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Description

An events domain that contains protocol violations and deviations during the course of the study.

dv.xpt, Protocol Deviations — Events. One record per protocol deviation 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 NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharDVIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
DVSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
DVREFIDReference IDChar
IdentifierInternal or external identifier.Perm
DVSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-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
DVTERMProtocol Deviation TermChar
TopicVerbatim 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
DVDECODProtocol Deviation Coded TermChar
Synonym QualifierControlled terminology for the name of the protocol deviation. Examples: "STUDY PRODUCT ASSIGNMENT DEVIATION", "EXCLUDED CONCOMITANT MEDICATION".Perm
DVCATCategory for Protocol DeviationChar
Grouping QualifierCategory of the protocol deviation criterion.Perm
DVSCATSubcategory for Protocol DeviationChar
Grouping QualifierA further categorization of the protocol deviation.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the element within the arm.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the deviation. Examples: "PRODUCT EXPOSURE", "SCREENING", "FOLLOW-UP".Perm
DVSTDTCStart Date/Time of DeviationCharISO 8601 datetime or intervalTimingStart date/time of deviation represented in ISO 8601 character format.Perm
DVENDTCEnd Date/Time of DeviationCharISO 8601 datetime or intervalTimingEnd date/time of deviation represented in ISO 8601 character format.Perm
DVSTDYStudy Day of Start of Deviation EventNum
TimingStudy day of start of event relative to the applicant-defined RFSTDTC.Perm
DVENDYStudy Day of End of Deviation EventNum
TimingStudy day of end of event relative to the applicant-defined RFSTDTC.Perm


Assumptions


  1. 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).
  2. 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.
  3. 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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