How does the ethical review process work in Croatia and which are the designated ethics committees?
Under the provisions of the Ordinance on Clinical trials and Good Clinical Practice and Ordinance on Clinical Trials of Medicinal Products and Good Clinical Practice, the scope of work of the Central Ethics Committee (CEC) is:
- to issue opinions in the procedure of granting approvals for clinical trials of medicinal products and/or medical devices, including academic clinical trials;
- to issue opinions in the procedure of granting approvals for non-interventional trials;
- to accept non-substantial amendments to previously approved clinical trial protocols;
- to issue opinions in the procedure of granting approvals for substantial amendments to the approved clinical trial protocols; and
- to accept final clinical trial reports.
The Central Ethics Committee is an independent committee of 19 members, healthcare professionals and members of non-medical professions. The chair of the Central Ethics Committee, deputy chair and members are appointed by the minister of health and social welfare.
Administrative support for the activities of the Central Ethics Committee is provided by the Agency for Medicinal Products and Medical Devices.
Submissions are undertaken as follows:
- Online submission through CEC Online database of a new application for obtaining an opinion on acceptability of a clinical trial or a non-interventional trial should be announced approximately a month before the announced deadline for submission of documentation in order to make sure that the trial will be assessed at a wanted meeting. On the basis of submitted data, Agency will send invoice for CEC opinion to the applicant. Confirmation of the payment must be submitted as a part of documentation for clinical trial application.
- The documentation for the opinion on acceptability of a new trial must be submitted in three hard-copies (one copy with the original documents for the CEC archive, and two copies with copies of the documents for the assessors).
- Applicants must in the CEC Online database enter the requested data in order to generate appropriate forms for submission of the application before the announced deadline for submission of documentation. The forms must be signed by the applicant and submitted in hard copy together with the application and required documentation to the Agency. The data entered into the SEP Online database and the data submitted to the Agency in hard copy must be identical.
- The applicants may collect two hard-copies with copies of the documents at Ksaverska 4 within 30 days after the new application has been reviewed. Through CEC online database you will be informed about dates and time when you can collect copies of the documentation. Otherwise, the documentation shall be destroyed.
Any queries or application-related error reports should be sent to the CEC’s professional secretary at: