Investigator-Sponsored Multi-Center Trials

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."