Ethics committee supervision is a vital part of all clinical trials. It acts to ensure that research is carried out in compliance with the international recommendations including the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice (ICH GCP), Directive 2001/20/EC of the European Parliament and Council and WHO recommendations etc. No clinical trial may be carried out with the prior approval of an ethics committee. In addition, ethics committees provide regular monitoring of clinical trials to ensure that trial conduct is adhering to national and international moral, ethical and legal standards.
For example, in Ukraine, the framework for the activity of ethics committees is as follows: there are two types of committees- the CEC of Ministry of Health of Ukraine (national level) and local ethics committees at healthcare institutions.
Ethics committees comprise specialists from various fields of medicine, as well as from other areas, and members of the public who monitor compliance with the rights and safety of research participants.
Evaluation and approval of clinical trials in Ukraine is carried out by the CEC of the Ministry of Health. Monitoring of the protection of moral, ethical and legal principles during trials is carried out by local committees under the guidance of CEC.
This system helps ensure the safety, well-being, and protection of rights of trial participants throughout the entire clinical research process. It also makes sure that the conduct of trials adheres to international and national principals and requirements.
COREX Logistics is proud to support clinical research in Eastern Europe and CIS region though its comprehensive clinical trial supply and logistics services.
#COREXLogistics #clinicaltrials #logistics #clinicalsupply
COREX Logistics is a supply and logistics company with headquarters in Ireland, working with pharma and patients to facilitate improved healthcare worldwide.
Our expert international team works across an 80-country network, specialising in the EMEA region, providing the latest in clinical trial logistics technology and systems, cold-chain delivery, temperature-controlled transportation and storage services. From sourcing, procurement and customs clearance, to labelling, returns and destruction, we cover every link in the supply chain. We also run an established Named Patient Programme and provide Patient-Oriented services. With extensive knowledge and on-the-ground insight into our markets, we create innovative solutions with the ultimate goal of improving the lives of patients.
To learn more about our range of expert services, contact us today on email@example.com
If you found this article helpful, consider sharing it with others who might also benefit from it. Sharing knowledge is a wonderful thing to do and can be very helpful to others.
We’re here to help.
Email us at firstname.lastname@example.org or use our feedback form to send us your question.