-
-
- R&D Unit
- Industrial Vaccine Production Unit
- Vaccine and Immunization Training Unit
- Vaccine Epidemiology Unit
- Preclinical and Clinical Research and Project Coordination Unit
- Epidemiology of Pandemic-Risk Infectious Agents Unit
- Bioterrorism Unit
- Laboratory Animal Production/Testing and Preclinical Research Unit
- Tissue Culture Collection, Viral and Bacterial Culture Banking Unit
- Quality Control Laboratory Unit
- Training, Administrative, and Financial Services Unit
-
-
-
- Announcements
- Key Dates
- FAQ
- Contact
Insurance
In accordance with the Guideline on Insurance Coverage to be Provided in Clinical Trials issued by the Turkish Medicines and Medical Devices Agency, insurance coverage must be provided by the sponsor of the research to protect volunteers/patients participating in clinical trials against any harm that may arise from the research. However, some clinical trials are excluded from the scope of insurance because there is no risk to the volunteer or the risk is at an acceptable level. The clinical trials included in or excluded from the scope of insurance are specified below:
A) All observational studies are excluded from the scope of insurance.
B) In Phase I, Phase II, and Phase III drug clinical trials, bioavailability and bioequivalence (BA/BE) studies, and comparability studies for biosimilar products, the insurance of volunteers is mandatory. However, Phase IV drug clinical trials are excluded from the scope of insurance.
C) Clinical trials to be conducted with traditional herbal medicinal products are excluded from the scope of insurance, provided they are conducted within the framework of the traditional use of these products. Otherwise, insurance is mandatory.
Ç) Clinical trials for medical devices that bear the CE mark and are conducted in accordance with the intended purpose specified in the medical device user manual are excluded from the scope of insurance; however, insurance for volunteers is mandatory in all other medical device clinical trials.
D) All non-interventional clinical trials are excluded from the scope of insurance.
E) Procedures for the collection of blood, urine, saliva, and similar materials that can be routinely performed in health institutions or organizations are excluded from the scope of insurance.
F) Matters to be followed regarding the insurance of volunteers for all other examination, diagnosis, testing, and treatment methods, as well as surgical interventions that are not covered by these and may be performed on volunteers during a clinical trial, shall be regulated by a guideline to be prepared by the General Directorate of Health Services on this subject.
https://titck.gov.tr/storage/Archive/2019/legislation/972bae83-9d23-45ae-b3a3-85b53bd853e1.pdf
https://www.resmigazete.gov.tr/eskiler/2011/08/20110819-9.htm