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Goals and Objectives

The MSc "Clinical Trials: Design and Conduct" aims to provide high level postgraduate education in line with the Declaration of Helsinki, which sets out the ethical principles that should be respected by medical practitioners when conducting medical research with humans or human material.

Among the basic principles of this Declaration are:

1. the physician's duty in a medical research to ensure life, health, privacy and dignity of the human subjects of the research.

2. the design and implementation of experimental procedures using human subjects should be clearly stated in a research protocol, which should be submitted to an independent bioethics committee for evaluation.

3. any research involving human subjects is conducted only when it is demonstrated that such research will have benefits for the individuals in the research population

4. special provision is made for obtaining informed consent from participants in a research project, with special emphasis on people who are unable to give their consent (minors, people with special needs)

Also, the content of the MSc is harmonized with the Rules of Good Clinical Practice (GCP). It is a series of documents and instructions, where the obligations of all those participating in Clinical research are mentioned. ICH-GCP is an international ethical and scientific quality standard for the design, conduct, recording and reporting of data from experiments on humans.

One of the most important issues likely to influence a patient's decision to participate in a Clinical Trial is whether and how their safety and rights are ensured during their participation. One of the most important parameters is that the patient should first have been informed by his doctor about all the information of the Study (rights, purpose of the Study, duration, required Procedures, Contact links) as they are mentioned in the Consent Form and have the time to later decide freely on his participation but also to withdraw whenever he wants as his consent is in no way a commitment. Adherence to all principles and legislation ensures patients' rights.

In Greece, according to the Ministerial Decision DYG3/89292, Greek Republic Gazette No B1973/31-12-2003, Clinical Studies (Trials) are approved by the EOF provided that the National Ethics Committee (E.E.C.) has given a positive opinion. The program is guided by the Scientific and Coordinating Committee, which annually evaluates and revises the curriculum and educational practice and is subject to student and faculty evaluation.

The program is open to health professionals (eg physicians, surgeons and nurses), postgraduate scientists or statisticians (eg from industry, contract research organisations, regulatory agencies) and experienced trial managers., emphasizing the specialization of people who work or wish to work either in the public or private sector of Clinical Trials.