NIH GUIDE, Volume 23, Number 41, November 25, 1994




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.


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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