SDTM 2.1 Spec Grabber

Source Page	SDTM2DOT1:SDTM tables
Valid Tables	34
Destination	Library
Options	Page diving Table walking Sequencing Exclude symbolic columns Exclude symbolic values Show line breaks
Output Format	Table

Variable Name	Variable Label	Type	Format	Role	Variable(s) Qualified	Usage Restrictions	Variable C-code	Definition	Notes	Examples	Variable Name (no prefix)	Seq. for Order	Observation Class	Dataset Name	Domain Prefix
--TRT	Name of Treatment or Product	Char		Topic			C82542	The reported name of the drug, procedure, therapy, or product.	The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, therapy, or product given during the dosing interval for the observation.		TRT	1	Interventions-General
--MODIFY	Modified Treatment Name	Char		Synonym Qualifier	--TRT		C170998	A value which represents an alteration to a collected value for coding purposes.	If the value for --TRT is modified for coding purposes, then the modified text is placed here.		MODIFY	2	Interventions-General
--DECOD	Standardized Treatment Name	Char		Synonym Qualifier	--TRT		C170991	Standardized or dictionary-derived text for the description of an event or intervention.	Equivalent to the generic drug name in WHODrug, or a term in SNOMED, ICD-9, or other published or sponsor-defined dictionaries.		DECOD	3	Interventions-General
--MOOD	Mood	Char		Record Qualifier			C117051	The state that may be applied to a record to indicate its phase in a life cycle or business process (e.g., scheduled, performed).		"SCHEDULED", "PERFORMED"	MOOD	4	Interventions-General
--CAT	Category	Char		Grouping Qualifier			C25372	A grouping or classification of the topic of the finding, event, or intervention.			CAT	5	Interventions-General
--SCAT	Subcategory	Char		Grouping Qualifier			C25692	A further grouping or classification of the category for the topic of the finding, event, or intervention.	The category is in --CAT.		SCAT	6	Interventions-General
--PRESP	Pre-Specified	Char		Variable Qualifier	--TRT	Not in nonclinical trials	C82510	An indication that the event or intervention was prospectively stated or detailed on the CRF.	Values should be "Y" or null.		PRESP	7	Interventions-General
--OCCUR	Occurrence Indicator	Char		Record Qualifier			C171000	An indication as to whether a prespecified event or intervention has occurred.			OCCUR	8	Interventions-General
--REASOC	Reason for Occur Value	Char		Record Qualifier					--REASOC is the reason the intervention did or did not occur, according to the value in --OCCUR. This does not replace --INDC.		REASOC	9	Interventions-General
--STAT	Completion Status	Char		Record Qualifier					Used to indicate when a question about the occurrence of a prespecified intervention was not answered. Should be null or have a value of "NOT DONE".		STAT	10	Interventions-General
--REASND	Reason Not Done	Char		Record Qualifier			C82556	The explanation for why requested information was not available.	Used in conjunction with --STAT when value is "NOT DONE".		REASND	11	Interventions-General
--CNTMOD	Contact Mode	Char		Record Qualifier					The way in which the event, visit, or contact was conducted.		CNTMOD	12	Interventions-General
--EPCHGI	Epi/Pandemic Related Change Indicator	Char		Record Qualifier					Indicates whether the intervention was changed due to an epidemic or pandemic.		EPCHGI	13	Interventions-General
--INDC	Indication	Char		Record Qualifier			C41184	The sign, symptom, or condition that is the basis for initiation of a treatment.			INDC	14	Interventions-General
--CLAS	Class	Char		Variable Qualifier	--TRT		C170987	A standardized or dictionary-derived name for a grouping of drugs, procedures, or therapies.			CLAS	15	Interventions-General
--CLASCD	Class Code	Char		Variable Qualifier	--TRT		C170988	A standardized or dictionary-derived short sequence of characters used to represent a grouping of drugs, procedures, or therapies.	Used to represent code for --CLAS.		CLASCD	16	Interventions-General
--DOSE	Dose	Num		Record Qualifier			C25488	The quantity of an agent (e.g., drug, substance, radiation) taken or absorbed at a single administration.	Not populated when --DOSTXT is populated.		DOSE	17	Interventions-General
--DOSTXT	Dose Description	Char		Record Qualifier			C70961	A textual description of the quantity of an agent (e.g., drug, substance, radiation) taken or absorbed at a single administration.	Not populated when --DOSE is populated.	"200-400"	DOSTXT	18	Interventions-General
--DOSU	Dose Units	Char		Variable Qualifier	--DOSE; --DOSTXT; --DOSTOT		C73558	The unit of measure for the administered agent (e.g., drug, substance, radiation), using standardized values.	Units for --DOSE, --DOSTOT, or --DOSTXT.	"ng", "mg", "mg/kg"	DOSU	19	Interventions-General
--TDOSD	Toxic/Physiologic Dose Descr	Char		Record Qualifier					A description of a statistically derived estimate of a dose with a certain toxicological or physiological effect in a population, based on data from a dose-response study.	"LD50", "ED90"	TDOSD	20	Interventions-General
--FTDOSD	Factor for Toxic/Physiologic Dose Descr	Num		Variable Qualifier	--TDOSD				The quantity given for the multiplier of --TDOSD.	If --TDOSD="LD50" and --FTDOSD="5", then the value represented by --DOSE and --DOSU is 5 times the LD50.	FTDOSD	21	Interventions-General
--DOSFRM	Dose Form	Char		Variable Qualifier	--TRT		C42636	Physical characteristics of a product, (e.g., tablet, capsule, solution) that contains a substance, generally (but not necessarily) in association with 1 or more other ingredients.		"TABLET", "CAPSULE"	DOSFRM	22	Interventions-General
--DOSFRQ	Dosing Frequency per Interval	Char		Record Qualifier			C15682	The number of times that an agent (e.g., drug, product, substance, radiation) is administered per unit of time.		"Q2H", "QD", "PRN"	DOSFRQ	23	Interventions-General
--DOSTOT	Total Daily Dose	Num		Record Qualifier			C70888	The quantity of an agent (e.g., drug, product, substance, radiation) taken or absorbed on a single day.	Uses the units in --DOSU.		DOSTOT	24	Interventions-General
--DOSRGM	Intended Dose Regimen	Char		Record Qualifier			C71137	The planned schedule for the administration of an agent (e.g., drug, product, substance, radiation).		"TWO WEEKS ON, TWO WEEKS OFF"	DOSRGM	25	Interventions-General
--ROUTE	Route of Administration	Char		Record Qualifier			C38114	Designation of the part of the body through which or into which, or the way in which, a substance is introduced.		"ORAL", "INTRAVENOUS"	ROUTE	26	Interventions-General
--LOT	Lot Number	Char		Record Qualifier			C70848	An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product.	Although the identifier for a lot is generally called a lot number, it may contain characters other than digits (e.g., letters).		LOT	27	Interventions-General
--LOC	Location of Administration	Char		Record Qualifier					Anatomical location of an intervention, such as an injection site.	"ARM" for an injection	LOC	28	Interventions-General
--METHOD	Method of Administration	Char		Record Qualifier		Not in human clinical trials; EX domain only		Method of administration of the treatment.		"INFUSION" when ROUTE is "INTRAVENOUS"	METHOD	29	Interventions-General
--LAT	Laterality	Char		Variable Qualifier	--LOC				Qualifier for anatomical location further detailing laterality of intervention administration.	"RIGHT", "LEFT", "BILATERAL"	LAT	30	Interventions-General
--DIR	Directionality	Char		Variable Qualifier	--LOC				Qualifier for anatomical location further detailing directionality of intervention administration.	"ANTERIOR", "LOWER", "PROXIMAL"	DIR	31	Interventions-General
--PORTOT	Portion or Totality	Char		Variable Qualifier	--LOC				Qualifier for anatomical location further detailing the distribution, which means arrangement of or apportioning of the intervention administration.	"ENTIRE", "SINGLE", "SEGMENT", "MANY"	PORTOT	32	Interventions-General
--FAST	Fasting Status	Char		Record Qualifier			C93566	An indication as to whether a subject has abstained from food and liquid for a prescribed amount of time.	Valid values include "Y", "N", "U", or null if not relevant.		FAST	33	Interventions-General
--PSTRG	Pharmaceutical Strength	Num		Record Qualifier			C53294	The amount of active ingredient per unit of pharmaceutical dosage form.		"50", "300"	PSTRG	34	Interventions-General
--PSTRGU	Pharmaceutical Strength Units	Char		Variable Qualifier	--PSTRG		C117055	The unit of measure for the amount of active ingredient per unit of pharmaceutical dosage form, using standardized values.	Unit for --PSTRG.	"mg/TABLET", "mg/mL"	PSTRGU	35	Interventions-General
--TRTV	Treatment Vehicle	Char		Record Qualifier			C927	A carrier or inert medium in which a medicinally active agent is administered.		"SALINE"	TRTV	36	Interventions-General
--VAMT	Treatment Vehicle Amount	Num		Record Qualifier			C82553	Amount of the prepared product (treatment plus vehicle) administered.	Note: Should not be diluent amount alone.		VAMT	37	Interventions-General
--VAMTU	Treatment Vehicle Amount Units	Char		Variable Qualifier	--VAMT		C82583	The unit of measure for the prepared product (treatment plus vehicle) using standardized values.		"mL", "mg"	VAMTU	38	Interventions-General
--ADJ	Reason for Dose Adjustment	Char		Record Qualifier			C82555	The explanation given for why a dose was changed as compared to a previous dose.		"ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON"	ADJ	39	Interventions-General
--RSDISC	Reason Treatment or Product Discontinued	Char		Record Qualifier					Reason the treatment or product was discontinued.		RSDISC	40	Interventions-General
--USCHFL	Unscheduled Flag	Char		Record Qualifier		Not in human clinical trials	C170510	An indication that the performed test or observation was done at a time that was not planned.	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. 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.		USCHFL	41	Interventions-General
--RSTIND	Restraint Indicator	Char		Record Qualifier		Not in human clinical trials			An indicator as to whether the animal subject was restrained during the intervention period. Expected values are "Y" or null.		RSTIND	42	Interventions-General
--RSTMOD	Restraint Mode	Char		Record Qualifier		Not in human clinical trials			A description of whether the restraint was physical and/or chemical.		RSTMOD	43	Interventions-General
--TERM	Reported Term	Char		Topic			C82571	The collected name for an event observation.	The verbatim or prespecified name of the event.		TERM	1	Events-General
--MODIFY	Modified Reported Term	Char		Synonym Qualifier	--TERM		C170998	A value which represents an alteration to a collected value for coding.	If the value for --TERM is modified for coding purposes, then the modified text is placed here.		MODIFY	2	Events-General
--LLT	Lowest Level Term	Char		Variable Qualifier	--TERM	Not in nonclinical trials	C71886	The lowest-level term assigned to the event from MedDRA.			LLT	3	Events-General
--LLTCD	Lowest Level Term Code	Num		Variable Qualifier	--LLT	Not in nonclinical trials	C117048	The lowest-level term code assigned to the event from MedDRA.			LLTCD	4	Events-General
--DECOD	Dictionary-Derived Term	Char		Synonym Qualifier	--TERM		C170991	Standardized or dictionary-derived text for the description of an event or intervention.	Equivalent to the Preferred Term ("PT" in MedDRA).		DECOD	5	Events-General
--EVDTYP	Medical History Event Date Type	Char		Variable Qualifier	--STDTC; --ENDTC	MH domain only			Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined.	"DIAGNOSIS", "SYMPTOM ONSET", "DISEASE RELAPSE"	EVDTYP	6	Events-General
--PTCD	Preferred Term Code	Num		Variable Qualifier	--DECOD	Not in nonclinical trials	C117056	The preferred term code assigned to the event from MedDRA.			PTCD	7	Events-General
--HLT	High Level Term	Char		Variable Qualifier	--TERM	Not in nonclinical trials	C71880	The high-level term from the primary hierarchy assigned to the event from MedDRA.			HLT	8	Events-General
--HLTCD	High Level Term Code	Num		Variable Qualifier	--HLT	Not in nonclinical trials	C117047	The high-level term code from the primary hierarchy assigned to the event from MedDRA.			HLTCD	9	Events-General
--HLGT	High Level Group Term	Char		Variable Qualifier	--TERM	Not in nonclinical trials	C71889	The high-level group term from the primary hierarchy assigned to the event from MedDRA.			HLGT	10	Events-General
--HLGTCD	High Level Group Term Code	Num		Variable Qualifier	--HLGT	Not in nonclinical trials	C117046	The high-level group term code from the primary hierarchy assigned to the event from MedDRA.			HLGTCD	11	Events-General
--CAT	Category	Char		Grouping Qualifier			C25372	A grouping or classification of the topic of the finding, event, or intervention.			CAT	12	Events-General
--SCAT	Subcategory	Char		Grouping Qualifier			C25692	A further grouping or classification of the category for the topic of the finding, event, or intervention.	The category is in --CAT.		SCAT	13	Events-General
--PRESP	Pre-Specified	Char		Variable Qualifier	--TERM		C82510	An indication that the event or intervention was prospectively stated or detailed on the CRF.	Value is "Y" for prespecified events, null for spontaneously reported events.		PRESP	14	Events-General
--OCCUR	Occurrence Indicator	Char		Record Qualifier		Not in AE domain	C171000	An indication as to whether a prespecified event or intervention has occurred.			OCCUR	15	Events-General
--REASOC	Reason for Occur Value	Char		Record Qualifier		Not in AE domain			--REASOC is the reason the event did or did not occur, according to the value in --OCCUR.		REASOC	16	Events-General
--STAT	Completion Status	Char		Record Qualifier		Not in AE domain			Used to indicate when a question about the occurrence of a prespecified event was not answered. Should be null or have a value of "NOT DONE".		STAT	17	Events-General
--REASND	Reason Not Done	Char		Record Qualifier		Not in AE domain	C82556	The explanation for why requested information was not available.	Used in conjunction with --STAT when its value is "NOT DONE".		REASND	18	Events-General
--BODSYS	Body System or Organ Class	Char		Record Qualifier			C170986	A standardized or dictionary-derived name for the body system or organ class.	Body system or system organ class assigned for analysis from a standard hierarchy (e.g., MedDRA) associated with an event.	"GASTROINTESTINAL DISORDERS"	BODSYS	19	Events-General
--BDSYCD	Body System or Organ Class Code	Num		Variable Qualifier	--BODSYS	Not in nonclinical trials	C170985	A standardized or dictionary-derived short sequence of characters used to represent the body system or organ class.	MedDRA System Organ Class (SOC) code corresponding to --BODSYS assigned for analysis.		BDSYCD	20	Events-General
