Clinical Research Support
Quality Assurance Office for Clinical Trials (QACT)
Multi-Center Trials
Dana-Farber/Harvard Cancer Center is committed to supporting Investigators interested in conducting PI-Initiated Multi-Center studies. Mutli-Center refers to institutions outside the DF/HCC umbrella (i.e. Memorial Sloan Kettering, Johns Hopkins, etc.). We understand the need for collaboration with other institutions to acheive accrual goals and to bring new treatments to fruition in a timely manner. However, PI-Initiated Multi-Center trials do present unique challenges and risks to study teams that are important to identify and address. In light of that, the Multi-Center Coordinating Committee (MCC) was established to assist in the review and development of DF/HCC PI-Initiated Multi-Center Data and Safety and Monitoring Plans (DSMPs) and provide tools to assist study teams in conducting these trials appropriately.
Policy and Procedure:
Procedures for Multi-Center Coordinating Committee Review & SRC/IRB Submission
This document outlines the procedure for obtaining MCC approval for PI-Initiated Multi-Center protocols. The MCC must review and approve all PI-Initiated Multi-Center protocols prior to IRB review.
PM 402 Conducting PI-Initiated Multi-Center Trials
This document is the DF/HCC Standard Operating Procedure for conducting PI-Initiated Multi-Center trials. It defines multi-center terms and outlines the roles and responsibilities of the individuals involved.
DSMP Templates:
DF/HCC Multi-Center Data and Safety Monitoring Plan (DSMP) Template
This template should be used to develop a DSMP that must accompany every DF/HCC PI-Initiated multi-center trial. It contains all of the required sections and boilerplate language that should be used to describe the different entities. This template should be tailored for the specific trial that is being submitted. If you have any questions please contact the CTEO at cteo@dfci.harvard.edu or 617-582-8310.
Multi-Center Coordinating Committee Checklist
This checklist must accompany PI-Initiated Multi-Center submissions to the MCC. It addresses the multi-center trial criteria, regulatory issues, monitoring/auditing and external site communication. This information is needed by the MCC in order to evaluate the plan for the trial and obtain MCC approval.
Multi-Center Study Start-Up Tools:
DF/HCC Model Consent Language
The Lead Site is responsible for reviewing the consent forms of all participating sites. This document should be used as a guide when reviewing participating sites consent forms. It indicates what information must be included in the consent form(s) and identifies sections that can be modified by the participating sites.
Site Initiation Checklist
This checklist can be used to when conducting the Site Initiation Visit (SIV) for participaing sites.
Information for External Sites
These documents are intended for participating sites and outline DF/HCC policies that participating sites need to be aware of.
Conducting and Managing Multi-Center Projects
Participating Site AE Tracking
Participating Site SAE Tracking
Source Documentation Verification
Contacts:
MCC Protocol Intake Coordinator: Jane Hazzard, 617-632-3762 or jane_hazzard@dfci.harvard.edu
MCC Approval Coordinator: Shannon Nelson, 617-582-8310 or shannon_nelson@dfci.harvard.edu
- Clinical Investigations Leadership Committee (CLC)
- Clinical Trials Education Office (CTEO)
- Clinical Research Unit (CRU)
- Protocol Review and Monitoring System (PRMS)
