How to respond to a Protocol Deviation in Vault CDMS?
In Vault CDMS, Monitors have the ability to track Protocol Deviations for a Study from within Vault CDMS.
There are two ways to create a Protocol Deviation:
- Manually - Navigate to the Review --> Protocol Deviations tab
- Programmatically - Using a rule
Use the following steps to locate the Protocol Deviation:
- Navigate to Review --> Protocol Deviations, which opens the Protocol Deviations listing.
- To open a Protocol Deviation, click on its Summary.
- Click Edit to allow the changing of fields.
- In the Sponsor Review section, update the Status and Severity fields as appropriate. Updates to the Resolution may also be made here.
- Click Save to keep any changes that are made. Note that all changes made are recorded in the Audit Trail.
Vault Help Documentation: Monitoring Protocol Deviations