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NIH GUIDE, Volume 23, Number 35, October 7, 1994


P.T. 34




  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.


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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