The course “Clinical Research: What’s it all about?” aims to provide robust skills concerning operational aspects on how to conduct clinical studies, all relevant regulations, provide to the research teams the tools to achieve a high performance concerning all steps of clinical research, while safeguarding the study participants’ safety and well being. It is designed to the Research teams (Senior and Junior Researchers, from Senior Physicians to Intern doctors, Nurses, Biomedical Scientists, Allied Health Professionals, Study Coordinators) with or without experience in clinical research.
With focus on the practical aspects of clinical studies, the course has the main objectives:
- Provide to the participants the tools and knowledge needed to successfully achieve quality and high performance in all steps of clinical research.
- Provide information on clinical research practical aspects, essential to achieve the highest quality data, ensuring the safety and well-being of study participants.
- Identify all the parties involved in a clinical trial and the main responsibilities associated with each of them (e.g. Sponsor, Principal Investigator, CRO, and Monitor).
- Understand the roles and responsibilities of the different parties involved in a clinical research, and the fundamentals of Good Clinical Practice (GCP).
- Understand the current legislation, National and European, and other standards of reference applicable to clinical research.
- Identify the responsible authorities for approving a clinical trial, their respective timelines for approval, and the documents required for submitting an application for a clinical trial authorization.
- Understand which the regulatory activities are after the clinical trial approval.
- Describe the different types of clinical research with emphasis on clinical trials and their phases.
- Understand the difference between Quality control vs. Quality assurance and Audits vs. Inspections.
The course has received scientific endorsement by the Faculty of Medicine, University of Lisbon, Portuguese Society of Cardiology and Portuguese Society of Cardiothoracic and Vascular Surgery. Additionally, it has been granted 12 Continuing Medical Education (CME) points from the European Accreditation UEMS-EACCME® which means that our Course has fulfilled the UEMS-EACCME® quality requirements.