Information notice for patients/participants in research studies
You consent to participate to a research study.
As a data controller, SERVIER processes your personal data on the basis of legitimate interest of Servier as a sponsor of the research study and also in order to comply with its legal and regulatory obligations (in particular those related to pharmacovigilance).
Your personal data may be collected and processed by SERVIER for one or more following purposes:
- Management of research studies activities;
- Management of pharmacovigilance activities;
- Management of medical information delivery.
Your personal data processed by SERVIER will only be accessible by a limited list of recipients on a need to know basis or where required by law.
Thus, the main categories of recipients will be SERVIER’s authorized employees and departments acting within their scope of activities including but not limited to:
- Clinical Operations Department;
- Medical Affairs Department;
- Pharmacovigilance Department;
- Research and Biopharmacy Department;
- Methodology and Valorisation of Data Department;
- Information Technology Department where necessary.
SERVIER also uses third party providers and partners (e.g. hosting providers, contractual research organizations, travel agencies, hotels, air carriers etc.) who may also access to your personal data in order to provide their services. Finally, SERVIER shall communicate some of your personal data to the competent authorities such as health authorities.
Your personal data may be transferred to other SERVIER entities, and to third-parties providers and health authority which may be located inside or outside the EEA, including in the countries which do not have the same level of protection of personal data as in the EEA, in particular for hosting and IT support purposes. In such cases, SERVIER ensures that such transfers are carried out in compliance with the applicable data protection laws and regulation. Data transfers to other SERVIER entities are covered by the Group’s Binding Corporate Rules submitted to the CNIL, French Data Protection Authority, for approval in December 2017 whereas transfers to third-party providers outside the EEA are secured through appropriate contractual guarantees such as the EU Commission’s Standard Contractual Clauses or an adherence to the Privacy Shield for transfers to the USA where applicable. You may request and receive copy of such documents.
Your personal data collected by SERVIER are kept in a form which permits your identification for no longer than is necessary for the purposes for which the personal data are processed. More specifically:
- Personal data collected for research studies activities are kept in the information systems of the data controller, participating centre or healthcare professional taking part in the research until the study product is marketed or until the final research report or until 2 years following the publication of the research results. They are then archived in paper or electronic form for a period in accordance with applicable laws and regulations;
- Personal data collected for pharmacovigilance activities are kept for 10 years after the relevant marketing authorisation has ceased to exist, then data are deleted or archived in an anonymised form, unless otherwise provided by mandatory local regulations;
- Personal data collected for medical information management are kept for 3 years after your request.
As a data subject, you have the right at any time to request from SERVIER as far as permitted by applicable laws and regulations, access to and rectification of your personal data. On legitimate grounds, you are also entitled to request a restriction of the processing of your personal data or to object to such processing.
Finally, you are entitled to lodge a complaint with the Data Protection Authority, related to SERVIER’s compliance with the applicable data protection laws and regulation.
Data protection contacts
ROLE | NAME | CONTACT DETAILS | |
---|---|---|---|
Data Protection Contact | to ask questions and exercise your rights | Your research doctor if you participate to a research study. SERVIER Local DPO: protectiondesdonnees@servier.com. if you request medical information | Name, address, e-mail address as mentioned on the documentation provided by SERVIER (ICF, information notice…) |
Data Controller | responsible of the use of your personal data | L’Institut Servier | Name, address, e-mail address as mentioned on the documentation provided by SERVIER (ICF, information notice…) |
Local/National Data Protection Authority | to lodge a complaint | Commission Nationale de l’Informatique et des Libertés (CNIL) | Name, address, e-mail address as mentioned on the documentation provided by SERVIER (ICF, information notice…) |