Politique de confidentialité des données pour les participants à une étude clinique

Dear Participant,

A-Mansia would like to thank you once again for participating in the Clinical Study. Participating in a Clinical Study is a brave and selfless decision that benefits public health and medical knowledge.

The conduct of the Clinical Study implies the processing of sensitive data concerning health. To fulfil the requirements of the General Data Protection Regulation (GDPR), you must read our Data Privacy Policy. Because of the specific nature of a Clinical Study, additional information must also be provided by A-Mansia.

A-Mansia is the Sponsor of the Clinical Study and therefore the data controller of your personal data. The subcontractors of A-Mansia for the Clinical Study (Study Doctor, clinical research organization (CRO), clinical sites, etc.) are either joint controllers or data processors.

We do our best efforts to use only joint controllers or processors providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that processing of personal data during the Clinical Study will meet the requirements of GDPR. 

Although A-Mansia is the data controller of your personal data, A-Mansia will only receive anonymized and/or pseudonymised sensitive data from the Study Doctor in the sense that the sensitive data received by A-Mansia can no longer be attributed to you.

Only the Study Doctor can attribute the sensitive data processed during the study to you. The sensitive data we (including our subcontractors) receive from the Study Doctor will be either anonymized or pseudonymised with no possibility for A-Mansia (or its subcontractors) of personal identification.

Your personal data are being processed for the purpose of a Clinical Study fully described (i) in the Protocol approved by the Ethics Committee and (ii) in the Informed Consent Form (ICF) that you have signed. Please do not hesitate to contact the Study Doctor should you need any further information with that regard.  

The processing of your sensitive data during the Clinical Study complies to the following legal bases:

  • With regard to the integrity and security of the Clinical Study:
    • Our legal obligations with the specific condition of public interest (health);
  • With regard to our research activities, either
    • Your (explicit) consent, or
    • The public interest with the specific condition of (i) public interest (health) or (ii) scientific research, or
    • Our legitimate interest with the specific condition of scientific research.

A-Mansia might transfer your anonymized or pseudonymised data to companies and/or authorities outside the European Union. In such a case, the transfer shall be subject to appropriate safeguards to ensure that technical and organisational measures are in place to protect the security and the confidentiality of your personal data. You can obtain a copy such appropriate safeguards by contacting the Study Doctor or our DPO.

Your data will be stored for all the duration of the Scientific Research including the pharmacovigilance period (25 years for the research data and 30 years for the medical record).

According to GDPR, you have a right to access to your data by contacting your Study Doctor. You also have the right to rectify, erase the data and restrict or object to the processing.

But where personal data are processed for Scientific Research purposes (i.e. a Clinical Study), national law may provide for derogations from those rights in so far as such rights are likely to render impossible or seriously impair the achievement of the purpose and such derogations are necessary for the fulfilment of the purpose.

Your participation to the Clinical Study is voluntary and must remain free from any coercion. Even after having signed the ICF prior to participate to the Clinical Study, you have the right to withdraw your explicit consent at any time: the withdrawal shall not affect the lawfulness of processing before the withdrawal.

Shall your personal data be processed for a secondary purpose other than that for which the personal data were initially collected, A-Mansia shall provide the Study Doctor with all the information.

We consider that the Belgian Data Protection Authority (Autorité de Protection des Données (APD) – www.apd-gba.be) shall act as lead supervisory authority for the Clinical Study). You also have the right to contact the supervisory authority of your origin/residence or where the Clinical Study takes place.

Do not hesitate to contact the Study Doctor shall you need any further information with regard to data privacy during the Clinical Study. You can also contact our Data Protection Officer (DPO) who is bound by professional secrecy at gab@hussard.com. Your identity shall not be disclosed to A-Mansia.