CERTIFICATION OF PROCESSES FOR PROCESSING PERSONAL DATA IN CLINICAL TRIALS
Clinical studies conducted in humans aim to find out the effects of drugs, including adverse reactions, to ensure their safety and efficacy. Studies sponsored by companies after preparing appropriate protocols are submitted to relevant authorities and ethics committees for approval.
Study activities are carried out at Hospital Institutions and facilities authorized by law and identified by the Sponsors. All medical/clinical information collected by the investigating physicians can be accessed by the Companies (Sponsors) through their own employees (Clinical Monitors) who, by constantly visiting the center, can also review the medical records of the study subjects.
Sometimes Clinical Monitors are external subjects and may reside outside of the company. As a result, the information of subjects and their related biological samples may have an extremely complex flow where some security holes may open up.
The collection, circulation, and storage of multiple pieces of information pertaining to the health and, in some cases, the sex lives of people involved in clinical trials present various aspects of criticality with reference to the protection of personal data. Therefore, they necessitate the adoption of high precautions aimed at preventing specific risks to data subjects.
The certificate issued by Inveo Certification certifies that the company complies with current regulations regarding the handling of personal data in clinical trials.
Certifications