Summary

This article covers the disposition dataset.   

Table of Contents


Mapping

Form Type IdQuestion IdInstructionValueColumn NumberColumn TitleData TypeData Format
ds,DS macroSTUDYID0STUDYIDString 
  constDS1DOMAINString 
  macroUSUBJID2USUBJIDString 
  nextSequenceIDSTUDYID,DOMAIN,USUBJID3DSSEQInteger 
    4DSGRPIDString 
    5DSREFIDString 
  formUniqueID 6DSSPIDString 
  const
$>ensure
Subject signed Informed Consent
$>csntdtc != ”
7DSTERMString 
 dsdecodparamListLookupncompltSDTMEx8DSDECODString 
 dscatparamListLookupdscatSDTM9DSCATString 
 dsscatuppercase 10DSSCATString 
 epochparamListLookupepochEx11EPOCHString 
 csntdtc
$>&&eventDate
$>
rememberQstID
$>invAnswerTime
$>toISO8601
eventDate
$>
 
12DSDTCString 
  const
$>setVar
$>const
$>setVar
$>toISO8601
dsstdat
$>dateVar
$>dssttim
$>timeVar
$>dateVar,timeVar
13DSSTDTCString 
 dsstdat
$>
invAnswerTime
$>studyDay
14DSSTDYInteger

Summary of Questions

questionTypeIdQuestion TextData TypeAnswer Options / Default Value
dscatCategory for Disposition Event:String1||Protocol Milestone::2||Other Event::3||Disposition Event
dsscatSubcategory for Disposition Event:String 
epochTrial Epoch:String1||Phase 1::2||Phase 2
dstermReported Term for the Disposition Event:String 
dsdecodStandardized Disposition Term:Integer1||Adverse Event::2||Completed::3||Death::4||Lack of Efficacy::5||Lost to Follow-Up::6||Non-Compliance with Study Drug::88||Other::7||Physician Decision::8||Pregnancy::9||Progressive Disease::10||Protocol Violation::11||Recovery::12||Screen Failure::13||Study Terminated by Sponsor::14||Technical Problems::15||Withdrawal by Subject::16||Informed Consent Obtained::17||Randomized
dsstdatDate of Completion or Discontinuation (dd-MMM-yyyy):Date 
dssttimTime of Completion or Discontinuation (HH:mm):Date 
dsunblndWas treatment unblinded by the site?Integer1||Yes::2||No
dscontWill the subject continue?Integer1||Yes::2||No
dsnextNext trial epoch or new trial subject will be entering:String

paramListLookup Formats

NameValue
ncompltSDTMEx1||ADVERSE EVENT::2||COMPLETED::3||DEATH::4||LACK OF EFFICACY::5||LOST TO FOLLOW-UP::6||NON-COMPLIANCE WITH STUDY DRUG::88||OTHER::7||PHYSICIAN DECISION::8||PREGNANCY::9||PROGRESSIVE DISEASE::10||PROTOCOL VIOLATION::11||RECOVERY::12||SCREEN FAILURE::13||STUDY TERMINATED BY SPONSOR::14||TECHNICAL PROBLEMS::15||WITHDRAWAL BY SUBJECT::16||INFORMED CONSENT OBTAINED::17||RANDOMIZED
dscatSDTM1||PROTOCOL MILESTONE::2||OTHER EVENT::3||DISPOSITION EVENT

To download an example Excel File of this export click on the attachment at the bottom of the page.

Summary of DS

The Disposition 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 post-treatment follow-up. Sponsors may choose which disposition events and milestones to submit for a study.


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