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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
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 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". 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" when DSCAT = "DISPOSITION EVENT"). The variable may be subject to controlled terminology for other categories of disposition event records.