The Center supports increasing the number of studies conducted in compliance with the principles of Good Clinical Practice – GCP. On this subject, another online seminar was held for medicinal product investigators and representatives of local ethics committees involved in conducting clinical trials in Ukraine.
The international GSP standard covers all processes of clinical study of a medicinal product, defines reporting and documentation requirements, and confirms its quality and its scientific and ethical soundness.
The seminar discussed, in particular:
- regulatory and legal framework for conducting clinical trials in Ukraine, taking into account ICH GCP requirements;
- organizing the activities of ethics committees at healthcare institutions where clinical trials of medicinal products are conducted;
- the procedure for obtaining informed consent from the subject;
- preparation of documents accompanying a clinical trial;
- duties of the sponsor and investigator of a clinical trial;
- conducting a clinical audit of a clinical trial.
Presentations and clarifications were given by specialists and experts of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials, the Division for Coordination of Local Ethics Committees, and the Department for Audit of Laboratory and Clinical Practices (GLP, GCP) of the Center.
In addition to the main aspects of organizing and overseeing clinical trials, current issues of conducting clinical trials under martial law were also considered.
About fifty participants joined the event.
As the organizer of the training, the Agency for Methodological and Scientific-Practical Work of the Center provides participants with the relevant certificates and also takes feedback into account. We urge those who took part to fill in the questionnaires received – this will allow us to improve the content and quality of future seminars.
Please note that enrollment of a group of listeners for the next seminar on this topic is already underway. Details and the application form at the link: https://www.dec.gov.ua/materials/navchalni-seminari-zaplanovani-decz/
