Sponsors/CROs Initial Submission Investigator Generated Studies: FAQs
Quorum Review IRB accepts Investigator Generated Studies. Generally, in these types of studies, the principal investigator is acting as both the sponsor and the investigator (a “sponsor-investigator” under FDA regulations). This means that the principal investigator initiates and conducts the research. In addition to Quorum’s standard site submission forms, for Investigator Generated studies the Principal Investigator is responsible for submitting all study-level information for review as well.
At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. For Investigator Generated studies there are additional requirements, please contact Initial Study Support for details.
Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), the site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator Brochures). Sites are also expected to promptly submit any Amendments, and consent form revisions.
Are there any extra steps during the submission process for Principal Investigator Generated Studies?
All Investigator Generated Studies submitted to Quorum Review IRB require pre-review by the Quorum Medical and Legal-Regulatory Consultants. During pre-review, the Consultants may request revisions or additional information before the submission can be scheduled for full Board review. This can extend the submission timelines considerably.
It is recommended that you review the Quorum Handbook for information on Board expectations for protocols to be considered for review. This information is available in Appendix A. Also, Quorum has developed a sample consent form which investigators are encouraged to use for guidance in developing consent forms. Quorum also has developed sample genetics consent forms and age appropriate consent forms. These can be provided upon request.
Quorum generally will not review research where a Sponsor-Investigator is also the sole sponsor of the IND, but may make exceptions on a case-by-case basis. For example, the Board may make an exception in instances where there are additional local protections for subjects that would be recruited for this type of research. The most common exception is where the Sponsor-investigators are still under the jurisdiction of an organization that provides the added protection of organizational policies and procedures, including the management of conflicts of interest, reporting of unanticipated problems and serious or continuing non-compliance, and reporting of scientific misconduct. Additionally, an exception may be made for this type of research if there is an Agreement between the organization and Quorum which requires Quorum to report certain events and actions to the organization. Such an agreements is further evidence that the organization has jurisdiction over of the Sponsor-investigator. Any restrictions imposed based on the forgoing however shall not apply to treatment INDs submitted by Principal Investigators.
I developed a protocol and received funding to conduct it from a federal agency. Is the federal agency considered the sponsor of the research?
Yes. You should follow the instructions for the submission of federally-funded research.
Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.
No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.
I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?
Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Quorum’s Site Support Team at (877) 472-9883 or firstname.lastname@example.org if you’d like more information about this process.