SDTM Disposition (DS)

An events domain that contains information encompassing and representing data related to subject disposition.

ds.xpt, Disposition — Events. One record per disposition status or protocol milestone per subject, Tabulation.

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	DS	Identifier	Two-character abbreviation for the domain.	Req
USUBJID	Unique Subject Identifier	Char		Identifier	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".	Req
DSDECOD	Standardized Disposition Term	Char	(TNCOMPLT) (PROTMLST) (OTHEVENT)	Synonym Qualifier	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.	Req
DSCAT	Category for Disposition Event	Char	(DSCAT)	Grouping Qualifier	Used to define a category of related records.	Exp
DSSCAT	Subcategory for Disposition Event	Char	(DSSCAT)	Grouping Qualifier	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.	Perm
EPOCH	Epoch	Char	(EPOCH)	Timing	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 applicant-defined RFSTDTC.	Perm
DSSTDY	Study Day of Start of Disposition Event	Num		Timing	Study day of start of event relative to the applicant-defined RFSTDTC.	Exp

Assumptions

The Disposition (DS) dataset provides an accounting for all subjects who entered the study and may include protocol milestones, such as randomization, as well as the subject's completion status or reason for discontinuation for the entire study or each phase or segment of the study, including screening and follow-up. Applicants may choose which disposition events and milestones to submit for a study in alignment with regulatory requirements.
Categorization
1. DSCAT is used to distinguish between disposition events, protocol milestones, and other events. The controlled terminology for DSCAT consists of "DISPOSITION EVENT", "PROTOCOL MILESTONE", and "OTHER EVENT".
2. An event with DSCAT = “DISPOSITION EVENT” describes either disposition of study participation or of a product exposure. It describes whether a subject completed study participation or a product exposure and, if not, the reason they did not complete it. Dispositions may be described for each epoch (e.g., screening, initial exposure, washout, cross-over, follow-up) or for the study as a whole. If disposition events for both study participation and product exposure(s) are to be represented, then DSSCAT provides this distinction. For records with DSCAT = "DISPOSITION EVENT",
  1. DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study participation.
  2. DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a single product.
  3. If a study has multiple products, then DSSCAT should name the individual product.
3. DSSCAT may be used when DSCAT = "PROTOCOL MILESTONE" or "OTHER EVENT", but would be subject to additional CDISC Controlled Terminology.
4. An event with DSCAT = “PROTOCOL MILESTONE” is a protocol-specified, point-in-time event. Common protocol milestones include “INFORMED CONSENT OBTAINED” and “RANDOMIZED.” DSSCAT may be used for subcategories of protocol milestones.
5. An event with DSCAT = "OTHER EVENT" is another important event that occurred during a study, but was not driven by protocol requirements and was not captured in another Events or Interventions class dataset.
DS description and coding
1. DSDECOD values are drawn from controlled terminology. The controlled terminology depends on the value of DSCAT.
2. When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if the subject did not complete, specific verbatim information about the reason for non-completion.
  1. When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the Controlled Terminology codelist NCOMPLT.
  2. When DSTERM contains verbatim text, DSDECOD will use the extensible Controlled Terminology codelist NCOMPLT. For example, DSTERM = "Subject moved" might be coded to DSDECOD = "LOST TO FOLLOW-UP".
3. When DSCAT = "PROTOCOL MILESTONE", DSTERM contains the verbatim (as collected) and/or standardized text, DSDECOD will use the extensible Controlled Terminology codelist PROTMLST.
4. When DSCAT = “OTHER EVENT”, DSDECOD uses applicant terminology.
  1. If a reason for the event was collected, the reason for the event is in DSTERM and the DSDECOD is a term from applicant terminology.
  2. If no reason was collected, then DSTERM should be populated with the value in DSDECOD.
Timing variables
1. DSSTDTC is expected and is used for the date/time of the disposition event. Events represented in the DS domain do not have end dates; disposition events do not span an interval, but rather occur at a single date/time (e.g., randomization date, disposition of study participation or product exposure).
2. DSSTDTC documents the date/time that a protocol milestone, disposition event, or other event occurred. For an event with DSCAT = "DISPOSITION EVENT" where DSTERM is not "COMPLETED", the reason for non-completion may be related to an observation reported in another dataset. DSSTDTC is the date/time that the Epoch was completed and is not necessarily the same as the date/time, start date/time, or end date/time of the observation that led to discontinuation.
  For example, a subject reported severe vertigo on June 1, 2006 (AESTDTC). After ruling out other possible causes, the investigator decided to discontinue product exposure on June 6, 2006 (DSSTDTC). The subject reported that the vertigo had resolved on June 8, 2006 (AEENDTC).
3. EPOCH may be included as a timing variable as in other general observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn from the Trial Arms (TA) dataset.
Any identifier variables, timing variables, or Events general observation-class qualifiers may be added to the DS domain, but the following Qualifiers would generally not be used: --PRESP, --OCCUR, --STAT, --REASND, --BODSYS, --LOC, --SEV, --SER, ‑‑ACN, ‑‑ACNOTH, --REL, --RELNST, --PATT, --OUT, --SCAN, --SCONG, --SDISAB, --SDTH, --SHOSP, --SLIFE, --SOD, --SMIE, ‑‑CONTRT, --TOXGR.

Page tree

SDTM Disposition (DS)