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)
Disclaimer
Thank you for your interest in our VACCELERATE Study Nurse Course. With our modules, we would like to provide helpful information in the field of clinical trials based on ICH-GCP.
We assume no liability for the accuracy, topicality, completeness and quality of the information provided. The offer can also be partially or completely changed or deleted at any time without prior notice. Liability claims for non-material or material damage resulting from the use of the information provided are excluded, unless there is evidence of willful intent or gross negligence. Despite careful content control, we cannot assume any liability for external links to third-party content.
We explicitly assume no liability with regard to national legislation and its specifics. Users remain responsible for verifying and aligning the content of this work with the local law and regulation applicable in their respective country as well as taking into account future changes in the law.
All contents of the course, in particular texts, images, graphics, sounds, videos, animations and layout, are protected by copyright. Unauthorised use, reproduction or distribution of individual contents, in particular the logo, or complete pages are expressly prohibited.
The course is maintained by VACCELERATE at the University Hospital Cologne (UHC) and has been developed with great care. Nevertheless, it is always possible that an error may occur. We would appreciate if you could bring this to our attention (studynursecourse@vaccelerate.eu).
