Question:

How to respond to a Protocol Deviation in Vault CDMS?

Answer:

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:

1. Navigate to Review --> Protocol Deviations, which opens the Protocol Deviations listing.
   
   
   
   
2. To open a Protocol Deviation, click on its Summary.
   
   
   
   
3. Click Edit to allow the changing of fields.
4. In the Sponsor Review section, update the Status and Severity fields as appropriate. Updates to the Resolution may also be made here.
   
   
   
   
5. Click Save to keep any changes that are made. Note that all changes made are recorded in the Audit Trail.

Related Documentation:

Vault Help Documentation: Monitoring Protocol Deviations