Observational Research Applications

As part of the European Union harmonization process, the Ministry of Health has been introducing a series of regulations on ethical rules in clinical research since 2008. The "Regulation on Clinical Research" prepared in this context was published in the Official Gazette and entered into force on 19 August 2011.

Pursuant to Article 2 (2)of this regulation, the Ministry of Health has grouped research that does not require direct intervention on humans by a physician, unlike drug research, under the heading "Non-Interventional Clinical Research" and excluded it from the scope of the regulation.

Non-interventional clinical research topics:

All observational studies,

Survey studies,

Retrospective archive reviews such as file and image records,

Research to be conducted on biochemistry, microbiology, pathology and radiology collection materials such as blood, urine, tissue and radiological images, or on materials obtained during routine examination, testing, analysis and treatment procedures,

Cell or tissue culture studies; research on genetic material for identification purposes, other than gene therapy clinical research,

Research to be conducted within the scope of nursing activities,

Diet studies with food additives,

Research on body physiology, such as exercise,

Studies based on anthropometric measurements,

It covers all research to be conducted without requiring direct intervention on humans by a physician, such as research evaluating lifestyle habits.

Sample Cover Letter for Observational Study Applications

Observational Studies Application Form

Institutional or Academic Board Permission Letter for Academic Research

Sample Short Protocol Template

Flowchart

Sample Minimum Informed Consent Form

CV Form

Sample Case Report Form

Authorized Signature Circulars of the Sponsoring Organization

Sample Literature

Sample Research Budget Form

Confidentiality Undertaking and Publication Permission Document

Good Clinical Practice Undertaking

File Checklist