Clinical Research SupportQuality Assurance Office for Clinical Trials (QACT)Multi-Center TrialsDana-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) PM 402 Conducting PI-Initiated Multi-Center Trials Forms: DF/HCC Multi-Center Data and Safety Monitoring Plan (DSMP) Template Multi-Center Coordinating Committee Checklist Site Qualification Questionnaire effective 7/1/11 for new trials and adding sites to existing protocols PI-Initiated Multi-Center Trials Guidance for International Site Inclusion Guidance: Auditing/Monitoring Information Sheet Auditing Plan Guidelines Multi-Center Study Start-Up Tools: DF/HCC Model Consent Language Site Initiation Checklist Information for External Sites Conducting and Managing Multi-Center Projects: Coordinating Center Regulatory Binder Instructions 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
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