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The DS domain provides an accounting for all subjects who entered the study. It includes disposition events and protocol milestones (e.g., informed consent obtained, randomized). Sponsors may choose which disposition events and milestones/other events to submit for a study.

This includes disposition events that describe a subject's completion status or reason for discontinuation of the entire study or a phase or segment of the study, including screening and post-treatment follow-up. The codelist used for DSDECOD is specific to this situation. (NCOMPLT) is used when DSCAT = "DISPOSTION EVENT".This is an example CRF used to collect the protocol milestone informed consent. 

Example CRF:  Protocol milestones (e.g., informed consent) 

Xformpusher
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target ValueSDTMIG Target MappingControlled Terminology Code List NameCRF Implementation NotesPermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
DSCAT1What was the category of the disposition?Disposition CategoryIf collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.TextDSCATDSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED"(DSCAT)Refer to the SDTMIG for guidelines for assigning DSCAT, DSTERM, and DSDECOD for events considered protocol milestones.
PROTOCOL MILESTONEprompt
Yes
DSSTDAT2What was the informed consent date?Informed Consent DateRecord the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY).DateDSSTDTC




qtext

DSSTTIM3What was the informed consent time?Informed Consent TimeRecord the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions.TimeDSSTDTC




qtext


This is an example CRF used to collect a Disposition Event.  In this study, subjects were randomized to a trial, which contain three phases. A screening phase, a "treatment phase", where subjects were required to use the tobacco product as described in the protocol, and a follow-up phase. A dispostion CRF was collected at the end of each phase of the trial.      

Example CRF :Study Participation Disposition Event

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