SDTM Product Accountability (DA)

Description

A findings domain that contains the accountability of study product, such as information on the receipt, dispensing, return, and packaging.

da.xpt, Product Accountability — Findings. One record per product accountability finding per subject, Tabulation.

Specification

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 within the submission.	Req
DOMAIN	Domain Abbreviation	Char	DA	Identifier	Two-character abbreviation for the domain.	Req
USUBJID	Unique Subject Identifier	Char		Identifier	Unique subject identifier within the submission.	Req
DASEQ	Sequence Number	Num		Identifier	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req
DAGRPID	Group ID	Char		Identifier	Used to tie together a block of related records in a single domain for a subject.	Perm
DAREFID	Reference ID	Char		Identifier	Internal or external identifier such as label number.	Perm
DASPID	Applicant-Defined Identifier	Char		Identifier	Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Examples: Line number on the Product Accountability page, product label code.	Perm
DATESTCD	Short Name of Accountability Assessment	Char	(DATESTCD)	Topic	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".	Req
DATEST	Name of Accountability Assessment	Char	(DATEST)	Synonym Qualifier	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. Example: "Dispensed Amount", "Returned Amount".	Req
DACAT	Category	Char		Grouping Qualifier	Used to define a category of topic-variable values (e.g., "STUDY PRODUCT)..	Perm
DASCAT	Subcategory	Char		Grouping Qualifier	Used to define a further categorization level for a group of related records.	Perm
DAORRES	Result or Finding in Original Units	Char		Result Qualifier	Result of the Product Accountability assessment as originally received or collected.	Exp
DAORRESU	Original Units	Char	(UNIT)	Variable Qualifier	Unit for DAORRES.	Perm
DASTRESC	Result or Finding in Standard Format	Char		Result Qualifier	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.	Exp
DASTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	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.	Perm
DASTRESU	Standard Units	Char	(UNIT)	Variable Qualifier	Standardized units used for DASTRESC and DASTRESN.	Perm
DASTAT	Completion Status	Char	(ND)	Record Qualifier	Used to indicate that a product accountability assessment was not done. Should be null or have a value of "NOT DONE".	Perm
DAREASND	Reason Not Done	Char		Record Qualifier	Reason not done. Used in conjunction with DASTAT when value is "NOT DONE".	Perm
VISITNUM	Visit Number	Num		Timing	An assigned numeric identifier that aligns to the chronological order of an encounter. Numeric version of VISIT, used for sorting.	Exp
VISIT	Visit Name	Char		Timing	The label for a protocol-defined encounter. May be used in addition to VISITNUM and/or VISITDY.	Perm
VISITDY	Planned Study Day of Visit	Num		Timing	Planned study day of the visit, based upon RFSTDTC in Demographics.	Perm
TAETORD	Planned Order of Element within Arm	Num		Timing	Number that gives the planned order of the Element within the Arm.	Perm
EPOCH	Epoch	Char	(EPOCH)	Timing	Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.	Perm
DADTC	Date/Time of Collection	Char	ISO 8601 datetime or interval	Timing	Date and time of the product accountability assessment represented in ISO 8601 character format.	Exp
DADY	Study Day of Visit/Collection/Exam	Num		Timing	Study day of product accountability assessment, measured in integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC in Demographics.	Perm

Assumptions

One way an applicant may choose to differentiate different types of products, (e.g., study product, comparator product) is to use DACAT.
DAREFID and DASPID are both available for capturing label information.
Any Identifiers, Timing variables, or Findings general observation class qualifiers may be added to the DA domain, but the following Qualifiers would not generally be used in DA: --MODIFY, --POS, --BODSYS, --ORNRLO, --ORNRHI, --STNRLO, --STNRHI, --STNRC, --NRIND, --RESCAT, --XFN, --NAM, --LOINC, --SPEC, --SPCCND, --METHOD, --BLFL, --FAST, --DRVFL, --TOX, --TOXGR, --SEV.

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SDTM Product Accountability (DA)