This course is designed for study nurses/research 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).
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:
First Module:
- General information and basics of clinical trials
- Regulatory aspects, ethical guidelines, and principles of clinical trials
- Study protocol, patient information and informed consent
- Adverse events and safety
Second Module:
- Practical information for the trial site, trial preparation and site organization
- Documentation and handling of trial data
- Subject enrolment and visits
Third Module:
- Quality control and completion of trials
- Monitoring and audits
- Archiving and essential documents
- Ethical evaluation
The course contains a variety of learning formats such as lectures, hands-on training for practical exercises and exams. Completion of Module 1 is a prerequisite for module 2 and 3.
Target Audience: Study Nurses/Research Nurses
Duration: The complete course contains learning material (lectures, hands-on trainings, and exams) of approximately 30 hours. After registration you have 4 weeks to complete the first module (9.5 hours learning material). The course can be started and stopped at any time.
Certificate: Upon successful course completion of each module and exam, a certificate can be downloaded.
Costs: Free of charge (The Study Nurse Course is part of the European trial site capacity building in VACCELERATE, funded by the European Union’s horizon 2020 research and innovation programme under grant agreement No 101037867)
Register here:
https://ucgn-academy.ispringlearn.eu/signup/-pB0YYnAurveniQEPstXqz0Ixyg
(Please use this link for registration purposes only. You will receive the link to your learning portal for future access via mail. For questions you can contact us by email: studynursecourse@vaccelerate.eu)
