The conduct of clinical studies involving human participants can only be ethically justified if they are appropriately planned, conducted, evaluated and reported in accordance with scientific and ethical standards. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in recent years. It is important that all persons involved in a clinical study comply with these regulations and quality standards to obtain reliable study results.

The objective of this training is to provide participants with a solid foundation in the legal, ethical, administrative, and scientific aspects of clinical studies.

Accredited and Certified GCP Online Training

The content and scope of this GCP Basic Training fully meet the requirements established on 3 July 2025, by the Executive Board of the German Medical Association (Bundesärztekammer) and approved on 6 June 2025, by the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK).

The Bremen Medical Association (Ärztekammer Bremen) has accredited the GCP Basic Training with 16 Continuing Medical Education (CME) credits. This accreditation is recognized by the medical associations of all other federal states. The eLearning quality criteria of the German Medical Association apply.

Upon successful completion of the Basic Training, participants can conveniently download and print their GCP certificate. The certificate documents the content and scope of the training, thereby meeting the documentation requirements of German ethics committees.

Description and Content of the GCP Basic Training

The content of this GCP Basic Training was compiled by Dr. Andreas Grund based on more than 18 years of experience in clinical studies and prepared by the GCP-Service team drawing on many years of practical experience. The training content serves as practical guide and clarifies common issues and misunderstandings that have arisen in recent years.

Our training materials are continually updated to ensure they always comply with current laws (subject to change).

Basic Training Modules

The Basic Training course consists of 8 teaching units (UE), which are divided into the following modules:

1. Basics (2 UE)  
1. Ethical Principles
2. Legal Basis 
3. Types of Clinical Studies
2. Implementation (6 UE)
1. Selection of Participants and Informed Consent
2. Protocol-Compliant Conduct and Documentation
3. Clinical Trial Monitoring and Management of Changes
4. Practical Exercise: Safety-Related Events  

All modules are designed in accordance with the following current standards: ICH-GCP E6(R3), ISO 14155:2026, ISO 20916, (EU) 536/2014 (CTR), (EU) 2017/745 (MDR), (EU) 2017/746 (IVDR), AMG, MPDG, and GDPR.

Instructions for Participants and General Conditions

All modules must be completed in the specified order. Each module consists of a 30- to 45-minute learning unit, followed by a test to assess learning progress.

Each test consists of ten randomly selected questions. Participants have three attempts to pass each test. The questions are newly randomized for each attempt. A minimum score of 80% is required to proceed within the GCP Basic Training. Completing a test typically takes approximately 10 minutes.

According to the Medical Association's requirements, the entire course must be completed within two months to access the GCP Basic Training Certificate online. If this time elapses and not all tests have been completed successfully, the course must be restarted in full.

We will submit your continuing medical education (CME) credits on your behalf. These credits are submitted to the German Medical Association once a year. Please provide your continuing education number (EFN) when booking.

Advantages of an Online GCP Basic Training Course

The online training format offers flexibility, accessibility, and practical suitability. Participants may complete the course at their own pace and from any location and can access the training content at any time within the two‑month access period.