Remote quality control of clinical trials during the health crisis (CNIL)

December 20, 2021

Studies that will start in France as of 1/1/2022 cannot do remote source verification without CNIL authorization. Remote source data verification authorization by CNIL can only be granted provided specific organizational and technical measures are in place.

Earlier this month, the CNIL published interim recommendations for the quality control of clinical trials during the health crisis. However, studies that will start in France as of 1/1/2022 cannot do remote source verification without CNIL authorization!

Quality control, or monitoring, consists of verifying the completeness and accuracy of the data transmitted by the investigation centers to the sponsor in order to ensure the reliability of the study results.

Remote source data verification authorization by CNIL can only be granted provided specific organizational and technical measures are in place (see recommendations below) – conditions are quite strict (Ibid., p.4-7).

What are these recommendations?  

The CNIL recommendations are temporary (valid until December 31, 2021). These recommendations specify in particular :

• the scope of the clinical trials concerned in accordance with the European guidelines drawn up by the health agencies;
• CNIL formalities and exemptions;
• information to be provided to the persons concerned;
• the general conditions to be respected;
• possible technical solutions and associated security conditions.

What about trials that have already started?

If the trial has already started in France and has been subject to remote verification of the source data, the data controllers can maintain these modalities of implementation beyond December 31, 2021 without filing an application for authorization with the CNIL. The first French patient should be enrolled before the end of this year. (This is on page 3 of the recommendations).

What to do now?

If you are concerned by clinical trials that should start in France in 2022, do not hesitate to contact your DPM/DPO/DPL at MyData-Trust to get acquainted with the conditions based on the recommendations of the CNIL.