Clinical Research Ethics Committiee - Application Forms

Application Forms for Non-Drug Researches

The entire reference file must be saved on the CD and submitted. Files with missing documents or without a CD will be returned unevaluated.

You can find the application form Guide at www.titck.gov.tr.

• Form 16 Application Checklist
• Form 01 Application Top article example can be found at www.titck.gov.tr.
• Form 17 Non-Drug Clinical Research Application Form
• Form 18 Non-Drug Clinical Research Application Form (Specialization Theses and / or Academic Purposes)
• Form 19 Protocol Information Form for Non-Drug Research
• Form 06 Research Budget Form: It should be detailed. You can get it at www.titck.gov.tr.
• Form 07 Helsinki Declaration: Each page of the declaration must be signed by all researchers. You can reach it at www.titck.gov.tr.
• Form 08 informed Volunteer form (BGOF) Example: The language must be understood by the participants and free of medical vocabulary. (It is necessary to write the name and surname of the volunteer or legal representative under his/her volunteer form with his/her handwritten signature.) You can reach it at www.titck.gov.tr.
• Form 09 Biological Material Transfer form (if required) can be found at 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 the Import of Research Products to be used in Clinical Drug Research (if necessary) can be found at www.titck.gov.tr
• Form 12 Institution Permit: Permission should be obtained from the Chief Physician in Hospitals, Dean's Office in Faculties, field or other institutions.
• Form 13 CV Form can be found at www.titck.gov.tr.
• Form 20 Commitment for use of Archive Materials (where applicable)
• Form 14 Research Team Information Sheet on IKU and ILU Framework
• Form 15 Üsküdar University Form for Declaring Applications to the Ethics Committee for Clinical Research
• The literature related to the research project in the form of three full texts.

*All forms in the file must be signed (all pages signed by the researcher responsible).

 

Application forms for Medical Device Research

The entire reference file must be saved on the CD and submitted. Files with missing documents or without a CD will be returned unevaluated.

You can find the application form Guide at www.titck.gov.tr.

• Form 21 Application Checklist
• Form 22 Application Top article example can be found at www.titck.gov.tr.
• Form 23 Medical Device Clinical Research Application Form: Purpose, materials and method should be written in detail. You can get the form at www.titck.gov.tr.
• Form 24 Medical Device Clinical Research application form (for specialization theses and/or academic purposes): purpose, materials and methods should be written in detail. You can reach it at www.titck.gov.tr.
• Form 25 Application Form for Observational Research made with Medical Devices: Objectives, materials and methods should be written in detail. You can get it at www.titck.gov.tr.
• Form 26 Application Form for Observational Research for Academic Purposes made with Medical Devices: Objectives, materials and methods should be written in detail. You can get it at www.titck.gov.tr.
• Form 17 Protocol information form for non-drug research
• Form 27 Research Budget Form. You can get it at www.titck.gov.tr.
• Form 07 Helsinki Declaration: Each page of the declaration must be signed by all researchers. You can reach it at www.titck.gov.tr.
• Form 28 informed Volunteer form (BGOF) Example: The language must be understood by the participants and free of medical vocabulary. (It is necessary to write the name and surname of the volunteer or legal representative under his/her volunteer form with his/her handwritten signature.) You can reach it at www.titck.gov.tr.
• Form 29 Biological Material Transfer form (if required) can be found at//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 30 CV Form can be found at //www.titck.gov.tr.
• Form 14 Research Team Information Sheet on IKU and ILU Framework: Must be signed by all research team members.
• Form 15 Üsküdar University Form for Declaring Applications to the Ethics Committee for Clinical Research
• Form 31 Application Form for Performance Evaluation Research conducted with In-Vitro Medical Diagnostic devices.
• Form 32 Application Form for Verification Procedures conducted with In-Vitro Medical Diagnostic Devices can be found at www.titck.gov.tr
• The literature related to the research project in the form of three full texts.

*All forms in the file must be signed (all pages signed by the researcher responsible).

INFORMATION

*The arrangements that are submitted to our Board and the initial application are made by you due to the evaluation of our request, the relevant parent article should be presented by you.

Information for Pharmaceutical Research

All the information should be submitted with the respective cover letters. You can obtain it from www.titck.gov.tr.

• Form 33 Amendment Form for Clinical Drug Research can be found in www.titck.gov.tr
• Form 34 Clinical Drug Research Finalization Notification Form can be reached at www.titck.gov.tr.
• Form 35 Clinical Drug Research Annual Notification Form can be reached at www.titck.gov.tr.
• Form 36 Observational Drug Research Finalization Notification Form can be reached at www.titck.gov.tr.
• Form 37 Clinical Drug Research Substantial Amendment Application Form can be found in www.titck.gov.tr.
• Form 38 Clinical Research Appointment Application Form can be found in www.titck.gov.tr
• Form 39 Observational drug studies Change application form can be obtained from www.titck.gov.tr.
• Form 40 Observational Drug Research Annual Notification Form can be obtained from www.titck.gov.tr.
• Form 41 Clinical Drug Research Substantial Amendment Application Form (for specialization Theses and / or Academic Purposes) can be obtained from www.titck.gov.tr
• Form 42 Amendment Application Form for Clinical Drug Research (fo specialization Theses and / or Academic Purposes) can be obtained at www.titck.gov.tr
• Form 43 Observational Drug Studies Important Changes Application Form can be obtained from www.titck.gov.tr.
• Form 44 Observational Drug Studies Important Amendment Application Form (for specialized Theses and / or Academic Purposes) can be obtained from www.titck.gov.tr
• Form 45 Observational Drug Studies Assignment Application Form can be obtained from www.titck.gov.tr.

Information for Non-Drug Researches

All the information should be submitted with the respective cover letters. You can obtain it from www.titck.gov.tr.

• Form 46 Non-Pharmaceutical Clinical Research Finalization Notification Form (for a new surgical method research requiring permission from the Ministry of Health, Stem Cell Transplantation research, Tissue Transplantation research, Organ Transplantation research) can be obtained from www.titck.gov.tr
• Form 47 Non-pharmaceutical clinical research annual Notification form (for a new surgical method research requiring the permission of the Ministry of Health, Stem cell transplantation research, tissue transplant research, Organ transplant Research) can be obtained from www.titck.gov.tr

Information for Medical Device Research

All the information should be submitted with the respective cover letters. You can obtain it from www.titck.gov.tr.

• Form 48 Medical Device Clinical Research Change Notification Form can be obtained from www.titck.gov.tr.
• Form 49 Medical Device Clinical Research Finalization Notification Form can be obtained from www.titck.gov.tr.
• Form 50 Medical Device Clinical Research Annual Notification Application Form can be obtained from www.titck.gov.tr.
• Form 51 Application Form for Amendments to Observational Medical Device Studies can be obtained from www.titck.gov.tr.
• Form 52 Termination Notification Form for Observational Studies made with Medical Devices can be obtained from www.titck.gov.tr.
• Form 53 Annual Notification for Observational Studies conducted with Medical Devices Form can be obtained from www.titck.gov.tr.