Since 2008, the Ministry of Health has been making a series of regulations on ethical rules in clinical research as required by the European Union harmonization studies. The “Regulation on Clinical Research” prepared within the context of these studies was published in the Official Gazette on 19 August, 2011 and put into circulation. According to Article 2 (2) of this regulation, the Ministry of Health has compiled studies that do not require the involvement of a physician, such as drug research, under the name “Non-Invasive Clinical Research” and excluded them from the scope of the regulation.
Non-interventional clinical research topics:
All observational studies;
Survey studies;
Retrospective archive scans such as file and image recordings;
Research to be conducted with biochemistry, microbiology, pathology and radiology collection materials such as blood, urine, tissue, radiological images or materials obtained during routine examinations, analyses and treatment processes;
Cell or tissue culture studies; research that is not included in gene therapy clinical studies and that will be conducted with genetic materials for identification purposes;
Research on nursing duties;
Dietary studies with food additives;
Research on body physiology such as the effects of exercise;
Studies based on anthropometric measurement;
It covers all research that does not require the direct involvement of a physician, such as the evaluation of lifestyle and habits.
Observational Study Application Cover Letter Example
Observational Studies Application Form
Institution or Academic Board Permission Letter for Research for Academic Purposes
Short Protocol Template Example
Local Signature Rolls of the Supporting Organization
Privacy Statement and Publication Permit
Good Clinical Practices Statement
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