Face to face lectures in the Laboratory of Biomathematics of the Department and the auditorium

MANDATORY PRESENCE: NO

Lectures in powerpoint (ppt) format
In each session, laboratory exercises and tutorials are carried out on a computer

Use of Computer technology in communication with students
(website, e-mail, etc.)

The general purpose of the course is to students to acquire the appropriate knowledge that will enable
them to understand the methodology for developing research protocols and conducting clinical studies.
The specific objectives of the course are specialized in the following intended learning outcomes:
He/she will be able to use the acquired knowledge in order:
• To recognize the phases of a clinical trial and understand their different characteristics and distinguish
between different types of clinical trials
• To become familiar with the basic principles of good clinical practice as well as identify typical deviations from it and develop appropriate corrective actions
• To set the appropriate objectives-questions of a clinical study and choose the type of study needed to evaluate a treatment
• To estimate the sample size of the study
• To understand and apply the statistical methods needed to analyze data from a study and interpret the results of a study and report
• To become familiar with the procedures (monitoring, audits) that contribute to ensuring the reliability of clinical study data and the safety of participants
• To become familiar with the regulatory guidances for the recording and reporting of events observed in subjects during the conduct of clinical studies
• To become familiar with the methodology of writing the final report of a study (CSR) for the competent authorities and how to present the results in a scientific publication

General Abilities

Research, analysis and synthesis of data and information, using the necessary technologies
Decision making
Autonomous work
Teamwork
Working in an international environment
Promoting free, creative and inductive thinking
Generating new research ideas
Project planning and management

Teaching notes are distributed:
Elias Zintzaras and Chrysoula Doxani (2015) “Methodology of Clinical Trials”
Postgraduate Programme (MSc) «Research Methodology in Biomedicine, Biostatistics and Clinical
Bioinformatics at University of Thessaly»
In addition, the following bibliography is indicated
S. Pocock. Clinical trials: A practical approach, Wiley (1984)
ICH – E6 Guideline for Good Clinical Practice
ICH E9 Statistical Principes for Clinical Trials, February 1998.