What happens to my data in a trial
Pseudonymization, consent, right of access – data protection in clinical trials explained.
In a clinical trial a lot of data is collected about you: findings, laboratory values, information about side effects. Who sees this data and what happens to it is strictly regulated.
Pseudonymization
Your data is stored under a code number, not under your name. Only the trial site can link the code number to you. The sponsor, authorities and analysts work exclusively with the pseudonymized data.
Consent
Data processing is part of your informed consent. It states which data is collected, who receives it and how long it is kept – in drug trials usually for at least 25 years.
Your rights
You have the right to access the data stored about you and to have it corrected. Your contact is the trial site; the contact details of the data protection officer are in the patient information.
This information is not a substitute for a conversation with your doctor.