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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

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).

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).

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.