The Clinical Trial Regulation (CTR) came into effect in January 2022 with a transition period until January 2025. With the implementation of the CTR, the processes for submission, assessment and supervision of clinical trials throughout the EU is harmonised through the Clinical Trial Information System (CTIS). It is now the single entry point for clinical trial data in the European Union. Learn more about its functionalities and how to use it on our CTIS page.
Competent Authority
Submission Fees
Initial submission of Interventional Commercial Study: 3.000€
Amendment of Interventional Commercial Study: 1.500€
Initial submission of Interventional Non-Commercial Study: 1.500€
Amendment of Interventional Non-Commercial Study: 750€
All the above fees are subject to an additional fee of 2,4%
Regarding the submission to the Competent Authority (EOF) the following items may be provided in the English language only on the first day (D0) of each CTIS submission:
- Cover letter
- Protocol (incl. Patient facing documents as part of the protocol)
- Application form.
However, Greek translations will be requested during Validation/Assessment.
Ethics Committee
Submission Fees
Additional Information & Specifics
Study Specific Requirements
Study participants - informed consent
The informed consent of the participant, or of the legal representative of the participant, should be in writing, dated and signed by them. Prior to the signature of the informed consent document, the PI or any member, of the Study Team that has been suggested by the PI, must inform the future participant orally and in simple and understandable language about 1. the nature of the study, its targets, the benefits, the consequences, the possible dangers, 2. the rights of the participant, the guarantees about their protection, their right to refuse to participate and their right to withdraw from the clinical trial, 3. all the conditions under which the trial is taking place. The participant should be in position to make any questions they wish.
FEK Β' 4131/22.12.2016 article 9
Study participants - vulnerable population
FEK Β' 4131/22.12.2016 article 10 (a)
Incapacitated persons must be fully informed about the study and understand all the dangers and benefits of participating. Both incapacitated persons and their legal guardians should sign a written informed consent.
FEK Β' 4131/22.12.2016 article 10 (b)
Studies are allowed only when the husband, partner or the closest ascendant or descendant relative of the patient give their consent.
FEK Β' 4131/22.12.2016 article 12
According to article 33 of Regulation (EU) No 536/2014
No national legal framework
Study participants - compensation & reimbursement
The Sponsor compensates:
-the emergency transportation expenses from and to the sites
-the travel expenses of the participants for the conduct of special medical examinations to medical centers, which are chosen by the Sponsor
-in case of adverse event during the study.
All the above are valid even if they not written in the informed consent, which are signed by the participants, and even if they are not questioned and/or commented by the Competent Authority (EOF) and the Ethics Committe (EED).
Data protection
Hellenic Data Protection Authority
According to the applicable law the sponsor should have implemented document(s), such as a data transfer agreement or other agreement, which ensure that the personal data and the personal data transfer are processed in compliance with the data protection rules. If there is no such agreement, the applicant shall state the reason and may predict for a specific patient consent for the transfer of the data, under the condition that the ICF will include explicit information stating that the protection guarantees of the EU are not applicable in the third country (which must be named). The use of the document “Statement of compliance with Regulation (EU) 2016/679 (GDPR)", which has been uploaded at Eudralex Vol. 10, Chapter 1, is recommended.
Additionally, as per the clinical trial contract template which is regulated in FEK 2015/3-6-2019, the contracted members of the clinical investigation acknowledge the ΕΕ regulation 2016/679 about data protection and all national regulations, which are the national laws 4624/2019 and 3471/2006.
Insurance
300.000€ per participant
FEK Β' 4131/22.12.2016 article 15
The sponsor has to contract insurance for the liability coverage of the sponsor, the PI and the study team members. The coverage sum for all clinical studies taking place in the national territory should cover the possible damages or disabilities, death or permanent incapacity for work which will result from the participation in the clinical study.
Additionally, all expenses for the below cases are covered bythe Sponsor:
- urgent transfers of the participants to the study sites for security reasons
- transfers of the participants for the conduct of special medical examinations which are needed for the study
- all medical examinations in case of adverse events.
National legislations
General Information
1. The National Printing House is the public service for the dissemination of Greek law and all national regulations can be found in the website in digital format.
2. The National Organisation for Medicines (EOF) is a public entity of the Ministry of Health and its objective is to ensure public health and safety. All national regulations about health can be found in the website at the respective sections.
Clinical trials on IMPs in Humans
Radiation & Radiotherapy
ACCORDING TO 536:
The sponsor should include information on exposure to ionising radiation in the protocol in order to allow assessment of the benefits and risks of the clinical trial. Exposure to radiation in clinical trials can be divided into two main situations:
- Radiodiagnostic procedures: the risks and inconveniences for the trial subjects regarding interventions involving radiation exposure should be justified in comparison to the exposure involved in the procedures used in normal clinical practice. Additionally, the following should be clarified in the protocol: maximum effective dose per procedure , number of procedures per trial participant per year, and estimated number of additional radiodiagnostic procedures per trial participant per year compared to normal clinical practice for the same indication.
- Radiotherapeutic procedures: systemic radiation therapies with radiopharmaceuticals. The sponsor should include in the protocol 1. a benefit/risk section and 2. a description of the dosimetric procedures, absorbed doses to tumour lesions and dose limits to risk organs based on the best available evidence.
Biobanking
No national legal framework available on Biobanking.
Definitions
Observational study
FEK Β' 4131/22.12.2016 article 23
The observational studies must meet the following conditions:
-the drug or drugs are prescribed as usual, according to the conditions provided in the marketing authorization
-the inclusion in the specific treatment strategy is not decided a priori by a study protocol, but it is determined by the current medical practice
-the decision to administrate the medicinal product is clearly separated from the decision to enroll the patient in the study
-no additional procedures (diagnostic or follow up) are applied to the patients
-epidemiological methods are applied for the analysis of the collected data
Academic sponsors
The clinical study which is conducted by investigators without the participation of a pharmaceutical company and it has all the following characteristics:
-The sponsor is a university, hospital, public scientific body, non-profit organization, patient organization or individual investigator, who does not act, directly or indirectly, on behalf of any pharmaceutical industry.
-The ownership of data of the research belongs to the Sponsor from the beginning of the trial.
-The planning, the conduct, the collection, the recording of data and the results of the clinical study as well as the communication is under the exclusive responsibility and the control of the sponsor.
-These clinical studies cannot be part of the development program for the issuance of marketing authorization of one pharmaceutical product (original approval, amendment or extension etc).
-Any third party provision or agreement between sponsor/ investigator and third party regarding the investigational medical product administration, the cover of medical examination expenses or any other expenses, do not depend to any kind of exchange, like eg commitment for future assignment of the study results, or license of use or exploitation of the ethical and intellectual property rights
of the sponsor.