This section dives into the basics of clinical research, reviewing what a clinical trial is, which laws govern clinical trial data in the EU, what individual participant data consists of, and how it is managed.
The first fact sheet is focused on clinical trials and provides basic information about clinical research to the public, recognizing that not everyone may have a clear understanding of what a clinical trial is and how it is conducted.
- Next, the EU regulations governing clinical trials are discussed. Familiarity with these regulations is essential for understanding issues related to the RoIPD. In particular, the GDPR is examined, as it currently guarantees the right of access to one’s own data and informed consent within the EU.
- Then, the definition of Individual Participant Data is provided. This is to avoid misunderstandings regarding the meaning of RoIPD, which should not be confused with the reporting of aggregated research results included in the lay summary.
The handling of personal data and the protection of privacy during the research, particularly the concepts of pseudonymization and anonymization, are finally explained in detail.
