After completing this e-learning, you will understand why certain procedures for medical research are the way they are, and the underlying idea. It will become clear to you why you have to perform certain actions and administrative actions according to a certain procedure.
Going through the training takes about 3 hours. You can go through the training at your own pace, stop in between, and continue at a later time.
This training contains the following basic principles of medical scientific research:
- History of laws and regulations (e.g. Nuremberg Code, Helsinki Declaration)
- National and international laws and regulations (including the Medical Research Involving Human Subjects Act).
- Responsibilities when conducting medical scientific research.
- Setting up, carrying out and completing WMO mandatory medical-scientific research.
- Additional requirements for research into medicines (e.g. ICH-GCP directive).
- Additional requirements for medical devices research (e.g. ISO14155 standard)