Good Clinical Practice (GCP) Refresher
Course Description:
Refresh your GCP knowledge!
This detailed GCP refresher course provides an entertaining, efficient, and comprehensive summary of current best practices in the preparation, conduct, and completion of clinical trials with medicinal products, with a focus on Germany, using examples and case reports.
In 12 modules, learners are guided through the legal and ethical framework and the most important steps in conducting a study at the trial site. The refresher course is based on current legislation (CTR, Clinical Trials Regulation) and the GCP guideline ICH E6(R3), which came into force in Europe on July 23, 2025. A summary of the most important changes for investigators and their teams resulting from the introduction of E6(R3) concludes this refresher course.
In accordance with the requirements of the curricula applicable in Germany, a learning assessment consisting of 10 questions must be successfully completed at the end of the course. Important to know: The eLearning course has been recognised by the Schleswig-Holstein Medical Association with 8 continuing education credits in Category I.
Who is this course intended for? For investigators who need a refresher course, study nurses, studycoordinators, and employees of sponsors and CROs. Our interactive e-learning program allows you to complete the course at your own pace using your smartphone, tablet, or PC.
A modular structure and accompanying division into chapters based on content enable you to learn at your own pace. Once you register, you have four weeks to complete the course. After successfully completing the final assessment, you will receive a certificate of participation.
Learning Outcome:
- Current legal framework for the preparation and conduct of clinical trials in Europe and specifically in Germany
- Key roles in conducting a clinical trial
- The principal investigator's role in the organization and management of the clinical trial at the study site
- The study protocol
- Recruitment of study participants into the clinical trial
- "Best practice" for data collection, documentation, storage, and archiving, and further insight into the role of the clinical monitor, CRA
- The identification and correct documentation of adverse events (AE) at the study site
- The identification, assessment, and management of a serious adverse event (SAE)
- Summary of the most important changes with the introduction of the ICH E6(R3) GCP guideline
- Current legal framework for the preparation and conduct of clinical trials in Europe and specifically in Germany
- Key roles in conducting a clinical trial
- The principal investigator's role in the organization and management of the clinical trial at the study site
- The study protocol
- Recruitment of study participants into the clinical trial
- "Best practice" for data collection, documentation, storage, and archiving, and further insight into the role of the clinical monitor, CRA
- The identification and correct documentation of adverse events (AE) at the study site
- The identification, assessment, and management of a serious adverse event (SAE)
- Summary of the most important changes with the introduction of the ICH E6(R3) GCP guideline
Course Features
| Modules | : | 12 |
| Duration | : | 06:00 Hour(s) |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
GCP Refresher Course Introduction (FDRF0101)
Welcome to the GCP Refresher Course for investigators and study teams. This course helps you revisit ICH E6, CTR, and GCP principles. Through 12 interactive modules, you’ll explore real-world cases, engage in activities and reinforce key concepts at your own pace.
Legal Basis (FDRF0201)
This module covers the current legal basis for the preparation and conduct of clinical trials in Europe and specifically in Germany.
Clinical Trial Regulation (CTR) (FDRF0301)
Whether you are involved in coordinating and conducting clinical trials at a trial site or, for example, in management at a sponsor or CRO, without solid knowledge of CTR (Clinical Trials Regulation), we cannot properly prepare, conduct and complete a clinical trial in Europe in accordance with GCP. Refresh your knowledge in this module!
Clinical Trials: Key Roles (FDRF0401)
In this module, we look at the key roles in conducting a clinical trial. In every clinical trial, various experts work together to ensure that the trial is conducted in an ethical, efficient and GCP-compliant manner. This module covers who does what—and why.
Principal Investigator: Oversight and Delegation (FDRF0501)
The principal investigator plays an essential role in the organisation and management of clinical trials at the trial site. This module will examine the responsibilities this entails in terms of selecting team members, delegating tasks and providing oversight.
Clinical Study Protocol (CSP) Core Components (FDRF0601)
The trial protocol, also known as the study protocol, is the central document for conducting the trial and is the subject of this module. Without a GCP-compliant protocol that has been approved by the ethics committee and regulatory authorities, it is not possible to conduct a clinical trial in a consistent and high-quality manner.
Recruitment of Study Participants (FDRF0701)
Without study participants, there can be no study. In this module, we therefore look at the process of enrolling study participants in clinical trials and examine various case reports on obtaining informed consent (consent to participate in the study). Special considerations that need to be taken into account are presented.
Documentation (FDRF0801)
The “Documentation” module covers the most important steps from data collection in the source documents to entry into the eCRF. You will learn about best practices for collecting, documenting, storing and securing data, and gain further insight into the role of the clinical monitor, CRA.
Adverse Events (FDRF0901)
The identification and correct documentation of adverse events (AEs) at the trial site is essential for the safety assessment of the investigational product in a clinical trial. The module presents a focused review of best practices using examples.
Serious Adverse Events (FDRF1001)
Serious adverse events (SAEs) are a subset of AEs and must be reported to the sponsor immediately. This module covers the identification, assessment and management of SAEs.
Summary – Main Changes due to ICH E6(R3) (FDRF1101)
In this module, we summarise the most important changes brought about by the introduction of the GCP guideline ICH E6(R3).
Assessment (FDRF1201)
This is the assessment module and is designed to evaluate your understanding of key concepts covered in the course. It will help reinforce key learnings and essential knowledge. Take your time, answer each question carefully.
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