Question:
How to create a manual protocol deviation in Vault CDMS?
Answer:
Monitoring users can manually create Protocol Deviations from the Review tab if the study has enabled this feature.
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Navigate to Review tab > Study > Site.
- Choose from the Subject, Event, Form or Item level.
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From the More Actions menu, select Create Protocol Deviation.
- In the Create Protocol Deviation dialog, fill the required fields.
- Click Save.
Related Documentation:
Vault Help Documentation: Monitoring Protocol Deviations