What is sponsor acknowledgement?

A sponsor acknowledgement is provided when a sponsor chooses to assume sole responsibility for submitting to Quorum Review IRB study-level safety information and Reportable Events (such as IND Safety Reports, Investigator Brochures, Package Inserts, and Device Manuals). Even if the sponsor assumes this responsibility; however, Quorum Review IRB will generate the acknowledgement letter upon receipt of the initial report without regard to who submitted it.

Quorum Review IRB will generate only one receipt letter per report, even if Quorum Review IRB receives multiple copies of the report. In addition, Quorum Review IRB will generate a standard stamp acknowledgement for each investigator who submits a copy of the report.