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.

Institutional Multi-Center Review Contacts Complete Multi-Center Sponsor Training

Operations and Guidance

MULTI-OP-1: Review and Approval Process for Investigator-Sponsored Multi-Center Trials
DF/HCC Guidance: Model Consent Language for DF/HCC Multi-Center, Investigator-Sponsored Trials

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.

For more information on each Institutional Review process:

DFCI Submission and Review Process:

Contact the Regulatory Affairs Partner assigned to your Disease Group, or DFCI_clinicaltrials@dfci.harvard.edu
For more information:
- DFCI Clinical Trials Office SOPs: http://dfcionline.org/clinical/clinicalresearch/clinical-trials-office/sops/
- Investigator-Sponsored Studies: http://dfcionline.org/clinical/clinicalresearch/clinical-trials-office/workflows/

MGH* Submission and Review Process:

Contact CCPO_MCGroup@partners.org and lraeke@mgh.harvard.edu
CCPO Information Sheet: Institutional Review Process for Multi-Center Trials (coming soon)
*For MGH trials that are not managed by the CCPO, please contact koretskaia.tatiana@mgh.harvard.edu

BIDMC Submission and Review Process:

Contact BIDMCCCTOQualityManagement@bidmc.harvard.edu

BWH Submission and Review Process:

Contact Yemi Otalabi at otalabi-oates@bwh.harvard.edu

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Multiple key stakeholders and leadership personnel from across the DF/HCC institutions have worked together to evaluate the process for approving DF/HCC Investigator-Sponsored Multi-Center Trials.

They found that a new process was needed in order to:
- Identify potential Investigator-Sponsored Multi-Center Trials earlier in the development process
  - -This will allow investigators more time to resolve significant concerns, and minimize the use of investigator and study team resources on trials that ultimately do not move forward
- Ensure the resource cost and risks of extending a trial to external sites are justified
- -The decision to allocate institutional resources towards the oversight and coordination of Investigator-Sponsored Multi-Center Trials is best made at the institutional level
- Reduce the number of submission forms in order to streamline the approval process
There will no longer be a central DF/HCC Multi-Center Coordinating Committee (MCC) reviewing Investigator-Sponsored Multi-Center Trial submissions.

Sponsor-Investigators will instead follow their home institution's process to obtain multi-center trial approval. Go to the Institutional Review Information tab on this page for more details.

In order to add non-DF/HCC sites to an Investigator-Sponsored trial, OHRS will need to receive a copy of the completed Institutional Approval Form for Multi-Center Trials, as provided by your institution.
Trials and external site that have a current approval from the DF/HCC Multi-Center Coordinating Committee (MCC) do not need to re-submit for institutional review. The MCC Approval form is valid, through it's expiration date (typically one year) to be submitted to OHRS for a new trial, or an add-site amendment.

The cut-off date for new submissions to the DF/HCC MCC was Thursday, August 24, 2017. The MCC will no longer accept submissions for new trials or add-sites.

For new submissions, please go to the "How to Obtain Multi-Center Approval" tab at the top of this page.
Please view the list of institutional multi-center review contacts available here.

Other questions about the changing process can be directed to ODQEducation@dfci.harvard.edu

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

Sponsor-Investigators who are planning to conduct multi-center research for the first time are encouraged to complete this training at any time.

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.

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