CLINICAL COORDINATING CENTER FOR ETIOLOGY OF SARCOIDOSIS: A CASECONTROL STUDY NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFP AVAILABLE: NHLBI-HR-94-20 P.T. 34 Keywords: Etiology 0765034 Data Management/Analysis+ National Heart, Lung, and Blood Institute The overall objective of this program is to support a six year multi-center case-control study on the potential etiologic factors for sarcoidosis. This program will consist of up to twelve clinical centers which will recruit 840 sarcoidosis patients and 1680 control subjects for study over a four year period. The cases will also be followed to gain information on the natural history of this disease including risk factors for progression of disease. The protocol to be developed during Phase I (12 Months) will include a comprehensive clinical characterization of each participant and determination of markers of immune responsiveness. During Phase II (48 Months) the coordinating center will collect, manage and analyze the data from the clinical centers. In addition, the coordinating center will organize and manage the biological banking system in collaboration with the NHLBI-supported repository. The clinical coordinating center will: (1) assume leadership in areas of statistics and epidemiology for the study; (2) coordinate and manage meetings of the steering committee with direction from NHLBI; (3) participate in steering committee meetings and produce and distribute minutes of these meetings; (4) interact with the clinical centers in preparing the specific study protocol, reporting forms, and the manual of operations; (5) assist the Project Officer in preparing the agendas for periodic meetings of the Policy Board and make presentations at the Policy Board meetings; (6) standardize, print, and distribute reporting forms, the study protocol, and the manual of operations; (7) receive, collect, process, store, provide quality control and analyze data collected from the participating clinical centers; (8) prepare and distribute periodic technical and statistical reports to the participating clinical centers, the project officer, and the contracting officer. During Phase III (12 Months) the coordinating center will collaborate with the other study investigators and project officer in developing and writing manuscripts describing results of the study. Coordinating Center staff will collaborate fully in the development of the study protocol, monitor the clinical centers to ensure that data are reviewed for completeness and that quality control is maintained prior to processing, and conduct proper statistical analysis of the data. Under the direction of the Principal Investigator, these persons will monitor the clinical centers' activities to insure that: (1) data are forwarded in accordance with an established time schedule, (2) data are reviewed for accuracy and completeness, (3) quality control is maintained prior to and during processing of data, and (4) data is analyzed using appropriate statistical tests. This proposed program is a 100 percent set-aside for small business competition. Only responsible small business firms as defined in Part 19 of the Federal Acquisition Regulation are asked to respond to this synopsis. The Standard Industrial Classification (SIC) Code is 7379. This announcement is for a clinical coordinating center only. A separate Request for Proposals (RFP) for the clinical centers will be released. INQUIRIES RFP NHLBI-HR-94-20 is now available and proposals are due on or about November 1, 1994. Copies of the RFP may be obtained by submitting a written request along with three self-addressed mailing labels to: Pamela S. Randall Contracts Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 654 Bethesda, MD 20892 .
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