Central Studies for Sites
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Study Start-Up Process
Welcome to the Quorum study start-up process. We are committed to working with you to make the submission process as straightforward as possible. If Quorum has been identified as the central review board for your study, the sponsor or CRO will submit the protocol, model consent form, and drug/device information on your behalf. You are responsible for submitting only those materials that pertain to the conduct of the study at your research site.
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 for submission
- Site Information Questionnaire
- Principal investigator's current Curriculum Vitae
Additional Requirements for Canadian Sites only
- Copy of current Medical License
- Clinical Trial Budget
Attachments from Site Information Questionnaire, as applicable
- 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
- Tracked, electronic copy for unique consent form
- Written sponsor approval for unique consent form
- Rationale for requested changes for unique consent form
- Additional Site Information Questionnaire
To print a copy of the Submission Checklist, see the forms tab.
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.
As Indicated
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-030 - Compensation Template
This is a compensation attachment to the Site Information Questionnaire that may be used when sites will be compensating varying amounts for each visit.
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.
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 - 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-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.
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.
- "Site Information Questionnaire: Primary Research Facility" form
- Principal investigator’s Curriculum Vitae including clinical research experience with human subjects and education (if applicable,the principal investigator needs to submit a CV to Quorum only once)
- Canada sites only: Hard copy of principal investigator’s Medical License
- "Site Information Questionnaire: Additional Research Facility" form
- Proposed site-specific advertisements and recruitment materials. These materials should be accompanied by written sponsor approval if this is required by the sponsor
- Proposed site-specific participant study materials (diaries, questionnaires, written study instructions, etc.)
- Supplemental material as appropriate based on "Site Information Questionnaire" responses (for example, FDA Audit information, letters of explanation, etc.)
Additional delays are caused when sites fail to completely and accurately respond to all questions on the SIQ. The best way to prevent this error is to address ALL questions and if you feel the question doesn’t pertain to your site write in "N/A" rather than leaving it blank.
To ensure that your submission is complete and able to be processed immediately upon receipt by Quorum, please reference the SIQ workbook on the forms tab. If you have any questions regarding your submission, please contact the Site Support Team.
Throughout the past year, Quorum has been analyzing data we collect on the reasons for held submissions. Our #1 hold reason is compensation issues. To better assist our clients, we have assembled a list of items you should review before sending your submission documents to Quorum. By going through this list, you can save yourself the delay of having us contact you to resolve issues which may arise from your payment plans.
- Did you add up the amount per visit and does it match the total you have listed on the SIQ (or compensation attachment)? Something as simple as making sure the ‘per visit’ amount adds up to the total you provide is a common error that is often overlooked.
- Ask your sponsor if there are any special compensation parameters for this study when they send you your enrollment forms. Some studies have very specific arrangements for payment. Find out before-hand if your study has any of these requirements.
- Feel free to use the Compensation Template available in the forms section of our website. The template provides you with a table format to easily list your visit payments and the combined total for the visits.
- Unless the study specifically states otherwise, please remember that a total for all visits is required for review by Quorum. While you may request that the total not be included in the consent form verbiage (which we typically allow unless the sponsor has locked the model language), we must always know the total possible for a participant to receive – it must be listed on the SIQ or the compensation attachment you provide. If you do not want the total listed on the consent form, and the language is allowed to be modified per the sponsor, please write a note on your SIQ’s compensation section indicating your choice to do so. Again, you must still list the total on the SIQ for your submission to be reviewed.
- If the study you are conducting has a sub-study associated with it or a study that may involve a caregiver consent form, be sure to find out if compensation plans are required for those as well. Contact your sponsor prior to submission to find out if there are special compensation worksheets or attachments that your study will use. This can include – but is not limited to - genetics, biomarker, or Caregiver consent forms. If you are not compensating for these things, please be sure to indicate that as well. Do not assume Quorum will automatically know your plans not to compensate.