To assist the Cancer Therapy Evaluation Program (CTEP) in fulfilling its responsibilities to the Food and Drug Administration (FDA) and HHS regulations as an IND sponsor and funding agency. The Clinical Trials Monitoring Service (CTMS) contract is responsible for: 1) providing a centralized patient registration, data management, and monitoring resource for clinical investigators conducting phase 1 and selected phase 2 clinical trials;2) providing an on-site auditing resource to assure that clinical investigators conducting phase 1 and selected phase 2 clinical trials are in compliance with Federal regulations, policies, and procedures;this is accomplished by verifying submitted data and assuring protocol compliance;3) assuring the adherence to CTMB audit guidelines through co-site visits with the Cooperative Groups, the Community Clinical Oncology Program (CCOP), the Cancer Trials Support Unit (CTSU), and other selected multi-institutional consortium;4) assuring the Division of Cancer Treatment and Diagnosis (DCTD) that Cancer Centers or single institutions participating in clinical trials utilizing DCTD sponsored IND agents/funds are in compliance with Federal regulations, policies and procedures;and 5)assuring through administrative and audit support that international groups/institutions collaborating with DCTD are in compliance to Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) standards.

Agency
National Institute of Health (NIH)
Type
Resource and Support Contracts (N02)
Project #
261201000017C-8-0-1
Application #
8659283
Study Section
Project Start
2010-05-01
Project End
2014-04-30
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$3,890,312
Indirect Cost
Name
Theradex Systems, Inc.
Department
Type
DUNS #
061814323
City
Princeton
State
NJ
Country
United States
Zip Code
08540