Good Clinical Practice
Good Clinical Practice (GCP) is defined by guidelines and regulations issued by the US Food and Drug Administration (FDA) and the International Conference on Harmonisation (ICH) covering the responsibilities of investigators and sponsors and the protection of research subjects, and providing guidelines that ensure interpretable outcomes of clinical studies.
For more information, see the FDA GCP Web site and the FDA/ICH publication "Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance." The Clinical Trials Office (see just below) offers GCP training for clinical coordinators and investigators.
SOM Clinical Trials Office (CTO). The CTO supports clinical trials in several areas, as described below:
- Support for clinical investigators. For faculty performing sponsored clinical trials, the CTO develops budgets based on current charges for Medical Center services and clinical laboratories. CTO will negotiate a study budget with the prospective sponsor. Once the study is underway, the CTO will work with the study coordinator to invoice the sponsor for services performed and will monitor the trial. The CTO supports investigator-initiated research by helping with submission of Investigational New Drug Applications and other regulatory documentation, and development and submission of protocols and case report forms for the IRB and GCRC.
- Support for clinical research coordinators (CRCs). New CRCs should refer to the CTO Orientation Manual for information on GCP, ethics, submitting protocols at UVA, managing clinical trials, and regulatory matters. The CTO trains, mentors, and provides continuing education for CRCs via a continuing education series, "brown bag" sessions, external audio conferences, and Tips of the Month.
- Monitoring of clinical trials. The CTO offers monitoring services and training for new monitors working with UVA investigators who have assumed the role of sponsor (as defined by the FDA) for a clinical trial.
- Quality assurance. The CTO maintains Standard Operating Procedures for the conduct of clinical trials. In the event that a sponsor or the FDA audits a UVA study, the CTO will assist the investigator and CRCs in preparing files for the audit visit.