Protocol Specific Res. Support

$168,197P30FY2009CANIH

University Of Virginia, Charlottesville VA

Investigators

Linked publications & trials

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Abstract

Funds are requested to partially support two research nurses who will be assigned to work on phase I and pilot/feasibility clinical trials designed and originating from the University of Virginia Cancer Center. The two nurses are employees of the UVa Cancer Center Clinical Trials Office. Their assignment to trials will be under the control of Dr. Weiss, Deputy Director for Clinical Research and Clinical Affairs. Assignment of the research nurses will follow approval of candidate protocols by the Cancer Center Protocol Review Committee and the University IRB. Using institutional funds, the Cancer Center has greatly expanded the CTO staff. Over the past year, over 60% of the patients enrolled on therapeutic trials were on UVa investigator-initiated trials. The Institution will continue to provide over $800,000 per year to support investigator initiated trials and the CCSG funds will augment that support. The Research Nurses supported under this Shared Resource shall: [unreadable] Each be assigned to 2 pilot/feasibility or early phase I clinical trials; [unreadable] Serve as an authoritative resource about assigned protocols to clinicians, patient-subjects, regulatory and oversight committees of the Cancer Center; [unreadable] Assist the investigator/co-investigator in assessing the eligibility of a patient-subject for protocol entry; [unreadable] Schedule clinical diagnostic studies for determination of patient-subject eligibility or for follow-up diagnostic studies for enrolled subjects; [unreadable] Counsel potential patient subjects about consent issues, study compliance, management of toxicities, and other protocol-related matters, by telephone or personal contact in clinic; [unreadable] Schedule initial and follow-up clinical evaluations for patient-subjects while entered on clinical trials; [unreadable] Assist the clinical investigator in managing and reporting protocol-related adverse events.

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