Investigator-Sponsored Multi-Center Trials

Investigator-Sponsored Multi-Center Trials require additional review and approval prior to conducting research at sites external to DF/HCC.

The information on this page reflects the new process for the review and conduct of DF/HCC Investigator-Sponsored Multi-Center Trials, effective August, 2017. Please carefully review the updated SOP MULTI-100 as well as the updated guidance and resources below.

Institutional Review and Additional Requirements

Institutional approval must be obtained prior to any new Investigator-Sponsored Multi-Center Trial, or add-site submission to OHRS. The specific review requirements may vary by institution, but this requirement includes all:

  • New Investigator-Sponsored Multi-Center Trials (prior to IRB review)
  • IRB-approved Investigator-Sponsored trials converting to Multi-Center
  • Revisions to the existing Investigator-Sponsored Multi-Center Trial approval (e.g., adding sites)

A completed Institutional Approval Form is required to prior to adding external sites to a DF/HCC Investigator-Sponsored trial.

For more information on each Institutional Review process:

DFCI Submission and Review Process:

MGH* Submission and Review Process:

BIDMC Submission and Review Process:

BWH Submission and Review Process:

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Per MULTI-100, "A DF/HCC Sponsor-Investigator planning to conduct a Multi-Center Trial for the first time will be required to complete appropriate training as designated by the Office of Data Quality (ODQ) prior to the initiation of research at an External Site."