Single Site Studies

If the sponsor has not identified a central IRB/REB for your study, you may apply for review as a "single site." In addition to Quorum's standard submission forms, single site investigators are also required to submit the protocol and protocol-level materials. Quorum's submission checklist contains a complete list of additional materials to be provided by a single site investigator.

For single site studies, you will be asked to submit an electronic copy of the proposed consent form. Quorum has developed a sample consent form which investigators are encouraged to use for guidance in developing single site consent forms. Quorum also has developed sample genetics consent forms and age appropriate consent forms. These can be provided upon request.

To guide you through the submission process, Quorum has developed a checklist of required submission elements. To ensure prompt review of your submission, please review the checklist carefully and complete all submission forms according to the instructions provided. All submission forms must be completed thoroughly before they will be submitted to the Board for review.

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)
• Single Site 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.

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
• Additional Site Information Questionnaire
• Protocol Study Tools - Protocol Study Tools are defined as items which are referenced in the Protocol and are provided to subjects soliciting responses, such as questionnaires, diaries, logs etc.
• Recruitment materials and participant study materials. Any developed recruitment materials and participant study materials should be submitted for review with the initial protocol. Materials that are reviewed with the initial protocol submission are reviewed free of charge. Materials submitted at a later date are subject to additional review charges.
• Addendum for Federally Funded Studies
• Waiver of Documentation of Informed Consent
• Waiver or Alteration of Informed Consent
• Quorum Review Device Study Submission Form

Required

F-036 - Single Site Study Questionnaire
When a site chooses to submit to Quorum as a single site (where Quorum is not the central IRB for the study), this form should be completed and submitted as part of the initial submission.

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.

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-033 - CV Sample
A CV example for Investigator's reference.

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.

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.

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 - Client Guide to Consent Form Evaluation (Requires an OnQ Portal Account)
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-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-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.

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.