This training is designed for non-physician clinical research site staff, including study nurses, clinical trial assistants, and clinical trial coordinators. Well-qualified and motivated trial staff contribute greatly to the quality and success of every clinical trial site.

The online training consists of six modules, each of which takes approximately 30–45 minutes to complete. After successfully completing all modules and assessments, participants can download a certificate of completion online. The certificate can be used to demonstrate GCP knowledge and maintain high-quality standards in clinical research.

Who are Non-Physician Clinical Research Site Personnel?

Study nurses and clinical trial assistants are professionals who play a key role in the proper conduct of clinical trials. Despite their critical importance, this group is often overlooked. However, it is widely recognized that the quality of a trial site frequently depends on the expertise and performance of its study nurse and supporting staff.

Study nurses perform a broad range of organizational, administrative, and operational responsibilities throughout a clinical trial. They support the informed consent process, coordinate participant visits, provide ongoing care to participants throughout the study, support follow-up activities, and ensure accurate and complete trial documentation.

All individuals involved in conducting a clinical trial should understand and carry out their responsibilities in accordance with applicable national legislation and the international quality standard of Good Clinical Practice (GCP). This online study nurse course aims to provide participants with a practical understanding of the legal, ethical, operational, and administrative aspects of conducting clinical trials.

Is Study Nurse Training an Official Qualification?

Currently, there are no legal requirements that specify how non-physician clinical trial staff must be trained. Since "study nurse" is not a legally protected profession in Germany, there is no standardized, government-recognized educational program for this position.

This course serves as a practice-oriented continuing education program that provides the essential knowledge required for participation in clinical trials.

This training is not part of the German Medical Association's (Bundesärztekammer) curriculum. However, sponsors or employers may require evidence of appropriate Good Clinical Practice (GCP) training as part of their quality management systems.

Description and content of the GCP Study Nurse Online Training

Dr. Andreas Grund and his team developed the course content based on more than 18 years of professional experience in clinical research. Consequently, the training has a strong practical focus and addresses many common challenges and misconceptions in Good Clinical Practice.

Our training materials are continuously reviewed and updated to reflect current legislation, regulations, and international guidelines (without guarantee).

Modules of the GCP Study Nurse Online Course

The course consists of six modules, each of which takes approximately 30–45 minutes to complete.

1. Types of Clinical Studies
2. Legal Basis
3. Participant Information and Consent
4. Planning and Preparation
5. Treatment and Documentation
6. Practical Exercise: Reporting Safety-Related Events

Course Structure: Download Your GCP Certificate Online

All modules must be completed in the prescribed order. Each module includes a presentation followed by a knowledge assessment. Each assessment consists of ten randomized multiple-choice questions. Participants have three attempts to successfully complete each assessment, and the questions are randomized for every attempt. A minimum score of 80% is required to pass and proceed to the next module. Completing each assessment typically takes around 10 minutes. Upon successfully completing all modules and assessments, participants can download their Certificate of Completion online. The narration in this course uses an AI-generated synthetic voice. All educational content has been reviewed and approved by qualified human experts.

Benefits of the GCP Study Nurse Online Course

Complete your study nurse training online with maximum flexibility. Our online course allows you to learn wherever and whenever it best suits your schedule. All you need is a computer or tablet, a reliable internet connection, and a current web browser. After receiving your login credentials, you will have access to the course for two months and can complete the modules at your own pace during this period. If the access period expires before you have successfully completed all required assessments, you will need to repeat the course in whole or in part.