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IRBNet Topics

You Spoke, We Listened, What We Are Doing

VAIRRS concern

When should the Project Cover Sheet be updated?

VAIRRS solution

The Project Cover Sheet (PCS) Additional Project Personnel section must be consistent with local requirements and must be kept up to date with project amendments. As Electronic Health Record (EHR) access needs change, the PCS Additional Project Personnel section must be updated to ensure continuation of appropriate EHR access. If a study team member change does not require an amendment, the Additional Project Personnel section should still be updated to reflect the study team member change and submitted to your local research administration in IRBNet. PCS updates for study team member changes that do not require an amendment must not include changes to study details (i.e. study characteristics), as additional changes may require an amendment and oversight committee/subcommittee review. You must follow the guidance of the oversight committee and/or subcommittee(s) for reporting changes in personnel that do not require an amendment.

Please note, all study team members should be included in the PCS Additional Project Personnel section and shared on the IRBNet project to ensure training can be tracked in IRBNet.

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