Basics on Regulatory Requirements in Clinical Research – eLearning
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| Basics on Regulatory Requirements in Clinical Research - eLearning | eLearning | EUR 240.00 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
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 are 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 clinical research regulatory requirements course is designed to provide a basic understanding of the current clinical research regulatory requirements for Clinical Trials for people who have limited or no background in these matters.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
- Course credit: 3h (3 months period to complete the course)
- Complete the course at any time, anywhere!
Programme highlight
- Clinical trials
- Why & 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
- Process
- Documents
Learning objectives
- 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
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.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (6)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Veronique Shiwa