The current health crisis can make difficult carry out the control of the quality of clinical experimentations in investigation centers. In order to facilitate those controls, the CNIL publishes recommendations which are valid until a month after the health emergency status.
The quality control (or control) consist in verifying the integrity and the accuracy of data shared by investigation center to the promotor (the person or the responsible body of the performance of the research), in order to guarantee the reliability of results. Usually it takes place in the center in which the patient is witnessed and is carried out under the supervision of the investigation team.
Quality control may in particular consist in verifying, by a “clinical researcher” (ARC) on behalf of the sponsor, the source documents (clinical records, laboratory analysis reports, etc.) Compared to the data collected in the notebook of observation by the investigator.
The problems encountered
Due to the constraints of the health situation, clinical research associates (ARC) can no longer, for some trials, go to the investigation centers to access the clinical records of the research participants.
Solutions must therefore be found to provide for remote quality control in certain cases, ensuring the protection of the data of the patients concerned.
CNIL recommendations
The CNIL recommendations are temporary (limited to 1 month after the end of the state of health emergency):
These recommendations shall specify in particular:
- the scope of the clinical trials concerned in accordance with European guidelines drawn up by health agencies;
- CNIL formalities and exceptions
- the information of the persons concerned;
- the general conditions to be observed;
- possible technical solutions and associated safety conditions.
The National Commission for Human Involvement Research (CNRIPH) and the National Agency for the Safety of Medicines and Health Products (ANSM) were also consulted on these recommendations.
SOURCE: AUTORITA’ PER LA PROTEZIONE DEI DATI DELLA FRANCIA – CNIL