The Clinical Trial - A Manual for Patients and their Families
Implementation of clinical trials is regulated by a number of laws and regulations, as well as by ethical standards. This manual is an opportunity to inform patients in greater detail of such regulations, methods of conducting clinical trials and their role in development of medicinal products, in a concise yet sufficiently informative way.
In the words of the author of the manual, Professor Dinko Vitezić, president of the Central Ethics Committee: "The primary object of the booklet is to assist in the gaining of basic knowledge about this important field and to inspire in clinical trials".
The manual was published at the initiative of the Coalition of Healthcare Sector Associations, and with the support of the Agency for Medicinal Products and Medical Devices, and the Croatian Association of Research-based Pharmaceutical Companies.
The questions answered in this manual include:
1. What is a clinical trial and why is it necessary?
2. Who can participate in a clinical research as a subject?
3. What is an informed consent and why is it important for each and every subject?
4. What are the risks of participation in a clinical trial?
5. Who approves clinical trials?
6. What rights trial subjects have and how are they protected?
7. What needs to be considered before taking part in clinical trials?
This manual is available only in Croatian language - download of the manual