--SOC	Primary System Organ Class	Char		Variable Qualifier	--TERM	Not in nonclinical trials	C71888	The SOC from the primary hierarchy assigned in the MedDRA dictionary.			SOC	21	Events-General
--SOCCD	Primary System Organ Class Code	Num		Variable Qualifier	--SOC	Not in nonclinical trials	C117059	The SOC code from the primary hierarchy assigned in the MedDRA dictionary.			SOCCD	22	Events-General
--CNTMOD	Contact Mode	Char		Record Qualifier					The way in which the event, visit, or contact was conducted.	"IN PERSON", "TELEPHONE", "IVRS"	CNTMOD	23	Events-General
--EPCHGI	Epi/Pandemic Related Change Indicator	Char		Record Qualifier					Indicates whether the event was changed due to an epidemic or pandemic. Not the same as whether a medical condition was caused by an epidemic or pandemic.		EPCHGI	24	Events-General
--LOC	Location of Event	Char		Record Qualifier					Describes anatomical location relevant for the event.	"ARM" for skin rash	LOC	25	Events-General
--LAT	Laterality	Char		Variable Qualifier	--LOC				Qualifier for anatomical location, further detailing laterality.	"RIGHT", "LEFT", "BILATERAL"	LAT	26	Events-General
--DIR	Directionality	Char		Variable Qualifier	--LOC				Qualifier for anatomical location, further detailing directionality.	"ANTERIOR", "LOWER", "PROXIMAL"	DIR	27	Events-General
--PORTOT	Portion or Totality	Char		Variable Qualifier	--LOC				Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).	"ENTIRE", "SINGLE", "SEGMENT", "MANY"	PORTOT	28	Events-General
--PARTY	Accountable Party	Char		Record Qualifier		Not in nonclinical trials	C117052	The role of the individual or entity responsible for the receipt of the transferred object (e.g., device, specimen).	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.		PARTY	29	Events-General
--PRTYID	Identification of Accountable Party	Char		Variable Qualifier	--PARTY	Not in nonclinical trials	C117054	A sequence of characters used to uniquely identify the individual or entity responsible for the receipt of the transferred object (e.g., device, specimen).	Used in conjunction with --PARTY.		PRTYID	30	Events-General
--SEV	Severity/Intensity	Char		Record Qualifier			C25676	The quality or degree of harm associated with a finding or event, as collected.		"MILD", "MODERATE", "SEVERE"	SEV	31	Events-General
--SER	Serious Event	Char		Record Qualifier			C82578	A collected indication as to whether an event meets regulatory criteria for seriousness.	Valid values are "Y" and "N".		SER	32	Events-General
--ACN	Action Taken w/ Study Trtmnt or Product	Char		Record Qualifier			C49499	An action taken with study treatment or product, as the result of the event.		"DOSE INCREASED", "DOSE NOT CHANGED"	ACN	33	Events-General
--ACNOTH	Other Action Taken	Char		Record Qualifier			C82509	An action taken unrelated to study treatment or product, as the result of the event.			ACNOTH	34	Events-General
--ACNDEV	Action Taken with Device	Char		Record Qualifier			C117037	An action taken with a device as the result of the event.	The device may or may not be the device under study.		ACNDEV	35	Events-General
--REL	Causality	Char		Record Qualifier			C103163	The investigator's assessment of the likelihood that the study treatment or product was the cause of the event.		"NOT RELATED", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED"	REL	36	Events-General
--RLDEV	Relationship of Event to Device	Char		Record Qualifier					A judgment as to the likelihood that the device caused the event. \n The device may or may not be the device under study. Controlled terminology from EC Directive MEDDEV 2.7/3 March 2015 is required in EU but not US.	"CAUSAL", "UNLIKELY"	RLDEV	37	Events-General
--RELNST	Relationship to Non-Study Treatment	Char		Record Qualifier			C82564	The investigator's assessment of the causal relationship of the event to a non-study treatment.		"MORE LIKELY RELATED TO ASPIRIN USE"	RELNST	38	Events-General
--PATT	Pattern of Event	Char		Record Qualifier			C82550	A characterization of the temporal pattern of occurrences of the event.		"INTERMITTENT", "CONTINUOUS", "SINGLE EVENT"	PATT	39	Events-General
--OUT	Outcome of Event	Char		Record Qualifier			C171001	The status associated with the result or conclusion of the event.		"RECOVERED/RESOLVED", "FATAL"	OUT	40	Events-General
--SCAN	Involves Cancer	Char		Record Qualifier		Not in nonclinical trials	C82561	An indication as to whether the reason an event was serious was because the event was associated with cancer.	Valid values are "Y", "N", and null. \n This is a legacy seriousness criterion. It is not included in ICH E2A or E2B.		SCAN	41	Events-General
--SCONG	Congenital Anomaly or Birth Defect	Char		Record Qualifier		Not in nonclinical trials	C2849	An indication as to whether the reason an event is serious is because the event is associated with congenital anomaly or birth defect in an offspring of the subject.	Valid values are "Y", "N", and null.		SCONG	42	Events-General
--SDISAB	Persist or Signif Disability/Incapacity	Char		Record Qualifier		Not in nonclinical trials	C68606	An indication as to whether the reason an event is serious is because the event resulted in a significant, persistent, or permanent change, impairment, damage, or disruption in the subject's body function/structure, physical activities, and/or quality of life.	Valid values are "Y", "N", and null.		SDISAB	43	Events-General
--SDTH	Results in Death	Char		Record Qualifier		Not in nonclinical trials	C82549	An indication as to whether the reason an event is serious is because the event resulted in death.	Valid values are "Y", "N", and null.		SDTH	44	Events-General
--SHOSP	Requires or Prolongs Hospitalization	Char		Record Qualifier		Not in nonclinical trials	C68605	An indication as to whether the reason an event is serious is because the event resulted in or prolonged hospitalization.	Valid values are "Y", "N", and null.		SHOSP	45	Events-General
--SLIFE	Is Life Threatening	Char		Record Qualifier		Not in nonclinical trials	C82508	An indication as to whether the reason an event is serious is because the event resulted in a substantial risk of dying.	Valid values are "Y", "N", and null.		SLIFE	46	Events-General
--SOD	Occurred with Overdose	Char		Record Qualifier		Not in nonclinical trials	C82548	An indication as to whether the reason an event is serious is because the event is associated with overdose.	Valid values are "Y", "N", and null. \n This is a legacy seriousness criterion. It is not included in ICH E2A or E2B.		SOD	47	Events-General
--SMIE	Other Medically Important Serious Event	Char		Record Qualifier		Not in nonclinical trials	C82521	An indication as to whether the reason an event is serious is because the event may jeopardize the subject and may require intervention to prevent one of the other outcomes associated with serious adverse events.	Valid values are "Y", "N", and null.		SMIE	48	Events-General
--SINTV	Needs Intervention to Prevent Impairment	Char		Record Qualifier		AE domain only			Valid values are "Y", "N", and null. Expected use is in medical device-related trials. It is part of the definition of a serious AE as represented in 21 CFR Part 803.3(w)(3). \n Records whether medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, with either situation suspected to be due to the use of a medical product.		SINTV	49	Events-General
--UNANT	Unanticipated Adverse Device Effect	Char		Record Qualifier		AE domain only			The assessment is about a device identified in the data (i.e., which has an SPDEVID). The device may be ancillary or under study. \n Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. (21 CFR 812.3(s)).		UNANT	50	Events-General
--RLPRT	Rel of AE to Non-Dev-Rel Study Activity	Char		Record Qualifier		AE domain only			The investigator's opinion as to the causality of the event as related to other protocol-required activities, actions or assessments (e.g., medication changes, tests/assessments, other procedures). \n The relationship is to a protocol-specified non-device-related activity where the device is identified in the data (i.e., which has an SPDEVID). The device may be ancillary or under study.	"CAUSAL", "UNLIKELY"	RLPRT	51	Events-General
--RLPRC	Rel of AE to Device-Related Procedure	Char		Record Qualifier		AE domain only			The investigator's opinion as to the likelihood that the device-related study procedure caused the AE (e.g., implant/insertion, revision/adjustment, explant/removal) \n The relationship is to a device-related procedure where the device is identified in the data (i.e., which has an SPDEVID). The device may be ancillary or under study.	"CAUSAL", "UNLIKELY"	RLPRC	52	Events-General
--CONTRT	Concomitant or Additional Trtmnt Given	Char		Record Qualifier			C170989	An indication as to whether a non-study treatment was given because of the occurrence of the event.	Valid values are "Y", "N", and null.		CONTRT	53	Events-General
--TOX	Toxicity	Char		Variable Qualifier	--TOXGR		C27990	The standardized or dictionary-derived name for an untoward event or finding.	Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.	An NCI CTCAE Short Name, "HYPERCALCEMIA", "HYPOCALCEMIA"	TOX	54	Events-General
--TOXGR	Toxicity Grade	Char		Record Qualifier			C82528	A categorical classification of the severity of an event or finding, based on a standard scale, used in study data tabulation.	Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.	A toxicity grade from the NCI CTCAE.	TOXGR	55	Events-General
--USCHFL	Unscheduled Flag	Char		Record Qualifier		Not in human clinical trials	C170510	An indication that the performed test or observation was done at a time that was not planned.	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. 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.		USCHFL	56	Events-General
--TESTCD	Short Name of Measurement, Test, or Exam	Char		Topic			C82503	The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination.	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.	"PLAT", "SYSBP", "RRMIN", "EYEEXAM"	TESTCD	1	Findings-General
--TEST	Name of Measurement, Test, or Exam	Char		Synonym Qualifier	--TESTCD		C82541	The standardized or dictionary-derived name of the measurement, test, or examination.		"Platelets", "Systolic Blood Pressure", "Summary (Min) RR Duration", "Eye Examination"	TEST	2	Findings-General
--SBMRKS	Sublineage Marker String	Char		Variable Qualifier	--TESTCD	CP domain only			Used to further subset the cell population identified in CPTEST based on the use of additional marker(s) that define a sublineage. The value in CPSBMRKS is used in combination with values in CPTEST and CPCELSTA to fully describe the cell population being measured. As such, it is an essential component of the full test name.	Three unnamed sublineages of monocytes have been identified: CCR2+CD16-; CCR2-CD16+; and CCR2+CD16+. Whereas the entire monocyte cell population can be defined as CD14+ cells, the additional CCR2 and CD16 markers are used to differentiate one sublineage from another, none of which has yet been given a name by the scientific community. By combining the CPTEST value of "Monocyte Subset" with the value of "CCR2+CD16-" in CPSBMRKS, the full test is defined to be the CCR2+CD16- monocyte subpopulation.	SBMRKS	3	Findings-General
--CELSTA	Cell State	Char		Variable Qualifier	--TESTCD	CP domain only			A textual description of a subset of the cell population identified in CPTEST based on a particular functional and/or biological state (e.g., primed, activated, proliferating, senescent, G2-arrested). When populated, the values in CPCELSTA and CPSMRKS, in combination with values in CPTEST and CPSBMRKS, fully describe the cell population being measured.		CELSTA	4	Findings-General
--CSMRKS	Cell State Marker String	Char		Variable Qualifier	--TESTCD	CP domain only			Identifies the marker(s) or indicator(s) used to define the cell state (i.e., the value in CPCELSTA).	When Ki67 expression is used to determine that a cell population is in a proliferating state (i.e., CPCELSTA value = "PROLIFERATING"), the value "Ki67+" in CPCSMRKS indicates that positive expression of Ki67 was used to define the population as proliferating. Similarly, a value of "Ki67-" in CPCSMRKS would indicate that lack of expression of Ki67 defined the "NON-PROLIFERATING" cell state in CPCELSTA. The CPCSMRKS value is useful for quickly determining which marker(s) were used to classify (i.e., operationally define) a cell population based on a functional/biological state.	CSMRKS	5	Findings-General
--CNTMOD	Contact Mode	Char		Record Qualifier					The way in which the measurement, test, or examination was conducted.		CNTMOD	6	Findings-General
--EPCHGI	Epi/Pandemic Related Change Indicator	Char		Record Qualifier					Indicates whether the measurement, test, or examination was changed due to an epidemic or pandemic.		EPCHGI	7	Findings-General
--TSTCND	Test Condition	Char		Variable Qualifier	--TESTCD	CP, IS, and LB domains only			Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed.	Stimulating or activating agents, assay temperature, incubation time \n "STIMULATED", "NON-STIMULATED", "25 C", "37 C".	TSTCND	8	Findings-General
--CNDAGT	Test Condition Agent	Char		Record Qualifier		CP, IS, and LB domains only			The textual description of the agent used to impose a test condition identified in CPTSTCND. For example, records might be produced for the same test run under stimulating (CPTSTCND value = "STIMULATED") conditions produced by different stimulating agents.	"Phorbol myristate acetate", "Concanavalin A, PHA-P", "TNF-alpha, Ionomycin", "Candida antigen"	CNDAGT	9	Findings-General
--BDAGNT	Binding Agent	Char		Variable Qualifier	--TESTCD	CP, IS, and LB domains only			The textual description of the agent that's binding to the entity in the --TEST variable. The --BDAGNT variable is used to indicate that there is a binding relationship between the entities in the --TEST and --BDAGNT variables, regardless of direction.--BDAGNT is not a method qualifier. It should only be used when the actual interest of the measurement is the binding interaction between the two entities in --TEST and --BDAGNT. In other words, the combination of --TEST and --BDAGNT should describe the thing, the entity, or the analyte being measured, without the need for additional variables. \n The binding agent may be, but is not limited to, a test article, a portion of the test article, a related compound, an endogenous molecule, an allergen, or an infectious agent.		BDAGNT	10	Findings-General
--ABCLID	Antibody Clone Identifier	Char		Record Qualifier		CP domain only			Identifies the antibody clone (e.g., supplier-provided catalog name) used to confer specificity for the binding agent specified in CPBDAGNT.		ABCLID	11	Findings-General
--MRKSTR	Marker String	Char		Record Qualifier		CP domain only			The text string identifying the full set of markers/indicators used by the laboratory to operationally define the complete test. Because laboratories often use different markers/indicators to identify a cell population, the relationship between a named cell population in CPTEST (as combined with CPSBMRKS and CPCELSTA values) and the set of markers used to identify that population is many-to-one. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different sets of markers, it is necessary to operationally define the test in terms of the markers/indicators used to perform that test.		MRKSTR	12	Findings-General
--GATE	Gate	Char		Record Qualifier		CP domain only			The sponsor-defined name assigned to a gate. Gates are electronic (device setting or software-defined) boundaries set by a user to virtually parse a specimen into discrete populations based on a set of defined characteristics (e.g., presence, absence, or intensity of expression of various markers; physical size; internal complexity or granularity). Gates are used to constrain data collection or analysis to a specific cell population or region of interest within the specimen.		GATE	13	Findings-General
--GATDEF	Gate Definition	Char		Record Qualifier		CP domain only			The text string identifying the set of parameters and the order in which they are applied to define the gating strategy. In practice, a series of 2-dimensional subgates based on 2 different cell characteristics (i.e., markers/indicators/physical properties) are most often combined until the cell population of interest is sufficiently resolved (i.e., electronically isolated) from other cell populations contained within the specimen. \n For complex analyses, differences in gating strategies can produce subtle differences in results obtained for a test. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different gating strategies, it is often necessary to qualify the test in terms of the gating strategy. For some purposes, however, and at the discretion of the sponsor, only the ultimate or penultimate gate is identified. When specifying the gating strategy in CPGATDEF, each subgate should be listed in the order it was applied and separated from the next sub-gate using the vertical line or pipe character ("\|").		GATDEF	14	Findings-General
--TSTOPO	Test Operational Objective	Char		Variable Qualifier	--TESTCD				The textual description of the high-level purpose of the test at the operational level.	"SCREEN", "CONFIRM", "QUANTIFY"	TSTOPO	15	Findings-General
--MSCBCE	Molecule Secreted by Cells	Char		Variable Qualifier	--TESTCD	IS domain only			The textual description of the entity secreted by the cells represented in --TEST. The combination of --TEST and --MSBCE should describe the thing, the entity, or the analyte being measured, without the need for additional variables.		MSCBCE	16	Findings-General
--AGENT	Agent Name	Char		Record Qualifier		MS Domain only			The name of the drug or other material for which resistance is tested. The agent may be used for in vitro testing or may be used in tests for genetic markers or in direct phenotypic drug-sensitivity testing.		AGENT	17	Findings-General
--CONC	Agent Concentration	Num		Variable Qualifier	--AGENT	MS Domain only			The amount of drug or other material listed in MSAGENT per unit volume or weight. Used when the agent is part of the prespecified test. Not to be used when the concentration is a result of a test such as minimal inhibitory concentration, IC50, or EC50.		CONC	18	Findings-General
--CONCU	Agent Concentration Units	Char		Variable Qualifier	--CONC	MS Domain only			Unit of measure for MSCONC.		CONCU	19	Findings-General
--MODIFY	Modified Result Term	Char		Synonym Qualifier	--ORRES		C170998	A value which represents an alteration to a collected value for coding purposes.			MODIFY	20	Findings-General
--TSTDTL	Measurement, Test, or Examination Detail	Char		Variable Qualifier	--TESTCD				Further description of --TESTCD and --TEST.	"STAINING INTENSITY" when MITEST="Human Epidermal Growth Factor Receptor 2"	TSTDTL	21	Findings-General
--SPTSTD	Sponsor Test Description	Char		Record Qualifier		CP domain only			Sponsor's description of a test. This variable is particularly valuable for identifying the cell population on which certain tests are conducted when it is not identified in the Test Name (CPTEST; e.g., tests for quantitative expression of a particular marker).		SPTSTD	22	Findings-General
--CAT	Category	Char		Grouping Qualifier			C25372	A grouping or classification of the topic of the finding, event, or intervention.		"HEMATOLOGY", "URINALYSIS", "CHEMISTRY", "HAMD 17", "SF36 V2.0 ACUTE", "EGFR MUTATION ANALYSIS"	CAT	23	Findings-General
--SCAT	Subcategory	Char		Grouping Qualifier			C25692	A further grouping or classification of the category for the topic of the finding, event, or intervention.	The category is in --CAT.	"WBC DIFFERENTIAL"	SCAT	24	Findings-General
--TSTPNL	Test Panel	Char		Grouping Qualifier		CP domain only			Sponsor-defined textual description used to group tests run together as part of a test panel. Can be used with --GRPID to ensure that relationships between associated tests are accurately identified.		TSTPNL	25	Findings-General
--POS	Position of Subject During Observation	Char		Record Qualifier			C171002	The particular way that a subject's body is placed or situated during an assessment.		"SUPINE", "STANDING", "SITTING"	POS	26	Findings-General
--BODSYS	Body System or Organ Class	Char		Record Qualifier			C170986	A standardized or dictionary-derived name for the body system or organ class.		MedDRA SOC	BODSYS	27	Findings-General
--ORRES	Result or Finding in Original Units	Char		Result Qualifier			C117221	The result of the measurement, test, or examination, as originally received or collected.		"120", "<1", "POS"	ORRES	28	Findings-General
--ORRESU	Original Units	Char		Variable Qualifier	--ORRES; --ORNRLO; --ORNRHI; --ORREF		C82586	The unit of measure for the result (as originally received or collected) of the measurement, test, or examination.	Unit for --ORRES and --ORREF.	"in", "LB", "kg/L"	ORRESU	29	Findings-General
--CELLEV	Number of Cells Evaluated	Num		Result Qualifier				The number of cells evaluated.		"150"	CELLEV	30	Findings-General
--RESSCL	Result Scale	Char		Record Qualifier					Classifies the scale of the original result value with respect to whether the result is, for example, ordinal, nominal, quantitative, or narrative.	"NARRATIVE", "NOMINAL", "ORDINAL", "QUANTITATIVE"	RESSCL	31	Findings-General
--RESTYP	Result Type	Char		Record Qualifier					Classifies the kind of result (i.e., property type) originally reported for the test.	"SUBSTANCE CONCENTRATION", "MASS RATE", "ARBITRARY CONCENTRATION"	RESTYP	32	Findings-General
--COLSRT	Collected Summary Result Type	Char		Variable Qualifier	--TESTCD				Used to indicate the type of a collected summary result. This is used for summary results collected on a CRF or provided by an external vendor (e.g., central lab). \n If the summary result is derived by the sponsor using individual source data records, the summary result is represented in ADaM. If a sponsor has both a collected or vendor-provided summary result and a derived summary result, the collected or vendor-provided summary result is represented in SDTM and the derived summary result is represented in ADaM.	"MAXIMUM", "MINIMUM", "MEAN", "MEDIAN", "NADIR"	COLSRT	33	Findings-General
--ORNRLO	Normal Range Lower Limit-Original Units	Char		Variable Qualifier	--ORRES		C82580	The lowest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination.			ORNRLO	34	Findings-General
--ORNRHI	Normal Range Upper Limit-Original Units	Char		Variable Qualifier	--ORRES		C70933	The highest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination.			ORNRHI	35	Findings-General
--ORREF	Reference Result in Original Units	Char		Variable Qualifier	--ORRES				Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable.	Value from predicted normal value in spirometry tests.	ORREF	36	Findings-General
--LLOD	Lower Limit of Detection	Char		Variable Qualifier	--TESTCD				The lowest threshold (as originally received or collected) for reliably detecting the presence or absence of substance measured by a specific test. The value for the field will be as described in documentation from the instrument or lab vendor.		LLOD	37	Findings-General
--STRESC	Result or Finding in Standard Format	Char		Result Qualifier			C117222	The standardized result of the measurement, test, or examination, in character format.	--STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN.	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".	STRESC	38	Findings-General
--IMPLBL	Implantation Site Label	Char		Record Qualifier		Not in human clinical trials; IC Domain only			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.		IMPLBL	39	Findings-General
--STRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier			C171009	The standardized result of the measurement, test, or examination in numeric format.	Copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings.		STRESN	40	Findings-General
--STRESU	Standard Units	Char		Variable Qualifier	--STRESC; --STRESN; --STNRLO; --STNRHI; --STREFC; --STREFN; --LLOQ; --ULOQ		C82587	The unit of measure for the standardized result of the measurement, test, or examination.		"mol/L"	STRESU	41	Findings-General
--STNRLO	Normal Range Lower Limit-Standard Units	Num		Variable Qualifier	--STRESC; --STRESN		C171008	The lowest value in a normal or reference range for the standardized result of the measurement, test, or examination.			STNRLO	42	Findings-General
--STNRHI	Normal Range Upper Limit-Standard Units	Num		Variable Qualifier	--STRESC; --STRESN		C171007	The highest value in a normal or reference range for the standardized result of the measurement, test, or examination.			STNRHI	43	Findings-General
--STNRC	Normal Range for Character Results	Char		Variable Qualifier	--STRESC		C171006	A set of normal or reference values for the standardized character result, in an ordinal scale or categorical grouping.		"Negative to Trace"	STNRC	44	Findings-General
--STREFC	Reference Result in Standard Format	Char		Variable Qualifier	--STRESC				Reference value for the result or finding copied or derived from --ORREF in a standard format.		STREFC	45	Findings-General
--STREFN	Numeric Reference Result in Std Units	Num		Variable Qualifier	--STRESN				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.		STREFN	46	Findings-General
--NRIND	Normal/Reference Range Indicator	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN		C170999	A classification of the original or standardized result as it relates to a normal or reference result range.	May be defined by --ORNRLO and --ORNRHI or other objective criteria.	"Y", "N"; "HIGH", "LOW"; "NORMAL", "ABNORMAL"	NRIND	47	Findings-General
--RESCAT	Result Category	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN		C82498	A grouping or classification of the results of an assessment.	The result is in --STRESC.	"MALIGNANT" or "BENIGN" for tumor findings	RESCAT	48	Findings-General
--INHERT	Inheritability	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			Identifies whether the variation can be passed to the next generation.		INHERT	49	Findings-General
--GENREF	Genome Reference	Char		Variable Qualifier	--METHOD	GF domain only			An identifier for the genome reference used to generate the reported result.	For example, Genome Reference Consortium Human Build 38 patch release 13 may be represented as GRCh38.p13.	GENREF	50	Findings-General
--CHROM	Chromosome Identifier	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			The designation (name or number) of the chromosome or contig on which the variant or other feature appears.	"17", "X"	CHROM	51	Findings-General
--SYM	Genomic Symbol	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			A published symbol for the portion of the genome serving as a locus for the experiment/test.		SYM	52	Findings-General
--SYMTYP	Genomic Symbol Type	Char		Variable Qualifier	--SYM	GF domain only			A description of the type of genomic entity that is represented by the published symbol in --SYM.		SYMTYP	53	Findings-General
--GENLOC	Genetic Location	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			Specifies the location within a sequence for the observed value in --ORRES.		GENLOC	54	Findings-General
--GENSR	Genetic Sub-Region	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			The portion of the locus in which the variation was found.	"Exon 15", "Kinase domain"	GENSR	55	Findings-General
--SEQID	Sequence Identifier	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			A unique identifier for the sequence used as the reference to identify the genetic variation in the result.	"NM_001234", "ENSG00000182533", "ENST00000343849.2"	SEQID	56	Findings-General
--PVRID	Published Variant Identifier	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			A unique identifier for the variation that has been publicly characterized in an external database.	"rs2231142", "COSM41596"	PVRID	57	Findings-General
--COPYID	Copy Identifier	Char		Variable Qualifier	--ORRES; --STRESC; --STRESN	GF domain only			An arbitrary identifier used to differentiate between copies of a genetic target of interest present on homologous chromosomes.		COPYID	58	Findings-General
--CHRON	Chronicity of Finding	Char		Variable Qualifier	--STRESC				Characterization of the duration of a biological process resulting in a particular finding.	"ACUTE", "CHRONIC", "SUBACUTE"	CHRON	59	Findings-General
--DISTR	Distribution Pattern of Finding	Char		Variable Qualifier	--STRESC				Description of the distribution pattern of a finding within the examined area.	"FOCAL", "MULTIFOCAL", "DIFFUSE"	DISTR	60	Findings-General
--RESLOC	Result Location of Finding	Char		Record Qualifier		Not in human clinical trials	C170500	Anatomical location where the result was observed.	Location where the result was observed (as opposed to the location specified for examination). This location may have a higher degree of specificity than the location specified for examination.	"PINNA" when --LOC is "EAR" \n "LUNG, LEFT LOWER LOBE" where --LOC is "CHEST" \n "CORTEX" when --SPEC is "KIDNEY"	RESLOC	61	Findings-General
