SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
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Release Notes
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
Sponsor-Defined Identifier
Char
Identifier
Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor'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., "TREATMENT DEVIATION").
Req
DVDECOD
Protocol Deviation Coded Term
Char
*
Synonym Qualifier
Controlled terminology for the name of the protocol deviation. Examples: "SUBJECT NOT WITHDRAWN AS PER PROTOCOL", "SELECTION CRITERIA NOT MET", "EXCLUDED CONCOMITANT MEDICATION", "TREATMENT DEVIATION".
Perm
DVCAT
Category for Protocol Deviation
Char
*
Grouping Qualifier
Category of the protocol deviationcriterion.
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.
Epoch associated with the start date/time of the deviation. Examples: "TREATMENT", "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 sponsor-defined RFSTDTC.
Perm
DVENDY
Study Day of End of Deviation Event
Num
Timing
Study day of end of event relative to the sponsor-defined RFSTDTC.
Perm
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.