Basics on Regulatory Requirements in Clinical Research – eLearning
Book a session
| 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 course is designed to provide a basic understanding of the current 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)
Be aware that attending one of the ECCRT open courses does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
Trainers
Chiara Zavattaro
Janssen
The trainer was FANTASTIC. She knew a lot, was extremely friendly, and was open to reply (and she knew the answer to) any question on the topic
Eline Thienpondt
Janssen
The trainer was well prepared, open and friendly - The trainer gave you the chance to ask questions - The system with the voting buttons was very interactive - Interactive session for people who are quite new in the field of regulatory.
Veronique Shiwa