NIH GUIDE, Volume 22, Number 41, November 12, 1993


P.T. 34



  Data Management/Analysis+ 

National Institute of Allergy and Infectious Diseases

The Division of AIDS (DAIDS), National Institute of Allergy and

Infectious Diseases (NIAID), has a requirement for the continuation

of the Terry Beirn Community Programs for Clinical Research on AIDS

(CPCRA) Statistical Center to work in partnership with a series of

CPCRA research units awarded to community-based health organizations.

The objective of this contract is to bring statistical expertise to

the design and analysis of community-based clinical research and

provide central data management of research data, thus contributing

to improving the clinical management of persons with HIV disease.

This Request for Proposals (RFP) represents the recompetition of the

CPCRA Statistical Center, with an October 1994 award date.  Necessary

functions relevant to this activity include: providing leadership

with regard to experimental design, sample size, protocol

feasibility, data analysis, and other statistical issues involving

protocol development, implementation, and analysis; performing

interim and final statistical analyses and being substantially

involved in the writing of scientific papers; conducting

methodological research on the efficient design, conduct, and

analysis of community-based clinical research studies; performing

cross-study analyses to identify new leads regarding prognostic

factors and late treatment effects; designing and implementing a

program to provide training to CPCRA participants with respect to

statistical and data management issues, including protocol-specific

training; serving on relevant CPCRA committees; providing for central

registration of patients and for randomization where appropriate;

identifying information to be included in protocol-specific research

records, developing study forms, and defining the computerized

database; providing for centralized data entry for all research

studies as well as computer processing, storage, and retrieval of

data at a central data management facility using a commercial

(nonproprietary) database management system; designing and

implementing quality assurance procedures to evaluate the validity

and completeness of data collected; and preparing and distributing a

variety of reports, operation manuals, and related material.

To perform the required work, the Contractor must be able to provide:

experience as a statistical and data management center for

multicenter clinical trials research efforts; Ph.D.-level

statisticians with experience and expertise in statistical techniques

required for the analysis of clinical trials; experience in active

collaborations with clinicians in the design, conduct, and analysis

of clinical trials; access to large-capacity computer facility; and

experience in the various activities described above.

This is an announcement for an anticipated RFP.  The issuance of RFP

NIH-NIAID-DAIDS-95-01 will be available on or about November 22,

1993, and proposals will be due by 4:30 p.m., local time, on February

15, 1994.  It is anticipated that one contract will be awarded as a

result of this solicitation.  It is expected that the contract will

have a seven-year period of performance, and a completion cost-

reimbursement type contract is anticipated.


Provide this office with five self-addressed mailing labels.

Telephone inquiries will not be honored, and all inquiries must be in

writing.  A short-form version of the RFP will be provided first,

which includes only the Statement of Work, Reporting Requirements,

and the Evaluation Criteria to be used for selection of the awardees.

After examining this, a full-text version of the RFP must be

requested, in writing, for those offerors interested in responding.

FAX requests are acceptable for full text versions of the RFP only.

All proposals from responsible sources will be considered by the

NIAID.  This advertisement does not commit the Government to award a

contract.  No collect calls will be accepted.

Requests for the RFP are to be directed in writing to:

Ms. Nancy M. Hershey

Contract Management Branch

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3C07

6003 Executive Boulevard

Bethesda, MD  20892

FAX:  (301) 402-0972


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