VISITDY,Planned Study Day of Visit,Num,Planned study day of VISIT. Should be an integer.,3,,,
,TAETORD,Planned Order of Element within Arm,Num,"Number that gives the planned order of the Element within the Arm (see Trial Arms, Section 3.2.2).",4,,,
,EPOCH,Epoch,Char,"Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. (See Section 3.2.2).",5,,,
,--DTC,Date/Time of Collection,Char,Collection date and time of an observation represented in IS0 8601 character format.,6,,,
,--STDTC,Start Date/Time of Observation,Char,Start date/time of an observation represented in IS0 8601 character format.,7,,,
,--ENDTC,End Date/Time of Observation,Char,End date/time of the observation represented in IS0 8601 character format.,8,,,
,--DY,Study Day of Visit/Collection/Exam,Num,Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,9,,,
,--STDY,Study Day of Start of Observation,Num,Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,10,,,
,--ENDY,Study Day of End of Observation,Num,Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.,11,,,
,--NOMDY,Nominal Study Day for Tabulations,Num,The nominal study day used by data-collection and reporting systems for grouping records for observations that may be scheduled to occur on different days into a single study day (such as for output on a tabulation report). Not to be used with human clinical trials.,12,,,
,--NOMLBL,Label for Nominal Study Day,Char,"A label for a given value of --NOMDY, within a domain, as presented in the study report. Not to be used with human clinical trials.",13,,,
,--DUR,Duration,Char,"Collected duration of an event, intervention, or finding represented in ISO 8601 character format. Used only if collected on the CRF and not derived.",14,,,
,--TPT,Planned Time Point Name,Char,"Text description of time when a measurement or 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 of last dose. See --TPTNUM and --TPTREF.",15,,,
,--TPTNUM,Planned Time Point Number,Num,Numeric version of planned time point used in sorting.,16,,,
,--ELTM,Planned Elapsed Time from Time Point Ref,Char,"Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference (--TPTREF) such as ""Previous Dose"" or ""Previous Meal"". This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.",17,,,
,--TPTREF,Time Point Reference,Char,"Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.",18,,,
,--RFTDTC,Date/Time of Reference Time Point,Char,Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 character format.,19,,,
,--STRF,Start Relative to Reference Period,Char,"Identifies the start of the observation as being before, during, or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics.",20,,,
,--ENRF,End Relative to Reference Period,Char,"Identifies the end of the observation as being before, during or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics.",21,,,
,--EVLINT,Evaluation Interval,Char,"Duration of interval associated with an observation such as a finding --TESTCD, represented in ISO 8601 character format. Example: -P2M to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire such as SF-36.",22,,,
,--EVINTX,Evaluation Interval Text,Char,"Evaluation interval associated with an observation, where the interval is not able to be represented in ISO 8601 format. Examples: LIFETIME, LAST NIGHT, RECENTLY, OVER THE LAST FEW WEEKS.",23,,,
,--STRTPT,Start Relative to Reference Time Point,Char,Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable --STTPT.,24,,,
,--STTPT,Start Reference Time Point,Char,Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-15" or "VISIT 1".,25,,,
,--ENRTPT,End Relative to Reference Time Point,Char,Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.,26,,,
,--ENTPT,End Reference Time Point,Char,Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --ENRTPT. Examples: "2003-12-25" or "VISIT 2".,27,,,
,MIDS,Disease Milestone Instance Name,Char,The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (See Section 3.5). This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC.,28,,,
,RELMIDS,Temporal Relation to Milestone Instance,Char,"The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. Examples: IMMEDIATELY BEFORE, AT TIME OF, AFTER.",29,,,
,MIDSDTC,Disease Milestone Instance Date/Time,Char,"The start date/time of the Disease Milestone Instance Name in MIDS, in ISO8601 format.",30,,,
,--STINT,Planned Start of Assessment Interval,Char,The start of a planned evaluation or assessment interval in ISO 8601 character format relative to the Time Point Reference (--TPTREF).,31,,,
,--ENINT,Planned End of Assessment Interval,Char,The end of a planned evaluation or assessment interval in ISO 8601 character format relative to the Time Point Reference (--TPTREF).,32,,,
,--DETECT,Time in Days to Detection,Num,The number of days from the start of dosing to the earliest detection of a condition or pathogen.,33,,,
Variable Qualifier of EGORRES,EGBEATNO,ECG Beat Number,Num,A sequence number that identifies the beat within an ECG.,,After EGPOS,EG,
Record Qualifier,EXMETHOD,Method of Administration,Char,Method of administration of the treatment. Not to be used with human clinical trials.,,After EXLOC,EX,
Record Qualifier,ICIMPLBL,Implantation Site Label,Char,Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn) when classifying implantations during a uterine examination in a reproductive toxicology study.,,After ICSTRESC,IC,
Record Qualifier,--OBJ,Object of the Observation,Char,"Used in domains modeled as Findings About Events or Findings About Interventions. Describes the event or intervention whose property is being measured in --TESTCD/--TEST. Example: an event of vomiting which has findings, where --OBJ = ""VOMIT"" and the volume of VOMIT is being measured where --TESTCD = ""VOLUME"".",,,,
,APID,Associated Persons Identifier,Char,"Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. (See Section 4.1.3 for Pool Definition Dataset and Section 5 for Associated Persons data).",1,,,
,RSUBJID,Related Subject or Pool Identifier,Char,Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool. RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects.,2,,,
,RDEVID,Related Device Identifier,Char,Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device.,3,,,
,SREL,"Subject, Device, or Study Relationship",Char,"If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID.",4,,,
Identifier,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
Identifier,DOMAIN,Domain Abbreviation,Char,Two-character abbreviation for the domain which must be CO.,2,,,
Record Qualifier,RDOMAIN,Related Domain Abbreviation,Char,Domain Abbreviation of the parent record(s). Null for records collected on general comments or additional information CRF page.,3,,,
Identifier,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,4,,,
Identifier,POOLID,Pool Identifier,Char,Used to identify a result for pooled subjects that is not assignable to any one individual within the pool.,5,,,
Identifier,COSEQ,Sequence Number,Num,Sequence number to ensure uniqueness within a domain. Should be assigned to be in a consistent chronological order.,6,,,
Record Qualifier,IDVAR,Identifying Variable,Char,Identifying variable in the parent dataset that identifies the record(s) to which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments are related to domain records. Null for comments collected on separate CRFs.,7,,,
Record Qualifier,IDVARVAL,Identifying Variable Value,Char,Value of identifying variable of the parent record(s). Null for comments collected on separate CRFs.,8,,,
Record Qualifier,COREF,Comment Reference,Char,"Sponsor-defined reference associated with the comment. May be the CRF page number (e.g. 650), or a module name (e.g. DEMOG), or a combination of information that identifies the reference (e.g. 650-VITALS-VISIT 2).",9,,,
Topic,COVAL,Comment,Char,The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.,10,,,
Record Qualifier,COEVAL,Evaluator,Char,Used to describe the originator of the comment. Example: CENTRAL REVIEWER.,11,,,
Timing,CODTC,Date/Time of Comment,Char,"Date/time of comment on dedicated comment form, if collected. Represented in ISO 8601 character format. Should be null if this is a child record of another domain or if comment date was not collected.",12,,,
Identifier,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
Identifier,DOMAIN,Domain,Char,"Two-character abbreviation for the domain, which must be SM.",2,,,
Identifier,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
Identifier,SMSEQ,Sequence Number,Num,Sequence Number given to ensure uniqueness of subject records. Should be assigned to be consistent with chronological order.,4,,,
Topic,MIDS,Disease Milestone Instance Name,Char,"Name of the specific Disease Milestone. For types of Disease Milestones that can occur multiple times, the name will end with a sequence number. Example: HYPO 1.",5,,,
