Investigator Generated studies for Sites
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Quorum requires all investigators submitting Principal Investigator Generated Studies to submit the following documents:
Required Elements:
- The Protocol
- Consent Form(s) (electronic and in MS Word format)
- Investigator Brochure or Package Insert (for all drugs involved with the study)
- Principal Investigator Generated Study Questionnaire
- Site Information Questionnaire
- Principal Investigator's 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.
- Indemnification of Quorum by Principal 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
Additional Requirements for Canadian Sites only:
- Copy of current Medical License
- Clinical Trial Budget
Additional Elements (as applicable):
- Letters of explanation (as required by the Site Information Questionnaire)
- Compensation schedule attachment (Please see Compensation Template)
- 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
Required
F-039 - Site Information Questionnaire
This form is a required element of an investigator's initial site submission to Quorum Review. This form is also required when the Principal Investigator of a site changes.
F-049 - Principal Investigator Generated Study Questionnaire
This form should be completed and submitted as part of the initial submission for Investigator generated studies.
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-016 - Institutional Jurisdiction Waiver Form
Formal document by which an institution waives local IRB jurisdiction of a particular study to Quorum Review IRB.
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-031 - Conflict of Interest Statement
This form is an attachment to the Site Information Questionnaire, and should be used to report any conflict of interest at a study site and to indicate how it will be managed. This form applies to the principal investigator, all members of the study staff, and the immediate family members (spouse, domestic partner, dependent child, etc.), of the principal investigator and study staff. The Principal Investigator may attest for all individuals on one form.
F-034 - Institutional Authorization Agreement
Formal document by which an institution (typically, one with an FWA) waives local IRB jurisdiction of a particular study to Quorum Review IRB.
F-038 - Additional Facility Site Information Questionnaire
This form is required for all addresses beyond the primary facility research facility where research is conducted and more than minimally invasive procedures are performed.
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.
Supplemental
F-026 - California Experimental Subject's Bill of Rights - English
The Experimental Subject's Bill of Rights is provided by Quorum as a service to California sites. This bill of rights is not required by any other state at this time.
F-027 - California Experimental Subject's Bill of Rights -Spanish
This is the translated Spanish version of the Experimental Subject's Bill of Rights. This document is provided by Quorum as a service to California sites. This bill of rights is not required by any other state at this time.
Guidance
F-025 - Board Meeting Schedule
This schedule provides a complete listing Quorum's meeting dates and submission deadlines for the entire year.
F-032 - CV Template
A blank CV template that may be completed by Investigators. This format is not required by Quorum and is only provided as a helpful tool to sites.
F-033 - CV Sample
A CV example for Investigator's reference.
G-010 - Site Submission Checklist
This guidance document provides a comprehensive listing of the materials that an investigator needs to provide to Quorum in an initial site submission.
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-037 - Site Information Questionnaire Workbook
This document is intended to answer commonly asked questions and should be used as a guidance document for completing Quorum's Site Information Questionnaire.
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-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-106 - Initial Protocol Submission for Single Site Study Checklist
This guidance document provides a comprehensive listing of the materials that a single site needs to provide to Quorum in an initial study submission.
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.