Disposition
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA
text
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): DS
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA
integer
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Used to tie together a block of related records in a single domain for a subject. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Internal or external identifier. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Disposition page. Controlled Terms or Format (if applicable): NA
Role: Topic CDISC Notes (for domains) Description (for General Classes): 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 Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 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 and codelist "PROTMLST" is used for protocol milestones. The variable may be subject to controlled terminology for other events. Controlled Terms or Format (if applicable): (NCOMPLT), (PROTMLST), both extensible; NCOMPLT added as codelist, entries from PROTMLST added as well and marked as being part of PROTMLST in the respective comment section.
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used to define a category of related records. Controlled Terms or Format (if applicable): (DSCAT), not extensible
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): A further categorization of DSCAT (e.g., "STUDY PARTICIPATION", "STUDY TREATMENT" when DSCAT = "DISPOSITION EVENT"). Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the start date/time of the event. Controlled Terms or Format (if applicable): (EPOCH), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Collection date and time of the disposition observation represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601
datetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): Start date/time of the disposition event in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601
Role: Timing CDISC Notes (for domains) Description (for General Classes): Start date/time of the disposition event in ISO 8601 character format. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of start of event relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA