Dana-Farber/Harvard Cancer Center is committed to supporting investigators interested in conducting PI-initiated multi-center studies. Multi-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 achieve 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 multi-center Data and Safety Monitoring Plans (DSMPs) and to provide tools to assist study teams in conducting these trials appropriately.

Policy and Procedure:

Multi-Center Coordinating Committee Procedures for Submission of PI-Initiated Multi-Center Protocols to the MCC [updated April 16, 2013]
     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.

MULTI-100 (formerly PM-402) Conducting PI-Initiated Multi-Center Trials [Effective September 17, 2012]
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.

Forms:

DF/HCC Multi-Center Data and Safety Monitoring Plan (DSMP) Template [updated November 30, 2012]
   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 QACT at QACT@partners.org.

Multi-Center Coordinating Committee Checklist [updated September 4, 2012]
     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.

MCC Checklist for International Site Inclusion in PI-Initiated Multi-Center Protocols [updated September 4, 2012]
   Use this form to review the feasibility of conducting a PI-Initiated multi-center protocol at an international site.

Site Selection and Feasibility Questionnaire Instructions [updated April 16, 2013]
The Site Selection & Feasibility Questionnaire (SSFQ) is intended to assess whether prospective Participating Institutions have the ability and the resources to comply with the requirements of participating in a DF/HCC Multi-Center Protocol.

Site Selection and Feasibility Questionnaire [updated April 16, 2013]    
This document should be used to evaluate a site's ability to meet DF/HCC and protocol requirements.

Satellite Feasibility Questionnaire [new April 16, 2013]
This document is intended to be for any prospective sites that will also have research being conducted at a satellite location. A separate Satellite Feasibility Questionnaire should be completed for each satellite site.

Protocol Feasibility Questionnaire [updated April 16, 2013]
The Protocol Feasibility Questionnaire (PFQ) is intended to be used for sites that have previously participated in a Multi-Center Protocol conducted by the same disease group and have previously completed the SSFQ for their site, within the past year.

Guidance:

MCC Information Sheet: Auditing Versus Monitoring
     This guidance clarifies the difference between auditing and monitoring.

MCC Auditing Plan Guidelines
      This document outlines the criteria to be considered when developing an auditing plan for PI-initiated Multi-center protocols.

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 when conducting the Site Initiation Visit (SIV) for participaing sites. 

Conducting and Managing Multi-Center Projects:

Communication Log

Lead Site AE Tracking

Lead Site SAE Tracking

Participating Institution Regulatory Binder Instructions (not for DF/HCC or DF/PCC sites) [updated 4/16/13]

Participating Site AE Tracking

Participating Site SAE Tracking

Source Documentation Verification

Regulatory Documents Tracking Log [updated 4/16/13] 

Contacts:

MCC Regulatory Affairs Specialist: Bryan Peterson, 617-632-6768 or
bryan_peterson@dfci.harvard.edu