DF/HCC is committed to supporting investigators interested in conducting investigator-sponsored multi-center trials....

We recognize the need for collaboration with external institutions as well as the unique challenges and risks to study teams conducting these trials. To ensure the feasibility and ultimate success of potential DF/HCC investigator-sponsored multi-center trials, there are additional review and approval requirements in place before a trial may extend collaboration to an external site

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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.
Step by Step Process for Creating or Converting a Multi-Center Trial:
  1. Write the protocol as multi-center (or concert currently approved study to multi-center)

  2. Obtain institutional multi-center approval of the study (reach out to your institutional contact to initiate this process)

  3. Identify potential participating sites and check this link to see if they exist in our systems. If not, request they be added.

  4. If not already listed on the institutional approval form, request the form be updated with specific sites listed on an updated and signed form.

  5. Include institutional approval form in submission to IRB 

  6. Wait for IRB approval of multi-center protocol

  7. Send IRB approved protocol to outside sites for local IRB review (if required) or for central IRB processes to add sites

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."