ZEG Berlin conducts drug safety studies to understand the risks and benefits of different medicines and medical devices. These studies require the collection of personal, health-related information from study participants. All data are pseudonymized, meaning that your personal data (name, contact details) are stored in a separate database from your health-related data (medical history, surgery, illnesses and pregnancies). Linking the two databases can only be done by a handful of data managers working at ZEG Berlin – maintaining your confidentiality and privacy is extremely important to us.
At study entry your Health Care Professional asked you to sign an informed consent form agreeing to participate in one of our studies. This form allows you to participate in the study and gives us permission to collect your data. You can withdraw your consent at any time – you also have the right to request that your data are removed from our records.
Your informed consent form and contact details are stored in secure facilities with restricted access at a field organization located in your country of residence. Your contact details are only used to reach you in connection with your study participation; they will never be shared with third-parties.
Health-related information is pseudonymized and transferred to ZEG Berlin via a secured exchange server that is located at ZEG Berlin in Berlin, Germany. This information is used to help answer questions about the benefits and risks of a medicine and/or medical device. Please be aware that the data collected includes special categories of personal data, namely information about:
- your age, sex, socio-demographic status
- medical history including surgical and medication history
- detailed case report(s) of study-specific health outcomes including the collection of hospital records, laboratory results and diagnostic reports
From time-to-time ZEG Berlin is legally required to forward pseudonymized information regarding a specific outcome onto government agencies (e.g. the European Medicines Agency). Your pseudonymized data may be forwarded if you report an adverse drug reaction during study participation.
Study data, including informed consent forms, are kept for 15 years after study close. This period may be prolonged to comply with changing legal requirements. You will not be automatically updated on changes to regulations.
As a study participant you have the following rights to your data:
- you may withdraw consent to participate in the study at any time. A withdrawal means that no further data about you will be collected and you will not be contacted by us or any third-parties. ZEG Berlin maintains the right to use data already collected for research (study) purposes.
- you may request deletion of your data. Data deletion requests can only be approved if there is no legal impediment to your data being deleted or your data are no longer required
- you may request to access (review) personal data we have about you
- you may request a copy of your personal information
- you may have your personal information amended, corrected or deleted
- you may object to and restrict the processing of personal information
If you would like to have more information and/or would like to take any other step in relation your data privacy rights, please contact: firstname.lastname@example.org