Guidance on the Management of Clinical Trial during the COVID-19 (Coronavirus) pandemic

Due to the corona crisis the source data verification for the majority of the clinical trials conducted is severely hampered. Since the pandemic is still ongoing and going back to ‘normal’ cannot be foreseen on short notice, the categories of clinical trials that might be subject to remote source data verification have been slightly broadened. This document is restricted to clinical trials under the Medical Research Involving Human Subjects Act (WMO).

The European Guidance, the advices and requirements of the CCMO and the revised document published by the IGJ (see above) remain in full force for the duration of the COVID-19 pandemic and/or until further notice. Please refer to the IGJ document mentioned above for links to all relevant documents and information.