The objective is to identify and plan the preclinical studies of vaccine candidates within the framework of the vaccine research and development process, and to evaluate their proficiency and compliance. Upon demonstrating safety and suitability for human application following preclinical studies, the unit initiates preparations for Phase studies. This includes planning, implementing, auditing, and approving study processes by evaluating protocols, designs, and regulatory compliance for Phase I, Phase II, and Phase III clinical trials. Furthermore, the unit is responsible for designing Phase IV clinical trials (post-licensure studies), ensuring compliance with regulatory requirements, and managing the planning, implementation, and oversight of these processes. It aims to identify competent centres and researchers for clinical trials and to establish comprehensive databases for centres and investigators. In addition, the unit plans and develops clinical research for novel vaccine delivery methods and tools through R&D, ensures project budgeting, and provides scientific consultancy and procedural support for other sponsor-led or investigator-initiated studies.

a) The objective of preclinical trials is to determine the safe and effective starting dose for human clinical trials, identify organs potentially susceptible to toxicity, assess whether any observed toxicity is reversible, and establish safety parameters for clinical monitoring.

b) The objective of clinical trials is to investigate novel therapeutic methods or products, as well as to discover more effective ways of utilizing existing treatments or to acquire more comprehensive information regarding these products and methods.

I. To ensure excellence in vaccine clinical trials conducted with the support of or in participation with the Vaccine Institute of Türkiye.

II. To collaborate with national and international authorities, international organizations, academia, the pharmaceutical/vaccine industry, and clinical centres to enhance the quality of clinical trials conducted within our country.

III. To play a leading role in the development of regulatory, operational, and supervisory conditions aimed at the establishment, progression, and modernization of the clinical research ecosystem in Türkiye.

IV. To conduct educational activities to enable the execution of clinical trials in accordance with international standards.

• Sebahat TEKCAN
• Seçil UYSAL

• Standard Operating Procedure for Preclinical and Clinical Research and Project Coordination Unit
• Standard Operating Procedure for Protocol Coding of TAE Clinical Trials
• Standard Operating Procedure for the TAE Independent Data Monitoring Committee (IDMC)
• Standard Operating Procedure for Archiving Clinical Research Data and Essential Documentation
• Sponsor Procedure for Clinical Trials of Medicinal and Biological Products

klinika.tae@tuseb.gov.tr