This course is designed for study nurses and will provide the needed expertise to conduct a clinical trial. Study nurses are responsible for organizational processes and they are the central link between physicians, patients, sponsors, clinical research organizations, and ethics committees.
The course is based on the curriculum of the KKS Network, a German association of academic coordinating centers for clinical studies, and uses the standards set out in ICH GCP E6 (R2) and EU Regulation 536/2014.
Next to the regulatory background the course also tackles and trains practical aspects necessary for the work as study nurse.
The course consists of 3 modules including, among others, the following topics:
- General information and basics on clinical trials
- Regulatory aspects and ethical guidelines
- Principles of clinical trials
- Study protocol, patient information, and informed consent
- Adverse events
- Practical information for the trial site
- Study preparation and site organization
- Documentation and handling of study data
- Patient recruitment and visits
- Quality control and completion of studies
- Monitoring and audits
- Essential documents
- Ethical evaluation