Protocol Review (Secondary)

1. Full board.

Resubmissions, amendments, and continuing review applications requiring full board deliberation will be forwarded to the primary reviewer originally assigned to that study within two days of receipt. The primary reviewers will evaluate the protocol using the Resubmitted Study Protocol Form (FM-URC-028) and present the evaluation to the board during the meeting. The board members will decide on the following actions using majority vote: approve, major modification, minor modification, disapprove.

2. Expedited review.

All protocols for secondary review classified under the expedited category will be evaluated at the level of the Chair. The chair will indicate one of the following actions on the form: approve, major modification, minor modification, disapprove. The Chair must accomplish the evaluation within seven working days of receipt.