Protocol Deviation
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Protocol Deviations
The intent of the domain is to capture protocol violations and deviations during the course of the study and will store only those criteria violation by or deviated from by the subject and not a response to each violation or deviation.
| Variables | Data Type | Question | Code List | Validation |
|---|---|---|---|---|
| dvyn | radio | Were there any protocol deviations? | ny | |
| dvdecod | dropdown | What was the protocol deviation? | dvterm | autocomplete |
| dvterm | text | What was the protocol deviation term? | ||
| epoch | dropdown | What was the Epoch? | epoch | autocomplete |
| dvstdat | text | What was the protocol deviation start date | date_dmy | |
| dvsttim | text | What was the protocol deviation start time? | time | |
| dvendat | text | What was the protocol deviation end date? | date_dmy | |
| dventim | text | What was the protocol deviation end time? | time | |
| dvspid | text | What is the protocol deviation ID? |