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

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.

Multi-Center Approval Requirements & Process Complete Multi-Center Sponsor Training

Operations and Guidance

Related DF/HCC Policies

MULTI-100: Conducting DF/HCC Investigator-Sponsored Multi-Center Trials

Forms and Templates

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:

Write the protocol as multi-center (or concert currently approved study to multi-center)
Obtain institutional multi-center approval of the study (follow your institutional process outlined here)
Identify potential participating sites and check this link to see if they exist in our systems. If not, request they be added.
If not already listed on the institutional approval form, request the form be updated with specific sites listed on an updated and signed form.
Include institutional approval form in submission to IRB
Wait for IRB approval of multi-center protocol
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."

Click Here to Complete Training

This training must be completed prior to activation of your new study, or activation of the amendment converting your study to multi-center.
Sponsor-Investigators who are required to complete the training may also be identified at the time of institutional or departmental review and contacted by ODQ to fulfill the requirement.
This training is currently provided by the Office of Data Quality (ODQ) as an online training module: DF/HCC Multi-Center Sponsor Training
A DF/HCC Sponsor-Investigator planning to conduct a DF/HCC Multi-Center Trial for the first time will be required to complete the New Multi-Center Sponsor training as provided by the Office of Data Quality (ODQ) prior to the initiation of research at any external site.
This requirement may be waived at the discretion of the ODQ Director for trials that are deemed minimal risk by the IRB.
Please contact ODQEducation@dfci.harvard.edu with questions about exceptions to the training requirement.
Keep in mind that other DF/HCC training requirements apply, per policy EDU-100.
These include:
- Current Human Subject Protection (HSP) and Good Clinical Practice (GCP) training
- DF/HCC Principal Investigator Training (required for anyone serving as PI on a DF/HCC study)
- DF/HCC IND-Holder Training Requirement (required for any investigator holding an IND)
Review the New Research Staff Checklist and the Education and Training Page for additional information and guidance on completing these requirements.

Provide Feedback/Suggestions to ODQ