Central Study Submission Checklist
PROTOCOL SUBMISSION REQUIREMENTSThe following documentation is required for all Central Study Submissions: All required forms can be found online at
Please note: Incomplete submissionswillnot be scheduled for review. Some circumstances may require the submission of other material in addition to the items listed below.
Central 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-055, Transfer of Jurisdiction Form – Protocol 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)
F-201, Electronic Informed Consent Questionnaire (for studies using an electronic informed consent tool other than Q Consent)
Study Protocol (version date required on title page)
Proposed Informed Consent Document (electronic copy, MS Word format)
Upon review and approval of the protocol, you will be contacted within 1 business day with any Board-requested modifications to the model consent(s) and will be given the opportunity to either accept the changes as presented or make additional modifications. On receipt of your final approval of the model consent (s) the process of approval document generation can begin. To facilitate the creation of effective and legal consent forms, Quorum offers a number of consent form templates containing language and formats preferred by Quorum’s Board. In addition, Quorum can negotiate specific ‘locked-in’ language for use as standard content in a customer’s consent forms. Please see Quorum’s Guide to Consent Form Development for more information.
Investigator’s Brochures, package inserts, or device background literature Required for all primary and comparative drugs/devices (where applicable)
Proposed study-specific research participant tools (e.g. diaries, questionnaires)
Please reference the “Recruitment and Participant Study Material” guidance document for more information.
Proposed participant recruitment material (e.g. newspaper ads, flyers)
Please reference the “Recruitment and Participant Study Material” guidance document for more information.
INVESTIGATOR SUBMISSION REQUIREMENTS
Investigator submission forms and guidelines can be found at .
Investigator submissions missing required elements may experience delays in routing and scheduling for Board review.
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, Seattle WA 98101.
Questions? Please contact us at or(206) 448-4082
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