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Saatja: Katarzyna Stankiewicz <[email protected]> Saaja: RA MSO Teema: [POTENTIAL PHISHING]Re: Vs: patient fee limits in clinical trials Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Merili, Thank you for answer. Best regards, Kasia On 4/16/2025 9:47 AM, RA MSO wrote: Dear Katarzyna, As it remains unclear whether the information requested is related to clinical trials of medicines or clinical investigations of medical devices, please note that I am only able to answer this question in the medical device clinical investigation point of view. In case you are seeking information on medicinal product clinical trial compensations, please contact [email protected] <mailto:[email protected]> There are no regulations regarding patient compensation fee limits in medical device clinical investigations in Estonia. Compensating subjects for costs resulting from participation in the clinical investigation (such as transportation, loss of earnings directly related to the participation in the clinical investigation) are generally appropriate, but the compensation can not be so large as to unduly encourage the subjects to participate or affect the subject’s ability to withdraw prematurely from the clinical investigation. Additionally, the sponsor is obligated to ensure an insurance cover for the compensation for any health damage suffered by a subject resulting from the participation in the investigation and which covers the liability of the sponsor and investigator and which is appropriate to the nature and extent of the risk. All the best, Merili Saar-Abroi on behalf of Department of Medical Devices State Agency of Medicines [email protected] <mailto:[email protected]> 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee <http://www.ravimiamet.ee> Saatja: Katarzyna Stankiewicz <[email protected]> <mailto:[email protected]> Saatmisaeg: teisipäev, 15. aprill 2025 15:43 Adressaat: Merili Saar-Abroi <[email protected]> <mailto:[email protected]> Teema: [POTENTIAL PHISHING]patient fee limits in clinical trials Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Merili, Could you please be so kind and help me with one issue. If there is some legal act/ regulation in your country regarding patient compensation fee limits in clinical trials? Sponsor will reimbursement the costs - travel cost for patients and I need to provide him information if there are some limits regulations in your country. Thank you for support. Best regards, Kasia -- Katarzyna Stankiewicz RA and Start-up Specialist I | Contracting Specialist II Mobile: +48512369646 <tel:+359123456789> Email: [email protected] <mailto:[email protected]%09%09> <https://comac-medical.com/> <https://comac-medical.com/> <https://www.linkedin.com/company/comac-medical/mycompany/> <https://comac-medical.com/events/> Please think before you print. In accordance with the internal company rules, emails sent or received in the evening, at the weekend and during periods of suspension of the contract (holidays, sick leave, etc.) do not call for immediate response. This communication may contain information that is proprietary, confidential, or exempt from disclosure. If you are not the intended recipient, please note that any other dissemination, distribution, use or copying of this communication is strictly prohibited. Anyone who receives this message in error should notify the sender immediately by telephone or by return e-mail and delete it from his or her computer. -- Katarzyna Stankiewicz RA and Start-up Specialist I | Contracting Specialist II Mobile: +48512369646 <tel:+359123456789> <tel:+35928921000> Email: [email protected] <mailto:[email protected]> <https://comac-medical.com/> <https://comac-medical.com/> <https://www.linkedin.com/company/comac-medical/mycompany/> <https://comac-medical.com/events/> Please think before you print. In accordance with the internal company rules, emails sent or received in the evening, at the weekend and during periods of suspension of the contract (holidays, sick leave, etc.) do not call for immediate response. This communication may contain information that is proprietary, confidential, or exempt from disclosure. If you are not the intended recipient, please note that any other dissemination, distribution, use or copying of this communication is strictly prohibited. Anyone who receives this message in error should notify the sender immediately by telephone or by return e-mail and delete it from his or her computer. Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: Katarzyna Stankiewicz, RA MSO Teema: Vs: patient fee limits in clinical trials Dear Katarzyna, As it remains unclear whether the information requested is related to clinical trials of medicines or clinical investigations of medical devices, please note that I am only able to answer this question in the medical device clinical investigation point of view. In case you are seeking information on medicinal product clinical trial compensations, please contact [email protected] <mailto:[email protected]> There are no regulations regarding patient compensation fee limits in medical device clinical investigations in Estonia. Compensating subjects for costs resulting from participation in the clinical investigation (such as transportation, loss of earnings directly related to the participation in the clinical investigation) are generally appropriate, but the compensation can not be so large as to unduly encourage the subjects to participate or affect the subject’s ability to withdraw prematurely from the clinical investigation. Additionally, the sponsor is obligated to ensure an insurance cover for the compensation for any health damage suffered by a subject resulting from the participation in the investigation and which covers the liability of the sponsor and investigator and which is appropriate to the nature and extent of the risk. All the best, Merili Saar-Abroi on behalf of Department of Medical Devices State Agency of Medicines [email protected] <mailto:[email protected]> 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee Saatja: Katarzyna Stankiewicz <[email protected]> Saatmisaeg: teisipäev, 15. aprill 2025 15:43 Adressaat: Merili Saar-Abroi <[email protected]> Teema: [POTENTIAL PHISHING]patient fee limits in clinical trials Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Merili, Could you please be so kind and help me with one issue. If there is some legal act/ regulation in your country regarding patient compensation fee limits in clinical trials? Sponsor will reimbursement the costs - travel cost for patients and I need to provide him information if there are some limits regulations in your country. Thank you for support. Best regards, Kasia -- Katarzyna Stankiewicz RA and Start-up Specialist I | Contracting Specialist II Mobile: +48512369646 <tel:+359123456789> Email: [email protected] <mailto:[email protected]%09%09> <https://comac-medical.com/> <https://comac-medical.com/> <https://www.linkedin.com/company/comac-medical/mycompany/> <https://comac-medical.com/events/> Please think before you print. In accordance with the internal company rules, emails sent or received in the evening, at the weekend and during periods of suspension of the contract (holidays, sick leave, etc.) do not call for immediate response. This communication may contain information that is proprietary, confidential, or exempt from disclosure. If you are not the intended recipient, please note that any other dissemination, distribution, use or copying of this communication is strictly prohibited. Anyone who receives this message in error should notify the sender immediately by telephone or by return e-mail and delete it from his or her computer.