National Institute of Child Health and Human Development, Contracts Management Branch, Executive Building, Suite 7A07, 6100 Executive Blvd. MSC 7510, Bethesda, Maryland 20892

A -- DATA COORDINATION CENTER FOR VACCINE EVALUATION Solicitation No. NICHD-DESPR-95-13. POC: Mya N. Hlaing, Contracting Officer, 301/496-4611. Data Coordination Center for Vaccine Evaluation--Proposals are solicited from all sources to perform as a Data Coordination Center for Vaccine Evaluation. Due to the rarity of many vaccine preventable diseases, studies to evaluate vaccine protection often require access to a large population through multiple clinical centers or to a field site in countries with high incidence of the target diseass. Characteristics of such studies include assembly of subjects; acquisitin of informed consent; collectin of clinical and demographic data; collection, storage, and testing of specimens; assignment and administration of experimental and non-experimental vaccine and control agents; shipment and storage of vaccine and control agents; monitoring of the side effects; disease surveillance; data entry, editing, and archiving; and statistical analysis. In addition, there are stringent U.S. Federal regulatory requirements about researchf design, execution, and documentation that need to be met. Because of the complexity of such studies, it is cruccial to have sufficient expertise to provide day-to-day assistance to clinical investigators to ensure that the protocol is followed properly and uniformly, that the data collected are of highest quality, that data are entered and edited in a timely manner, and that all regulatory requirements are followed. In order to conduct Phase I-3 trials of experimental vaccine in both developed anddeveloping country settings, as well as related epidemiological studies of infectious diseases, NICHD will require the services of a Data Coordination Center (DCC). The DCC will, on a task order basis, support these research projectss in one or more of the following ways: Collaborate on developing protocols and manuals of operations, and produce final versions of these documents; Collaborate on developing data collection instruments, and arrange for printing of final versions of these instruments; Develop systems and conduct computerized data entry, editing, and archiving for all demographic, clinical, and laboratory data; Train and certify study personnel; Manage project logistics, including acquisition and shipment of supplies and equipment, storage and shipment of specimens (including devlopment and maintenance of computerized tracking systems for stored and tested specimens), and arrangement of meetings of investigators; Code tested agents and randomize subjects to the agents; Develop and conduct quality assurance procedures and accompanying documentation to ensure compliance with Federal regulations concerning Investigational New Drugs; and Collaborate on statisitcal analyses of the data. In addition, the DCC is anticipated to provide services in making arrangements for telephone conferences; preparing regular reports and summaries of the progress of the study; and providing regular performance feedback to the participating centers. The RFP will be available on January 13, 1995 and the proposals will be due by 4:00 p.m. (Local Time) February 24, 1995. Those organizations desiring to receive a copy of the above RFP may send their written request to Mya N. Hlaing at the address listed above. (SICC 7379). All requests must cite the RFP number above and include two (2) self-addressed mailing labels. (364)

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