Europe – Euro Regulatory Roundup

Pandemic-related remote source data verification for clinical trials should focus on critical data, such as the primary efficacy endpoint and key safety measures, according to updated guidance from the Swiss Agency for Therapeutic Products (Swissmedic).

Early in the pandemic, the European Commission began allowing clinical trials of COVID-19 products and pivotal studies of treatments for serious or life-threatening conditions to use remote source data verification (SDV) to spare monitors of the need to travel.

Under Swissmedic’s update guidance, monitors also can review secondary efficacy data at the same time provided the information is included in the documents shared to support verification of the critical data. The goal is to minimize the burden remote SDV places on site staff.

Swissmedic wants principal investigators to decide whether their sites can give monitors direct, controlled remote access to trial participants’ electronic medical records (EMRs) while preventing them from recording images, or can share coded copies of the source documents. Zoom, Skype and similar tools cannot be used in the video review of medical records…