Sponsors/CROs

How To Submit 2017-09-19T12:43:24+00:00
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How to Submit

CGIRB accepts study and site submissions via our online portal, MyConnexus. To register for an account with MyConnexus, or to login, click here.

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FORMS

To locate the appropriate forms for your submission, visit our forms page. If you use the MyConnexus portal, our step-by-step wizard will walk you through each form that is required for your submission. Similarly, we have outlined a list of information and forms that should be included in the submission packet to CGIRB, but recommend that you check with your sponsor contact to determine what is needed from their end to submit.

Please note: a review cannot be performed prior to the receipt of all appropriate information.

For Protocol Submissions

  • Submission Letter for CGIRB Review
  • Study Protocol (final version)
  • Proposed Subject Information and Consent Form and Authorization to Use and Disclose Personal Health Information for Research Template (must be in Microsoft Word format on CD or submitted electronically)
  • Clinical Investigator’s Brochure (CIB) or Package Insert
  • Proposed advertisement/recruitment material
  • Study Application Form
  • CGIRB Indemnification Agreement signed by sponsor

For New Investigator Submissions

  • Initial Review Submission Form completed for the primary research site that is listed in section three on the 1572
  • Any supporting documents needed to provide information for answers provided on the Initial Review Submission Form
  • Current curriculum vitae (CV) of PI – CVs must verify affiliation to at least one study site and must be current within 2 years
  • Sub-investigator CVs are not generally required, but if provided must be current within 2 years. If the PI is not an MD and the study requires an MD, one of the sub-investigators must be an MD.
  • Current professional license of PI – If PI is licensed in Massachusetts, a copy of the research license must also be included (Controlled Substance License)
  • Proposed site-specific advertisement/recruitment material and site-specific requirements for the subject information and consent form (including any state and/or local requirements that are stricter than the Federal requirements)
  • Any additional study-related documentation to be provided to the subject (eg, diaries)

What to Expect

When you work with CGIRB, you can expect:

  • A single point of contact for the duration of your study
  • Timely and prompt turnaround; we hold ourselves to a 24-48 hour guarantee for all expedited reviews
  • Courteous and attentive staff that communicate updates frequently
  • Experienced staff knowledgeable in reviewing all phases, types, and therapeutic areas of research