Depending on the type of study, the researcher, the sponsor, or in cases where the sponsor is not established in our country, by the contract research organization (CRO) authorized by the sponsor;
- A contract is signed with a researcher who is qualified to conduct the study, capable of taking responsibility for the study, trained in the relevant field, and meets the requirements outlined in the legal regulations.
- First, the clinical research protocol, as well as all documents required for a clinical study (forms, Investigator’s Brochure, etc.), are prepared in accordance with the Good Clinical Practice (GCP) Guidelines and EN ISO 14155 standards, based on the type of study.
- An ethics committee application is submitted.
- For medical device clinical studies, following the ethics committee approval, Ministry approval is obtained.
See: TİTCK Clinical Research Regulations
https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihazda-klinik-arastirmalar
See: TİTCK Ethics Committees List