--STAT	Completion Status	Char		Record Qualifier					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".		STAT	62	Findings-General
--REASND	Reason Not Done	Char		Record Qualifier			C82556	The explanation for why requested information was not available.	Used in conjunction with --STAT when value is "NOT DONE".		REASND	63	Findings-General
--XFN	External File Path	Char		Record Qualifier			C82536	The filename and/or path to external data not stored in the same format and possibly not the same location as the other data for a study.		A filename and/or path for an ECG waveform or a medical image.	XFN	64	Findings-General
--NAM	Laboratory/Vendor Name	Char		Record Qualifier			C117200	The name of the vendor performing an assessment.		A laboratory name.	NAM	65	Findings-General
--LOINC	LOINC Code	Char		Record Qualifier			C82502	A short sequence of characters used to represent laboratory and clinical tests within the Logical Observation Identifiers Names and Codes (LOINC) database.			LOINC	66	Findings-General
--SPEC	Specimen Material Type	Char		Record Qualifier			C70713	The type of sample material taken from a product or biological entity.		"SERUM", "PLASMA", "URINE", "DNA", "RNA", "LIVER", "KIDNEY", "SMOKE CONDENSATE", "TOBACCO PARTICULATE MATTER"	SPEC	67	Findings-General
--ANTREG	Anatomical Region	Char		Variable Qualifier	--SPEC		C170983	The specific anatomical or biological region of a tissue or organ specimen.	As defined in the protocol. \n A section or part of what is described in the --SPEC variable.	"CORTEX", "MEDULLA", "MUCOSA"	ANTREG	68	Findings-General
--SPCCND	Specimen Condition	Char		Record Qualifier			C70714	The physical state or quality of a sample for assessment.		"CLOUDY"	SPCCND	69	Findings-General
--SPCUFL	Specimen Usability for the Test	Char		Record Qualifier			C171004	An indication as to whether a sample is suitable for testing.	The value will be "N" if the specimen is not usable, and null if the specimen is usable.		SPCUFL	70	Findings-General
--LOC	Location Used for the Measurement	Char		Record Qualifier					Anatomical location of the subject relevant to the collection of the measurement.	"RECTUM" for temperature, "ARM" for blood pressure	LOC	71	Findings-General
--LAT	Laterality	Char		Variable Qualifier	--LOC; --SPEC				Qualifier for anatomical location or specimen further detailing laterality.	"RIGHT", "LEFT", "BILATERAL"	LAT	72	Findings-General
--DIR	Directionality	Char		Variable Qualifier	--LOC; --SPEC				Qualifier for anatomical location or specimen further detailing directionality.	"ANTERIOR", "LOWER", "PROXIMAL"	DIR	73	Findings-General
--PORTOT	Portion or Totality	Char		Variable Qualifier	--LOC; --SPEC				Qualifier for anatomical location or specimen further detailing the distribution (i.e., arrangement or apportioning of).	"ENTIRE", "SINGLE", "SEGMENT", "MANY"	PORTOT	74	Findings-General
--METHOD	Method of Test or Examination	Char		Record Qualifier					Method of the test or examination.	"EIA" (enzyme immunoassay), "ELECTROPHORESIS", "DIPSTICK"	METHOD	75	Findings-General
--RUNID	Run ID	Char		Record Qualifier			C117058	A sequence of characters used to uniquely identify a particular run of a test on a particular batch of samples.			RUNID	76	Findings-General
--ANMETH	Analysis Method	Char		Record Qualifier					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, a genetic sequence).		ANMETH	77	Findings-General
--TMTHSN	Test Method Sensitivity	Char		Record Qualifier					The sensitivity of the test methodology with respect to observation, detection, or quantification.	"LOW SENSITIVITY", "HIGH SENSITIVITY", "ULTRA-HIGH SENSITIVITY"	TMTHSN	78	Findings-General
--LEAD	Lead Identified to Collect Measurements	Char		Record Qualifier			C170997	An electrical recording from some region of the body that represents the voltage difference between 2 electrodes.		"LEAD I", "LEAD V2", "LEAD CM5"	LEAD	79	Findings-General
--CSTATE	Consciousness State	Char		Record Qualifier			C88429	The subject's level of consciousness.		"CONSCIOUS", "SEMI-CONSCIOUS", "UNCONSCIOUS"	CSTATE	80	Findings-General
--LOBXFL	Last Observation Before Exposure Flag	Char		Record Qualifier					Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null.		LOBXFL	81	Findings-General
--BLFL	Baseline Flag	Char		Record Qualifier			C82526	An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation.	Result value is in --STRESC. Should be "Y" or null.		BLFL	82	Findings-General
--FAST	Fasting Status	Char		Record Qualifier			C93566	An indication as to whether a subject has abstained from food and liquid for a prescribed amount of time.	Valid values include "Y", "N", "U", or null if not relevant.		FAST	83	Findings-General
--DRVFL	Derived Flag	Char		Record Qualifier			C81197	An indication that the measurement or finding is not a collected value but is processed or computed by the sponsor from collected data.	Should be "Y" or null.	The average of other records used as a computed baseline.	DRVFL	84	Findings-General
--EVAL	Evaluator	Char		Record Qualifier		Not in QS, FT, and clinical classifications use case of RS	C51824	The role of the person(s) providing an evaluation, appraisal, or interpretation.	Used only for results that are subjective (e.g., assigned by a person or a group).	"ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR"	EVAL	85	Findings-General
--EVALID	Evaluator Identifier	Char		Variable Qualifier	--EVAL	Not in QS, FT, and clinical classifications use case of RS	C117043	A sequence of characters used to uniquely identify the evaluator(s).	Used to distinguish multiple evaluators with the same role recorded in --EVAL.	"RADIOLOGIST1", "RADIOLOGIST2"	EVALID	86	Findings-General
--ACPTFL	Accepted Record Flag	Char		Record Qualifier			C117038	An indication that a record is the endorsed assessment.	Expected values can include "Y", "N", or null. This is not intended to be an analysis flag to indicate acceptability for a given analysis.		ACPTFL	87	Findings-General
--TOX	Toxicity	Char		Variable Qualifier	--TOXGR		C27990	The standardized or dictionary-derived name for an untoward event or finding.	Sponsors should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.	An NCI CTCAE Short Name. \n "HYPERCALCEMIA", "HYPOCALCEMIA"	TOX	88	Findings-General
--TOXGR	Toxicity Grade	Char		Record Qualifier			C82528	A categorical classification of the severity of an event or finding, based on a standard scale, used in study data tabulation.	Sponsors should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.	A grade from the NCI CTCAE. \n "2"	TOXGR	89	Findings-General
--SEV	Severity/Intensity	Char		Record Qualifier			C25676	The quality or degree of harm associated with a finding or event, as collected.		"MILD", "MODERATE", "SEVERE"	SEV	90	Findings-General
--CLSIG	Clinically Significant, Collected	Char		Record Qualifier			C93532	An indication as to whether an observation is clinically significant based on judgment.	For collected assessments of clinical significance of a result.	"Y", "N"	CLSIG	91	Findings-General
--DTHREL	Relationship to Death	Char		Record Qualifier		Not in human clinical trials	C82563	An indication that a particular finding is related to the cause of death.		"Y", "N", or "U"	DTHREL	92	Findings-General
--LLOQ	Lower Limit of Quantitation	Num		Variable Qualifier	--STRESC; --STRESN		C82589	The lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units.	Units will be those used for --STRESU.		LLOQ	93	Findings-General
--ULOQ	Upper Limit of Quantitation	Num		Variable Qualifier	--STRESC; --STRESN		C85533	The highest threshold for reliably detecting the result of a specific test in standardized units.	Units will be those used for --STRESU.		ULOQ	94	Findings-General
--REASPF	Reason Test Performed	Char		Record Qualifier			C171003	The explanation for why a test, measurement, or assessment is executed.			REASPF	95	Findings-General
--EXCLFL	Exclude from Statistics	Char		Record Qualifier		Not in human clinical trials	C117045	An indication that the result is to be excluded from all calculations.	Expected to be "Y" or null. --EXCLFL should be null when --STAT is "NOT DONE".		EXCLFL	96	Findings-General
--REASEX	Reason for Exclusion from Statistics	Char		Record Qualifier		Not in human clinical trials	C117057	The explanation for why a result is excluded from all calculations.	Used in conjunction with --EXCLFL when its value is "Y".		REASEX	97	Findings-General
--USCHFL	Unscheduled Flag	Char		Record Qualifier		Not in human clinical trials	C170510	An indication that the performed test or observation was done at a time that was not planned.	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. 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.		USCHFL	98	Findings-General
--REPNUM	Repetition Number	Num		Record Qualifier					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).	Multiple measurements of blood pressure or multiple analyses of a sample.	REPNUM	99	Findings-General
--RSTIND	Restraint Indicator	Char		Record Qualifier		Not in human clinical trials			An indicator as to whether the animal was restrained during the observation period. Expected values are "Y" or null.		RSTIND	100	Findings-General
--RSTMOD	Restraint Mode	Char		Record Qualifier		Not in human clinical trials			A description of whether the restraint was physical and/or chemical.		RSTMOD	101	Findings-General
--OBJ	Object of the Observation	Char		Record Qualifier					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.	An event of vomiting which has findings, where --OBJ="VOMIT" and the volume of VOMIT is being measured where --TESTCD="VOLUME".	OBJ	1	Findings About-Findings
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	All Classes-General
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation. The domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.		DOMAIN	2	All Classes-General
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	All Classes-General
POOLID	Pool Identifier	Char		Identifier			C117053	A sequence of characters used to uniquely identify a group of subjects that have been pooled together.	Used for results that are not assignable to a specific subject.		POOLID	4	All Classes-General
SPDEVID	Sponsor Device Identifier	Char		Identifier			C117060	A sequence of characters used by the sponsor to uniquely identify a specific device.			SPDEVID	5	All Classes-General
SPTOBID	Applicant-Defined Tobacco Product ID	Char		Identifier		Tobacco IG only		A sequence of characters used by the applicant to uniquely identify a tobacco product.			SPTOBID	6	All Classes-General
IGDCMPID	Ingredient or Component Identifier	Char		Identifier		PT Domain Only		A sequence of characters used by the applicant to uniquely identify an ingredient, substance or component of a tobacco product.		"Burley Tobacco", "Cellulose Pulp"	IGDCMPID	7	All Classes-General
STOCONID	Applicant-defined Storage Conditions ID	Char		Identifier		PT Domain Only		A sequence of characters used by the applicant to uniquely identify a set of environmental conditions under which a product was stored.		"E-Liquid Standard Long Term Conditions", "Storage Conditions 1"	STOCONID	8	All Classes-General
NHOID	Non-Host Organism Identifier	Char		Identifier					Sponsor-defined identifier for a non-host organism. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by the lab.	"A/California/7/2009 (H1N1)"	NHOID	9	All Classes-General
FETUSID	Fetus Identifier	Char		Identifier		Not in human clinical trials	C170497	A sequence of characters used to uniquely identify a fetus associated with a maternal subject, for a particular prenatal evaluation.			FETUSID	10	All Classes-General
FOCID	Focus of Study-Specific Interest	Char		Identifier					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. The value in this variable should have inherent semantic meaning.	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), "Upper left quadrant of the back")	FOCID	11	All Classes-General
--SEQ	Sequence Number	Num		Identifier			C70710	A number used in combination with the identifier of the subject of the observation to uniquely identify a record within a domain.	May be any valid number (including decimals) and does not have to start at 1. Datasets that do not contain subject data, such as the Trial Summary (TS) domain and the Device Tracking (DT) domains, use --SEQ as a sequence number to ensure uniqueness within the dataset.		SEQ	12	All Classes-General
--GRPID	Group ID	Char		Identifier			C170996	A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the TS dataset.	See also Section 5.1.6, Trial Summary Information and Section 5.1.7, Challenge Agent Characterization.		GRPID	13	All Classes-General
--REFID	Reference ID	Char		Identifier			C82531	A sequence of characters used to uniquely identify a source of information.		A lab specimen ID, the UUID for an ECG waveform or a medical image.	REFID	14	All Classes-General
--RECID	Invariant Record Identifier	Char		Identifier					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.		RECID	15	All Classes-General
--SPID	Sponsor-Defined Identifier	Char		Identifier			C82530	A sponsor-defined sequence of characters used to identify an instance of an observation.		A preprinted line identifier on a Concomitant Medications form.	SPID	16	All Classes-General
--LNKID	Link ID	Char		Identifier			C117050	A sequence of characters used to uniquely identify a record, for a subject, in one domain and link it to 1 or more records for that subject in another domain.	This may be a one-to-one or a one-to-many relationship.	A value that links a single tumor to multiple measurements/assessments performed at different times.	LNKID	17	All Classes-General
--LNKGRP	Link Group ID	Char		Identifier			C117049	A sequence of characters used to uniquely identify a group of records, for a subject, in one domain and link it to 1 or more records for that subject in another domain.	This will usually be a many-to-one relationship.	A value that links multiple tumor measurement/assessments to a single response to therapy.	LNKGRP	18	All Classes-General
--BEATNO	ECG Beat Number	Num		Identifier		EG Domain only			A sequence number that identifies the beat within an ECG.		BEATNO	19	All Classes-General
APID	Associated Persons Identifier	Char		Identifier					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 6.3, Pool Definition Dataset, and Section 4, Associated Persons Data).		APID	1	Associated Persons
RSUBJID	Related Subject or Pool Identifier	Char		Identifier					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. \n RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects.		RSUBJID	2	Associated Persons
RDEVID	Related Device Identifier	Char		Identifier					Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device.		RDEVID	3	Associated Persons
SREL	Subject, Device, or Study Relationship	Char		Identifier					If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. \n If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the device identified in RDEVID. \n If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID.		SREL	4	Associated Persons
VISITNUM	Visit Number	Num		Timing			C83101	An assigned numeric identifier that aligns to the chronological order of a clinical encounter.	Numeric version of VISIT, used for sorting. VISITNUM does not have to be an integer value.	1, 1.1, 503.75	VISITNUM	20	All Classes-General
VISIT	Visit Name	Char		Timing			C171010	The label for a protocol-defined clinical encounter.			VISIT	21	All Classes-General
VISITDY	Planned Study Day of Visit	Num		Timing			C171011	The planned study day of a clinical encounter relative to the sponsor-defined reference start date.	Should be an integer.		VISITDY	22	All Classes-General
TAETORD	Planned Order of Element Within Arm	Num		Timing			C83438	An assigned numeric identifier that gives the planned order of the element within the trial arm of the study.	See Section 5.1.1.2, Trial Arms.		TAETORD	23	All Classes-General
EPOCH	Epoch	Char		Timing			C71738	A time period defined in the protocol with a study-specific purpose.	The epoch associated with an observation is determined by the start date or start date and time of the observation, or the date/time of collection if start date/time is not collected (see Section 5.1.1.2, Trial Arms).		EPOCH	24	All Classes-General
RPHASE	Repro Phase	Char		Timing		Not in human clinical trials			Reproductive phase with which the reproductive stage of the reproductive path is associated. Defined in Trial Paths domain. The RPHASE variable is Required when any Reproductive Phase Day variable is used.		RPHASE	25	All Classes-General
RPPLDY	Planned Repro Phase Day of Observation	Num		Timing		Not in human clinical trials	C170506	The day within the reproductive phase on which the test or observation was scheduled to occur.	Expressed as an integer.		RPPLDY	26	All Classes-General
RPPLSTDY	Planned Repro Phase Day of Obs Start	Num		Timing		Not in human clinical trials	C170508	The day within the reproductive phase on which the test or observation was scheduled to begin.	Expressed as an integer.		RPPLSTDY	27	All Classes-General
RPPLENDY	Planned Repro Phase Day of Obs End	Num		Timing		Not in human clinical trials	C170507	The day within the reproductive phase on which the test or observation was scheduled to end.	Expressed as an integer.		RPPLENDY	28	All Classes-General
--DTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing			C82515	The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format.			DTC	29	All Classes-General
--STDTC	Start Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing		Not in Findings class domains	C82517	The start date or date and time of an intervention or event, represented in a standardized character format.	The start date of a Findings class record is stored in the --DTC variable.		STDTC	30	All Classes-General
--ENDTC	End Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing			C82516	The end date or date and time of an intervention, event, or finding, represented in a standardized character format.			ENDTC	31	All Classes-General
--DY	Study Day of Visit/Collection/Exam	Num		Timing			C170993	The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation.	The sponsor-defined reference start date is RFSTDTC in Demographics.		DY	32	All Classes-General
--STDY	Study Day of Start of Observation	Num		Timing		Not in Findings class domains	C171005	The number of days from the sponsor-defined reference start date to the start of an intervention or event (--STDTC), used for study data tabulation.	The sponsor-defined reference start date is RFSTDTC in Demographics.		STDY	33	All Classes-General
--ENDY	Study Day of End of Observation	Num		Timing			C170995	The number of days from the sponsor-defined reference start date to the end of an intervention, event, or finding (--ENDTC), used for study data tabulation.	The sponsor-defined reference start date is RFSTDTC in Demographics.		ENDY	34	All Classes-General
--NOMDY	Nominal Study Day for Tabulations	Num		Timing		Not in human clinical trials	C170498	The nominal study day, relative to the sponsor-defined reference start date, 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 (e.g., for output on a tabulation report).			NOMDY	35	All Classes-General
--NOMLBL	Label for Nominal Study Day	Char		Timing		Not in human clinical trials	C170499	The name for a protocol-defined nominal study day.	As presented in the study report.		NOMLBL	36	All Classes-General
--RPDY	Actual Repro Phase Day of Observation	Num		Timing		Not in human clinical trials	C170504	The day within the reproductive phase on which the test or observation occurred.	Expressed as an integer.		RPDY	37	All Classes-General
--RPSTDY	Actual Repro Phase Day of Obs Start	Num		Timing		Not in human clinical trials	C170509	The day within the reproductive phase on which the test or observation began.	Expressed as an integer.		RPSTDY	38	All Classes-General
--RPENDY	Actual Repro Phase Day of Obs End	Num		Timing		Not in human clinical trials	C170505	The day within the reproductive phase on which the test or observation ended.	Expressed as an integer.		RPENDY	39	All Classes-General
--XDY	Day of Obs Relative to Exposure	Num		Timing					The actual study day of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics.		XDY	40	All Classes-General
--XSTDY	Start Day of Obs Relative to Exposure	Num		Timing		Not in Findings class domains			The actual study day of the start of an intervention or event, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics.		XSTDY	41	All Classes-General
--XENDY	End Day of Obs Relative to Exposure	Num		Timing					The actual study day of the end of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment or product. Expressed in integer days relative to RFXSTDTC in Demographics.		XENDY	42	All Classes-General
--CHDY	Day of Obs Rel to Challenge Agent	Num		Timing					The actual study day of an intervention, event, or finding, derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics.		CHDY	43	All Classes-General
--CHSTDY	Start Day of Obs Rel to Challenge Agent	Num		Timing		Not in Findings class domains			The actual study day of the start of an intervention or event derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to c ure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics.		CHSTDY	44	All Classes-General
--CHENDY	End Day of Obs Rel to Challenge Agent	Num		Timing					The actual study day of the end of an intervention, event, or finding derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics.		CHENDY	45	All Classes-General
--DUR	Collected Duration	Char	ISO 8601 duration	Timing			C170992	The collected length of time during which an observation continues, represented in a standardized character format.	Used only if collected on the CRF and not derived.		DUR	46	All Classes-General
--TPT	Planned Time Point Name	Char		Timing			C171029	The description of the time when a protocol-defined activity is planned to occur, used for study data tabulation.	This may be represented as an elapsed time relative to a fixed reference point (e.g., time since last dose). See --TPTNUM and --TPTREF.	"PREDOSE", "1 HOUR POST-DOSE"	TPT	47	All Classes-General
--TPTNUM	Planned Time Point Number	Num		Timing			C82545	The numeric identifier of when an observation is planned to occur.	Used in sorting.		TPTNUM	48	All Classes-General
--ELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing			C170994	The interval of time between a planned time point and a fixed reference point, represented in a standardized character format.	The fixed reference point is in --TPTREF. This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval.		ELTM	49	All Classes-General
--TPTREF	Time Point Reference	Char		Timing			C171030	The description of a time point that acts as a fixed reference for a series of planned time points, used for study data tabulation.	Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT.	"PREVIOUS DOSE", "PREVIOUS MEAL"	TPTREF	50	All Classes-General
--RFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing			C82518	The actual date or date and time of a time point that acts as a fixed reference for a series of planned time points, represented in a standardized character format.	The fixed reference point is in --TPTREF.		RFTDTC	51	All Classes-General
--STRF	Start Relative to Reference Period	Char		Timing			C82559	The characterization of the start of an observation relative to the study 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.		STRF	52	All Classes-General
--ENRF	End Relative to Reference Period	Char		Timing			C82557	The characterization of the end of an observation relative to the study 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.		ENRF	53	All Classes-General
--EVLINT	Evaluation Interval	Char	ISO 8601 duration or interval	Timing			C82534	The planned time interval for which an observation is assessed, represented in a standardized character format.	Usually used with --DTC to describe an interval of this duration that ended at the time represented in --DTC.	"-P2M" to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire.	EVLINT	54	All Classes-General
--EVINTX	Evaluation Interval Text	Char		Timing			C117044	A textual description of the planned time interval for which an observation is assessed, where the interval is not able to be represented in a standardized character format.	A value that cannot be represented in ISO 8601 format.	"LIFETIME", "LAST NIGHT", "RECENTLY", "OVER THE LAST FEW WEEKS"	EVINTX	55	All Classes-General
--STRTPT	Start Relative to Reference Time Point	Char		Timing			C82560	The characterization of the start of an observation relative to a reference time point.	The sponsor-defined reference time point is in --STTPT.		STRTPT	56	All Classes-General
--STTPT	Start Reference Time Point	Char		Timing			C82575	The description or date and/or time of a time point that acts as a fixed reference for characterizing the start of an observation.	This is the sponsor-defined reference point referred to by --STRTPT.	"2003-12-15", "VISIT 1"	STTPT	57	All Classes-General
--ENRTPT	End Relative to Reference Time Point	Char		Timing			C82558	The characterization of the end of an observation relative to a reference time point.	The sponsor-defined reference time point is in --ENTPT.		ENRTPT	58	All Classes-General
--ENTPT	End Reference Time Point	Char		Timing			C82574	The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation.	This is the sponsor-defined reference point referred to by --ENRTPT.	"2003-12-25", "VISIT 2"	ENTPT	59	All Classes-General
MIDS	Disease Milestone Instance Name	Char		Timing					The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (see Section 5.1.4.3, Trial Disease Milestones). This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC.		MIDS	60	All Classes-General
RELMIDS	Temporal Relation to Milestone Instance	Char		Timing					The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS.	"IMMEDIATELY BEFORE", "AT TIME OF", "AFTER"	RELMIDS	61	All Classes-General
MIDSDTC	Disease Milestone Instance Date/Time	Char	ISO 8601 datetime or interval	Timing					The start date/time of the Disease Milestone Instance Name in MIDS.		MIDSDTC	62	All Classes-General
--STINT	Planned Start of Assessment Interval	Char	ISO 8601 duration	Timing			C117061	The start of a planned assessment interval relative to a reference time point, represented in a standardized character format.	The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed.		STINT	63	All Classes-General
--ENINT	Planned End of Assessment Interval	Char	ISO 8601 duration	Timing			C117042	The end of a planned assessment interval relative to a reference time point, represented in a standardized character format.	The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed.		ENINT	64	All Classes-General
--DETECT	Time in Days to Detection	Num		Timing		Not in human clinical trials	C117041	The number of days from the start of dosing to the earliest detection of a condition or pathogen.			DETECT	65	All Classes-General
--PTFL	Point in Time Flag	Char		Timing		Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP			An indication that the specimen was collected at a single point in time. The value is "Y" or null.		PTFL	66	All Classes-General
--PDUR	Planned Duration	Char	ISO 8601 duration	Timing		Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP			Planned duration of a finding. For a sample-based finding, this could apply to the planned duration of specimen collection.		PDUR	67	All Classes-General
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Special-Purpose	CO
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "CO".		DOMAIN	2	Special-Purpose	CO
RDOMAIN	Related Domain Abbreviation	Char		Record Qualifier					Domain abbreviation of the parent record(s). Null for records collected on general comments or additional information section of CRF.		RDOMAIN	3	Special-Purpose	CO
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	4	Special-Purpose	CO
POOLID	Pool Identifier	Char		Identifier			C117053	A sequence of characters used to uniquely identify a group of subjects that have been pooled together.	The result is not assignable to any one individual.		POOLID	5	Special-Purpose	CO
SPDEVID	Sponsor Device Identifier	Char		Identifier			C117060	A sequence of characters used by the sponsor to uniquely identify a specific device.			SPDEVID	6	Special-Purpose	CO
COSEQ	Sequence Number	Num		Identifier					Sequence number to ensure uniqueness within the dataset.		SEQ	7	Special-Purpose	CO	CO
IDVAR	Identifying Variable	Char		Record Qualifier					Identifying variable in the parent dataset that identifies the record(s) to which the comment applies (e.g., AESEQ, CMGRPID). Used only when individual comments are related to domain records. Null for comments collected on separate CRFs.		IDVAR	8	Special-Purpose	CO
IDVARVAL	Identifying Variable Value	Char		Record Qualifier					Value of identifying variable of the parent record(s). Null for comments collected on separate CRFs.		IDVARVAL	9	Special-Purpose	CO
COREF	Comment Reference	Char		Record Qualifier					Sponsor-defined reference associated with the comment.	A CRF page number (e.g., 650), a module name (e.g., "DEMOG"), or a combination of information that identifies the reference (e.g., "650-VITALS-VISIT 2")	REF	10	Special-Purpose	CO	CO
COVAL	Comment	Char		Topic					The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn.		VAL	11	Special-Purpose	CO	CO
