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Course Information

Course Information

Course Title	Code	Semester	L+U Hour	Credits	ECTS
PRINCIPLES OF GOOD CLINICAL PRACTICE	58405005		2 + 2	3.0	8.0

Prerequisites

None

Language of Instruction	Turkish
Course Level	Graduate Degree
Course Type	Compulsory
Mode of delivery
Course Coordinator
Instructors
Assistants
Goals	To provide understanding and evaluation of the set of rules emerging in historical development for clinical research within the framework of national/international legislation.
Course Content	Clinical trial history, the birth of the Declaration of Helsinki and its updates, GCP guideline history, clinical trial legislation in Turkey, TITCK GCP definitions, Research team selection and training, “Research center” features in clinical trials, Basic features of the research product, Informed Consent form, its content and signing process, What is an adverse event and regulation of adverse event notifications, Pharmacovigilance terminology and dictionaries, and the latest developments in the regulations regarding social security institiution or private health insurance institutions in clinical researches.
Learning Outcomes	1) To learn the history of clinical research, 2) To learn about good clinical practices, and the origins/evolution and updates of the Declaration of Helsinki, 3) To have information about clinical research legislation and storage of research documents in Turkey, and to learn the definitions of "The Turkish Medicines and Medical Devices Agency (TMMDA or TITCK)", " The Good Clinical Practices (GCP or IKU)" and the basic points in these definitions, 4) To Assimilate the basic information about research team selection and training, 5) To learn the features of “Research center” in clinical research, 6) Understand the key features of the reserch product(s), 7) To have information about the content and signing process of the "Informed Consent Form", 8) To have knowledge about what is an "Adverse Event" and the regulation of "Adverse Event Reporting Form" , 9) To learn pharmacovigilance terminology and dictionaries, 10) To have knowledge about "the regulations of social security or private health insurance institutions" and "the storage of research documents in clinical rese