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Clinical Research Support

Quality Assurance Office for Clinical Trials (QACT)

Multi-Center Trials

Dana-Farber/Harvard Cancer Center (DF/HCC) is committed to supporting investigators interested in conducting PI-initiated multi-center studies. Multi-center refers to the inclusion of institutions outside of the DF/HCC umbrella in a DF/HCC investigator trial (i.e. Memorial Sloan-Kettering Cancer Center, MD Anderson Cancer Center, etc.).  DF/HCC recognizes the need for collaboration with other institutions to achieve accrual goals and to develop new treatments 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 study specific 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 July 8, 2014]
This document outlines the procedure for obtaining MCC approval for PI-Initiated Multi-Center protocols.  The MCC must review all PI-Initiated Multi-Center protocols prior to IRB review.

MULTI-100 (formerly 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 [updated July 8, 2014]
This template should be used to develop a DSMP that must accompany every DF/HCC PI-Initiated multi-center trial. This template should be tailored for the specific trial that is being submitted.  If you have any questions please direct your questions to the attention of the MCC Regulatory Affairs Specialist.

Multi-Center Coordinating Committee Checklist [updated July 8, 2014]
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.  

MCC Checklist for International Site Inclusion in PI-Initiated Multi-Center Protocols [updated July 8, 2014]
This form must be submitted to the MCC in addition to the MCC Checklist for any PI-Initiated multi-center protocol that will include an international site.

Multi-Center Coordinating Committee Checklist for NCI/CTEP Sponsored Multi-Center Protocols
This form should be completed by the DF/HCC Protocol Chair or designee for any NCI/CTEP Sponsored Multi-Center protocol under the Experimental Therapeutics Clinical Trials Network (ET-CTN), where a DF/HCC Investigator is serving as the Protocol Chair. This form is not applicable for any cooperative group studies. (Multi-Center Coordinating Committee Guidance: MCC Process for Multi-Center CTEP Studies where a DF/HCC Investigator is Protocol Chair)

Site Selection and Feasibility Questionnaire Instructions [updated July 8, 2014]
The Site Selection & Feasibility Questionnaire (SSFQ) is intended to assess whether prospective external sites 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 July 8, 2014]    
This document should be used to evaluate a site's ability to meet DF/HCC and protocol requirements.

Satellite Feasibility Questionnaire [updated July 8, 2014]
This document is intended 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 July 8, 2014]
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 two years.

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 DF/HCC Sponsor or designee is responsible for reviewing the consent forms of all participating sites.  This document should be used as a guide when reviewing a participating site's consent form.  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 participating sites. 

Contact:

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