By Michelle Sceppa
Good Clinical Practices (GCPs) provide a platform for the quality of the data and a unified standard for the conduct of clinical trials. In a clinical study, all data must be recorded, handled, and stored properly. Confidentiality of subject records must be maintained in accordance with applicable regulatory requirements. Patient rights, safety, and well-being are of primary concern. Foreseeable risks and inconveniences should be weighed against anticipated benefit. Clinical trials should be scientifically sound and clearly described in the study protocol. The clinical trial should be conducted in compliance with the study protocol.
The protection of the rights of subjects and the safety of the subjects is paramount. This can be obtained by thorough oversight by the sponsor, meticulous documentation. Here we review what GCPs require of a clinical study, the regulatory requirements, and the most common issues cited in FDA inspections of clinical trials.