If you need support to conduct a clinical trial in Greece, please contact us at info@sofpromed.com
When it comes to conducting clinical trials, Greece is an attractive destination for researchers and pharmaceutical companies alike.
In this article you will learn about:
With its well-established infrastructure, robust regulatory framework, and a pool of qualified healthcare professionals, Greece offers a conducive environment for running clinical trials.
In this comprehensive guide, we will explore the authorization procedure, good clinical practices, reporting and disclosure requirements, informed consent obligations, insurance requirements, and data protection issues related to conducting clinical trials in Greece.
Authorization Procedure
The authorization procedure for conducting clinical trials in Greece is governed by Ministerial Decision G5a/59676/2016, which implements the EU Clinical Trials Regulation (2014/536).
To start the process, the study sponsor must obtain written approval from the National Ethics Committee (NEC) and the National Organization for Medicines (EOF).
The NEC, along with the competent authority for clinical trials in Greece, reviews the application and completed file within 60 days.
Additionally, the Scientific Boards and Administrations of the relevant hospitals must inform the NEC of any concerns regarding the investigator’s adequacy and the suitability of the hospital facilities within 30 days of the application.
Good Clinical Practices
In Greece, good clinical practices are adopted to ensure the quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects.
Greece actively participates in the Eudract and Eudravigilance databases, which contribute to the safety and transparency of clinical trials.
These practices adhere to the guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP).
Reporting and Disclosure Requirements
In accordance with EU Regulation 536/2014, sponsors are required to notify each member state concerned and any third countries where the clinical trial was conducted through the EU portal within 15 days of its completion.
Furthermore, sponsors must submit a summary of the study’s results to the EU database within one year of the trial’s completion.
This summary should be written in a manner understandable to laypersons.
If there are scientific reasons that prevent the submission of results within one year, the protocol should specify an alternative timeline.
Informed Consent Obligations
In Greece, obtaining informed consent from clinical trial subjects is a critical ethical consideration.
Every subject must provide written consent after receiving an explicit and detailed explanation from the physician in charge.
Even children under the age of 18 and individuals incapable of representing themselves can participate in clinical trials under certain conditions.
A competent healthcare professional ensures that the participant understands the study’s objectives, risks, possible side effects, duration, and conditions.
The subject is also informed about the cost and insurance coverage, and they have the right to withdraw consent at any time.
Insurance Requirements
To conduct a clinical trial in Greece, sponsors must maintain an insurance contract with a reputable EU-registered insurer.
The insurance coverage should adequately address the liability of the sponsor, principal investigator, and research members.
The contract should cover any damage, disability, or death resulting from participation in the clinical trial.
The minimum reparation for death or permanent disability should be at least €200,000 per participant.
Data Protection Issues
When conducting clinical trials, data protection is a crucial consideration.
In Greece, the National Organization for Medicines recognizes anonymized data of study subjects as personal data, requiring authorization from the Data Protection Authority.
However, with the implementation of the General Data Protection Regulation (GDPR) in May 2018, compliance with the Data Protection Authority is no longer mandatory.
Conclusion
Running clinical trials in Greece offers numerous advantages, including a well-defined authorization procedure, adherence to good clinical practices, robust reporting and disclosure requirements, strict informed consent obligations, comprehensive insurance requirements, and an evolving data protection landscape.
With its favorable regulatory environment and experienced healthcare professionals, Greece continues to be an attractive destination for researchers and pharmaceutical companies looking to conduct clinical trials.
By following the guidelines outlined in this comprehensive guide, stakeholders can navigate the process with confidence and ensure the successful execution of their clinical trials in Greece.
If you need support to conduct a clinical trial in Greece, please contact us at info@sofpromed.com
