The objectives of this article are to verify that:

• The rights, safety and well-being of subjects are protected
• That the reported data are reliable and robust
• That the conduct of the CI is in compliance with the requirements of this regulation

Nature of the Monitoring

In order to achieve these objectives, it is the responsibility of the sponsor to determine the extent and nature of the monitoring required to ensure adequate and proper conduct of the CI.

Accurately Reported

In addition, all CI information must be recorded, processed, handled, and stored by the sponsor or investigator in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records and the personal data of the subjects remain protected, in accordance with personal data protection laws.