COEVAL	Evaluator	Char		Record Qualifier					Used to describe the originator of the comment.	"CENTRAL REVIEWER"	EVAL	12	Special-Purpose	CO	CO
COEVALID	Evaluator Identifier	Char		Variable Qualifier	COEVAL				Used to distinguish multiple evaluators with the same role recorded in --EVAL.	"RADIOLOGIST1", "RADIOLOGIST2"	EVALID	13	Special-Purpose	CO	CO
CODTC	Date/Time of Comment	Char	ISO 8601 datetime or interval	Timing					Date or date and time of comment on dedicated comment form, if collected. Should be null if this is a child record of another domain or if comment date was not collected.		DTC	14	Special-Purpose	CO	CO
CODY	Study Day of Comment	Num		Timing					Actual study day of the comment, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.		DY	15	Special-Purpose	CO	CO
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Special-Purpose	DM
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "DM".		DOMAIN	2	Special-Purpose	DM
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Special-Purpose	DM
SUBJID	Subject Identifier for the Study	Char		Topic					Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF.		SUBJID	4	Special-Purpose	DM
RFSTDTC	Subject Reference Start Date/Time	Char	ISO 8601 datetime or interval	Record Qualifier			C83395	The start date or date and time of the sponsor-defined study reference period, represented in a standardized character format.	Usually equivalent to date/time when subject was first exposed to study treatment or product. 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.		RFSTDTC	5	Special-Purpose	DM
RFENDTC	Subject Reference End Date/Time	Char	ISO 8601 datetime or interval	Record Qualifier			C83394	The end date or date and time of the sponsor-defined study reference period, represented in a standardized character format.	Usually equivalent to the date/time when a subject was determined to have ended the trial. Often equivalent to either date/time of last exposure to study treatment or product or date/time of last contact with the subject. Required for all randomized subjects; null for screen failures or unassigned subjects.		RFENDTC	6	Special-Purpose	DM
RFXSTDTC	Date/Time of First Study Exposure	Char	ISO 8601 datetime or interval	Record Qualifier			C170502	The start date or date and time of the first exposure to any protocol-specified treatment, therapy, or product represented in a standardized character format.			RFXSTDTC	7	Special-Purpose	DM
RFXENDTC	Date/Time of Last Study Exposure	Char	ISO 8601 datetime or interval	Record Qualifier			C170501	The end date or date and time of the last exposure to any protocol-specified treatment, therapy, or product represented in a standardized character format.			RFXENDTC	8	Special-Purpose	DM
RFCSTDTC	Date/Time of First Challenge Agent Admin	Char	ISO 8601 datetime or interval	Record Qualifier					The start date or date and time of the first exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. \n Equal to the earliest value of AGSTDTC for the challenge agent.		RFCSTDTC	9	Special-Purpose	DM
RFCENDTC	Date/Time of Last Challenge Agent Admin	Char	ISO 8601 datetime or interval	Record Qualifier					The end date or date and time of the last exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. \n Equal to the latest value of AGENDTC for the challenge agent.		RFCENDTC	10	Special-Purpose	DM
RFICDTC	Date/Time of Informed Consent	Char	ISO 8601 datetime or interval	Record Qualifier		Not in nonclinical trials	C117452	The date or date and time of informed consent, represented in a standardized character format.			RFICDTC	11	Special-Purpose	DM
RFPENDTC	Date/Time of End of Participation	Char	ISO 8601 datetime or interval	Record Qualifier		Not in nonclinical trials	C117453	The date or date and time of last contact with or information about a subject in a trial, represented in a standardized character format.	Should correspond to the last known date of contact.		RFPENDTC	12	Special-Purpose	DM
DTHDTC	Date/Time of Death	Char	ISO 8601 datetime or interval	Record Qualifier		Not in nonclinical trials	C117450	The date or date and time of death, represented in a standardized character format.	Should represent the date/time that is captured in the clinical-trial database.		DTHDTC	13	Special-Purpose	DM
DTHFL	Subject Death Flag	Char		Record Qualifier		Not in nonclinical trials	C117451	An indication that the subject died.	A value of "Y" indicates the subject died. Should be "Y" or null. Should be populated even when the death date is unknown.		DTHFL	14	Special-Purpose	DM
SITEID	Study Site Identifier	Char		Record Qualifier			C83081	A sequence of characters used to uniquely identify the facility associated with study-specific activities.			SITEID	15	Special-Purpose	DM
INVID	Investigator Identifier	Char		Record Qualifier		Not in nonclinical trials			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.		INVID	16	Special-Purpose	DM
INVNAM	Investigator Name	Char		Synonym Qualifier	INVID	Not in nonclinical trials			Name of the investigator for a site.		INVNAM	17	Special-Purpose	DM
BRTHDTC	Date/Time of Birth	Char	ISO 8601 datetime or interval	Record Qualifier			C83217	The date or date and time of birth, represented in a standardized character format.			BRTHDTC	18	Special-Purpose	DM
AGE	Age	Num		Record Qualifier			C170981	A numeric representation of the elapsed time since birth at a specific point in time defined for the trial, used for study data tabulation.	May be derived as (RFSTDTC-BRTHDTC), but BRTHDTC may not be available in all cases (due to subject privacy concerns).		AGE	19	Special-Purpose	DM
AGETXT	Age Text	Char	number-number	Record Qualifier			C170982	The age at a specific point in time defined for the trial, expressed as a range.	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.		AGETXT	20	Special-Purpose	DM
AGEU	Age Units	Char		Variable Qualifier	AGE; AGETXT		C50400	The unit of time used to express the age, using standardized values.			AGEU	21	Special-Purpose	DM
SEX	Sex	Char		Record Qualifier					Sex of the subject.		SEX	22	Special-Purpose	DM
RACE	Race	Char		Record Qualifier		Not in nonclinical trials			Race of the subject. Sponsors should refer to FDA guidance regarding the collection of race data.		RACE	23	Special-Purpose	DM
ETHNIC	Ethnicity	Char		Record Qualifier		Not in nonclinical trials			The ethnicity of the subject. Sponsors should refer to FDA guidance regarding the collection of ethnicity data.		ETHNIC	24	Special-Purpose	DM
SPECIES	Species	Char		Record Qualifier		Not in human clinical trials	C96433	The common (non-taxonomic) name for an animal used as the test system in a study.		"MOUSE", "RAT", "DOG", "MONKEY"	SPECIES	25	Special-Purpose	DM
STRAIN	Strain/Substrain	Char		Record Qualifier		Not in human clinical trials	C14419	The vendor-supplied species/strain/substrain designation for the test system under study. It may combine the species, background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g. FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, RHESUS, CHIMPANZEE).		"C57BL/6", "A/J", "B6.129-Pparg<tm2Rev>/J", "FISCHER 344", "SPRAGUE DAWLEY IGS", "WISTAR Kyoto", "BEAGLE", "CYNOMOLGUS", "CHIMPANZEE"	STRAIN	26	Special-Purpose	DM
SBSTRAIN	Strain/Substrain Details	Char		Variable Qualifier	STRAIN	Not in human clinical trials	C90460	Additional clarifying details regarding the test system under study, such as a description of a phenotypic alteration associated with the specific genetic modification captured or collected in the Strain/Substrain variable.			SBSTRAIN	27	Special-Purpose	DM
ARMCD	Planned Arm Code	Char		Record Qualifier			C83216	A short sequence of characters that represents the planned arm to which the subject was assigned.	Limited to 20 characters.		ARMCD	28	Special-Purpose	DM
ARM	Description of Planned Arm	Char		Synonym Qualifier	ARMCD		C170984	The name of the planned arm to which the subject was assigned.			ARM	29	Special-Purpose	DM
ACTARMCD	Actual Arm Code	Char		Record Qualifier		Not in nonclinical trials	C117449	A short sequence of characters that represents the arm in which the subject actually participated.	Limited to 20 characters.		ACTARMCD	30	Special-Purpose	DM
ACTARM	Description of Actual Arm	Char		Synonym Qualifier	ACTARMCD	Not in nonclinical trials	C117448	The name of the arm in which the subject actually participated.			ACTARM	31	Special-Purpose	DM
ARMNRS	Reason Arm and/or Actual Arm is Null	Char		Record Qualifier					The reason why the actual arm variables are null or why both the planned and actual arm variables are null. It is assumed that if the arm and actual arm variables are null, the same reason applies to both.	"SCREEN FAILURE", "NOT ASSIGNED", "NOT TREATED", "UNPLANNED TREATMENT"	ARMNRS	32	Special-Purpose	DM
ACTARMUD	Description of Unplanned Actual Arm	Char		Record Qualifier					A description of actual treatment or product for a subject who did not receive treatment or the product described in one of the planned trial arms.		ACTARMUD	33	Special-Purpose	DM
SETCD	Set Code	Char		Record Qualifier			C117457	The standardized or dictionary-derived short sequence of characters used to represent the trial set.	Defined by the sponsor (see Section 5.1.2, Trial Sets). Maximum of 8 characters. This represents the code for the trial set for which parameters are being submitted.		SETCD	34	Special-Purpose	DM
RPATHCD	Planned Repro Path Code	Char		Record Qualifier		Not in human clinical trials	C170503	A short sequence of characters that represents the planned reproductive path to which the subject was assigned.	Limited to 20 characters.		RPATHCD	35	Special-Purpose	DM
COUNTRY	Country	Char	ISO 3166-1 Alpha-3	Record Qualifier		Not in nonclinical trials	C170990	The country in which the investigational site is located.			COUNTRY	36	Special-Purpose	DM
DMDTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing			C83243	The date or date and time of demographic data collection, represented in a standardized character format.			DTC	37	Special-Purpose	DM	DM
DMDY	Study Day of Collection	Num		Timing			C83244	The actual study day of demographic data collection derived relative to the sponsor-defined reference start date.	The sponsor-defined reference start date is RFSTDTC.		DY	38	Special-Purpose	DM	DM
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Special-Purpose	SE
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "SE".		DOMAIN	2	Special-Purpose	SE
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Special-Purpose	SE
SESEQ	Sequence Number	Num		Identifier					Sequence number to ensure uniqueness within the dataset. Should be assigned to be in a consistent chronological order.		SEQ	4	Special-Purpose	SE	SE
ETCD	Element Code	Char		Topic					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.		ETCD	5	Special-Purpose	SE
ELEMENT	Description of Element	Char		Synonym Qualifier	ETCD				The name of the element. If ETCD has a value of "UNPLAN" then ELEMENT should be null.		ELEMENT	6	Special-Purpose	SE
TAETORD	Planned Order of Element within Arm	Num		Timing			C83438	An assigned numeric identifier that gives the planned order of the element within the trial arm of the study.	Value for the element within the subject's assigned arm.		TAETORD	7	Special-Purpose	SE
EPOCH	Epoch	Char		Timing			C71738	A time period defined in the protocol with a study-specific purpose.	Value for the element within the subject's assigned arm.		EPOCH	8	Special-Purpose	SE
SESTDTC	Start Date/Time of Element	Char	ISO 8601 datetime or interval	Timing					Start date or start date and time for an element for each subject.		STDTC	9	Special-Purpose	SE	SE
SEENDTC	End Date/Time of Element	Char	ISO 8601 datetime or interval	Timing					End date/time of an element for each subject.		ENDTC	10	Special-Purpose	SE	SE
SESTDY	Study Day of Start of Element	Num		Timing					Study day of start of element relative to the sponsor-defined RFSTDTC.		STDY	11	Special-Purpose	SE	SE
SEENDY	Study Day of End of Element	Num		Timing					Study day of end of element relative to the sponsor-defined RFSTDTC.		ENDY	12	Special-Purpose	SE	SE
SEUPDES	Description of Unplanned Element	Char		Synonym Qualifier	ETCD				Description of what happened to the subject during an unplanned element. Used only if ETCD has the value of "UNPLAN".		UPDES	13	Special-Purpose	SE	SE
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Special-Purpose	SV
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "SV".		DOMAIN	2	Special-Purpose	SV
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Special-Purpose	SV
VISITNUM	Visit Number	Num		Topic			C83101	An assigned numeric identifier that aligns to the chronological order of a clinical encounter.	Decimal numbering may be useful for inserting unplanned visits. Used for sorting.		VISITNUM	4	Special-Purpose	SV
VISIT	Visit Name	Char		Synonym Qualifier	VISITNUM		C171010	The label for a protocol-defined clinical encounter.	May be used in addition to VISITNUM and/or VISITDY.		VISIT	5	Special-Purpose	SV
SVPRESP	Pre-Specified	Char		Variable Qualifier	VISITNUM				An indication that the visit is planned. Values should be "Y" or null.		PRESP	6	Special-Purpose	SV	SV
SVOCCUR	Occurrence	Char		Record Qualifier					An indication as to whether a prespecified (planned) visit has occurred.		OCCUR	7	Special-Purpose	SV	SV
SVREASOC	Reason for Occur Value	Char		Record Qualifier					The reason for the value in SVOCCUR. If SVOCCUR="N", SVREASOC is the reason the visit did not occur.		REASOC	8	Special-Purpose	SV	SV
SVCNTMOD	Contact Mode	Char		Record Qualifier					The way in which the visit or contact was conducted.	"IN PERSON", "TELEPHONE", "IVRS".	CNTMOD	9	Special-Purpose	SV	SV
SVEPCHGI	Epi/Pandemic Related Change Indicator	Char		Record Qualifier					Indicates whether the visit was changed due to an epidemic or pandemic.		EPCHGI	10	Special-Purpose	SV	SV
VISITDY	Planned Study Day of Visit	Num		Timing			C171011	The planned study day of a clinical encounter relative to the sponsor-defined reference start date.	The reference start date is RFSTDTC in Demographics.		VISITDY	11	Special-Purpose	SV
SVSTDTC	Start Date/Time of Visit	Char	ISO 8601 datetime or interval	Timing					Start date or start date and time for a subject's visit.		STDTC	12	Special-Purpose	SV	SV
SVENDTC	End Date/Time of Visit	Char	ISO 8601 datetime or interval	Timing					End date/time of a subject's visit.		ENDTC	13	Special-Purpose	SV	SV
SVSTDY	Study Day of Start of Visit	Num		Timing					Study day of start of visit relative to the sponsor-defined RFSTDTC.		STDY	14	Special-Purpose	SV	SV
SVENDY	Study Day of End of Visit	Num		Timing					Study day of end of visit relative to the sponsor-defined RFSTDTC.		ENDY	15	Special-Purpose	SV	SV
