This 5-day intensive program teaches the basic principles of clinical research, and gives a thorough insight into how clinical trials are conducted in hospitals and doctors’ practices. It focuses particularly on the recent developments in the field of clinical research and the latest legal and regulatory guidelines (ICH-GCP/AMG).
The practical nature of the course means that you will be familiar with all standard study documentation, and be able to perform all the tasks required of you in your daily work as a Study Nurse.
On completion of the seminar you will receive a certificate that is recognized within the clinical research industry.
The German Association for Study Nurses and Study Coordinators (BUVEBA) was founded in 2011 in order to define the training requirements and qualifications for Study Nurses nationwide. Every year the Association hosts the Federal Congress for Study Nurses to link its members and to discuss current topics within the profession. You can find more information about the Association and its activities at BUVEBA.de.
The Study Nurse course is offered in two formats: Weekday course: Monday to Friday Weekend course: Friday/Saturday/Sunday and two weeks later Saturday/Sunday. The length (5 days in total) and content of both courses is identical.
Weekend Course in March 2018
02 – 04 March 2018 (Fr & Sat 9.00 – 5.00 | Sun 9.00 – 4.00
16 – 18 March 2018 (Sat 9.00 – 5.00 | Sun 9.00 – 4.00)
Professional and well-trained study teams are key to ensuring that clinical trials are carried out in accordance with national and international guidelines. As the primary contact for patients, Investigators and Clinical Monitors, Study Nurses play a central role in clinical research. They ensure that everything runs smoothly at the site. They look after subjects, collect and record relevant study data and prepare for monitoring visits and audits. This course equips you for all of these tasks and keeps your knowledge and skills up-to-date.
Professional and well-trained study teams are key to ensuring that clinical trials are carried out in accordance with national and international guidelines. As the primary contact for patients, Investigators and Clinical Monitors, Study Nurses play a central role in clinical research. They ensure that everything runs smoothly at the site. They look after subjects, collect and record relevant study data and prepare for monitoring visits and audits. This course equips you for all of these tasks and keeps your knowledge and skills up-to-date.
- Introduction to clinical research
- Guidelines
- Regulatory framework
- International Ethical Principles and Guidelines Ethical considerations and
- Competent Authorities
- Roles and responsibilities according to ICH-GCP
- Protocol, Patient information, Investigator’s Brochure
- Case Report Forms (CRFs)
- Source data - Requirements of medical records
- Investigator Brochure
- AE / SAE – Safety data
- Study medication
- Laboratory
- Types of monitoring visits
- Audits
- Study coordination
