Observational & Minimal Risk Registries

If the study is observational registry qualified, principal investigators should submit a modified version of the Site Information Questionnaire (F-101), which is shorter than the standard site questionnaire and has been specifically tailored to ask questions pertinent to observational registry studies. Additionally, for observational registry sites there are no requirements for sites to submit CVs along with their Observational Registry SIQ.

If a Principal Investigator is unsure if their study is classified by Quorum as an Observational Registry study, they should contact either their Sponsor or Quorum’s Site Support Team for more information. Quorum’s Site Support Team can be reached at SiteSupport@QuorumReview.com or by calling 877-472-9883 and selecting option 1.

Depending on the site and study, the following supplemental materials may still be required.

  • 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)
  • 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
  • Any e-Consent certificates
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