R -- Clinical Trials Monitoring System

THIS IS NOT A REQUEST FOR PROPOSAL. The National Cancer Institute intends to negotiate a modification for additional effort and funds to an existing contract (N02-CM-87020) with Theradex. This contract provides the Cancer Therapy Evaluation Program (CTEP) and other selected investigators participating in the Division of Cancer Treatment and Diagnosis (DCTD) sponsored clinical trials with a Clinical Trials Monitoring Services (CTMS). The contract includes 5 tasks: 1) to provide a central data management resource for DCTD sponsored investigational agent Phase 1 and selected Phase 2 clinical trials, 2) to provide an on-site auditing resource for the DCTD to assure compliance with Federal regulations and to verify submitted data and assure protocol compliance, 3) to provide oversight of quality assurance programs of groups and consortiums through co-site audits, 4) to assure that cancer centers or single institutions conducting DCTD sponsored clinical trials are in compliance with Federal regulations, and 5) to assure that international groups/institutions are in compliance with Good Clinical Practices (GCP) and International Conference on Harmonization standards. The increased use of labor hours for data collection; database maintenance and reporting is running ahead of the planned cumulative level of effort. Some of the factors that have affected the increased level of effort are: an increased proportion of multi-site phase 1 protocols have been assigned to CTMS; there is a greater need for increased scrutiny of patient safety data; there are more frequent ad hoc reporting requests; there are increased programming needs to coordinate CTMS reporting with the CTEP Clinical data Update Summary (CDUS); there are continuing data submission and compliance issues at the NCI Center for Cancer Research; and there are increased programming needs to assure the CTMS database is compatible with the CTEP Enterprise system. The level of effort shall be increased by 38,656 hrs for the period 6/1/02 -4/30/03, to provide for additional support services as outlined above. Authority: 41 U.S.C 253 (c)(1), as set forth in FAR 6.302-1. The RFP for re-competition of this contract will be released in the June-July time frame. See numbered Note 22 which applies. Collect calls will not be accepted.