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.
Related DF/HCC Policies
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)
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:
BWH Submission and Review Process:
- Contact Yemi Otalabi at otalabi-oates@bwh.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."