Single Site Study Submission Checklist

Quorum defines a single site study as a study where Quorum is not identified by the sponsor as the Central IRB for the study. Instead, Quorum communicates directly with the site only and the site is responsible for submitting all study materials to Quorum. This checklist solicits the necessary protocol information. The Site Submission Checklist solicits information about the site and investigators.
All required forms can be found online at .
Please note: Incomplete submissionswill result in delay of review. Some circumstances may require the submission of other material in addition to the items listed below.
F-036,Single Site Study Questionnaire
Include attachments listed below as applicable
F-019, Device Study Submission Form(for device study submissions)
F-015, Federal Funding Addendum (federally and publicly funded studies, with research in US)
F-042, Waiver of Documentation of Informed ConsentSubmission Form (for studies requesting a waiver of documentation of consent)
F-043, Waiver or Alteration of Informed Consent Submission Form (for studies not regulated by the FDA requesting a waiver or alteration of consent)
F-057, Transfer of Jurisdiction Form – Single Site Level (for studies that are transferring jurisdiction from another IRB). Contact Quorum’s Initial Study Support Team for a copy of this form.
F-179, Expedited Review Request for Initial Review of Research Form (for research requesting review via Quorum’s Expedited Review process)
Study Protocol(version date required on title page)
Proposed Informed Consent Document (Electronic copy)
Investigator’s Brochure, package inserts, or device background literature
Required for all primary and comparative drugs/devices (asapplicable).
Proposed study-specific research participant tools (e.g. diaries, questionnaires)
Please reference the “Participant Study Material” guidance document for more information.
Site submission materials that apply as per G-010 Site Submission Checklist
Additional requirementsfor 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 responsibilities. If you have any questions regarding if your study qualifies as an investigator generated study, please contact Quorum’s Initial Study Support Team.
Indemnification of Quorum by Investigator and/or his/her organization (Quorum has a standard agreement that can be provided upon request)
Written documentation of liability coverage from the Principal Investigator’s insurance company for conducting investigator generated protocols. If the investigator-generated research is submitted with a request for Expedited Review, Quorum does not require proof of insurance. (Note, insurance may be required if the reviewer determines the research should be reviewedby the full Board.)
Please Note:
  • If the PI is located in Canada (with the exception of Quebec), Quorum does not require proof of insurance if the PI is a member of Canadian Medical Protective Association (CMPA), the Canadian Nurses Protective Society (CNPS), or the College of Registered Nurses of British Columbia (CRNBC). For PIs located in Quebec and for those located in Canada that are not members of the referenced groups, proof of insurance is needed.
  • All Investigator Generated Protocols submitted 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. Contact us if you need additional information on timelines.

SUBMISSION INSTRUCTIONS
Protocol Submissions can be made electronically through the OnQ portal or by email to . Hard copy submissions should be sent to Quorum Review, 1501 Fourth Avenue, Suite 800, SeattleWA98101.

Questions? Please contact Initial Study Support

or(206) 448-4082

G-106-005, Single Site Study Submission Checklist, 05Jan2015Page 1 of 2

This form may also be found online at