STUDY COORDINATING AND DATA MANAGEMENT UNIT (CU) FOR A STUDY OF THECLINICAL MANAGEMENT OF LOW GRADE CERVICAL CYTOLOGIC ABNORMALITIES NIH GUIDE, Volume 23, Number 41, November 25, 1994 P.T. Keywords: RFP AVAILABLE: NCI-CN-55041-46 National Cancer Institute The Division of Cancer Prevention and Control, Early Detection Branch is seeking a contractor capable of maintaining an "Atypical Squamous Cells of Undetermined Significance" (ASCUS)/"Low-grade Squamous Intra-epithelial Lesions" (LSIL) Study Coordinating and Data Management Unit for a proposed study of the clinical management of low grade cervical cytologic abnormalities. The proposed Coordinating Unit (CU) will be responsible for four major areas of this clinical Trial: (1) Preparation of the study protocols, data systems and forms, and communication plans in the first year of the Trial; (2) Monitoring and support of enrollment and follow-up activities; (3) Compilation and preparation of data; and (4) Support for the work of the Project Officer and Trial Committees. The Contractor will establish a Study CU to develop and maintain systems and procedures needed for the successful conduct of the Trial. The CU in its coordination efforts will act as a liaison between the four to six (estimated) Clinical Centers, and three Quality Control Groups (HPV Testing, Pathology, and Colposcopy), the Steering Committee and its subcommittees, the Data Monitoring and Ethics Committee, the NCI Project Officer and other collaborating institutions as frequently as daily, either by phone or personal contact. It will plan, schedule, and arrange meetings with study investigators, coordinate the development of final study protocols and data systems, obtain information used to perform and monitor the Trial, collect study data (in confidential and masked fashion when appropriate), and facilitate timely distribution of information to study collaborators, participants, and the community. The protocol development and monitoring phases of the Trial will be unusually complex, because the project combines the organizational difficulties of a multi-center clinical trial with highly technical clinical and laboratory procedures. The CU staff will need to be expert in the following critical areas: (1) molecular epidemiology, specifically the meticulously-organized collection of interview and abstract data, and biospecimens from large groups (greater than 1000) of study individuals; (2) gynecologic terminology and practice related to screening for cervical cancer; (3) clinical trials; and (4) laboratory and repository sciences as related to clinical diagnostics. The tasks of the Coordinating Unit will involve technical and politically sensitive organizational efforts in the clinical work of gynecology and the laboratory world of diagnostics. INQUIRIES The Request for Proposals (RFP) is tentatively scheduled for release on December 1, 1994. One award is anticipated. No collect calls will be accepted. Requests for this solicitation must be reference RFP No. NCI-CN-55041-46 and be submitted in writing to: Mr. Schuyler T. Eldridge Research Contracts Branch National Cancer Institute Executive Plaza South, Room 635 Bethesda, MD 20892 Telephone: (301) 496-8603 .
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