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.
Quorum defines a study as a single site when the sponsor or sponsor representative has not designated Quorum as the central IRB for the study; and an investigator has elected to submit the study for review. The investigator is the Quorum contact for all site and protocol related decisions. For additional information regarding the differences between a single site and central study, please see our FAQ section. 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 Site Submission 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.
- 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
- Any e-Consent certificates
Need additional information on preparing your site submission to send to Quorum Review? Download our guidance document to help — Site Submission Simplified.