Central Studies

When Quorum Review IRB is identified as the central IRB for a study, the sponsor must submit the following documents to Quorum Review IRB on behalf of investigators:

• Study protocol
• All proposed consent forms (in electronic Microsoft Word format)
• Investigator’s brochures, package inserts, or device background literature for all primary and comparator drugs/devices
• Central Study Questionnaire
• Proposed study-wide advertisements and recruitment materials
• Proposed study-wide participant study materials (diaries, questionnaires, written study instructions, etc.)
• Device Study Submission form (as applicable)

The following items must be submitted by the investigator (under the central model these can/should be submitted separate from the protocol information listed above):

• Site Information Questionnaire
• Principal investigator's current Curriculum Vitae – A CV template and sample are available. (Effective January 2008, the PI needs to submit a CV only once. We do not need additional copies of the CV for subsequent site submissions.)

Additional Requirements for Canadian Sites only:

• Copy of current Medical License
• Clinical Trial Budget

Depending on the site and study, some supplemental material may be necessary as part of the site submission, such as:

• Letters of explanation (as required by the Site Information Questionnaire)
• Compensation schedule attachment (Please see Compensation Template if sponsor has not provided one)
• Conflict of Interest Statement
• Documentation of any audits from regulatory agencies (FDA, Canada Ministry of Health, etc.) within the past three years
• Institutional Jurisdiction Waiver Form (or an Institutional Authorization Agreement)
• State law documentation
• Advertising and recruitment materials
• Written sponsor approval for advertising and recruitment materials
• Written sponsor approval for unique consent form
• Rationale for requested changes for unique consent form
• Additional Site Information Questionnaire

Required

F-013 - Central Study Questionnaire
When a Sponsor or CRO chooses Quorum as the Central IRB for the study, this form should be completed and submitted as part of the initial protocol submission.

As Indicated

F-015 - Federal Funding Addendum
This form, along with supporting documentation named within this form, is required to be completed and submitted along with the Central Study Questionnaire for any studies which are funded in whole or in part by the federal government of the United States.

F-019 - Device Study Submission Form
Device studies require completion of a Quorum Review Device Study Submission Form at the time of initial study submission to Quorum.

F-020 - Exemption Determination Request
If an applicant would like Quorum Review to make a determination regarding whether research is exempt from review, this form should be submitted. The protocol must also accompany the Exemption Determination Request Form.

F-042 - Waiver of Documentation of Informed Consent Submission Form
This form is required if a Waiver of Documentation of Informed Consent will be necessary.

F-043 - Waiver or Alteration of Informed Consent Submission Form
This form is required if a Waiver or Alteration of Informed Consent will be necessary.

Guidance

F-025 - Board Meeting Schedule
This schedule provides a complete listing Quorum's meeting dates and submission deadlines for the entire year.

G-034 - Consent Form Development Guide
This guide briefly describes Quorum Review's consent form editing process.

G-035 - Consenting Research Participant Guidelines
This document contains some guidelines on consenting research participants, including sections on the informed consent process, the Principal Investigator's signature, Non-English speaking research participants, Illiterate participants, enrollment of minors, revised consent forms, and compliance with HIPAA privacy protections.

G-039 - Consent Form Versioning Guidelines
This guidance document helps customers understand Quorum Review's version management system for consent forms. Quorum issues consent form versions which are whole numbers, pointed or alpha-numeric.

G-041 - Submission Illustration for Central Studies
Illustration that provides a depiction of the initial submission process for Central Studies.

G-043 - Handbook for Quorum Review IRB (Requires an OnQ Portal Account)
The Handbook provides a guide for using Quorum Review IRB as an ethics review board. It contains policies, procedures, and guidelines to be used in preparing materials for Board review, as well as information on managing ongoing research activities, continuing and periodic review, and closing.

G-091 - Central Study Submission Checklist
This guidance document provides a comprehensive listing of the materials that a sponsor/CRO needs to provide to Quorum in an initial study submission.