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CTSU Independent Clinical Research Site (CICRS) Initiative

The Cancer Trials Support Unit (CTSU) initiated the CTSU Independent Clinical Research Sites (CICRS) program to open its protocol menu to qualified medical, radiation, and surgical oncologists and hematologists located throughout the USA who are not Cooperative Group members.  This program allows these physicians to offer Phase III treatment trials in their practice setting and facilitates the enrollment of eligible cancer patients who wish to participate.

The CTSU offers a broad menu of Phase III treatment trials for a diversity of diseases including breast, gastrointestinal, genitourinary, gynecologic, head and neck, lung, metastatic, and ovarian cancers, as well as leukemia, lymphoma, and myeloma. Using a World Wide Web-based system, the CTSU provides a wealth of protocol information and patient education materials, in addition to various links and useful resources. Benefits available through CTSU participation include:

  • Entry to streamlined mechanisms for registration and enrollment via the CTSU website that can minimize the administrative burden of clinical trial management

  • Financial reimbursement for each patient enrolled

  • Ability to enroll patients to Phase III National Cancer Institute (NCI)-sponsored clinical trials

  • A CTSU Help Desk (1-888-823-5923) to take calls and track down answers to questions

  • Important and timely e-mail updates on the status of protocols, CTSU activities and training opportunities, information about health insurance coverage resources, and credentialing services

A physician who is interested in becoming a CTSU-credentialed investigator through the CICRS program and who is not a member of a Cooperative Group or NCI's Expanded Participation Project (EPP) should complete an online Interest Form.  This form can be located on the public side of the CTSU website at www.ctsu.org under the Non-Group Investigators tab. Alternatively, a postcard version of the interest form can be obtained by contacting the CTSU Help Desk at: 1-888-823-5923.  Before non-Group-affiliated physicians can enroll patients in CTSU trials, they must meet qualifications similar to those for Cooperative Group members. For example, candidate physician credentials must be verified and practice setting preparedness must be assessed.

Prior research experience is not a requirement for CTSU membership.  However, as part of the membership application process, a CTSU staff member may perform a Site Evaluation Visit.  This visit will determine if requirements for participation with the CTSU are met, and CTSU staff will review enrollment and data collection procedures. The CTSU must ensure that investigators are qualified and have the appropriate staff and facilities to participate in clinical research.

Materials have been developed by the NCI to educate new investigators on clinical research.  These materials are available on the CTSU website.  The CTSU has also provided links to Researcher Resources (Responsible Conduct of Research, Dangerous Goods Shipping Requirements, Human Subjects Protection, NCI’s Clinical Trials Education Series, etc.) to assist researchers with their implementation of clinical trials.

Please visit the CTSU website at www.ctsu.org for more information, or contact the CTSU at 1-888-823-5923 or by email at CTSUContact@westat.com.

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