National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Room 2230, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD 20892-7612

A -- CLINICAL RESEARCH OPERATIONS AND MONITORING CENTER SOL RFP NIH-NIAID-DAIDS-01-15 DUE 101000 POC Donald E. Collie, Contract Specialist Ph: 301-496-0992 Fax: 301-480-5253 WEB: CMB Home Page, http://www.niaid.nih.gov/contract. E-MAIL: Donald E. Collie, dc128b@nih.gov. The Division of Acquired Immunodeficiency Syndrome (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is requesting proposals to establish and maintain a Clinical Research Operations and Monitoring Center. This new contract will support the operational, regulatory, and site-monitoring needs of clinical trials and research funded by DAIDS that are not currently supported by the contract services established for DAIDS funded networks. For the most part, services provided by this contract will be for investigator-initiated clinical research funded as grants or contracts to individual investigators. DAIDS currently sponsors approximately 50 clinical studies through non-network grants and contracts and is responsible ultimately for adequate study conduct and monitoring. The types of studies are broad and varied and include therapeutic, vaccine and non-vaccine prevention clinical trials and epidemiologic, pathogenesis, and behavioral studies. The studies are performed at both domestic and international sites. For the most part, projects that involve the testing of new investigational agents or medical interventions are, or will be performed under an Investigational New Drug (IND) held by the investigator or the grantee's institution. The primary goal of this five-year effort is to ensure that the data produced by DAIDS-funded investigators are of the highest quality and are in compliance with Good Clinical Practice/International Conference on Harmonisation (GCP/ICH) guidelines and Department of Health and Human Services guidelines. In order to meet the goals of this contract, the Contractor's role will be multifaceted. For selected clinical research studies and trials, the Contractor will be asked to: a) provide expert assistance and advice to facilitate protocol development; b) monitor the ability of the site(s) to initiate and conduct studies in accordance with current U.S. and international guidelines on human subjects protection and good clinical practice and laboratory guidelines; c) provide guidance and training to sites for study implementation and conduct; and d) provide administrative and logistical support including establishing a data base that captures essential information about the clinical research planned and conducted by DAIDS non-network grantees. In summary, this multifaceted effort will support and enable DAIDS staff to monitor and provide assistance as necessary to DAIDS funded investigators. The services provided will enhance the capability of domestic and international sites to perform clinical research and will ensure that research of high quality is conducted in full compliance with DAIDS regulatory and ethical standards. It is anticipated that one (1) cost reimbursement, completion type contract will be awarded for a period of five (5) years, beginning approximately June 15, 2001. RFP NIH-NIAID-DAIDS-01-15 will be available electronically on or about May 8, 2000, and may be accessed through the NIAID Contract Management Branch (CMB) Home Page by using the following electronic address: http://www.niaid.nih.gov/contract. All information required for the submission of an offer will be contained in the electronic RFP package. Responses to this RFP will be due on October 10, 2000. Any responsible Offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. Collect calls will not be accepted. Posted 04/25/00 (W-SN448279). (0116)

Loren Data Corp. http://www.ld.com (SYN# 0003 20000427\A-0003.SOL)