e-Learning: Good Clinical Practice - GCP in the EU and Germany
Regulatory landscape, responsibilities, and practical work in clinical trials
- The basics of GCP in the EU & in Germany
- Free demo account to try it out
- IKnowledge checks after each module (*) and a certificate of completion
- Officially certified: ISO 9001 + 21001
e-Learning
From
490,00 €
plus VAT
Services & Process
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is € 490,- (excluding German VAT). You can access the modules/single lessons as often as you want during this time. You will be awarded a certificate of completion at the end.
Booking details
e-Learning
From
490,00 €
plus VAT
Services & Process
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is € 490,- (excluding German VAT). You can access the modules/single lessons as often as you want during this time. You will be awarded a certificate of completion at the end.
The fundamentals of Good Clinical Practice - use this e-learning course to build a solid basis for your work in clinical drug trials in the EU and in Germany. Learn what it means to plan and conduct clinical trials in accordance with GCP, and discover the specific responsibilities you have in your day-to-day work in clinical trials. On-demand learning - complete the course anytime!
Your speaker
Dr. Steffi Hansen
Serum Life Science Europe GmbH, Hannover
Director QA & Deputy QPPV;
After completing her studies in pharmacy and her post-doctoral fellowship, Dr Steffi Hansen began her career in the pharmaceutical…
Your speaker
Dr. Steffi Hansen
Serum Life Science Europe GmbH, Hannover
Director QA & Deputy QPPV;
After completing her studies in pharmacy and her post-doctoral fellowship, Dr Steffi Hansen began her career in the pharmaceutical industry as a project manager and moved into quality management a few years later. Since 2018, she has served as Director of Quality Assurance and Data Protection Officer; since 2023, she has also served as Deputy Qualified Person for Pharmacovigilance.
Dr Steffi Hansen handles tasks in the area of QA/QMS consulting and is a passionate trainer for numerous courses in clinical trials and pharmacovigilance.
What to Expect
- Regulatory framework and key terminology
- The parties involved in a clinical trial and their responsibilities
- The authorization process for clinical trials in the EU
- Study documentation, essential documents, Trial Master File
- Risk-based quality management
- Investigational medicinal product handling
- Drug safety: classification of incidents, reporting and timelines
- Proper handling of GCP deviations and violations
Who Should Attend
This e-learning course is designed for beginners and participants with limited experience in clinical research who require a foundational understanding of the Good Clinical Practice guideline in order to properly fulfill their responsibilities in clinical trials conducted in Germany or Europe, and to understand the obligations it imposes on them as well as on all other parties involved in clinical trials.
This e-learning is the perfect opportunity to become familiar with GCP requirements step by step and to work through the content at your own pace and schedule.
Important note for medical study personnel: This e-learning course does not align with the curricula of the German Medical Association (BĂ„K) and German Working Group of Medical Ethics Committees (AKEK).
Objective of the Event
Good Clinical Practice (GCP) is the core framework for clinical trials and an indispensable reference for your day-to-day work in clinical studies.
This e-learning takes you step by step through the key topic areas and provides a solid understanding of regulatory requirements, essential terminology, and the roles and responsibilities of sponsor and investigator. You will learn the fundamentals of planning, approval, and practical conduct of clinical trials, including risk-based quality management and drug safety. The modules include videos, audio content, interactive elements, and exercises to ensure active and sustainable knowledge transfer.
After completing the e-learning, you will have a comprehensive overview of GCP. You will understand the requirements for planning and conducting clinical trials, be aware of your responsibilities, and be well prepared to carry out your tasks in clinical trials involving investigational medicinal products in accordance with GCP standards.
The e-learning requires about 5 hours to complete. It was developed in 2025 and translated into English in 2026 with the assistance of AI technology.
Your Benefit
- Compact foundational GCP knowledge - what does Good Clinical Practice mean in the day-to-day conduct of clinical trials in the EU and Germany, and what are the requirements of ICH E6(R3)?
- On-demand learning - gain knowledge whenever you want, at your own individual pace
- Knowledge checks after each module (*) and a certificate of completion upon finishing the e-learning as documentation of GCP training
(*) The learning assessments are generated on the basis of an automated, non-individualized multiple-choice test.
