Clinical audit is an important component of ensuring the quality of clinical trials. It makes it possible to assess compliance with Good Clinical Practice (GCP) requirements, the organization of the research team's work, the reliability of trial results, and adherence to ethical principles for protecting the rights, safety, and well-being of trial subjects.
These and other issues were the focus of the seminar held by the Center’s specialists for research teams.
During the training, participants became familiar with the regulatory and legal aspects of conducting a clinical audit, its stages, and the specifics of inspecting the activities of a trial site.
Particular attention was paid to the preparation of clinical trial documentation, work with the investigator site file, ethical aspects of research, and typical findings identified during audits.
The training was conducted by Deputy Director for Registration, Pharmacovigilance and Audit Olena Semenchenko and specialists of the Center's Department for Audit of Clinical and Preclinical Studies and Pharmacovigilance Systems. During the training, they shared practical recommendations that will help participants better prepare for a clinical audit.
Such training is an important component of developing the quality assurance system for clinical trials in Ukraine, enhancing the professional competence of research teams, and harmonizing national practice with international standards.
The knowledge and practical recommendations gained will help participants organize clinical trials more effectively, ensure their quality, and maintain a high level of trust in study results.
