The interventional and non-interventional clinical research projects are carried out by a team of primary investigator and co-investigators, two research nurses, a research pharmacist, and the field coordinating team. 

In this unit, volunteers are enrolled in national and international Phase 2 and 3 clinical trials of a new drug or a biological product in order to test their safety and efficacy before marketing. Every step in this procedure is in accordance with the Gooc Clinical Practice Guidelines.

The Process of Activity in a Clinical Trial:

All members of our team 

• • Act in accordance with the rules and regulations stated in the Good Clinical Practice Guideline of the Ministry of Health (https://www.titck.gov.tr/mevzuat/2150), and Declaration of Helsinki (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ ), following the updates in these areas.
  • Provide full, updated, and complete access to the main research files, materials and drugs. 
• Work in cooperation with the sponsoring as well as independent reseach companies.
• Receive the necessary onlien training for randomization, electronic case report forms, and open an account for data entry.
• Review the database records with a focus on inclusion and exclusion criteria. They visit the patients in ICUs or wards to determine potential volunteers for the trial.
• Interview the patient and/or their legal representative to give necessary information about the study, encourage a thorough reading of the Informed Consent Form of the particular clinical study, and enable appropriate filling of the Volunteer Informed Concent Form. 
• Enter data via an electronic system, and provide appropriate preparation and administration of the study drug(s) as per the protocol. They monitor the patient closely, and report drug-related adverse events to the Ethical Committee 24/7.
• Perform follow-up visits as determined in the protocol, and gather the necessary data.
• Make a study file for each volunteer. All hospital records, source documents, lab forms, nurse observation forms, case report forms and a signed copy of the informed concent form is kept in this file.
• Provide all necessary records, patient study charts and procedure list for the personnel in monitoring visits. They also reply all electronic queries. 

The activity of our Unit is carried out as per the “Regulations Pertaining Clinical Studies of Drugs and Biological Products” of the Ministry of Health published in the Official Gazzette dated June 25th 2014, and numbered: 29041 (https://www.titck.gov.tr/mevzuat/ilac-ve-biyolojik-urunlerin-klinik-arastirmalari-hakkinda-yonetmelik-27122018172740)