Guidance on how to manage the conduct of clinical trials in the context of the COVID19 pandemic
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) released a guidance report on how to manage the conduct of clinical trials in the context of the COVID19 pandemic. This document is particularly relevant to ‘official’ clinical trials. However, this document is relevant also for all projects, including TechCare, where researchers interact or meet real persons (research participants, or end users or stakeholders). This document, as mentioned on the first page, is only a guiding document. Therefore, it is important to note that, while it might provide guidance, in some cases, national law may complement these guidelines or in others, take priority over it.
Taking these two caveats into account, we hope that sharing this document might nevertheless be helpful.