Qualifier,MIDSTYPE,Disease Milestone Type,Char,The type of Disease Milestone. Example: HYPOGLYCEMIC EVENT.,6,,,
Timing,SMSTDTC,Start Date/Time of Milestone,Char,"Start date/time of Milestone Instance, if Milestone is an intervention or event, or date of Milestone if Milestone is a finding.",7,,,
Timing,SMENDTC,End Date/Time of Milestone,Char,End date/time of Disease Milestone Instance.,8,,,
Timing,SMSTDY,Study Day of Start of Milestone,Num,"Study day of start of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC.",9,,,
Timing,SMENDY,Study Day of End of Milestone,Num,"Study day of end of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC.",10,,,
Identifier,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
Identifier,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be SV.",2,,,
Identifier,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
Topic,VISITNUM,Visit Number,Num,"Clinical encounter number. (Decimal numbering may be useful for inserting unplanned visits.) Numeric version of VISIT, used for sorting.",4,,,
Timing,VISIT,Visit Name,Char,Protocol-defined description of clinical encounter or description of unplanned visit. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter.,5,,,
Timing,VISITDY,Planned Study Day of Visit,Num,Planned study day of the start of the visit based upon RFSTDTC in Demographics.,6,,,
Timing,SVSTDTC,Start Date/Time of Visit,Char,"Start date/time for a subject's visit, represented in ISO 8601 character format.",7,,,
Timing,SVENDTC,End Date/Time of Visit,Char,"End date/time of a subject's visit, represented in ISO 8601 character format.",8,,,
Timing,SVSTDY,Study Day of Start of Visit,Num,Study day of start of visit relative to the sponsor-defined RFSTDTC.,9,,,
Timing,SVENDY,Study Day of End of Visit,Num,Study day of end of visit relative to the sponsor-defined RFSTDTC.,10,,,
Optional Qualifier*,SVUPDES,Description of Unplanned Visit,Char,Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits.,11,,,
Identifier,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
Identifier,DOMAIN,Domain Abbreviation,Char,Two-character abbreviation for the domain which must be SE.,2,,,
Identifier,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
Identifier,SESEQ,Sequence Number,Num,Sequence number to ensure uniqueness within dataset. Should be assigned to be in a consistent chronological order.,4,,,
Topic,ETCD,Element Code,Char,"ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.",5,,,
Qualifier,ELEMENT,Description of Element,Char,The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should be null.,6,,,
Timing,SESTDTC,Start Date/Time of Element,Char,"Start date/time for an Element for each subject, represented in ISO 8601 character format.",7,,,
Timing,SEENDTC,End Date/Time of Element,Char,"End date/time of an Element for each subject, represented in ISO 8601 character format.",8,,,
Timing,TAETORD,Planned Order of Element within Arm,Num,Number that gives the planned order of the Element within the subject's assigned ARM.,9,,,
Timing,EPOCH,Epoch,Char,Epoch associated with the Element in the planned sequence of Elements for the ARM to which the subject was assigned,10,,,
Optional Qualifier*,SEUPDES,Description of Unplanned Element,Char,Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of "UNPLAN".,11,,,
Identifier,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
Identifier,DOMAIN,Domain Abbreviation,Char,Two-character abbreviation for the domain which must be DM.,2,,,
Identifier,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
Topic,SUBJID,Subject Identifier for the Study,Char,"Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF.",4,,,
Qualifier,RFSTDTC,Subject Reference Start Date/Time,Char,"Reference Start Date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study treatment. Required for all randomized subjects; will be null for all subjects who did not meet the milestone the date requires, such as screen failures or unassigned subjects.",5,,,
Qualifier,RFENDTC,Subject Reference End Date/Time,Char,"Reference End Date/time for the subject in ISO 8601 character format. Usually equivalent to the date/time when subject was determined to have ended the trial, and often equivalent to date/time of last exposure to study treatment. Required for all randomized subjects; null for screen failures or unassigned subjects.",6,,,
