Are there any extra steps during the submission process for Principal Investigator Generated Studies?

The assessment of whether a study is investigator generated is based on a consideration of factors including: the author of the protocol, who initiated the research, and who assumes regulatory sponsor responsibilities. All investigator generated studies will require pre-payment and be pre-reviewed by a Board member to determine if the protocol is ready for Board review. Additionally, Investigator generated studies must be submitted using Quorum’s consent form template located on the OnQ Portal.