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	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
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	Optional internal or external identifier such as a code from the product packaging (e.g., bottle label, package label, kit label).
7	DA	DASPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Examples: Line number on the Product Accountability CRF page, a code from the product packaging (e.g., bottle label, package label, kit label).
8	DA	DALNKID	Link ID	Char		Identifier	Perm	Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.
9	DA	DALNKGRP	Link Group ID	Char		Identifier	Perm	Identifier used to link related records across domains. This will usually be a many-to-one relationship.
10	DA	DATESTCD	Short Name of Accountability Assessment	Char	C78732	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. Examples: "DISPAMT", "RETAMT".
11	DA	DATEST	Name of Accountability Assessment	Char	C78731	Synonym Qualifier	Req	Verbatim name corresponding to the topic variable of the test or examination used to obtain the product accountability assessment. The value in DATEST cannot be longer than 40 characters. Examples: "Dispensed Amount", "Returned Amount".
12	DA	DACAT	Category	Char		Grouping Qualifier	Perm	Used to define a category of topic-variable values. Examples: "STUDY MEDICATION", "RESCUE MEDICATION".
13	DA	DASCAT	Subcategory	Char		Grouping Qualifier	Perm	Used to define a further categorization level for a group of related records.
14	DA	DAORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the product accountability assessment as originally received or collected.
15	DA	DAORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Unit for DAORRES.
16	DA	DASTRESC	Result or Finding in Standard Format	Char		Result Qualifier	Exp	Contains the result value for all product 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.
17	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.
18	DA	DASTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized units used for DASTRESC and DASTRESN.
19	DA	DASTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that a product accountability assessment was not done. Should be null or have a value of "NOT DONE".
20	DA	DAREASND	Reason Not Done	Char		Record Qualifier	Perm	Reason not done. Used in conjunction with DASTAT when value is "NOT DONE".
21	DA	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
22	DA	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of a clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
23	DA	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit, based upon RFSTDTC in Demographics.
24	DA	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the element within the arm (see Section 7.2.1, Trial Arms).
25	DA	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.
26	DA	DADTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing	Exp	Date and time of the product accountability assessment represented in ISO 8601 character format.
27	DA	DADY	Study Day of Visit/Collection/Exam	Num		Timing	Perm	Study day of product accountability assessment, measured in integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC in Demographics.