Qualifier,RFXSTDTC,Date/Time of First Study Treatment,Char,First date/time of exposure to any protocol-specified treatment or therapy for the subject in ISO 8601 character format.,7,,,
Qualifier,RFXENDTC,Date/Time of Last Study Treatment,Char,Last date/time of exposure to any protocol-specified treatment or therapy for the subject in ISO 8601 character format.,8,,,
Qualifier,RFICDTC,Date/Time of Informed Consent,Char,Date/time of informed consent in ISO 8601 character format.,9,,,
Qualifier,RFPENDTC,Date/Time of End of Participation,Char,"Date/time when subject ended participation or follow-up in a trial, in ISO 8601 character format. Should correspond to the last known date of contact.",10,,,
Qualifier,DTHDTC,Date/Time of Death,Char,"Date/time of death for any subject who died, in ISO 8601 format. Should represent the date/time that is captured in the clinical-trial database.",11,,,
Qualifier,DTHFL,Subject Death Flag,Char,A value of 'Y' indicates the subject died. Should be Y or null. Should be populated even when the death date is unknown.,12,,,
Qualifier,SITEID,Study Site Identifier,Char,Unique identifier for a site within a study.,13,,,
Qualifier,INVID,Investigator Identifier,Char,An identifier to describe the Investigator for the study. May be used in addition to the SITEID. Not needed if SITEID is equivalent to INVID.,14,,,
Qualifier,INVNAM,Investigator Name,Char,Name of the investigator for a site.,15,,,
Qualifier,BRTHDTC,Date/Time of Birth,Char,Date/time of birth of the subject in ISO 8601 character format.,16,,,
Qualifier,AGE,Age,Num,"Age expressed in AGEU. May be derived as (RFSTDTC-BRTHDTC), but BRTHDTC may not be available in all cases (due to subject privacy concerns).",17,,,
Qualifier,AGETXT,Age Text,Char,"The age of the subject at study start, as planned, expressed as a range. If an age integer value is available, then populate the age variable instead. Either the AGE or AGETXT variable should be populated, but not both.",18,,,
Qualifier,AGEU,Age Units,Char,Units associated with AGE or AGETXT.,19,,,
Qualifier,SEX,Sex,Char,Sex of the subject.,20,,,
Qualifier,RACE,Race,Char,"Race of the subject. Sponsors should refer to ""Collection of Race and Ethnicity Data in Clinical Trials"" (FDA, September 2005) for guidance regarding the collection of race (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf)",21,,,
Qualifier,ETHNIC,Ethnicity,Char,"The ethnicity of the subject. Sponsors should refer to ""Collection of Race and Ethnicity Data in Clinical Trials"" (FDA, September 2005) for guidance regarding the collection of ethnicity (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf)",22,,,
Qualifier,SPECIES,Species,Char,"Used to identify the common species name of the subject (i.e., test system) under study (e.g., MOUSE, RAT, DOG, MONKEY).",23,,,
Qualifier,STRAIN,Strain/Substrain,Char,"Used to identify the vendor-supplied strain/substrain designation for the subject (i.e., test system) under study. When applicable, it combines the root 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, CHIMPANZEE).",24,,,
Qualifier,SBSTRAIN,Strain/Substrain Details,Char,"Free-text field that allows the sponsor to enter additional details regarding the subject (i.e. test system) under study, such as a description of a specific genetic alteration.",25,,,
Qualifier,ARMCD,Planned Arm Code,Char,"Short name for the Arm to which the subject was assigned, limited to 20 characters.",26,,,
Qualifier,ARM,Description of Planned Arm,Char,Name of the Arm to which the subject was assigned.,27,,,
Qualifier,ACTARMCD,Actual Arm Code,Char,"Short name for the actual Arm in which the subject participated during the trial, limited to 20 characters.",28,,,
Qualifier,ACTARM,Description of Actual Arm,Char,Description of the actual Arm in which the subject participated during the trial.,29,,,
Qualifier,SETCD,Set Code,Char,"Short name of a specific Trial Set (see Table 3.2.4), as defined by the sponsor. Maximum of 8 characters. This represents the code for the Trial Set for which parameters are being submitted.",30,,,
Qualifier,COUNTRY,Country,Char,Country of the investigational site at which the subject participated in the trial in ISO 3166 three-character format.,31,,,
Timing,DMDTC,Date/Time of Collection,Char,Date/time of collection of the demographic information in ISO 8601 character format.,32,,,
