National Cancer Institute, Research Contracts Branch, PCCS, Executive Plaza South, Room 635, Bethesda, Md 20892

R -- CANCER CHEMOPREVENTION CLINICAL TRIALS MONITORING/COORDINATION SUPPORT SOL N02-CN-75009-39 POC Theresa H. Shroff, Contracting Officer, 301-496-8603 E-MAIL: Theresa H. Shroff, shrofft@rcb.nci.nih.gov. RFP ANNOUNCEMENT. The proposed contract is a 100% set-aside for small business concerns. For the purpose of this procurement a small business is classified as small if its average annual receipts for its preceding three (3) fiscal years do not exceed $5 million. The Standard Industrial Code (SIC) applicable to this procurement is 8742. It is anticipated that one cost-reimbursement, level of effort contract will be awarded for five (5) years. The purpose of this procurement is to provide support for activities which include monitoring study conduct, auditing generated data and integrating results of the clinical studies that the Chemoprevention Branch Clinical Research Program of the Division of Cancer Prevention and Control (DCPC) oversees. The Chemoprevention Branch, DCPC, currently oversees more than 80 Phase I, II and III clinical trials of potential chemopreventive agents. Specifically, the work involves 1) protocol finalization/coordination for approximately 10-15 new protocols per year, preparation of preliminary reviews of draft final protocols, Informed Consent and Case Report Forms, biostatistics and data management for compliance with Good Clinical Practices and regulatory requirements; 2) off-site data auditing and cumulative data review for 80 studies, checking for such factors as adverse events and analytical difficulties/successes; 3) on-site clinical monitoring including maintaining Standard Operating Procedures for monitoring chemoprevention clinical trials, preparing study documentation, training study personnel and managing adverse event reporting by maintaining a 24 hour phone/fax line to receive reports; 4) off-site clinical monitoring and trial coordinating; and 5) final data and quality assurance audits. The RFP will be available on or about April 2, 1997. Requests should be submitted to Theresa H. Shroff, Contracting Officer, Research Contracts Branch, National Cancer Institute, Executive Plaza South, Room 635, Bethesda, Maryland 20892-7226. Phone: (301) 496-8603. Fax number: (301) 402-8579. Electronic mail address: shrofft@rcb.nci.nih.gov. No collect calls will be accepted. (0076)

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