SDTM Demographics (DM)

dm.xpt, Demographics — Special-Purpose. One record per subject, Tabulation.

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	DM	Identifier	Two-character abbreviation for the domain.	Req
USUBJID	Unique Subject Identifier	Char		Identifier	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. This must be a unique value, and could be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID.	Req
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.	Req
RFSTDTC	Subject Reference Start Date/Time	Char	ISO 8601 datetime or interval	Record Qualifier	Reference start date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study product.	Exp
RFENDTC	Subject Reference End Date/Time	Char	ISO 8601 datetime or interval	Record Qualifier	Reference end date/time for the subject in ISO 8601 character format. Usually equivalent to the date/time when subject was determined to have ended the study/trial, and often equivalent to date/time of last exposure to study product. Required for all randomized subjects; null for screen failures or unassigned subjects.	Exp
RFXSTDTC	Date/Time of First Study Exposure	Char	ISO 8601 datetime or interval	Record Qualifier	First date/time of exposure to any protocol-specified product, equal to the earliest value of EXSTDTC.	Exp
RFXENDTC	Date/Time of Last Study Exposure	Char	ISO 8601 datetime or interval	Record Qualifier	Last date/time of exposure to any protocol-specified product, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing).	Exp
RFICDTC	Date/Time of Informed Consent	Char	ISO 8601 datetime or interval	Record Qualifier	Date/time of informed consent in ISO 8601 character format. This will be the same as the date of informed consent in the Disposition domain, if that protocol milestone is documented. Would be null only in studies not collecting the date of informed consent.	Exp
RFPENDTC	Date/Time of End of Participation	Char	ISO 8601 datetime or interval	Record Qualifier	Date/time when subject ended participation or follow-up in a study/trial, as defined in the protocol, in ISO 8601 character format. Should correspond to the last known date of contact. Examples include completion date, withdrawal date, last follow-up, date recorded for lost to follow up, and death date.	Exp
DTHDTC	Date/Time of Death	Char	ISO 8601 datetime or interval	Record Qualifier	Date/time of death for any subject who died, in ISO 8601 format. Should represent the date/time that is captured in the clinical-study database.	Exp
DTHFL	Subject Death Flag	Char	(NY)	Record Qualifier	Indicates the subject died. Should be "Y" or null. Should be populated even when the death date is unknown.	Exp
SITEID	Study Site Identifier	Char		Record Qualifier	Unique identifier for a site within a study.	Req
INVID	Investigator Identifier	Char		Record Qualifier	An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID.	Perm
INVNAM	Investigator Name	Char		Synonym Qualifier	Name of the investigator for a site.	Perm
BRTHDTC	Date/Time of Birth	Char	ISO 8601 datetime or interval	Record Qualifier	Date/time of birth of the subject.	Perm
AGE	Age	Num		Record Qualifier	Age expressed in AGEU. May be derived from RFSTDTC and BRTHDTC, but BRTHDTC may not be available in all cases (due to subject privacy concerns).	Exp
AGEU	Age Units	Char	(AGEU)	Variable Qualifier	Units associated with AGE.	Exp
SEX	Sex	Char	(SEX)	Record Qualifier	Sex of the subject.	Req
RACE	Race	Char	(RACE)	Record Qualifier	Race of the subject. Race will be collected and represented per regulatory requirements.	Exp
ETHNIC	Ethnicity	Char	(ETHNIC)	Record Qualifier	The ethnicity of the subject. Ethnicity will be collected and represented per regulatory requirements.	Perm
ARMCD	Planned Arm Code	Char		Record Qualifier	ARMCD is limited to 20 characters. It is not subject to the character restrictions that apply to TESTCD. The maximum length of ARMCD is longer than for other "short" variables to accommodate the kind of values that are likely to be needed for crossover studies/trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each product and separating hyphens, the length of ARMCD values would be 20. If the subject was not assigned to an arm, ARMCD is null and ARMNRS is populated. With the exception of studies which use multistage arm assignments, must be a value of ARMCD in the Trial Arms dataset.	Exp
ARM	Description of Planned Arm	Char		Synonym Qualifier	Name of the arm to which the subject was assigned. If the subject was not assigned to an arm, ARM is null and ARMNRS is populated. With the exception of studies which use multistage arm assignments, must be a value of ARM in the Trial Arms dataset.	Exp
ACTARMCD	Actual Arm Code	Char		Record Qualifier	Code of actual arm. ACTARMCD is limited to 20 characters. It is not subject to the character restrictions that apply to TESTCD. The maximum length of ACTARMCD is longer than for other short variables to accommodate the kind of values that are likely to be needed for crossover studies/trials. With the exception of studies which use multistage arm assignments, must be a value of ARMCD in the Trial Arms dataset. If the subject was not assigned to an arm or followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is populated.	Exp
ACTARM	Description of Actual Arm	Char		Synonym Qualifier	Description of actual arm. With the exception of studies which use multistage arm assignments, must be a value of ARM in the Trial Arms dataset. If the subject was not assigned to an arm or followed a course not described by any planned arm, ACTARM is null and ARMNRS is populated.	Exp
ARMNRS	Reason Arm and/or Actual Arm is Null	Char	(ARMNULRS)	Record Qualifier	A coded reason that arm variables (ARM and ARMCD) and/or actual arm variables (ACTARM and ACTARMCD) are null. Example: "SCREEN FAILURE". It is assumed that if the arm and actual arm variables are null, the same reason applies to both arm and actual arm.	Exp
ACTARMUD	Description of Unplanned Actual Arm	Char		Record Qualifier	A description of actual product for a subject who did not receive the product described in one of the planned arms.	Exp
COUNTRY	Country	Char		Record Qualifier	Country of the investigational site in which the subject participated in the study/trial. Generally represented using ISO 3166-1 Alpha-3. Regulatory agencies may require other terminologies; in such cases, follow regulatory requirements.	Req
DMDTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing	Date/time of demographic data collection.	Perm
DMDY	Study Day of Collection	Num		Timing	Study day of collection measured as integer days.	Perm