Timing,DMDY,Study Day of Collection,Num,Study day of collection measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC in Demographics.,33,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be TE.",2,,,
,ETCD,Element Code,Char,"ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.",3,,,
,ELEMENT,Description of Element,Char,The name of the Element.,4,,,
,TESTRL,Rule for Start of Element,Char,Expresses the rule for beginning the Element.,5,,,
,TEENRL,Rule for End of Element,Char,Expresses the rule for ending the Element. Either TEENRL or TEDUR must be present for each Element.,6,,,
,TEDUR,Planned Duration of Element,Char,Planned Duration of Element in ISO 8601 format. Used when the rule for ending the Element is applied after a fixed duration.,7,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be TA.",2,,,
,ARMCD,Planned Arm Code,Char,"ARMCD is limited to 20 characters and does not have special character restrictions. If the timing of visits for a trial does not depend on which ARM a subject is in, then ARMCD should be null.",3,,,
,ARM,Description of Planned Arm,Char,Name given to Arm or treatment group.,4,,,
,TAETORD,Planned Order of Element within Arm,Num,Number that gives the order of the Element within the Arm.,5,,,
,ETCD,Element Code,Char,"ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.",6,,,
,ELEMENT,Description of Element,Char,The name of the Element.,7,,,
,TABRANCH,Branch,Char,"Condition subjects meet, at a ""branch"" in the Trial Design at the end of this Element, to be included in this Arm. Example: Randomization to DRUG X.",8,,,
,TATRANS,Transition Rule,Char,"If the trial design allows a subject to transition to an Element other than the next Element in sequence, then the conditions for transitioning to those other Elements, and the alternative Element sequences, are specified in this rule (e.g., Responders go to washout).",9,,,
,EPOCH,Epoch,Char,Name of the Trial Epoch with which this Element of the Arm is associated.,10,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be TV.",2,,,
,VISITNUM,Visit Number,Num,Clinical encounter number. Numeric version of VISIT can be used for sorting.,3,,,
,VISIT,Visit Name,Char,Protocol-defined description of the clinical encounter. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter.,4,,,
,VISITDY,Planned Study Day of Visit,Num,"Planned study day of VISIT. Due to its sequential nature, can be used for sorting.",5,,,
,ARMCD,Planned Arm Code,Char,"ARMCD is limited to 20 characters and does not have special character restrictions. If the timing of visits for a trial does not depend on which ARM a subject is in, then ARMCD should be null.",6,,,
,ARM,Description of Planned Arm,Char,Name given to Arm or treatment group.,7,,,
,TVSTRL,Visit Start Rule,Char,"Rule describing when the visit starts, in relation to the sequence of Elements.",8,,,
,TVENRL,Visit End Rule,Char,"Rule describing when the visit ends, in relation to the sequence of Elements.",9,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be TX.",2,,,
,SETCD,Set Code,Char,"Short name of a specific Trial Set, as defined by the sponsor. Maximum 8 characters. This represents the Trial Set for which parameters are being submitted.",3,,,
,SET,Set Description,Char,"Long description of a specific Trial Set, as defined by the sponsor.",4,,,
,TXSEQ,Sequence Number,Num,Unique number for this record within this dataset.,5,,,
,TXPARMCD,Trial Set Parameter Short Name,Char,Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters.,6,,,
,TXPARM,Trial Set Parameter,Char,Term for the Trial Set parameter. Maximum 40 characters.,7,,,
,TXVAL,Trial Set Parameter Value,Char,"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.",8,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain,Char,"Two-character abbreviation for the domain, which must be TM.",2,,,
,MIDSTYPE,Disease Milestone Type,Char,The type of Disease Milestone. Example: HYPOGLYCEMIC EVENT.,3,,,
,TMDEF,Disease Milestone Definition,Char,Definition of the Disease Milestone.,4,,,
,TMRPT,Disease Milestone Repetition Indicator,Char,Indicates whether this is a Disease Milestone that can occur only once (N) or a type of Disease Milestone that can occur multiple times (Y).,5,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be TD.",2,,,
,TDORDER,Sequence of Planned Assessment Schedule,Num,A number given to ensure ordinal sequencing of the planned assessment schedules within a trial.,3,,,
