Swiss guidance document on the conduct of clinical trials and research projects during the COVID-19 pandemic
DUE TO THE END OF THE COVID-19 PANDEMIC, THE Swiss GUIDANCE DOCUMENT AND THE ADDENDUM TO THE PATIENT INFORMATION AND CONSENT FORM ARE NO LONGER IN FORCE. The documents are retained here for informational purposes only.
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.
Addendum to the patient information / consent form of clinical trials during the COVID 19 pandemic: telephone visits and home delivery of the investigational study drug