SOLICITATION NOTICE
R -- Data & Safety Monitoring Board
- Notice Date
- 2/27/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541618
— Other Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, IRP, 9000 Rockville Pike Room 1B59, Bethesda, MD, 20892, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 48NIDAIRP2007
- Response Due
- 3/15/2007
- Archive Date
- 3/30/2007
- Description
- The National Institutes of Health (NIH), National Institute of Drug Abuse (NIDA), Intramural Research Program (IRP), intends to procure the following: The objectives of this contract are the establishment of a Data and Safety Monitoring Board (DSMB) to provide protocol oversight to the National Institute on Drug Abuse, Intramural Clinical Research Program and also provide the clinical program with Clinical Quality Assurance (CQA) site assessments to maintain compliance with international Good Clinical Practices (GCP) standards. These services are being contracted in order to comply with the National Institutes of Health (NIH) POLICY FOR DATA AND SAFETY MONITORING release date: June 10, 1998. This policy states that clinical research protocols require a DSMB when studies are deemed by the local Intuitional Review Board (IRB) to require DSMB review; when protocols generate blinded/randomized data; for multi-center protocols which present more than minimal risk to subjects; for all protocols that use gene transfer or gene therapy methodology. Protocols that may require a DSMB or an individual independent monitor include protocols that pose more than minimal risk to the subjects. In addition, protocols that the sponsoring Institute and Center (IC) believes require special scrutiny because of high public interest or public perception of risk may require DSMB oversight. The DSMB provides for each IC a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials. . North American Industry Classification System (NAICS) code is 541618 and Size Standard is $6.0. This is a Simplified Acquisition with the estimated value of less than $100,000.00 threshold. This acquisition is being procured under Federal Acquisition Regulation (FAR) part13. This notice of intent is a request for competitive proposals. Interested parties are requested to review the requirement and submit a request for quote by March 15, 2007, 3:00.p.m., The statement must also include any prompt payment discount terms, the Dun and Bradstreet number (DUNS), the Taxpayer Identification Number (TIN) and Offer?s business size. The Offeror must also register in the Governments Contractor Registry System, note: www.ccr.gov. To obtain a DUNS NUMBER CALL 800-333-0505. Respond to this announcement, referencing synopsis number 48NIDA-IRP-2007, may be faxed to NIDA/IRP, Bldg. C Room 250, 5500 Nathan Shock Drive, Baltimore, Maryland 21224 Attention: Gloria Mancuso, 410-550-1424, Fax 410-550-3146. Please leave your fax number when calling for a copy of the quote . Fax responses will only be accepted if dated and signed by an authorized company representative. You can also email gmancuso@intra.nida.nih.gov for a copy of the quotation and Statement Of Work.
- Place of Performance
- Address: 5500 Nathan Shock Drive, Baltimore, Maryland
- Zip Code: 21224
- Country: UNITED STATES
- Zip Code: 21224
- Record
- SN01239635-W 20070301/070227220505 (fbodaily.com)
- Source
-
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