Ethics Committees Clinical Research Ethics Committee Application Forms

Application Forms for Non-Drug Research

All application file content must be saved on CD and submitted with the application file. Files with missing documents or without a CD will be returned without evaluation.

Guidance on the application form can be found at //www.titck.gov.tr.

• Form 16 Application Checklist
• Form 01 Application Cover Letter Sample //www.titck.gov.tr
• Form 17 Non-Drug Clinical Trials Application Form
• Form 18 Non-Drug Clinical Research Application Form (Specialization Theses and/or Studies to be Conducted for Academic Purposes)
• Form 19 Protocol Information Form for Non-Drug Studies
• Form 06 Research Budget Form: Available at. You can access it at //www.titck.gov.tr.
• Form 07 Declaration of Helsinki: Each page of the declaration must be signed by all researchers. You can access it at //www.titck.gov.tr.
• Form 08 Informed Consent Form (ICVF): The language should be free of medical words and understandable by the participants. (Under the Informed Consent Form, the volunteer or legal representative should write the name and surname of the volunteer or legal representative in their own handwriting and sign it). //www.titck.gov.tr
• Form 09 Biological Material Transfer Form (when necessary) //www.titck.gov.tr
• Form 10 Case Report Form (Patient data tracking form): It will be prepared according to the nature of the research.
• Form 11 Application Form for Import of Investigational Products to be used in Clinical Trials (when necessary ) //www.titck.gov.tr
• Form 12 Institutional Authorization Certificate: Chief Physician's Office in hospitals, Dean's Office in faculties, if it will be carried out in the field or other institutions, permission must be obtained from there.
• Form 13 Curriculum Vitae Form //www.titck.gov.tr
• Form 20 Undertaking for the Use of Archival Material (where necessary)
• Form 14 Document for Informing the Research Team within the Framework of IKU and ILU
• Form 15 Declaration Form for Applications to Üsküdar University Clinical Research Ethics Committee
• Three full texts of literature related to the research project.

*All forms in the file must be signed (all pages must be signed by the principal investigator).

Application Forms for Medical Device Research

All application file content must be saved on CD and submitted with the application file. Files with missing documents or without a CD will be returned without evaluation.

The application guide isavailable at //www.titck.gov.tr

• Form 21 Application Checklist
• Form 22 Application Cover Letter Sample //www.titck.gov.tr
• Form 23 - Medical Device Clinical Trials Application Form: Purpose, material and method should be written in detail //www.titck.gov.tr
• Form 24 - Medical Device Clinical Trials Application Form (Specialization Theses and/or Studies to be conducted for Academic Purposes): Purpose, material and method should be written in detail. You can access it at //www.titck.gov.tr
• Form 25 - Application Form for Observational Studies with Medical Devices: Purpose, material and method should be written in detail //www.titck.gov.tr
• Form 26 - Application Form for Observational Studies with Medical Devices for Academic Purposes: Purpose, material and method should be written in detail. //www.titck.gov.tr
• Form 17 - Protocol Information Form for Non-Drug Studies
• Form 27 - Research Budget Form //www.titck.gov.tr
• Form 07 - Declaration of Helsinki: Each page of the declaration must be signed by all researchers. You can access it at //www.titck.gov.tr.
• Form 28 - Informed Voluntary Consent Form (ICVF) Sample: The language should be free of medical words and understandable by the participants. (The volunteer or legal representative should write the name and surname of the volunteer or legal representative in their own handwriting and sign it under the Informed Consent Form. You can access it at //www.titck.gov.tr.
• Form 29 - Biological Material Transfer Form (when necessary) //www.titck.gov.tr
• Form 10 - Case Report Form (Patient data tracking form) (if available): It will be prepared according to the nature of the research.
• Form 30 - Curriculum Vitae Form. You can access it at //www.titck.gov.tr.
• Form 14 - Document for Informing the Research Team within the Framework of IKU and ILU: It must be signed by all research team members.
• Form 15 - Declaration Form for Applications to Üsküdar University Clinical Research Ethics Committee
• Form 31 - Application Form for Performance Evaluation Studies with In-Vitro Medical Diagnostic Devices.
• Form 32 - Application Form for Validation Studies with In-Vitro Medical Diagnostic Devices //www.titck.gov.tr
• Three full texts of literature related to the research project.

*All forms in the file must be signed (all pages must be signed by the principal investigator).

Information Notice

*The arrangements we request as a result of the evaluation of the information and initial application files submitted to our Board by our Board should be made by you and submitted as an attachment to the relevant cover letter.

Information for Pharmaceutical Research

All notifications must be submitted with the relevant cover letter. //www.titck.gov.tr

• Form 33 - Amendment Form for Clinical Drug Trials //www.titck.gov.tr
• Form 34 - Clinical Drug Trials Termination Notification Form //www.titck.gov.tr
• Form 35 - Annual Notification Form for Clinical Drug Trials //www.titck.gov.tr
• Form 36 - Observational Drug Trials Termination Notification Form //www.titck.gov.tr
• Form 37 - Clinical Drug Trials Significant Change Application Form //www.titck.gov.tr
• Form 38 - Clinical Research Assignment Application Form //www.titck.gov.tr
• Form 39 - Observational Drug Studies Change Application Form //www.titck.gov.tr
• Form 40 - Observational Drug Trials Annual Notification Form //www.titck.gov.tr
• Form 41 - Clinical Drug Trials Substantive Amendment Application Form (for Specialty Theses and/or Academic Purposes) //www.titck.gov.tr
• Form 42 - Amendment Application Form for Clinical Drug Trials (for Specialty Theses and/or Academic Purposes ) //www.titck.gov.tr
• Form 43 - Important Change Application Form for Observational Drug Studies //www.titck.gov.tr
• Form 44 - Important Amendment Application Form for Observational Drug Studies (for Specialty Theses and/or Academic Purposes) //www.titck.gov.tr
• Form 45 - Application Form for Assignment to Observational Drug Studies //www.titck.gov.tr

Information for Non-Drug Research

All notifications must be submitted with the relevant cover letter. //www.titck.gov.tr

• Form 46 -Non-Drug Clinical Trials Termination Notification Form (For a new surgical method research, Stem cell transplantation research, Tissue transplantation research, Organ transplantation research that requires permission from the Ministry of Health) //www.titck.gov.tr
• Form 47 -Annual Notification Form for Non-Drug Clinical Trials (For a new surgical method research, Stem cell transplantation research, Tissue transplantation research, Organ transplantation research that requires permission from the Ministry of Health) //www.titck.gov.tr

Information for Medical Device Research

All notifications must be submitted with the relevant cover letter. You can reach from //www.titck.gov.tr

• Form 48 - Medical Device Clinical Trials Amendment Notification Form //www.titck.gov.tr
• Form 49 - Medical Device Clinical Trials Termination Notification Form //www.titck.gov.tr
• Form 50 - Medical Device Clinical Trials Annual Notification Application Form //www.titck.gov.tr
• Form 51 - Application Form for Amendments to Observational Medical Device Studies //www.titck.gov.tr
• Form 52 - Endpoint Notification Form for Observational Studies with Medical Devices //www.titck.gov.tr
• Form 53 - Annual Notification Form for Observational Studies on Medical Devices //www.titck.gov.tr