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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 DS STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 DS DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 DS USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 DS DSSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 DS DSGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 DS DSREFID Reference ID Char Identifier Perm Internal or external identifier.
7 DS DSSPID Sponsor-Defined Identifier Char Identifier Perm 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.
8 DS DSTERM Reported Term for the Disposition Event Char Topic Req 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".
9 DS DSDECOD Standardized Disposition Term Char C66727
C114118
C150811 		Synonym Qualifier Req 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.
10 DS DSCAT Category for Disposition Event Char C74558 Grouping Qualifier Exp Used to define a category of related records.
11 DS DSSCAT Subcategory for Disposition Event Char C170443 Grouping Qualifier Perm 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.
12 DS EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the event.
13 DS DSDTC Date/Time of Collection Char ISO 8601 datetime or interval Timing Perm Collection date and time of the disposition observation represented in ISO 8601 character format.
14 DS DSSTDTC Start Date/Time of Disposition Event Char ISO 8601 datetime or interval Timing Exp Start date/time of the disposition event in ISO 8601 character format.
15 DS DSDY Study Day of Collection Num Timing Perm Study day of collection of event relative to the sponsor-defined RFSTDTC.
16 DS DSSTDY Study Day of Start of Disposition Event Num Timing Exp Study day of start of event relative to the sponsor-defined RFSTDTC.