The current health situation can complicate the quality control of clinical studies in investigation centers. In order to facilitate these controls, the CNIL publishes recommendations in force within of November 15^th 2021.

It has been updated on the September 24^th 2021 after the publication of the Law n. 2021-689 since the May 31 2021 after the end of the health crisis management, edited by the Law n. 2021-1040 on August 5^th 2021.

The quality control (monitoring) consists in the verification of completeness and accuracy of personal data shared by investigation centers to the investor (the person or the organization who is responsible for the realization of a study), in order to guarantee the reliability of the study’s results. Usually, it takes place in the center in which the patient is cured, and it is carried out under the supervision of the investigation team.

The quality control consists in the verification, by a “clinical research associate” (CRA) on behalf of the investor, of starting documents (clinical records, reports of laboratories analysis, etc.) compared with personal data recollected into the observation booklet by the investor.

Issues found

Due to constraints linked to the health situation, clinical research associates (CRAs) can no longer travel to the investigation centres for some trials to access the medical records of research participants.

Solutions must therefore be found to implement remote quality control in certain cases, while guaranteeing the protection of the patients’ data.

CNIL recommendations

The CNIL’s recommendations are temporary (valid until November 15^th  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 for the persons concerned;
• the general conditions to be respected;
• possible technical solutions and associated safety conditions.

The National Commission for Research Involving the Human Person (CNRIPH) and the National Agency for the Safety of Medicines and Health Products (ANSM) were also consulted on these recommendations.

Interim recommendations – remote quality control of clinical trials during the COVID-19 health crisis:

SOURCE: FRENCH DATA PROTECTION AUTHORITY – CNIL