,TDANCVAR,Anchor Variable Name,Char,A reference to the date variable name that provides the start point from which the planned disease assessment schedule is measured. This must be referenced from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date variable name.,4,,,
,TDSTOFF,Offset from the Anchor,Char,A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this variable will be either zero or a positive value and will be represented in ISO 8601 character format.,5,,,
,TDTGTPAI,Planned Assessment Interval,Char,The planned interval between disease assessments represented in ISO 8601 character format.,6,,,
,TDMINPAI,Planned Assessment Interval Minimum,Char,The lower limit of the allowed range for the planned interval between disease assessments represented in ISO 8601 character format.,7,,,
,TDMAXPAI,Planned Assessment Interval Maximum,Char,The upper limit of the allowed range for the planned interval between disease assessments represented in ISO 8601 character format.,8,,,
,TDNUMRPT,Maximum Number of Actual Assessments,Num,"This variable must represent the maximum number of actual assessments for the analysis that this disease assessment schedule describes. In a trial where the maximum number of assessments is not defined explicitly in the protocol (e.g. assessments occur until death) TDNUMRPT should represent the maximum number of disease assessments that support the efficacy analysis, encountered by any subject across the trial at that point in time.",9,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be TS.",2,,,
,TSSEQ,Sequence Number,Num,Sequence number to ensure uniqueness within the dataset.,3,,,
,TSGRPID,Group ID,Char,Used to tie together a group of related records.,4,,,
,TSPARMCD,Trial Summary Parameter Short Name,Char,"TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names. Examples: AGEMIN, AGEMAX",5,,,
,TSPARM,Trial Summary Parameter,Char,"Term for the Trial Summary Parameter. The value in TSPARM cannot be longer than 40 characters. Examples Planned Minimum Age of Subjects, Planned Maximum Age of Subjects",6,,,
,TSVAL,Parameter Value,Char,Value of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Indications". If TSVAL is null; a value is required for TSVALNF. Text over 200 characters can be added to additional columns TSVAL1-TSVALn.,7,,,
,TSVALNF,Parameter Null Flavor,Char,"Null flavor for the value of TSVAL describing the reason the value is null, to be populated if and only if TSVAL is null.",8,,,
,TSVALCD,Parameter Value Code,Char,Code of the term in TSVAL from Reference Terminology cited in TSVCDREF.,9,,,
,TSVCDREF,Name of the Reference Terminology,Char,"The name of the reference terminology or standard format from which TSVALCD is taken. For example; CDISC, SNOMED, ISO8601.",10,,,
,TSVCDVER,Version of the Reference Terminology,Char,"The version number of the Reference Terminology cited in TSVCDREF, if applicable.",11,,,
,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
,DOMAIN,Domain Abbreviation,Char,"Two-character abbreviation for the domain, which must be TI.",2,,,
,IETESTCD,Inclusion/Exclusion Criterion Short Name,Char,"Short name IETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., ""1TEST""). IETESTCD cannot contain characters other than letters, numbers, or underscores. The name ""IE"" prefix is used to ensure consistency with the IE domain",3,,,
,IETEST,Inclusion/Exclusion Criterion,Char,Full text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain.,4,,,
,IECAT,Inclusion/Exclusion Category,Char,"Used for categorization of the Inclusion/Exclusion Criterion: INCLUSION, EXCLUSION.",5,,,
,IESCAT,Inclusion/Exclusion Subcategory,Char,"A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or for to categorize as a major or minor exceptions. Examples: MAJOR, MINOR.",6,,,
,TIRL,Inclusion/Exclusion Criterion Rule,Char,Rule that expresses the criterion in computer-executable form.,7,,,
,TIVERS,Protocol Criteria Versions,Char,The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only one version.,8,,,
,STUDYID,Study Identifier,Char,Study Identifier of the parent record(s).,1,,,
,POOLID,Pool Identifier,Char,Identifier used for pooling subjects to assign a single finding to multiple subjects.,2,,,
,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
,APID,Associated Persons Identifier,Char,"Identifier for a single associated person, a group of associated persons, or a pool of associated persons.",4,,,
,STUDYID,Study Identifier,Char,,1,,,Unique identifier for a study.
