Management of quality assurance in clinical trials

Good Clinical Practices (GCP) were first established by the FDA and are now actively implemented by different countries. This becomes necessary as multinational large clinical programs are more complex, involving a large diversity of personnel and locations, with different practices of medicine and local regulatory requirements.

The responsibility of an independent Quality Assurance (QA) organization is to oversee the quality and integrity of research activities, and to assure compliance with company's regulatory requirements, and ethical considerations in order to facilitate worldwide registration of new compounds. The goal of a Clinical QA group is to provide continuous assistance to monitoring teams and investigators to ascertain authentic and reliable clinical trials. The Clinical QA programs must be flexible, calling for active communication and good understanding of quality requirements.

Clinical auditing is one of the instruments of Clinical QA. Study audit activities begin with the protocol, encompass all facets of the clinical trial and end with the final study report.

The focus of the presentation is geared towards auditing activities at investigator's site, purpose of which is to ensure that data gathered in the final clinical study report reflects the raw data collected at the source.