Investigator Generated Studies 1

Quorum is an Independent IRB and accepts Investigator Generated Studies. Generally, in these types of research studies, the principal investigator is acting as both the sponsor and the investigator (a “sponsor-investigator” under FDA regulations). This means that the principal investigator initiates and conducts the research. In addition to Quorum’s standard study site submission forms, for Investigator Generated studies the Principal Investigator is responsible for submitting all study-level information for review as well. To guide you through the investigator generation study submission process, Quorum has developed a checklist of required submission elements. Quorum’s submission checklist contains a complete list of additional materials to be provided by the site for a Principal Investigator Generated Study. 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.

Quorum Review IRB requires all investigators submitting Principal Investigator Generated Studies to submit the following documents:

Required Elements:

  • 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
  • Principal Investigator’s curriculum vitae.
  • Indemnification of Quorum by Principal Investigator and/or his/her organization (Quorum has a standard agreement that can be provided upon request)
  • Written documentation of liability coverage from the Principal Investigator’s insurance company for conducting investigator generated protocols

Additional Requirements for Sites Conducting Research in Canada

  • Copy of current Medical License
  • Clinical Trial Budget

Additional Requirements for Study 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

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
  • Recruitment materials and participant study materials
  • Addendum for Federally Funded Studies
  • Waiver of Documentation of Informed Consent
  • Waiver or Alteration of Informed Consent
  • Any e-Consent certificates
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