,USUBJID,Unique Subject Identifier,Char,,2,,,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.
,POOLID,Pool Identifier,Char,,3,,,"Identifier used to identify a pool of subjects. If POOLID is entered, POOLDEF records must exist for each subject in the pool and USUBJID must be null. Either USUBJID or POOLID must be populated."
,RSUBJID,Related Subject or Pool Identifier,Char,,4,,,Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool.
,SREL,Subject Relationship,Char,,5,,,Describes the relationship of the subject identified in USUBJID or the pool identified in POOLID to the subject or pool identified in RSUBJID.
,STUDYID,Study Identifier,Char,Study Identifier of the domain record(s).,1,,,
,RDOMAIN,Related Domain Abbreviation,Char,Two-character abbreviation for the domain of the parent record(s).,2,,,
,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
,APID,Associated Persons Identifier,Char,"Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. (See Section 4.1.3 for Pool Definition Dataset and Section 5 for Associated Persons data).",4,,,
,POOLID,Pool Identifier,Char,Identifier used for pooling subjects to assign a single finding to multiple subjects.,5,,,
,IDVAR,Identifying Variable,Char,Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID.,6,,,
,IDVARVAL,Identifying Variable Value,Char,"Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ would be entered here.",7,,,
,RELTYPE,Relationship Type,Char,"Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. However, values are only necessary when identifying a relationship between datasets.",8,,,
,RELID,Relationship Identifier,Char,"RELID value should be unique within the ID variable (e.g., USUBJID, APID, POOLID, SPDEVID) that is the subject of the relationship. All records with this ID variable that have the same RELID are considered ""related/associated."" RELID can be any value the sponsor chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records.",9,,,
,STUDYID,Study Identifier,Char,Study Identifier of the parent record(s).,1,,,
,RDOMAIN,Related Domain Abbreviation,Char,Two-character abbreviation for the domain of the parent record(s).,2,,,
,USUBJID,Unique Subject Identifier,Char,Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.,3,,,
,APID,Associated Persons Identifier,Char,"Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. (See Section 4.1.3 for Pool Definition Dataset and Section 5 for Associated Persons data).",4,,,
,POOLID,Pool Identifier,Char,Identifier used for pooling subjects to assign a single finding to multiple subjects.,5,,,
,IDVAR,Identifying Variable,Char,"Identifying variable in the parent dataset that identifies the related record(s). Examples: --SEQ, --GRPID.",6,,,
,IDVARVAL,Identifying Variable Value,Char,Value of identifying variable of the parent record(s).,7,,,
,QNAM,Qualifier Variable Name,Char,"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""). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset.",8,,,
,QLABEL,Qualifier Variable Label,Char,This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the sponsor's original dataset.,9,,,
,QVAL,Data Value,Char,"Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in a SUPP-- dataset with a null value for QVAL",10,,,
,QORIG,Origin,Char,"Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. Examples include CRF, ASSIGNED, or DERIVED.",11,,,
,QEVAL,Evaluator,Char,"Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include ADJUDICATION COMMITTEE, STATISTICIAN, DATABASE ADMINISTRATOR, CLINICAL COORDINATOR, etc.",12,,,
Identifier,STUDYID,Study Identifier,Char,Unique identifier for a study.,1,,,
Identifier,APID,Associated Persons Identifier,Char,"Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person. (See Section 4.1.3 for Pool Definition Dataset and Section 5 for Associated Persons data).",2,,,
Identifier,RSUBJID,Related Subject or Pool Identifier,Char,Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool. RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects.,3,,,
Identifier,RDEVID,Related Device Identifier,Char,Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device.,4,,,
Record Qualifier,SREL,"Subject, Device, or Study Relationship",Char,"If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID.",5,,,