Coronavirus: impact on the conduct of clinical trials
The coronavirus outbreak affects the conduct of clinical trials under the Medical Research involving Subjects Act (WMO) and also trial participants. The rights, safety and wellbeing of trial participants should prevail.
Note: If needed, the information given below may be adjusted. Please check our website and the information given by other parties (see hyperlinks below) regularly for updates.
In order to mitigate the negative impact on the conduct of clinical trials and trial participants during the coronavirus outbreak, a European Guidance has been developed. This Guidance is applicable in all member states of the European Union and countries in the European Economic Area.
Additionally, the Central Committee on Research involving Human Subjects (CCMO) formulated several recommendations on her website.
The IGJ emphasises that national legislation (like the WMO and Medicines Act) sometimes prevails over the European Guidance. The IGJ formulated recommendations (see below) on several relevant topics.
The IGJ expects that investigators and sponsors take duly notice of the above mentioned European Guidance. Any deviation in procedures related to the clinical trial due to the corona crisis needs to be documented adequately. A proportionate approach will be followed by the GCP inspectors when such deviations are reviewed during inspections.