Intro to the Principles and Practice of Clinical&Translational Research

About this event

The “Introduction to the Principles and Practice of Clinical Research” free course trains registrants on how to effectively and safely conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more.

The course provides participants with an overview of the regulatory framework for clinical research, including the role of Institutional Review Boards (IRBs), the European Medicines Agency (EMA), and other governing bodies.

In conclusion, the Introduction to the Principles and Practice of Clinical Research course provides participants with a comprehensive understanding of the clinical research process and the various roles and responsibilities involved in conducting successful and ethical clinical research studies. The course is essential for those who are interested in pursuing a career in clinical research or for those who are already working in this field and wish to expand their knowledge and skills.

Intended Audience
This course will be of interest to Physicians, Scientists, Medical and Dental students, Nurses, public health Professionals, and others conducting or planning a career in clinical research. It is also valuable for individuals who are involved in the administration or management of Clinical Research programs, including Research Coordinators, Data Managers, and Quality Assurance Professionals.

Additionally, individuals who are involved in the regulation of clinical research, such as members of Institutional Review Boards (IRBs), will find this course relevant to their work.

The course is designed to be accessible to individuals with varying levels of experience and expertise in clinical research, from those who are new to the field to experienced professionals who wish to refresh their knowledge and skills.

Why Attend: “Principles and Practice of Clinical and
Translational Research”
Attendance can be used as continuing education for those who are seeking to maintain or enhance their professional credentials in the field. Attending the course can provide a solid foundation for individuals who are interested in pursuing further education and training in Clinical & Translational Research, including Master's degree programs or Doctoral programs in related fields.

This course will be advanced to a full Master’s degree by the Hellenic American College / Hellenic American University.

Syllabus
Module 1: Introduction to Clinical Reseach
1 History of Clinical Research Prof G. Chrousos
2 Ethical Principles & Legal issues in Clinical Research Asst Prof Fereniki Panagopoulou-Κoutnatzi, Panteion University

3 Clinical (Preclinical - Traslational) research Overview - Team, EMA Drug development and Regulation Prof. Theofilos Kolettis

Module 2: Conceptualizing the Clinical Trial/Study Protocol
1 History of Clinical Trials/Introduction to Clinical Study Design/Information Resources for Clinical Research Assoc. Prof. Dimitrios Vlachakis
2 Choosing a Research Question - Designing Trials Efficiently - Overview of Hypothesis Testing - Measures, Study Participant Selection, Issues in Randomization - Good Clinical Practices Dr Constantinos Stratakis
3 The role of Clinical Trials in Health Care - Health Research Linked to Disasters and other Humanitarian Crises Dr Evi Hatziandreou

Module 3: Protocol Review, Implementation and Monitoring
1 Developing Protocols and Manuals of Operating Procedures/ Type of clinical studies Assoc. Prof. Karolina Akinosoglou
2 Peer Review - Data and Safety Monitoring Committees - Institutional Review Boards - Overview Charikleia Stefanaki
3 Mock Independent Ethics Committees approval for trials (IEC) Christos Yapijakis

Module 4: Data Quality & Results Reporting
1 Quality Management and Sharing in Clinical Research Prof. Apostolos Vantarakis
2 Data Management - Clinical Trials Registration & Results Reporting/Dissemination Prof. Vasileios Megalooikonomou
3 Research Misconduct: Fabrication, falsification & Plagiarism/also diccuss the ChatGTP J.P.A. Ioannidis

Module 5: Topics of Special Interest for Clinical trials
1 Secondary Data/Meta-Analysis - Using large Datasets for Population-Based Research Prof. Stylianos Antonarakis
2 Pharmaceutical Development: Management of Projects - Outcomes Research and Comparative Effectiveness Research A. Gravanis
3 Medical wearables and continuous monitoring of health & Use of sensors and smart devices in biomedical research - Prof. Panayiotis Tsanakas & Dr. Eleni Papakonstaninou
4 Personalized Medicine and Biomarkers - Ch. Gogos
5 Development of new vaccines - G. Pavlakis
6 Technology Transfer - Career Development in Clinical and Translational Research - T. Zacharis