What are my options for safety information acknowledgment?
Quorum Review IRB provides sponsors with two types of acknowledgement for Safety Information and Unanticipated Problems:
- Option one – sponsor acknowledgment only: Quorum Review IRB sends the receipt letter to the sponsor only. The sponsor then accepts responsibility for distributing acknowledgments to the sites as necessary.
- Option two – study-wide acknowledgment: Quorum Review IRB distributes receipt letter to each site that is open at the time of receipt. For this service, Quorum Review IRB will charge on a per site basis.
When Quorum Review IRB is reviewing a study on a single-site basis, Quorum Review IRB will always send the Standard acknowledgment as described above. When Quorum Review IRB is acting as a central Ethics Review Board, the sponsor determines the type of acknowledgement investigators will receive for study-wide reports at the time of protocol submission. The sponsor makes this choice on the “Central Study Questionnaire” (CSQ).