Clinical Research Ethics Committee

The main legislation for the Clinical Research Ethics Committee processes is given below.

Regulation on Clinical Trials of Pharmaceuticals and Biological Products 

Guide on Application Form in Clinical Trials of Pharmaceuticals and Biological Products 

Guideline for Observational Drug Studies  

To the Ethics Committee in Clinical Research Guide on Application Form 

Good i Clinical Practices Guide

“Ministry of Health and Article 45 

Health Services Basic Law “Additional Article 10” 

Archiving Principles in Clinical Practices

Storage of Investigational Products Used in Clinical Trials and Guide for Distribution 

Guide for Independent Data Monitoring Committees 

Guide on Principles and Principles for Good Clinical Practice of Advanced Therapy Medicinal Products

Guide on Ethical Approaches in Clinical Trials in Pediatric Population 

Guide on Insurance Coverage in Clinical Research 

Central Organization in Clinical Research Guide to the Principles of Management 

Principles of Clinical Research Advisory Board Standard Operating Method

Medical Device Clinical Trials Regulation ( 2014-29111) 

Regulation on Medical Diagnostic Devices Used Outside the Body (in Vitro) (2007-26398) 

Regulation on Active Implantable Medical Devices 

Medical Device Regulation

Medical Device Clinical Trials Reference Guide

A Guideline for Observational Studies with Medical Devices

Specialty Dissertations and/or Clinical Research Applications for Medical Research Purposes Directory

Regulation on Efficacy and Safety Studies and Clinical Researches of Cosmetic Product or Raw Materials (2015-29481 )