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Clinical Research Ethics Committe

NOTE: Clinical Research Ethics Committee has started removing files.

Bahçeşehir University Clinical Research Ethics Committee was established with the approval of the Ministry of Health, General Directorate of Pharmaceuticals and Pharmacies, dated 19.11.2014 and numbered 138589.

The Applicants must hand-deliver their complete application files (Clinical Pharmaceutical Studies 2 files +2 Cd, all other studies one file) to the Board Secretariat, adhering to the "File Content" order. 
Applications must be made by hand; applications made via cargo/mail are not accepted. 

Files that have been considered and corrected by the committee must be submitted with the "Ethics Committee Correction/Amendment Form Cover Letter". 

An application fee is charged for non-pharmaceutical and non-interventional research to be conducted outside the institution, except for specialty theses, academic research, and state funds (TÜBİTAK, DPT, University Fund, etc.). 

There is no application fee for applications made within the institution, for non-sponsored specialization theses or research for academic purposes. 

After the application fee is paid, the bank receipt is attached to the application file.

Application forms for pharmaceutical research can be obtained from the Turkish Medicines and Medical Devices Agency page.
 

Phase I, II, III- Clinical Research First Application of Pharmaceuticals, Medicinal and Biological Products and Herbal Products (Except for Specialization Theses or Academic Purposes) 2.663,96
Phase IV Pharmaceuticals, Medicinal and Biological Products and Herbal Products for Clinical Research First Application (Except for Specialization Theses or Academic Purposes) 1.335,58
BY/BE Studies First Application (Except for Specialization Theses or Academic Purposes) 1.335,58
First Application of Observational Drug Studies (Except for Specialization Theses or Academic Purposes) 1.335,58
Phase I, II, III Pharmaceuticals, Medicinal and Biological Products and Herbal Products for Clinical Research Significant Change Application (Except for Specialization Theses or Academic Purposes) 906,18
Phase IV Pharmaceuticals, Medicinal and Biological Products and Herbal Products for Clinical Research Significant Change Application (Except for Specialization Theses or Academic Purposes) 604,12
BY/BE Studies Significant Change Application (Except for Specialization Theses or Academic Purposes) 604,12
Observational Drug Studies Significant Change Application (Excluding Specialization Theses or Academic Purposes) 604,12
Phase I, II, III Pharmaceuticals, Medicinal and Biological Products and Clinical Research Amendment Application for Herbal Products (Except for Specialization Theses or Academic Purposes) 52,79
Phase IV Pharmaceuticals, Medicinal and Biological Products and Herbal Products Clinical Research Amendment Application (Except for Specialization Theses or Academic Purposes) 52,79
BY/BE Studies Amendment Application (Except for Specialization Theses or Academic Purposes) 52,79
Observational Drug Studies Amendment Application (Except for Specialization Theses or Academic Purposes) 52,79
Clinical Research Documents Archiving Service Control Application 3.624,69
Import Application for the Investigational Products to be Used in Clinical Trials 244,13
Clinical Investigation Product Storage Compliance Certificate 350,00
Certificate of Conformity for Clinical Research Documents Archiving Service 350,00
Loss of Clinical Investigation Product Storage Compliance Certificate 350,00
Loss Clinical Research Documents Archiving Service Control Application 350,00
Clinical Research Investigator Meeting Applications 105,58
Other - All Non-Pharmaceutical Studies (Except for Specialization Theses or Academic Purposes) 1000,00

 

CLINICAL TRIALS ETHICS COMMITTEE MEETING DATES

DEADLINE FOR APPLICATION

 

JANUARY

WEDNESDAY

4.01.2023 29.12.2022  
18.01.2023 12.01.2023  

FEBRUARY

WEDNESDAY

1.02.2023 26.01.2023  
15.02.2023 9.02.2023  

MARCH

WEDNESDAY

1.03.2023 23.02.2023  
15.03.2023 9.03.2022  

APRIL

WEDNESDAY

5.04.2023 30.03.2023  
19.04.2023 13.04.2023  

MAY

WEDNESDAY

3.05.2023 27.04.2023  
17.05.2023 11.05.2023  

JUNE

WEDNESDAY

7.06.2023 1.06.2023  
21.06.2023 15.06.2023  

JULY

WEDNESDAY

5.07.2023 26.06.2023  
19.07.2023 13.07.2023  

AUGUST

WEDNESDAY

2.08.2023

27.07.2023

 
 

SEPTEMBER

WEDNESDAY

6.09.2023 31.08.2023  
20.09.2023 14.09.2023  

OCTOBER

WEDNESDAY

4.10.2023 28.09.2023  
18.10.2023 12.10.2023  

NOVEMBER

WEDNESDAY

1.11.2023 26.10.2023  
15.11.2022 9.11.2023  

DECEMBER

WEDNESDAY

6.12.2023 30.11.2023  
20.12.2023 14.12.2023  
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