SVUPDES	Description of Unplanned Visit	Char		Record Qualifier					Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits.		UPDES	16	Special-Purpose	SV	SV
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Special-Purpose	SM
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "SM".		DOMAIN	2	Special-Purpose	SM
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Special-Purpose	SM
SMSEQ	Sequence Number	Num		Identifier					Sequence number given to ensure uniqueness of subject records. Should be assigned to be consistent with chronological order.		SEQ	4	Special-Purpose	SM	SM
MIDS	Disease Milestone Instance Name	Char		Topic					Name of the specific disease milestone. For disease milestones that can occur multiple times, the name will end with a sequence number.	"HYPO1"	MIDS	5	Special-Purpose	SM
MIDSTYPE	Disease Milestone Type	Char		Record Qualifier					The type of disease milestone.	"HYPOGLYCEMIC EVENT"	MIDSTYPE	6	Special-Purpose	SM
SMSTDTC	Start Date/Time of Milestone	Char	ISO 8601 datetime or interval	Timing					Start date or start date and time of milestone instance (if milestone is an intervention or event), or date of milestone if the milestone is a finding.		STDTC	7	Special-Purpose	SM	SM
SMENDTC	End Date/Time of Milestone	Char	ISO 8601 datetime or interval	Timing					End date/time of disease milestone Instance.		ENDTC	8	Special-Purpose	SM	SM
SMSTDY	Study Day of Start of Milestone	Num		Timing					Study day of start of disease milestone instance, relative to the sponsor-defined RFSTDTC.		STDY	9	Special-Purpose	SM	SM
SMENDY	Study Day of End of Milestone	Num		Timing					Study day of end of disease milestone instance, relative to the sponsor-defined RFSTDTC.		ENDY	10	Special-Purpose	SM	SM
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Special-Purpose	SJ
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "SJ".		DOMAIN	2	Special-Purpose	SJ
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Special-Purpose	SJ
SJSEQ	Sequence Number	Num		Identifier		Not in human clinical trials			Sequence number to ensure uniqueness within the dataset. Should be assigned to be in a consistent chronological order.		SEQ	4	Special-Purpose	SJ	SJ
RSTGCD	Repro Stage Code	Char		Topic		Not in human clinical trials			Short name of the Repro Stage used for programming and sorting. Maximum 8 characters.		RSTGCD	5	Special-Purpose	SJ
RSTAGE	Description of Repro Stage	Char		Synonym Qualifier	RSTGCD	Not in human clinical trials			The name of the Repro Stage. If RSTGCD has a value of "UNPLAN" then RSTAGE should be null.		RSTAGE	6	Special-Purpose	SJ
SJSTDTC	Start Date/Time of Repro Stage	Char	ISO 8601 datetime or interval	Timing		Not in human clinical trials			Start date or start date and time for a Repro Stage for each subject.		STDTC	7	Special-Purpose	SJ	SJ
SJENDTC	End Date/Time of Repro Stage	Char	ISO 8601 datetime or interval	Timing		Not in human clinical trials			End date/time for a Repro Stage for each subject.		ENDTC	8	Special-Purpose	SJ	SJ
RPHASE	Repro Phase	Char		Timing		Not in human clinical trials			Name of the reproductive phase with which this Repro Stage of the Repro Path is associated.		RPHASE	9	Special-Purpose	SJ
SJUPDES	Description of Unplanned Repro Stage	Char		Synonym Qualifier	RSTGCD	Not in human clinical trials			Description of what happened to the subject during an unplanned Repro Stage. Used only if RSTGCD has the value of "UNPLAN".		UPDES	10	Special-Purpose	SJ	SJ
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TA
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TA".		DOMAIN	2	Trial Design	TA
ARMCD	Planned Arm Code	Char		Topic			C83216	A short sequence of characters that represents the planned arm to which the subject was assigned.	ARMCD is limited to 20 characters and does not have special character restrictions.		ARMCD	3	Trial Design	TA
ARM	Description of Planned Arm	Char		Synonym Qualifier	ARMCD		C170984	The name of the planned arm to which the subject was assigned.			ARM	4	Trial Design	TA
TAETORD	Planned Order of Element within Arm	Num		Timing			C83438	An assigned numeric identifier that gives the planned order of the element within the trial arm of the study.			ETORD	5	Trial Design	TA	TA
ETCD	Element Code	Char		Record Qualifier					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.		ETCD	6	Trial Design	TA
ELEMENT	Description of Element	Char		Synonym Qualifier	ETCD				The name of the element.		ELEMENT	7	Trial Design	TA
TABRANCH	Branch	Char		Rule					Condition subjects meet, at a "branch" in the trial design at the end of this element, to be included in this arm.	"Randomization to DRUG X"	BRANCH	8	Trial Design	TA	TA
TATRANS	Transition Rule	Char		Rule					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.	"Responders go to washout"	TRANS	9	Trial Design	TA	TA
EPOCH	Epoch	Char		Timing			C71738	A time period defined in the protocol with a study-specific purpose.	The epoch associated with the value in ELEMENT and the value in ARMCD.		EPOCH	10	Trial Design	TA
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TD
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TD".		DOMAIN	2	Trial Design	TD
TDORDER	Sequence of Planned Assessment Schedule	Num		Timing					A number given to ensure ordinal sequencing of the planned assessment schedules within a trial.		ORDER	3	Trial Design	TD	TD
TDANCVAR	Anchor Variable Name	Char		Timing					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 subject-level (ADSL) dataset (e.g., ANCH1DT). \n Note: TDANCVAR is to contain the name of a reference date variable name.		ANCVAR	4	Trial Design	TD	TD
TDSTOFF	Offset from the Anchor	Char	ISO 8601 duration	Timing					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 a non-negative duration.		STOFF	5	Trial Design	TD	TD
TDTGTPAI	Planned Assessment Interval	Char	ISO 8601 duration	Timing					The planned interval between disease assessments.		TGTPAI	6	Trial Design	TD	TD
TDMINPAI	Planned Assessment Interval Minimum	Char	ISO 8601 duration	Timing					The lower limit of the allowed range for the planned interval between disease assessments.		MINPAI	7	Trial Design	TD	TD
TDMAXPAI	Planned Assessment Interval Maximum	Char	ISO 8601 duration	Timing					The upper limit of the allowed range for the planned interval between disease assessments.		MAXPAI	8	Trial Design	TD	TD
TDNUMRPT	Maximum Number of Actual Assessments	Num		Record Qualifier					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.		NUMRPT	9	Trial Design	TD	TD
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TM
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TM".		DOMAIN	2	Trial Design	TM
MIDSTYPE	Disease Milestone Type	Char		Topic					The type of disease milestone.	"HYPOGLYCEMIC EVENT"	MIDSTYPE	3	Trial Design	TM
TMDEF	Disease Milestone Definition	Char		Variable Qualifier	MIDSTYPE				Definition of the disease milestone.		DEF	4	Trial Design	TM	TM
TMRPT	Disease Milestone Repetition Indicator	Char		Record Qualifier					Indicates whether this is a disease milestone that can occur only once ("N") or one that can occur multiple times ("Y").		RPT	5	Trial Design	TM	TM
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TE
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TE".		DOMAIN	2	Trial Design	TE
ETCD	Element Code	Char		Topic					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.		ETCD	3	Trial Design	TE
ELEMENT	Description of Element	Char		Synonym Qualifier	ETCD				The name of the element.		ELEMENT	4	Trial Design	TE
TESTRL	Rule for Start of Element	Char		Rule					Expresses the rule for beginning the element.		STRL	5	Trial Design	TE	TE
TEENRL	Rule for End of Element	Char		Rule					Expresses the rule for ending the element. Either TEENRL or TEDUR must be present for each element.		ENRL	6	Trial Design	TE	TE
TEDUR	Planned Duration of Element	Char	ISO 8601 duration	Timing					Used when the rule for ending the element is applied after a fixed duration.		DUR	7	Trial Design	TE	TE
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TI
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TI".		DOMAIN	2	Trial Design	TI
IETESTCD	Inclusion/Exclusion Criterion Short Name	Char		Topic					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 prefix "IE" is used to ensure consistency with the IE domain.		IETESTCD	3	Trial Design	TI
IETEST	Inclusion/Exclusion Criterion	Char		Synonym Qualifier	IETESTCD				Full text of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain.		IETEST	4	Trial Design	TI
IECAT	Inclusion/Exclusion Category	Char		Grouping Qualifier					Used for categorization of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain.	"INCLUSION", "EXCLUSION"	IECAT	5	Trial Design	TI
IESCAT	Inclusion/Exclusion Subcategory	Char		Grouping Qualifier					A further categorization of the exception criterion. Can be used to distinguish criteria for a substudy or to categorize major or minor exceptions. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain.	"MAJOR", "MINOR"	IESCAT	6	Trial Design	TI
TIRL	Inclusion/Exclusion Criterion Rule	Char		Rule					Rule that expresses the criterion in computer-executable form.		RL	7	Trial Design	TI	TI
TIVERS	Protocol Criteria Versions	Char		Record Qualifier					The number of this version of the inclusion/exclusion criteria. May be omitted if there is only 1 version.		VERS	8	Trial Design	TI	TI
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TP
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TP".		DOMAIN	2	Trial Design	TP
RPATHCD	Planned Repro Path Code	Char		Topic		Not in human clinical trials	C170503	A short sequence of characters that represents the planned reproductive path to which the subject was assigned.	Limited to 20 characters. Should be populated in Demographics when repro paths have been defined in this domain.		RPATHCD	3	Trial Design	TP
RPATH	Description of Planned Repro Path	Char		Synonym Qualifier	RPATHCD	Not in human clinical trials			Name of the planned repro path.		RPATH	4	Trial Design	TP
TPSTGORD	Order of Repro Stage within Repro Path	Num		Timing		Not in human clinical trials			Number that gives the planned order of the repro stage within the repro path.		STGORD	5	Trial Design	TP	TP
RSTGCD	Repro Stage Code	Char		Topic		Not in human clinical trials			Short name of the repro stage used for programming and sorting. Maximum 8 characters. The values of RSTGCD used in the Trial Paths dataset must match values for the same repro stage in the Trial Stages dataset.		RSTGCD	6	Trial Design	TP
RSTAGE	Description of Repro Stage	Char		Synonym Qualifier	RSTGCD	Not in human clinical trials			The name of the repro stage.		RSTAGE	7	Trial Design	TP
TPBRANCH	Branch	Char		Rule		Not in human clinical trials			Conditions subjects meet, occurring at the end of a repro stage, which cause a repro path to branch off from another repro path.		BRANCH	8	Trial Design	TP	TP
RPHASE	Repro Phase	Char		Timing		Not in human clinical trials			Name of the reproductive phase with which this repro stage of the repro path is associated.		RPHASE	9	Trial Design	TP
RPRFDY	Repro Phase Start Reference Day	Num		Timing		Not in human clinical trials			Sponsor protocol-defined first day of repro phase. Should be zero or 1.		RPRFDY	10	Trial Design	TP
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TT
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	A sequence of characters used by the sponsor to uniquely identify the study.	2-character abbreviation, which must be "TT".		DOMAIN	2	Trial Design	TT
RSTGCD	Repro Stage Code	Char		Topic		Not in human clinical trials			Short name of the repro stage, used for programming and sorting. Maximum 8 characters.		RSTGCD	3	Trial Design	TT
RSTAGE	Description of Repro Stage	Char		Synonym Qualifier	RSTGCD	Not in human clinical trials			The name of the repro stage.		RSTAGE	4	Trial Design	TT
TTSTRL	Rule for Start of Repro Stage	Char		Rule		Not in human clinical trials			Expresses the rule for beginning the repro stage.		STRL	5	Trial Design	TT	TT
TTENRL	Rule for End of Repro Stage	Char		Rule		Not in human clinical trials			Expresses the rule for ending the repro stage. Either TTENRL or TTDUR must be present for each repro stage.		ENRL	6	Trial Design	TT	TT
TTDUR	Planned Duration of Repro Stage	Char	ISO 8601 duration	Timing		Not in human clinical trials			Used when the rule for ending the repro stage is applied after a fixed duration.		DUR	7	Trial Design	TT	TT
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TX
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TX".		DOMAIN	2	Trial Design	TX
SETCD	Set Code	Char		Identifier			C117457	The standardized or dictionary-derived short sequence of characters used to represent the trial set.	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.		SETCD	3	Trial Design	TX
SET	Set Description	Char		Synonym Qualifier	SETCD				Long description of a specific trial set, as defined by the sponsor.		SET	4	Trial Design	TX
TXSEQ	Sequence Number	Num		Identifier					Unique number for this record within this dataset.		SEQ	5	Trial Design	TX	TX
TXPARMCD	Trial Set Parameter Short Name	Char		Topic					Short character value for the trial set parameter described in TXPARM. Maximum 8 characters.		PARMCD	6	Trial Design	TX	TX
TXPARM	Trial Set Parameter	Char		Synonym Qualifier	TXPARMCD				Term for the trial set parameter. Maximum 40 characters.		PARM	7	Trial Design	TX	TX
TXVAL	Trial Set Parameter Value	Char		Result Qualifier					Value of the trial set parameter. Some parameters may be subject to controlled terminology.	"Fed ad libitum" or "Restricted Feeding" when TXPARM is "FEEDREG"	VAL	8	Trial Design	TX	TX
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TS
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TS".		DOMAIN	2	Trial Design	TS
TSSEQ	Sequence Number	Num		Identifier					Sequence number to ensure uniqueness within the dataset.		SEQ	3	Trial Design	TS	TS
TSGRPID	Group ID	Char		Identifier					Used to tie together a group of related records.		GRPID	4	Trial Design	TS	TS
TSPARMCD	Trial Summary Parameter Short Name	Char		Topic					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.	"AGEMIN", "AGEMAX"	PARMCD	5	Trial Design	TS	TS
TSPARM	Trial Summary Parameter	Char		Synonym Qualifier	TSPARMCD				Term for the trial summary parameter. The value in TSPARM cannot be longer than 40 characters.	"Planned Minimum Age of Subjects", "Planned Maximum Age of Subjects"	PARM	6	Trial Design	TS	TS
TSVAL	Parameter Value	Char		Result Qualifier					Value of TSPARM. If TSVAL is null, a value is required for TSVALNF. Text over 200 characters can be added to additional columns TSVAL1-TSVALn.	"ASTHMA" when TSPARM value is "Trial Indications"	VAL	7	Trial Design	TS	TS
