- 5.1 Introduction
- 5.2 Clinical research
- 5.2.1 Obtaining approval
- 5.2.2 Additional requirements
- 5.2.3 Manufacturing
- 5.2.4 Investigational
- 5.2.5 Storage and distribution
- 5.2.6 Registration of the trial
- 5.2.7 Data management
- 5.2.8 Monitoring
- 5.2.9 Doing the research
- 5.2.10 Statistical analysis plan
- 5.2.11 Reporting on the research
- 5.3 Research support
The Medical Research Involving Human Subjects Act (WMO) covers medical scientific research in which people are subjected to interventions or have to follow established behavioural rules. The main purpose of the act is to protect research subjects (patients and healthy volunteers) against the risks and burdens of biomedical research involving human subjects without unnecessarily hampering the progress of medical–scientific research.
All clinical researchers, including PhD students doing research covered by the WMO, are obliged to follow the foundation course Legislation and Organization for Clinical Researchers (BROK course). The aim of this course is to provide clinical researchers with knowledge of the laws and regulations covering clinical research and their practical consequences. The course is completed by sitting an official national examination for the certificate of the NFU (Nederlandse Federatie van Universitair Medische Centra). The AMC and the VUmc provide the BROK course on a regular basis.
In line with the WMO, this chapter explains the requirements for clinical research methods and good clinical practice in all stages of the study.