Clinical Trials

Clinical Trials

Regulation 536/2014 constitutes the basic regulatory framework for clinical trials in the EU. However, Greece has not yet ratified the relevant Protocol of the Oviedo Convention on biomedical research.

The Regulation refers in detail to the rights of persons undergoing clinical research that should be interpreted under the light of the national Code on Medical Ethics (l. 3418/2005). Specific informed consent procedures ensuring best clinical practice, in terms of ethics, including the right to withdrawal, as well as specific provisions on data protection and insurance coverage are major requirements, controlled by a National Ethics Committee on Clinical Trials that grants licensing for clinical trial proposals.

Volunteers’ data protection is also governed by the GDPR which establishes the liability of both the trial sponsor and the investigator usually as the data controller and data processor respectively, supported by a responsible Data Protection Officer, acting also as a contact person for the donors of data.

Our services: With the experience of permanent participation in the National Ethics Committee on Clinical Trials and in the Ethics Panels that review clinical research proposals at the European Commission, we offer services related to:

- Preparation of legally sound information documents and consent forms for the participation in clinical trials of patients and healthy persons, including minors or adults unable to provide consent

- Consultation on regulatory issues, particularly regarding: a) professional liability of medical doctors acting both as attending physicians and investigators, b) medical data processing and protection, c) insurance coverage, d) role arrangement and corresponding rights and obligations in sponsor/CRO/investigator relationships,