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  1. Definition:
    1. The Disposition (DS) dataset provides a record of the final disposition of subjects, which can be recorded at any stage throughout a study. At study completion, a record must exist for each subject in the study.
    2. Disposition records are required for carcinogenicity studies to support the creation of the tumor.xpt file.
    3. The DSDECOD values of MISSING, REMOVED FROM STUDY ALIVE, RECOVERY SACRIFICE, and NON-MORIBUND SACRIFICE do not map to the DTHSACST variable of the tumor.xpt (see Appendix C2, Mapping DSDECOD to DTHSACST).
  2. DS Description and coding: DSTERM is not under controlled terminology, but should be mapped to controlled terminology for DSDECOD.
  3. Timing variables:
    1. DSSTDTC is used for the date/time of the disposition event. Disposition events do not have end dates, because these events do not span an interval but occur at a single date/time (e.g., date of terminal sacrifice). The use of an An interval of uncertainty , as described in Section 4.4.2, Date/Time Precision, cannot be used for DSSTDTC.

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