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Regulations

In France today, numerous French and European regulations govern clinical research. Their purpose is to define the role and rights of each stakeholder, but also to ensure the protection of their personal data.

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Also, a sponsor cannot access a patient's patronal data. However, the law does oblige him to reimburse the expenses incurred by the latter.

Therefore, how to manage these fees or how to pay compensation to patients?

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As compensation and other travel expenses are not additional hospital costs, they cannot be managed by the study centers themselves due to the use of the Sole agreement in France. The only solution is then to call on a service provider such as TrialPEX to act as intermediary and ensure the anonymity of patients in compliance with the Reference Methodologies (RM) and the GDPR.

Below, you will find the various texts related to the role of subcontractors in the management of reimbursements / compensation.

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French laws

A promoter must reimburse a patient for his costs incurred and can compensate him ... but without accessing his personal data!

The Sole agreement

This mandatory contract in France does not allow the investigative centers to manage patient reimbursements themselves.

Reference methodologies

In France, the Reference Methodologies now govern the personal data that a subcontractor like TrialPEX can access.

GDPR

This European regulation ensures that the personal data of patients participating in clinical research is respected.

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