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:

Procedures for Multi-Center Coordinating Committee Review & SRC/IRB Submission (Effective October 3, 2011)
     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.

Forms:

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 QACT at QACT@partners.org.

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.

Site Qualification Questionnaire effective 7/1/11 for new trials and adding sites to existing protocols
     This document should be used to evaluate a site's ability to meet DF/HCC and protocol requirements.

PI-Initiated Multi-Center Trials Guidance for International Site Inclusion
      Use this form to review the feasibility of conducting a PI-Initiated multi-center protocol at an international site.

Guidance:

Auditing/Monitoring Information Sheet
     This guidance clarifies the difference between auditing and monitoring.

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. 

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:

Communication Log

Coordinating Center Regulatory Binder Instructions

Lead Site AE Tracking

Lead Site SAE Tracking

Participating Institution Regulatory Binder Instructions (not for DF/HCC or DF/PCC sites)

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:  Alyssa Gateman, 617-617-3731 or alyssa_gateman@dfci.harvard.edu