Assumptions

Investigator and site identification: Companies use different methods to distinguish sites and investigators. CDISC assumes that SITEID will always be present, with INVID and INVNAM used as necessary.
Every subject in a study must have a subject identifier (SUBJID). In some cases a subject may participate in more than 1 study. To identify a subject uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) must be included in all datasets. Subjects occasionally change sites during the course of a clinical study. Applicants must decide how to populate variables such as USUBJID, SUBJID and SITEID based on their operational and analysis needs, but only 1 DM record should be submitted for each subject. The Supplemental Qualifiers dataset may be used if appropriate to provide additional information.
Concerns for subject privacy suggest caution regarding the collection of variables like BRTHDTC. This variable is included in the Demographics model in the event that an applicant intends to submit it; however, applicants should follow regulatory guidelines and guidance as appropriate.
With the exception of studies that use multistage processes to assign subjects to arms described below, ARM and ACTARM must be populated with ARM values from the Trial Arms (TA) dataset and ARMCD and ACTARMCD must be populated with ARMCD values from the TA dataset or be null. The ARM and ARMCD values in the TA dataset have a one-to-one relationship, and that one-to-one relationship must be preserved in the values used to populate ARM and ARMCD in DM, and to populate the values of ACTARM and ACTARMCD in DM.
1. Rules for the arm-related variables:
  1. If ARMCD is null, then ARM must be null and ARMNRS must be populated with the reason ARMCD is null.
  2. If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated with the reason ACTARMCD is null. Both ARMCD and ACTARMCD will be null for subjects who were not assigned to an arm. The same reason will provide the reason that both are null.
  3. ARMNRS may not be populated if both ARMCD and ACTARMCD are populated. ARMCD and ACTARMCD will be populated if the subject was assigned to an arm and received exposure consistent with 1 of the arms in the TA dataset. If ARMCD and ACTARMCD are not the same, that is sufficient to explain the situation; ARMNRS should not be populated.
2. Multistage assignment to an arm: Some studies use a multistage process for assigning a subject to an arm. In such a case, best practice is to create ARMCD values composed of codes representing the results of the multiple stages of the are assignment process. If a subject is partially assigned, then truncated codes representing the stages completed can be used in ARMCD, and similar truncated codes can be used in ACTARMCD. The descriptions used to populate ARM and ACTARM should be similarly truncated, and the one-to-one relationship between these truncated codes should be maintained for all affected subjects in the study. Note that this use of values not in the TA dataset is allowable only for studies with multistage assignment to arms and to subjects in those studies who do not complete all stages of the assignment.
Study population flags should not be included in SDTM data. The ADaM Subject-level Analysis Dataset (ADSL) specifies standard variable names for the most common populations and requires the inclusion of these flags when necessary for analysis.
Race and ethnicity will be represented per regulatory requirements. Submission of multiple race responses should be represented in the Demographics (DM) domain and Supplemental Qualifiers (SUPPDM) dataset. If multiple races are collected, then the value of RACE should be “MULTIPLE” and the additional information will be included in the Supplemental Qualifiers dataset. Controlled terminology for RACE should be used in both DM and SUPPDM so that consistent values are available for summaries regardless of whether the data are found in a column or row. If multiple races were collected and 1 was designated as primary, RACE in DM should be the primary race and additional races should be reported in SUPPDM. For subjects who refuse to provide or do not know their race information, the value of RACE could be “UNKNOWN”.
