Demographics (DM)

SDTM v2.0 Metadata Check for Class and Dataset Specification Table 1.4.0

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#	Variable Name	Variable Label	Type	Format	Role	Variable(s) Qualified	Usage Restrictions	Variable C-code	Definition	Notes	Examples
1	STUDYID	Study Identifier	Char		Identifier			C83082	A sequence of characters used by the sponsor to uniquely identify the study.
2	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".
3	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.
4	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.
5	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.
6	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.
7	RFXSTDTC	Date/Time of First Treatment or Product	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.
8	RFXENDTC	Date/Time of Last Treatment or Product	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.
9	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. Equal to the earliest value of AGSTDTC for the challenge agent.
10	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. Equal to the latest value of AGENDTC for the challenge agent.
11	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.
12	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.
13	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.
14	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.
15	SITEID	Study Site Identifier	Char		Record Qualifier			C83081	A sequence of characters used to uniquely identify the facility associated with study-specific activities.
16	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.
17	INVNAM	Investigator Name	Char		Synonym Qualifier	INVID	Not in nonclinical trials			Name of the investigator for a site.
18	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.
19	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).
20	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.
21	AGEU	Age Units	Char		Variable Qualifier	AGE; AGETXT		C50400	The unit of time used to express the age, using standardized values.
22	SEX	Sex	Char		Record Qualifier					Sex of the subject.
23	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.
24	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.
25	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"
26	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"
27	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.
28	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.
29	ARM	Description of Planned Arm	Char		Synonym Qualifier	ARMCD		C170984	The name of the planned arm to which the subject was assigned.
30	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.
31	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.
32	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"
33	ACTARMUD	Description of Unplanned Actual Arm	Char		Record Qualifier				A description of the pathway through the study for a subject who did not follow one of the planned trial arms.	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.
34	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.
35	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.
36	COUNTRY	Country	Char	ISO 3166-1 Alpha-3	Record Qualifier		Not in nonclinical trials	C170990	The country in which the investigational site is located.
37	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.
38	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.

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Demographics (DM)