Comment from Vera Pomerantseva
AnonymousSupportIndividual
Summary: The commenter, who identifies as having industry experience, suggests that the draft guidance should be expanded to include more specific details. They recommend adding examples, governance metrics, escalation procedures, and guidance on variables and levels for capturing protocol deviations.
I would recommend to elaborate on difference between GCP issues and PDs, cases when NIPD may need reclassification. Some examples would be helpful.
Also, I did not see guidance on governance, recommended metrics and escalation. Also, references to the process of assessing some IPD from the perspective of serious breach are important.
Based on my industry experience, sponsors struggle with developing good practices for capturing PDs. Some additional guidance on variables and levels would be helpful. It might even be in the form of Annex.