SDTM Protocol Deviations (DV)

Description

An interventions domain that contains concomitant and prior medications used by the subject, such as those given on an as needed basis or condition-appropriate medications.

cm.xpt, Concomitant/Prior Medications — Interventions. One record per recorded intervention occurrence or constant-dosing interval 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.	Req
DOMAIN	Domain Abbreviation	Char	DV	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
DVSEQ	Sequence Number	Num		Identifier	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req
DVREFID	Reference ID	Char		Identifier	Internal or external identifier.	Perm
DVSPID	Applicant-Defined Identifier	Char		Identifier	Applicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF page.	Perm
DVTERM	Protocol Deviation Term	Char		Topic	Verbatim name of the protocol deviation criterion. Example: "IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED". DVTERM values will map to the controlled terminology in DVDECOD (e.g., "STUDY PRODUCT ASSIGNMENT DEVIATION").	Req
DVDECOD	Protocol Deviation Coded Term	Char		Synonym Qualifier	Controlled terminology for the name of the protocol deviation. Examples: "STUDY PRODUCT ASSIGNMENT DEVIATION", "EXCLUDED CONCOMITANT MEDICATION".	Perm
DVCAT	Category for Protocol Deviation	Char		Grouping Qualifier	Category of the protocol deviation criterion.	Perm
DVSCAT	Subcategory for Protocol Deviation	Char		Grouping Qualifier	A further categorization of the protocol deviation.	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 deviation. Examples: "PRODUCT EXPOSURE", "SCREENING", "FOLLOW-UP".	Perm
DVSTDTC	Start Date/Time of Deviation	Char	ISO 8601 datetime or interval	Timing	Start date/time of deviation represented in ISO 8601 character format.	Perm
DVENDTC	End Date/Time of Deviation	Char	ISO 8601 datetime or interval	Timing	End date/time of deviation represented in ISO 8601 character format.	Perm
DVSTDY	Study Day of Start of Deviation Event	Num		Timing	Study day of start of event relative to the applicant-defined RFSTDTC.	Perm
DVENDY	Study Day of End of Deviation Event	Num		Timing	Study day of end of event relative to the applicant-defined RFSTDTC.	Perm

Assumptions

The DV domain is an Events model for collected protocol deviations and not for derived protocol deviations that are more likely to be part of analysis. Events typically include what the event was, captured in --TERM (the topic variable), and when it happened (captured in its start and/or end dates). The intent of the domain model is to capture protocol deviations that occurred during the course of the study (see ICH E3, Section 10.2; https://database.ich.org/sites/default/files/E3_Guideline.pdf).
This domain should not be used to collect entry-criteria information. Violated inclusion/exclusion criteria are stored in IE. The DV domain is for more general deviation data. A protocol may indicate that violating an inclusion/exclusion criterion during the course of the study (after first exposure) is a protocol violation. In this case, this information would go into DV.
Any identifier variables, timing variables, or Events general observation-class qualifiers may be added to the DV domain, but the following qualifiers would generally not be used: --PRESP, --OCCUR, --STAT, --REASND, --BODSYS, --LOC, --SEV, --SER, --ACN, ‑‑ACNOTH, --REL, --RELNST, --PATT, --OUT, --SCAN, --SCONG, --SDISAB, --SDTH, --SHOSP, --SLIFE, --SOD, --SMIE, --CONTRT, --TOXGR.

dv.xpt, Protocol Deviations — Events. One record per protocol deviation per subject, Tabulation.

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SDTM Protocol Deviations (DV)