Early Phase Clinical Research Support

University Of Texas Hlth Science Center, San Antonio TX

Investigators

Linked publications & trials

Abstract

The Clinical Protocol and Data Management component of the Cancer Therapy & Research Center (CTRC) includes the Clinical Trials Office (CTO) and Data and Safety Monitoring Committee (DSMC) activities including the Quality Assurance Division (QAD). The CTO provides central management, research support and oversight functions for the conduct of cancer-related clinical trials at the CTRC. CTO services are available to all members of CTRC engaged in clinical research; however some researchers elect to use research staff within their departments working in concert with CTO to provide umbrella oversight. The major functions of the CTRC CTO are to: Facilitate timely activation and administration of clinical trials, including preparations and communications required for scientific, ethical, operations and logistics reviews ? Ensure the research team is adequately trained to support each trial ? Maintain a centralized web-based repository of all protocol specific documents and consents Provide clinical assistance to facilitate the conduct of clinical trials including but not limited to enrollment and verification of patient eligibility, scheduling of appropriate tests, treatments, and assessments ? Provide data management support for clinical trials The QAD is separate from the CTO to minimize conflicts. Working with the DSMC, the functions of the QAD are to: Ensure that all reports, including reports of serious adverse events and unanticipated problems, are submitted in accordance with appropriate guidelines. Ensure protocol compliance with institutional policies and agreements, state and federal regulations, data accuracy and data integrity through a system of monitoring and quality assurance Provide training and education regarding best practices in conducting clinical trials to investigators and staff.