RFSTDTC, RFENDTC, RFXSTDTC, RFXENDTC, RFCSTDTC, RFCENDTC, RFICDTC, RFPENDTC, DTHDTC, and BRTHDTC represent date/time values, but they are considered to have a record qualifier role in DM. They are not considered to be timing variables because they are not intended for use in the general observation classes.
Additional permissible identifier, qualifier, and timing variables:
1. Only the following timing variables are permissible and may be added as appropriate: VISITNUM, VISIT, VISITDY. The record qualifier DMXFN (External File Name) is the only additional qualifier variable that may be added, which is adopted from the Findings general observation class, may also be used to refer to an external file, such as a patient narrative.
2. The order of these additional variables within the domain should follow variable order in the SDTM.
RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined as the date/time when a subject was first exposed to study product.
The DM domain contains several pairs of reference period variables: RFSTDTC and RFENDTC, RFXSTDTC and RFXENDTC, RFCSTDTC and RFCENDTC, and RFICDTC and RFPENDTC. There are 4 sets of reference variables to accommodate distinct reference-period definitions and there are instances when the values of the variables may be exactly the same, particularly with RFSTDTC-RFENDTC and RFXSTDTC-RFXENDTC.
1. RFSTDTC and RFENDTC: This pair of variables is applicant-defined, but usually represents the date/time of first and last study exposure. However, there are certain study designs where the start of the reference period is defined differently, such as studies that have a washout period. In these cases, RFSTDTC may be the enrollment date, which is prior to first exposure. Because study day values are calculated using RFSTDTC, in this case study days would not be based on the date of first exposure.
2. RFXSTDTC and RFXENDTC: This pair of variables defines a consistent reference period for all studies and is not open to customization. RFXSTDTC and RFXENDTC always represent the date/time of first and last study exposure. This reference period often duplicates the reference period defined in RFSTDTC and RFENDTC, but not always. Therefore, this pair of variables is important as they guarantee that a reviewer will always be able to reference the first and last study exposure reference period. RFXSTDTC should be the same as SESTDTC for the first element described in the SE dataset. RFXENDTC may often be the same as the SEENDTC for the last element described in the SE dataset.
3. RFICDTC and RFPENDTC: The definitions of this pair of variables are consistent in every study in which they are used: They represent the entire period of a subject’s involvement in a study, from providing informed consent through the last participation event or activity. There may be times when this period coincides with other reference periods but that is unusual. RFICDTC should correspond to the date of the informed consent protocol milestone in Disposition (DS), if that protocol milestone is documented in DS. In the event that there are multiple informed consents, this will be the date of the first. RFPENDTC will be the last date of participation for a subject for data included in a submission. This should be the last date of any record for the subject in the database at the time it is locked for submission. As such, it may not be the last date of participation in the study if the submission includes interim data.

Page tree

SDTM Demographics (DM)