Summary
This article covers the disposition dataset.
Table of Contents
Mapping
| Form Type Id | Question Id | Instruction | Value | Column Number | Column Title | Data Type | Data Format |
|---|---|---|---|---|---|---|---|
| ds,DS | macro | STUDYID | 0 | STUDYID | String | ||
| const | DS | 1 | DOMAIN | String | |||
| macro | USUBJID | 2 | USUBJID | String | |||
| nextSequenceID | STUDYID,DOMAIN,USUBJID | 3 | DSSEQ | Integer | |||
| 4 | DSGRPID | String | |||||
| 5 | DSREFID | String | |||||
| formUniqueID | 6 | DSSPID | String | ||||
| const $>ensure | Subject signed Informed Consent $>csntdtc != ” | 7 | DSTERM | String | |||
| dsdecod | paramListLookup | ncompltSDTMEx | 8 | DSDECOD | String | ||
| dscat | paramListLookup | dscatSDTM | 9 | DSCAT | String | ||
| dsscat | uppercase | 10 | DSSCAT | String | |||
| epoch | paramListLookup | epochEx | 11 | EPOCH | String | ||
| csntdtc $>&&eventDate $> | rememberQstID $>invAnswerTime $>toISO8601 | eventDate $> | 12 | DSDTC | String | ||
| const $>setVar $>const $>setVar $>toISO8601 | dsstdat $>dateVar $>dssttim $>timeVar $>dateVar,timeVar | 13 | DSSTDTC | String | |||
| dsstdat $> | invAnswerTime $>studyDay | 14 | DSSTDY | Integer |
Summary of Questions
| questionTypeId | Question Text | Data Type | Answer Options / Default Value |
|---|---|---|---|
| dscat | Category for Disposition Event: | String | 1||Protocol Milestone::2||Other Event::3||Disposition Event |
| dsscat | Subcategory for Disposition Event: | String | |
| epoch | Trial Epoch: | String | 1||Phase 1::2||Phase 2 |
| dsterm | Reported Term for the Disposition Event: | String | |
| dsdecod | Standardized Disposition Term: | Integer | 1||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 |
| dsstdat | Date of Completion or Discontinuation (dd-MMM-yyyy): | Date | |
| dssttim | Time of Completion or Discontinuation (HH:mm): | Date | |
| dsunblnd | Was treatment unblinded by the site? | Integer | 1||Yes::2||No |
| dscont | Will the subject continue? | Integer | 1||Yes::2||No |
| dsnext | Next trial epoch or new trial subject will be entering: | String |
paramListLookup Formats
| Name | Value |
|---|---|
| ncompltSDTMEx | 1||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 |
| dscatSDTM | 1||PROTOCOL MILESTONE::2||OTHER EVENT::3||DISPOSITION EVENT |
Downloadable Link
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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