MODIFICATION
R -- Cancer Trials Support Unit (CTSU)
- Notice Date
- 1/10/2006
- Notice Type
- Modification
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-67001-48
- Response Due
- 2/23/2006
- Archive Date
- 3/10/2006
- Point of Contact
- John Manouelian, Contract Specialist, Phone (301) 435-3813, Fax (301) 402-6699, - Richard Hartmann, Contracting Officer, Phone (301) 496-8620, Fax (301) 402-6699,
- E-Mail Address
-
jm486p@nih.gov, rh75f@nih.gov
- Description
- The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute?s (NCI?s) Division of Cancer Treatment and Diagnosis (DCTD) has a continuing requirement for a Cancer Trials Support Unit (CTSU). Beginning in September 1999, the NCI created via contract the CTSU; the intent was to facilitate access by investigators to a broader menu of clinical trials led by Cooperative Groups or other investigators and to centralize and make more efficient a number of administrative tasks common to all the Cooperative Group Operations and Statistical/Data Management Centers. The CTSU has, in fact, facilitated the conduct of trials by allowing a participating physician to perform registration and data management of patients on the trials of all Groups irrespective of the Group in which he/she is a member. To further facilitate these cross-Group enrollments, the CTSU developed auditing, financial payment, and education/training systems that complement and interdigitate with the existing Cooperative Group systems. In addition to Group members, the CTSU has also provided a mechanism for unaffiliated sites to participate in trials on the CTSU menu. The CTSU systems are primarily web-based (www.ctsu.org) and there is a public and private website. Only registered investigators have access to the private site where they can access materials and tools for enrolling patients on clinical trials. Presently the CTSU menu of over 60 trials consists primarily of phase 3 treatment trials in breast, lung, gastrointestinal, genitourinary, head and neck, hematologic and other less common tumors. In addition, a more limited menu of phase 2 multi-center treatment trials is also available. Investigators who are members of a Cooperative Group automatically have access to all CTSU trials, and some sites unaffiliated with Groups, have also been granted access, after undergoing a credentialing and review process conducted by the CTSU. The purpose of this acquisition is to build upon the progress made over the last 6 years and expand the CTSU?s primary tasks, which include: 1) Operation of the CTSU comprehensive system for clinical trials management with state-of-the-art, web-based, registration, randomization and data collection/query systems; 2) Operation of the CTSU Regulatory Support System (RSS) to consolidate IRB approvals along with site and investigator credentialing for all Adult Group trials, phases 1-3; 3) Operation of the CTSU web site for accessing protocols, forms, and education/training materials; 4) Conduct education and training (generic and study-specific) for the CTSU systems and its menu of protocols; 5) Operation of the CTSU quality assurance system, including on-site auditing and real-time monitoring of data collection delinquencies and errors; 6) Operation of the CTSU financial management system for distribution of per case payments, leadership funds, investigator travel and technical expertise reimbursements; and 7) Operation of the CICRS (Clinical Independent Cancer Research Sites) program to permit unaffiliated sites to join the CTSU. This is a recompetition of a previous requirement and the Government anticipates that one (1) contract will be awarded on an incrementally funded basis for a base period of three years with the opportunity for the contractor to earn up to four additional contract years (Award Terms). RFP No. N02-CM-67001-48 will be issued on or about January 10, 2006. The RFP will be available at the website of the Office of Acquisitions (OA), NCI, at the following url: http://rcb.cancer.gov/rcb-internet/ . The NAICS Code is 541690. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. No Collect Calls will be accepted.
- Place of Performance
- Address: To Be Negotiated
- Record
- SN00963782-W 20060112/060110211747 (fbodaily.com)
- Source
-
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