Summary
This article covers the deviations dataset.
Table of Contents
Mapping
| Form Type Id | Question Id | Instruction | Value | Column Number | Column Title | Data Type | Data Format |
|---|---|---|---|---|---|---|---|
| dv,DV | macro | STUDYID | 0 | STUDYID | String | ||
| const | DV | 1 | DOMAIN | String | |||
| macro | USUBJID | 2 | USUBJID | String | |||
| nextSequenceID | STUDYID,DOMAIN,USUBJID | 3 | DVSEQ | Integer | |||
| 4 | DVREFID | String | |||||
| dvterm $>&&term | rememberQstId $>questionUniqueID | term $> | 5 | DVSPID | String | ||
| &&term | uppercase | 6 | DVTERM | String | |||
| pdtype | paramListLookup | pdtypeSDTM | 7 | DVDECOD | String | ||
| 8 | DVCAT | String | |||||
| 9 | DVSCAT | String | |||||
| 10 | EPOCH | String | |||||
| const $>setVar $>const $>setVar $>toISO8601 | dvstdat $>dateVar $>dvsttim $>timeVar $>dateVar,timeVar | 11 | DVSTDTC | String | |||
| const $>setVar $>const $>setVar $>toISO8601 | dvendat $>dateVar $>dventim $>timeVar $>dateVar,timeVar | 12 | DVENDTC | String |
Summary of Questions
| questionTypeId | Question Text | Data Type | Answer Options / Default Value |
|---|---|---|---|
| dvyn | Were there any protocol deviations? | Integer | 1||Yes::2||No |
| dvspid | Protocol Deviation Number: | Integer | sequenceNumber |
| dvterm | Protocol Deviation Term: | String | |
| dvdecod | Protocol Deviation Coded Term: | String | SUBJECT NOT WITHDRAWN AS PER PROTOCOL||Subject not withdrawn as per protocol::SELECTION CRITERIA NOT MET||Selection criteria not met::EXCLUDED CONCOMITANT MEDICATION||Excluded concomitant medication::TREATMENT DEVIATION||Treatment deviation |
| dvstdat | Start Date (dd-MMM-yyyy): | Date | |
| dvsttim | Start Time (HH:mm): | Date | |
| dvendat | End Date (dd-MMM-yyyy): | Date | |
| dventim | End Time (HH:mm): | Date |
paramListLookup Formats
| Name | Value |
|---|---|
| pdtypeSDTM | 0||ELIGIBILITY CRITERIA NOT MET::1||EXCLUDED CONCOMITANT MEDICATION::2||DEVIATION RELATED TO TEST ARTICLE APPLICATION::3||DEVIATION RELATED TO THE TEST ARTICLE PREPARATION::4||INTERIM VISIT OUTSIDE OF WINDOW OR NOT PERFORMED::5||SECOND BIOPSY VISIT OUTSIDE OF WINDOW OR NOT PERFORMED::6||EXIT VISIT OUTSIDE OF WINDOW OR NOT PERFORMED::7||OTHER |
Downloadable Link
To download an example Excel File of this export click on the attachment at the bottom of the pag.e
Summary of DV
The DV domain is an Events model for collected protocol deviations and not for derived protocol deviations that are more likely to be part of analysis. Events typically include what the event was, captured in –TERM (the topic variable), and when it happened (captured in its start and/or end dates). The intent of the domain model is to capture protocol deviations that occurred during the course of the study. Usually these are deviations that occur after the subject has been randomized or received the first treatment.
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