Central Studies

Central Study

Quorum defines a central study as a study in which the sponsor or sponsor representative has designated Quorum as the central IRB for the study.  Protocol level decisions are made by the sponsor or sponsor representative on behalf of site(s).  For additional information regarding the differences between a central study and single site study, please see our FAQ section.

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 Sites Conducting Research in Canada

  • Copy of current Medical License
  • Clinical Trial Budget

Additional Requirements for Sites Conducting Research in Puerto Rico

  • Copy of current Medical License

Additional Requirements for Sites Conducting Research in a Jurisdiction which Does Not Provide Online License Verfication

  • Copy of current Medical License

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
  • Any e-Consent certificates

Click here to download the Site Submission Checklist.

Need additional information on preparing your site submission to send to Quorum Review?  Download our guidance document to help — Site Submission Simplified.

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