Programme
- Regulatory framework and core regulations
- Clinical trial phases and the path to approval
- Essential terminology you should know in clinical trials
- The stakeholders involved, their roles and responsibilities
- The investigator`s responsibilities
- The sponsor`s responsibilities
- Shared responsibilities of sponsor and investigator
- Basics of the approval process
- Submitting an application via CTIS: application contents, evaluation, and process
- Changes to ongoing clinical trials
- Proper clinical trial documentation - the basics
- Essential documents
- The Trial Master File (TMF)
- Structure, contents, and TMF Management Plan
- Quality control
- Archiving and inspection readiness
- Regulatory requirements in accordance with ICH E6 and E8
- The principles of quality management: quality by design (QbD), quality assurance, and quality control
- Risk management process
- Risk identification
- Risk analysis and assessment
- Risk control and risk reassessment
- Risk communication
- GMP requirements for investigational medicinal products
- Responsibilities of the sponsor, investigator, and Qualified Person (QP)
- Labeling requirements for IMPs
- Definitions and evaluation criteria for adverse events (SAE/SUSAR)
- Safety communication, reporting, and deadlines
- The Sponsor's Periodic Safety Reports (DSUR & PBRER)
- Definitions, regulatory requirements, and responsibilities
- Objectives and the process of nonconformity management
- Corrective and Preventive Actions (CAPA)
Module 1: Regulatory landscape
Module 1: Regulatory landscape
- Regulatory framework and core regulations
- Clinical trial phases and the path to approval
- Essential terminology you should know in clinical trials
Module 2: The key stakeholders in a clinical trial
Module 2: The key stakeholders in a clinical trial
- The stakeholders involved, their roles and responsibilities
- The investigator`s responsibilities
- The sponsor`s responsibilities
- Shared responsibilities of sponsor and investigator
Module 3: The approval process for clinical trials in the EU
Module 3: The approval process for clinical trials in the EU
- Basics of the approval process
- Submitting an application via CTIS: application contents, evaluation, and process
- Changes to ongoing clinical trials
Module 4: Essential documents and the Trial Master File
Module 4: Essential documents and the Trial Master File
- Proper clinical trial documentation - the basics
- Essential documents
- The Trial Master File (TMF)
- Structure, contents, and TMF Management Plan
- Quality control
- Archiving and inspection readiness
Module 5: Risk-based management in clinical trials
Module 5: Risk-based management in clinical trials
- Regulatory requirements in accordance with ICH E6 and E8
- The principles of quality management: quality by design (QbD), quality assurance, and quality control
- Risk management process
- Risk identification
- Risk analysis and assessment
- Risk control and risk reassessment
- Risk communication
Module 6: The investigational medicinal product (IMPD)
Module 6: The investigational medicinal product (IMPD)
- GMP requirements for investigational medicinal products
- Responsibilities of the sponsor, investigator, and Qualified Person (QP)
- Labeling requirements for IMPs
Module 7: Drug safety in clinical trials
Module 7: Drug safety in clinical trials
- Definitions and evaluation criteria for adverse events (SAE/SUSAR)
- Safety communication, reporting, and deadlines
- The Sponsor's Periodic Safety Reports (DSUR & PBRER)
Module 8: Handling deviations and violations
Module 8: Handling deviations and violations
- Definitions, regulatory requirements, and responsibilities
- Objectives and the process of nonconformity management
- Corrective and Preventive Actions (CAPA)
Downloads
Request the documents using our form.
Brochure
Abbreviation list Clinical Research
Further Informations
Your learning objectives in detail
- Be familiar with the regulatory requirements for clinical drug trials in the EU and in Germany.
- Understand what Good Clinical Practice means for the practical work involved in planning, conducting, and ensuring data integrity in clinical trials.
- Internalize the roles and responsibilities of those involved in clinical trials and be familiar with essential documents as well as the requirements for study documentation.
- Comprehensively understand the procedures and processes of risk-based quality management and drug safety in clinical trials.
- Develop an awareness of one’s own responsibilities in clinical trials and be able to act accordingly.
Learn GCP - anytime and at your own pace
This e-learning course gives you the opportunity to acquire basic knowledge of Good Clinical Practice whenever and wherever you like.
The e-learning course consists of 8 pedagogically designed learning modules. Through videos, audio recordings, interactive learning elements, and exercises, you will acquire essential knowledge about Good Clinical Practice, specifically regarding the planning and conduct of clinical drug trials in the EU and in Germany. You will learn about regulatory requirements, key definitions and terms, as well as the roles and responsibilities that all stakeholders involved in clinical trials must fulfill.
Each learning module concludes with a knowledge check. Once you have completed all modules and passed the knowledge checks, you will receive a GCP certificate that you can download immediately and use as proof of qualification. The knowledge checks are generated based on an automated, non-individualized multiple-choice test.
Completing the e-learning course will take approximately 5 hours.
How exactly does it work?
1. You sign up for the e-learning course on our website.
2. You will receive an email with your login credentials for our customer portal, and from there you will be redirected to the learning platform.
3. You start with the first learning module and complete the remaining modules at your own pace.
4. You complete each module with a knowledge check.
5. After successfully completing all modules, you will receive a GCP certificate, which you can easily download.
Try the DEMO version of our e-learning course for free and get a glimpse into our learning world!
Special conditions for group accounts
Would you like to train multiple employees, or do you need a quote for a flexible annual access to provide new hired person with the basic knowledge they need for their roles at any time?
No problem - we also offer attractive group accounts!
Or would you like to offer the e-learning courses on your company’s internal learning platform?
That’s possible too: You can also purchase our e-learning courses as SCORM files, which can be easily integrated into your company’s internal learning platform.
Contact us directly: r.goerner@forum-institut.de or v.kluever@forum-institut.de. We would be happy to provide you with a customized quote!
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Further Information
DEMO-Account e-Learning
Try out our e-Learning programmes free of charge and without any obligation.
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We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Regine Görner
Dr. Verena KlĂĽver
r.goerner@forum-institut.de
v.kluever@forum-institut.de