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.

When Quorum Review IRB is identified as the central IRB for a study, the sponsor must submit the following documents to Quorum Review IRB on behalf of investigators:

  • Study protocol
  • All proposed consent forms (in electronic Microsoft Word format)
  • Investigator’s brochures, package inserts, or device background literature for all primary and comparator drugs/devices
  • Central Study Questionnaire
  • Proposed study-wide advertisements and recruitment materials
  • Proposed study-wide participant study materials (diaries, questionnaires, written study instructions, etc.)
  • Device Study Submission form (as applicable)

The following items must be submitted by the investigator (under the central model these can/should be submitted separate from the protocol information listed above):

  • Site Information Questionnaire
  • Principal investigator’s current 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:

  • Clinical Trial Budget

Depending on the site and study, some supplemental material may be necessary as part of the site submission, such as:

  • 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
  • Written sponsor approval for unique consent form
  • Rationale for requested changes for unique consent form
  • Additional Site Information Questionnaire
  • Any e-Consent certificates
  • Medical License Requirements – click here
AAHRPP Full Accreditation Badge IASSC Badge HII