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October 26, 2007

To Cancer Center Members:

PI-initiated multi-center trials are a high priority for DF/HCC. As you know, these kinds of trials have special requirements. They also bring added responsibility and risk to the overall PI.

The DF/HCC clinical trials team wants to provide greater guidance to those members who are planning PI-initiated clinical trials. We have developed a package of information, including a template for a Multi-Center Data and Safety Monitoring Plan and information that can be distributed to participating sites. We have also created an internal team that will meet with the PI and study team as soon as the protocol is submitted for SRC and IRB review so that they can provide information, answer questions, and let the SRC know that the information required for PI-initiated multi-center protocols has been provided.

Our goal is to help PIs minimize risk and enhance participant safety.

Brief presentations regarding the procedures for new PI-initiated multi-center trial submissions will be held at upcoming faculty meetings. The purpose of these presentations is to provide you with information specific to the new procedures, to elicit feedback, and to respond to your questions.  We encourage your attendance and input.

These procedural changes are preliminary steps to support multi-center clinical trials. We look forward to sharing with you additional solutions that will support the multi-center clinical trials effort.

In the meantime, should you be planning a PI-initiated multi-center trial, please contact Jane Russell at 617-632-3764 or Michele Copersino at 617-582-8422 for information.

Beverly Ginsburg-Cooper, MBA
Administrator, DF/HCC


Jeffrey Clark, MD
Medical Director, Clinical Trials Operations, DF/HCC

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