COVID-2019:information from the UACR
The World Health Organization declared the pandemic state of coronavirus infection COVID-2019 . Worldwide restrictive measures, including Ukraine, can cause the process of clinical trials significantly and concern the interests of all investigated subjects. The regulatory organs of different countries have already responded to these changes. For example, FDA has published the Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. MHRA has explained its opinion regarding a predicted increase of protocol deviations. The State expert center of the Ukrainian Ministry of Health published its "Recommendations about conduction of clinical trials in the conditions of coronavirus infection spreading". The pandemic is going to be a catalyst for the development of “site-less” clinical trials (virtual, decentralized, digital, hybrid, etc.) in our area. We propose you to get acquainted with the future of virtual clinical trials with materials prepared by the partners of the Ukrainian Association for Clinical Research.
Association of Clinical Research Professionals:
Society for Clinical Research Sites:
Keep Calm, Stay Safe!