TSVALNF	Parameter Null Flavor	Char		Result Qualifier					Null flavor for the value of TSVAL describing the reason the value is null, to be populated only if TSVAL is null.		VALNF	8	Trial Design	TS	TS
TSVALCD	Parameter Value Code	Char		Result Qualifier		Not in nonclinical trials			Code of the term in TSVAL from the reference terminology cited in TSVCDREF.		VALCD	9	Trial Design	TS	TS
TSVCDREF	Name of the Reference Terminology	Char		Result Qualifier		Not in nonclinical trials			The name of the reference terminology or standard format from which TSVALCD is taken.	"CDISC CT", "SNOMED", "ISO 8601"	VCDREF	10	Trial Design	TS	TS
TSVCDVER	Version of the Reference Terminology	Char		Result Qualifier		Not in nonclinical trials			The version number of the reference terminology cited in TSVCDREF, if applicable.		VCDVER	11	Trial Design	TS	TS
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	TV
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "TV".		DOMAIN	2	Trial Design	TV
VISITNUM	Visit Number	Num		Topic			C83101	An assigned numeric identifier that aligns to the chronological order of a clinical encounter.	Numeric version of VISIT can be used for sorting.		VISITNUM	3	Trial Design	TV
VISIT	Visit Name	Char		Synonym Qualifier	VISITNUM		C171010	The label for a protocol-defined clinical encounter.	May be used in addition to VISITNUM and/or VISITDY.		VISIT	4	Trial Design	TV
VISITDY	Planned Study Day of Visit	Num		Timing			C171011	The planned study day of a clinical encounter relative to the sponsor-defined reference start date.	Due to its sequential nature can be used for sorting.		VISITDY	5	Trial Design	TV
ARMCD	Planned Arm Code	Char		Record Qualifier			C83216	A short sequence of characters that represents the planned arm to which the subject was assigned.	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.		ARMCD	6	Trial Design	TV
ARM	Description of Planned Arm	Char		Synonym Qualifier	ARMCD		C170984	The name of the planned arm to which the subject was assigned.			ARM	7	Trial Design	TV
TVSTRL	Visit Start Rule	Char		Rule					Rule describing when the visit starts, in relation to the sequence of elements.		STRL	8	Trial Design	TV	TV
TVENRL	Visit End Rule	Char		Rule					Rule describing when the visit ends, in relation to the sequence of elements.		ENRL	9	Trial Design	TV	TV
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Trial Design	AC
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "AC".		DOMAIN	2	Trial Design	AC
ACSEQ	Sequence Number	Num		Identifier					Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same ACPARMCD.		SEQ	3	Trial Design	AC	AC
ACGRPID	Group ID	Char		Identifier					Used to tie together a group of related records.		GRPID	4	Trial Design	AC	AC
ACPARMCD	Challenge Agent Parameter Short Name	Char		Topic					ACPARMCD (the companion to ACPARM) 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 ACPARMCD will need to serve as variable names.		PARMCD	5	Trial Design	AC	AC
ACPARM	Challenge Agent Parameter	Char		Synonym Qualifier	ACPARMCD				Term for the challenge agent characterization parameter. The value in ACPARM cannot be longer than 40 characters.		PARM	6	Trial Design	AC	AC
ACVAL	Parameter Value	Char		Result Qualifier					Value of ACPARM.		VAL	7	Trial Design	AC	AC
ACVALU	Parameter Units	Char		Variable Qualifier	ACVAL				Units for the value in ACVAL, if applicable.		VALU	8	Trial Design	AC	AC
ACVALNF	Parameter Null Flavor	Char		Result Qualifier					Null flavor for the value of ACPARM, to be populated if and only if ACVAL is null.		VALNF	9	Trial Design	AC	AC
ACVALCD	Parameter Value Code	Char		Result Qualifier					This is the code of the term in ACVAL.		VALCD	10	Trial Design	AC	AC
ACVCDREF	Name of the Reference Terminology	Char		Result Qualifier					The name of the reference terminology from which ACVALCD is taken.	"CDISC," "ISO 8601"	VCDREF	11	Trial Design	AC	AC
ACVCDVER	Version of the Reference Terminology	Char		Result Qualifier					The version number of the reference terminology cited in ACVCDREF, if applicable.		VCDVER	12	Trial Design	AC	AC
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Relationship	POOLDEF
POOLID	Pool Identifier	Char		Identifier			C117053	A sequence of characters used to uniquely identify a group of subjects that have been pooled together.	Used to identify a result that is not assignable to a specific subject.		POOLID	2	Relationship	POOLDEF
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Relationship	POOLDEF
APID	Associated Persons Identifier	Char		Identifier					Identifier for a single associated person, a group of associated persons, or a pool of associated persons.		APID	4	Relationship	POOLDEF
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Relationship	RELREC
RDOMAIN	Related Domain Abbreviation	Char		Identifier					2-character abbreviation for the domain of the parent record(s).		RDOMAIN	2	Relationship	RELREC
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Relationship	RELREC
APID	Associated Persons Identifier	Char		Identifier					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 6.3, Pool Definition Dataset, and Section 4, Associated Persons Data).		APID	4	Relationship	RELREC
POOLID	Pool Identifier	Char		Identifier			C117053	A sequence of characters used to uniquely identify a group of subjects that have been pooled together.			POOLID	5	Relationship	RELREC
SPDEVID	Sponsor Device Identifier	Char		Identifier			C117060	A sequence of characters used by the sponsor to uniquely identify a specific device.			SPDEVID	6	Relationship	RELREC
IDVAR	Identifying Variable	Char		Identifier					Name of the identifying variable in the general-observation-class dataset that identifies the related record(s).	--SEQ and --GRPID	IDVAR	7	Relationship	RELREC
IDVARVAL	Identifying Variable Value	Char		Identifier					Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ is entered here.		IDVARVAL	8	Relationship	RELREC
RELTYPE	Relationship Type	Char		Record Qualifier					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.		RELTYPE	9	Relationship	RELREC
RELID	Relationship Identifier	Char		Record Qualifier					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.		RELID	10	Relationship	RELREC
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Relationship	RELREF
SETCD	Trial Set Code	Char		Identifier				The short sequence of characters used to represent the trial set.	The value "ALL" is used to indicate all trial sets within the assay.		SETCD	2	Relationship	RELREF
REFID	Reference ID	Char		Identifier				A sequence of characters used to uniquely identify a source of information.			REFID	3	Relationship	RELREF
PARENT	Parent Reference ID	Char		Identifier				The identifier for the immediate progenitor of a source of information.	Identifies the REFID of the parent.		PARENT	4	Relationship	RELREF
LEVEL	Reference ID Generation Level	Num		Variable Qualifier	REFID			The generation number of the information source in relation to the first generation of the source of information.	Identifies the level number of the reference ID.		LEVEL	5	Relationship	RELREF
LVLDESC	Reference ID Level Description	Char		Variable Qualifier	LEVEL			A description of the generation number of the information source in relation to the first generation of the source of information.		ASSAY, TRIAL SET, EXPERIMENTAL UNIT, OBSERVATIONAL UNIT	LVLDESC	6	Relationship	RELREF
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Relationship	RELSUB
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.	Either USUBJID or POOLID must be populated.		USUBJID	2	Relationship	RELSUB
POOLID	Pool Identifier	Char		Identifier			C117053	A sequence of characters used to uniquely identify a group of subjects that have been pooled together.	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.		POOLID	3	Relationship	RELSUB
RSUBJID	Related Subject or Pool Identifier	Char		Identifier					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.		RSUBJID	4	Relationship	RELSUB
SREL	Subject Relationship	Char		Record Qualifier					Describes the relationship of the subject identified in USUBJID or the pool identified in POOLID to the subject or pool identified in RSUBJID.		SREL	5	Relationship	RELSUB
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Associated Persons	APRELSUB
APID	Associated Persons Identifier	Char		Identifier					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 6.3, Pool Definition Dataset, and Section 4, Associated Persons Data).		APID	2	Associated Persons	APRELSUB
RSUBJID	Related Subject or Pool Identifier	Char		Identifier					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. \n RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects.		RSUBJID	3	Associated Persons	APRELSUB
RDEVID	Related Device Identifier	Char		Identifier					Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device.		RDEVID	4	Associated Persons	APRELSUB
SREL	Subject, Device, or Study Relationship	Char		Record Qualifier					If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. \n If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RDEVID. \n If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID.		SREL	5	Associated Persons	APRELSUB
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Relationship	SUPPQUAL
RDOMAIN	Related Domain Abbreviation	Char		Identifier					2-character abbreviation for the domain of the parent record(s).		RDOMAIN	2	Relationship	SUPPQUAL
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Relationship	SUPPQUAL
APID	Associated Persons Identifier	Char		Identifier					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 6.3, Pool Definition Dataset, and Section 4, Associated Persons Data).		APID	4	Relationship	SUPPQUAL
POOLID	Pool Identifier	Char		Identifier				A sequence of characters used to uniquely identify a group of subjects that have been pooled together.			POOLID	5	Relationship	SUPPQUAL
SPDEVID	Sponsor Device Identifier	Char		Identifier			C117060	A sequence of characters used by the sponsor to uniquely identify a specific device.			SPDEVID	6	Relationship	SUPPQUAL
IDVAR	Identifying Variable	Char		Identifier					Identifying variable in the parent dataset that identifies the related record(s).	--SEQ, --GRPID	IDVAR	7	Relationship	SUPPQUAL
IDVARVAL	Identifying Variable Value	Char		Identifier					Value of identifying variable of the parent record(s).		IDVARVAL	8	Relationship	SUPPQUAL
QNAM	Qualifier Variable Name	Char		Topic					The short name of the qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). \n QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset. QNAM should not be the name of any standard ADaM variable.		QNAM	9	Relationship	SUPPQUAL
QLABEL	Qualifier Variable Label	Char		Synonym Qualifier	QNAM				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.		QLABEL	10	Relationship	SUPPQUAL
QVAL	Data Value	Char		Result Qualifier					Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in a SUPP-- dataset with a null value for QVAL.		QVAL	11	Relationship	SUPPQUAL
QORIG	Origin	Char		Record Qualifier					Because QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data.		QORIG	12	Relationship	SUPPQUAL
QEVAL	Evaluator	Char		Record Qualifier					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.	"ADJUDICATION COMMITTEE", "STATISTICIAN", "DATABASE ADMINISTRATOR", "CLINICAL COORDINATOR"	QEVAL	13	Relationship	SUPPQUAL
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.	Study identifier of the domain record(s).		STUDYID	1	Relationship	DR
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "DR".		DOMAIN	2	Relationship	DR
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	3	Relationship	DR
SPDEVID	Sponsor Device Identifier	Char		Identifier					Sponsor-defined identifier for the device. It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers) as defined in DI.		SPDEVID	4	Relationship	DR
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Relationship	RELSPEC
USUBJID	Unique Subject Identifier	Char		Identifier			C69256	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.			USUBJID	2	Relationship	RELSPEC
REFID	Reference ID	Char		Identifier			C82531	A sequence of characters used to uniquely identify a source of information.			REFID	3	Relationship	RELSPEC
SPEC	Specimen Type	Char		Variable Qualifier	REFID		C70713	The type of sample material taken from a biological entity.			SPEC	4	Relationship	RELSPEC
PARENT	Specimen Parent	Char		Identifier					Identifies the REFID of the parent of a specimen to support tracking its genealogy.		PARENT	5	Relationship	RELSPEC
LEVEL	Specimen Level	Num		Variable Qualifier	REFID				Identifies the generation number of the sample where the collected sample is considered the first generation.		LEVEL	6	Relationship	RELSPEC
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Study Reference	DI
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "DI".		DOMAIN	2	Study Reference	DI
SPDEVID	Sponsor Device Identifier	Char		Identifier					Sponsor-defined identifier for the device.		SPDEVID	3	Study Reference	DI
DISEQ	Sequence Number	Num		Identifier					Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID).		SEQ	4	Study Reference	DI	DI
DIPARMCD	Device Identifier Element Short Name	Char		Topic					Short name of the identifier characteristic of the device.		PARMCD	5	Study Reference	DI	DI
DIPARM	Device Identifier Element Name	Char		Synonym Qualifier	DIPARMCD				Name of the identifier characteristic of the device.		PARM	6	Study Reference	DI	DI
DIVAL	Device Identifier Element Value	Char		Result Qualifier					Value for the parameter.		VAL	7	Study Reference	DI	DI
STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.			STUDYID	1	Study Reference	OI
DOMAIN	Domain Abbreviation	Char		Identifier			C49558	An abbreviation for a collection of observations, with a topic-specific commonality.	2-character abbreviation, which must be "OI".		DOMAIN	2	Study Reference	OI
NHOID	Non-Host Organism Identifier	Char		Identifier					Sponsor-defined identifier for a non-host organism.		NHOID	3	Study Reference	OI
OISEQ	Sequence Number	Num		Identifier					Sequence number given to ensure uniqueness within a parameter within an organism (NHOID).		SEQ	4	Study Reference	OI	OI
OIPARMCD	Non-Host Organism ID Element Short Name	Char		Topic					Short name of the taxon being described.		PARMCD	5	Study Reference	OI	OI
OIPARM	Non-Host Organism ID Element Name	Char		Synonym Qualifier	OIPARMCD				Name of the taxon being described.		PARM	6	Study Reference	OI	OI
OIVAL	Non-Host Organism ID Element Value	Char		Result Qualifier					Value for the taxon in OIPARMCD/OIPARM for the organism identified by NHOID.		VAL	7	Study Reference	OI	OI

Page tree

SDTM 2.1 Spec Grabber