SDTM.DA

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	DA	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study within the submission.
2	DA	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	DA	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Unique subject identifier within the submission.
4	DA	DASEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	DA	DAGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	DA	DAREFID	Reference ID	Char		Identifier	Perm	Internal or external identifier such as label number.
7	DA	DASPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Examples: Line number on the Drug Accountability page, drug label code.
8	DA	DATESTCD	Short Name of Accountability Assessment	Char		Topic	Req	Short character value for DATEST 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 and cannot begin with a number or contain characters other than letters, numbers or underscores. Example: DISPAMT, RETAMT.
9	DA	DATEST	Name of Accountability Assessment	Char		Synonym Qualifier	Req	Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the drug accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: Dispensed Amount, Returned Amount.
10	DA	DACAT	Category of Assessment	Char		Grouping Qualifier	Perm	Used to define a category of related records. Examples: STUDY MEDICATION, RESCUE MEDICATION.
11	DA	DASCAT	Subcategory of Assessment	Char		Grouping Qualifier	Perm	Used to define a further categorization level for a group of related records.
12	DA	DAORRES	Assessment Result in Original Units	Char		Result Qualifier	Exp	Result of the Drug Accountability assessment as originally received or collected.
13	DA	DAORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Unit for DAORRES.
14	DA	DASTRESC	Assessment Result in Std Format	Char		Result Qualifier	Exp	Contains the result value for all Drug Accountability assessments, copied or derived from DAORRES in a standard format or in standard units. DASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DASTRESN.
15	DA	DASTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Perm	Used for continuous or numeric results or findings in standard format; copied in numeric format from DASTRESC. DASTRESN should store all numeric test results or findings.
16	DA	DASTRESU	Assessment Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized units used for DASTRESC and DASTRESN.
17	DA	DASTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that a drug accountability assessment was not done. Should be null or have a value of NOT DONE.
18	DA	DAREASND	Reason Not Performed	Char		Record Qualifier	Perm	Reason not done. Used in conjunction with DASTAT when value is NOT DONE.
19	DA	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
20	DA	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter 2. May be used in addition to VISITNUM and/or VISITDY
21	DA	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
22	DA	DADTC	Date/Time of Accountability Assessment	Char	ISO 8601	Timing	Exp
23	DA	DADY	Study Day of Accountability Assessment	Num		Timing	Perm	1. Study day of drug accountability assessment, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.