The objective of this contract is to provide a Clinical Trials Monitoring Service (CTMS) for Phase I Cancer Therapy Evaluation Program (CTEP), Biological Response Modifier Program (BRMP) investigators and other selected investigators using DCT sponsored investigational agents. This service shall have four components (Tasks): TASK I - To provide a central data management resource to both the Cancer Therapy Evaluation Program (CTEP, DCT), the Biological Response Modifiers Program (BRMP, DCT) and for clinical investigators conducting Phase I and selected Phase II clinical trials. TASK II - To provide an on-site monitoring resource for DCT to assure that Phase I contractors and other clinical investigators conducting Phase I and selected Phase II clinical trials are in compliance with Federal regulations, procedures and to verify submitted data. TASK III - To assure the DCT that Clinical Trials Cooperative Groups and Cancer Center Community Clinical Oncology Program (CCOP) Research Bases with quality assurance programs are actively monitoring their NCI sponsored clinical studies for the quality of clinical data and compliance with federal regulations, policies and procedures for clinical trials. This shall be accomplished by co-site visiting with the Cooperative Group or Cancer Center CCOP Research Base as observers of the audits and the audit process. TASK IV - To assure the DCT that all other investigators or institutions, not covered in Task II or Task III, who are participating in clinical trials using DCT sponsored trials are in compliance with federal regulations, policies and procedures. This shall be accomplished by on- site monitoring of the investigators at least once every three years.
