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
DSSEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
Req
DSGRPID
Group ID
Char
Identifier
Used to tie together a block of related records in a single domain for a subject.
Perm
DSREFID
Reference ID
Char
Identifier
Internal or external identifier.
Perm
DSSPID
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 Disposition page.
Perm
DSTERM
Reported Term for the Disposition Event
Char
Topic
Verbatim name of the event or protocol milestone. Some terms in DSTERM will match DSDECOD, but others, such as "Subject moved", will map to controlled terminology in DSDECOD, such as "LOST TO FOLLOW-UP".
Controlled terminology for the name of disposition event or protocol milestone. Examples of protocol milestones: "INFORMED CONSENT OBTAINED", "RANDOMIZED". There are separate codelists used for DSDECOD where the choice depends on the value of DSCAT. Codelist "NCOMPLT" is used for disposition events, codelist "PROTMLST" is used for protocol milestones, and codelist "OTHEVENT" is used for other events.
A further categorization of DSCAT (e.g., "STUDY PARTICIPATION", "STUDY TREATMENT" when DSCAT = "DISPOSITION EVENT"). The variable may be subject to controlled terminology for other categories of disposition event records.
Epoch associated with the start date/time of the event.
Perm
DSDTC
Date/Time of Collection
Char
ISO 8601 datetime or interval
Timing
Collection date and time of the disposition observation represented in ISO 8601 character format.
Perm
DSSTDTC
Start Date/Time of Disposition Event
Char
ISO 8601 datetime or interval
Timing
Start date/time of the disposition event in ISO 8601 character format.
Exp
DSDY
Study Day of Collection
Num
Timing
Study day of collection of event relative to the sponsor-defined RFSTDTC.
Perm
DSSTDY
Study Day of Start of Disposition Event
Num
Timing
Study day of start of event relative to the sponsor-defined RFSTDTC.
Exp
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.