SEND Demographics (DM)

Description TOBA-273 - Getting issue details... STATUS

A special-purpose domain that includes a set of essential standard variables that describe each subject in a nonclinical study. A record will exist for each subject. TOBA-294 - Getting issue details... STATUS

A special-purpose domain that includes a set of essential standard variables that describe each subject in a nonclinical study. One record will exist for each subject.

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

Specification

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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.	Req
SUBJID	Subject Identifier for the Study	Char		Topic	Subject (i.e., Animal) identifier used within the study.	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 format. Usually equivalent to date/time when subject was first exposed to study product. Study day calculation (the --DY variable) in all domains will be based on this date. The collected date used to populate RFSTDTC must be defined in the data definition file.	Req
RFENDTC	Subject Reference End Date/Time	Char	ISO 8601 datetime or interval	Record Qualifier	Reference end date/time for the subject in ISO 8601 format. Usually equivalent to the date/time when the subject was determined to have left the study. The collected date used to populate RFSTDTC must be defined in the data definition file.	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 exposure, equal to the earliest value of EXSTDTC. Note: Absolute first.	Perm
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). Note: Absolute last.	Perm
SITEID	Study Site Identifier	Char		Record Qualifier	Unique identifier for a study site within a submission. Use only if subjects are housed at different sites.	Perm
BRTHDTC	Date/Time of Birth	Char	ISO 8601 datetime or interval	Record Qualifier	Date/Time of birth of the subject, in ISO 8601 format.	Perm
AGE	Age	Num		Record Qualifier	May be derived (RFSTDTC - BRTHDTC), but BRTHDTC may not be available in all cases. Age may also be collected.	Perm
AGETXT	Age Range	Char	number-number	Record Qualifier	Used when the age is a range and the exact birthdate is not known. This variable is a character field for the purposes of defining age ranges, e.g., if the information available for the age of the subject is 6-8 and AGEU is WEEKS. Populate only when BRTHDTC or AGE is not specified. The format for AGETXT is "number-number" (e.g., 6-8).	Perm
AGEU	Age Unit	Char	(AGEU)	Variable Qualifier	Units associated with AGE and AGETXT.	Exp
SEX	Sex	Char	(SEX)	Record Qualifier	The sex of the subject.	Req
SPECIES	Species	Char	(SPECIES)	Record Qualifier	If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary).	Perm
STRAIN	Strain/Substrain	Char	(STRAIN)	Record Qualifier	Used to identify the vendor-supplied strain, substrain, or breed designation for the test system under study. It may combine the background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, and CHIMPANZEE). The SEND Controlled Terminology codelist consists of commonly used wild type strains. It is extensible to accommodate strains not listed and genetically modified substrains. If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). Country of origin for non-human primates should not go into STRAIN. In general, details related to coat color (e.g., White and Red designations for New Zealand Rabbits) should not go into STRAIN.	Perm
SBSTRAIN	Strain/Substrain Details	Char		Record Qualifier	Free-text field that allows the to enter further details qualifiying the SPECIES and/or STRAIN, depending on the level to which these variables were defined. Examples include the description of a specific genetic alteration, country of origin for non-human primates, details related to coat color (e.g., White and Red designations for New Zealand Rabbits), and important animal husbandry information (e.g., SPF, BR, VAF).	Perm
ARMCD	Planned Arm Code	Char		Record Qualifier	Short name for ARM (may be up to 20 characters) used for sorting and programming. Should be populated when Arms have been defined in the TA domain.	Exp
ARM	Description of Planned Arm	Char		Synonym Qualifier	Descriptive name given to a specific Trial Arm to which the subject was assigned.	Perm
SETCD	Set Code	Char		Record Qualifier	Short name of a specific Trial Set to which the subject was assigned, as defined by the applicant. Maximum of 8 characters. This represents the Trial Set for which parameters are being submitted.	Req

Assumptions

Subject identification: It is presumed that every subject (i.e., animal) in a study will have a subject identifier (SUBJID). In some cases, a subject may be included in more than 1 study within a submission, and, more commonly, subjects from different studies may have the same subject identifier. To identify a subject uniquely across a submission, a unique identifier (USUBJID) should be assigned and included in all subject-related datasets in the submission.
Arm identification: When submitting study design information, the values of ARMCD and ARM should be identical to the values defined for that subject in the Subject Elements (SE) dataset. The assignment of values should be consistent, if possible, within a submission.
When additional information is reported about the subjects, this information should be placed in the Subject Characteristics (SC) domain, adding the specific variable as a value in SCTEST. Study design information that does not vary on an individual subject level should be placed in the Trial Sets (TX) table.
BRTHDTC, AGE, and AGETXT: These variables represent 3 levels of precision for the age of the subject, and they should be used according to the information available.
1. AGE and AGETXT should never both be populated for the same subject. AGEU refers to whichever variable is used.
2. If information is available about the time of birth for the subject, it should be presented in the variable BRTHDTC in ISO 8601 format, even if this is only partial information (not a complete date of birth).
3. Data in BRTHDTC should never be derived from another variable. Either this information is collected or this variable should be blank.
4. If a specific age for the subject is known, but no information regarding date/time of birth is available, then AGE and AGEU should be populated, using the most descriptive/precise unit for the data (e.g., 1 year, 2 months would be AGE = "14" and AGEU = "MONTHS").
5. AGE and AGEU may be derived using an algorithm involving BRTHDTC and RFSTDTC. In this case, comments in the define file should indicate how AGE was populated.
6. If only an approximate age is known (e.g., 6-8 weeks), then use AGETXT in conjunction with AGEU (e.g., AGETXT = "6-8" and AGEU = "WEEKS"). The format for AGETXT is number-number (e.g., "6-8").
RFSTDTC, RFENDTC, 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 as described in SDTM v1.5, Section 2.2.6, because they are not intended for use in the general observation classes. The subject may have records in other domains with a date/time prior to RFSTDTC and after the RFENDTC.
SPECIES and STRAIN: These variables are permissible and should be used only if different species or strains are used during 1 study. If all the subjects in 1 study are of the same species, strain, and substrain, then this information is collected in the Trial Summary (TS) table. TX can have multiple species and/or strains if they are different by set.
The SETCD variable is to be used to uniquely identify all distinct "groups" or "trial sets." A trial set is a collection of subjects that have a common set of parameters defined in the protocol, where those parameters include experimental parameters, product exposure strategies, inherent characteristics (e.g., strain) parameters, and/or applicant-defined attributes (e.g., control group designation). In general, if a distinction between arms does not cause the subjects to be summarized or grouped independently, then the arms should not be reflected as a separate trial set. A subject may belong to 1 and only 1 trial set.
ARM: An arm is a planned path through a study. This path covers the entire time of the study. The group of subjects assigned to an arm is also often colloquially called an "arm." The group of subjects assigned to an arm is also often called an "exposure group," although it is not necessarily a product exposure group. The same arm can be used to separate subjects into different satellites. For example, use SETCD for assigning main study subjects and TK study subjects.

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SEND Demographics (DM)