Clinical trials on medicinal products - Pandemic by SARS-CoV-2

Recommendations Swissmedic / swissethics for the treatment of patients - update


The spread of the new coronavirus (SARS-CoV-2) also poses a major challenge for clinical trials of medicinal products in Switzerland. Swissmedic and swissethics have therefore published a joint document, which describes the most important recommendations for the treatment of patients in clinical trials of medicinal products.

Due to the ongoing pandemic, the chapter on "Monitoring” was revised. "Remote source data verification” of aspects critical for patient safety and data integrity is permitted under certain conditions within the framework of clinical trials with medicinal products in times of the pandemic. Adjustments have also been made to the submission process for reportings / applications due to the current situation. Details related to the amended submission process are outlined in the guidance paper.