Clinical Research is one of the most regulated industries in the world. Not a surprise, as we are dealing with research involving human beings. Therefore safeguarding study participant’s rights, wellbeing and safety is of utmost importance. This is why before starting a clinical trial, you need to obtain appropriate approvals. Authorities and Ethics Committees play a major role in this approval process.
This ½ day course is designed to provide basic understanding of the current regulatory requirements for Clinical Trials for people who have limited or no background in these matters.
Course time09h00 - 12h30
Who should attend
People starting in the clinical research field in operational roles as well as people in other domains, who want to have a clear and basic understanding of clinical trial rules.
- Clinical trials
- Why and When
- Difference with regular medical practice
- Rules for clinical research:
- History (tragic mistakes)
- Declaration of Helsinki
- ICH-Good Clinical Practice
- Legal framework
- Definitions and frequently used abbreviations (plus exercise)
- Getting the approval for starting a clinical trial
- Workshop on starting up a clinical study (with a real live simulation)
- Understand the basic concepts of and obtain a clear view on the clinical research regulations and how they came to existence
- Be able to identify what is needed in order to get the required approvals to start a clinical study
- Get familiar with terminology and abbreviations