Biomedical research : information for professionals
LFB BIOTECHNOLOGIES (hereinafter LFB) acts as a sponsor and data controller. As the data controller, LFB will process your personal data. The data we will collect consist of your identification data and your contact details (name, surname, mail and email address, telephone number) and the necessary information concerning your experience/training or any other information concerning your career and, if applicable, history of access and connections to the medical data of persons taking part in research (audit trail) and any financial information, including the amount of indemnities, remuneration and benefits that you could receive when participating in a study sponsored by LFB.
Your personal data will be processed to
- assess your interest in the project (feasibility on the research)
- verify your ability to direct and monitor research as an investigator or as a team member,
- (set up and conduct the study and
- meet our legal obligation regarding transparency of personal interests.
The legal basis for the processing of your personal data is two-fold:
- Respect of legal obligations connected with:
- evaluation of your skills as investigator in accordance with Good Clinical Practices.
- the local regulation, LFB will be required to process transparency data nominatively if required by local regulation or aggregated
- Our legitimate interests: We will process your personal data in order to assess your interest, to set up and conduct the study in compliance with applicable regulations.
We inform you that we need your data in order to comply with our legal obligations. If you do not provide your data, we will not be able to collaborate with you as part of this study.
The legitimate interests of LFB are balanced against your interests, freedom and fundamental rights requiring protection of your personal data. The interests of LFB may not prevail over yours.
Recipients and storage of the personal data:
The following organisations and companies, which may be located outside of the European Union and according to the research / project], may have confidential access to your personal data:
- LFB (as the sponsor), including LFB’s internal auditors, the scientific research officer and their colleagues and its staff in the group having an interest in having access to it and external consultants
- The contract research organisation (CRO) and the other data processors involved.
- The ethics committees or other authorized committees to examine and approve this study / project.
- Health authorities.
- The qualified staff acting under the responsibility of the insurance company covering the civil liability of the sponsor.
- The people involved in the study (such as CRAs) and people acting under their responsibility.
- The people responsible for regulatory affairs and registration of the study with the competent authorities who act on behalf of the data controller or are employed by the companies in the LFB group.
Retention period of the data:
Your collected data will be kept for at most 15 years after the last study / project in which you participated and will then be archived for 10 or 25 years in order to comply with regulations on biomedical research. The sponsor will keep the documents and data concerning such research for a period of 25 years (for research not relating to a medicinal product derived from blood) or 40 years (for research relating to a medicinal product derived from blood) after the end of the biomedical research or its early termination.
Transfer of data outside of the European Union:
Depending on the study / project and for the purposes described above, your personal data may be transferred to the following countries outside of the European Union. As the data controller, LFB guarantees that the transfer(s) of your data are properly supervised. For example, in the event of data transfer to a third country, our relations with importer of your data may be subject to Standard Contractual Clauses approved by the European Commission.
Exercise of your rights:
Within the limits and conditions of applicable regulations, you have a right to access, correct, delete, limit and oppose the processing.
To exercise your rights or for any questions, you can contact our Data Protection Officer by sending an email to Privacy@lfb.fr or by sending a letter to the following postal address: LFB BIOMEDICAMENTS, Data Protection Officer, Department of Legal Affairs and Conformity, ZA de Courtabœuf, 3 avenue des Tropiques, 91940 LES ULIS, FRANCE.
We also ask that you notify us of any request by a patient to exercise his/her rights, by sending an email to Privacy@lfb.fr within 24-hour business hours following receipt of the request.
If you believe after having contacted LFB that your rights are not respected or that the processing of personal data does not comply with data protection rules, you can submit a complaint your supervisory authority in charge personal data protection (e.g. the CNIL in France).
Version: February 2022