Refresher course for investigators and medically qualified members of a study site team conducting clinical trials, performance studies, or other clinical investigations in accordance with European Regulations (EU) No. 536/2014 (human medicinal products), No. 2017/745 (medical devices) and No. 2017/746 (in vitro diagnostics)

Refresher training is intended for study personnel who have not actively participated in conducting clinical studies according to the German Medical Association curriculum for more than three years. In practice, completing a refresher course is common every two years.

With a total of four modules, each lasting 30-45 minutes, participants can use this program to acquire basic knowledge of clinical research. Upon successfully completing the Good Clinical Practice (GCP) online training, participants can download a GCP certificate, helping ensure the continued high quality of clinical trials.

Our AMG/MPDG Refresher Course

This course is intended for individuals who have previously completed an investigator training course and now need to demonstrate refresher training to their responsible ethics committee. A refresher course is useful because topics not applied regularly can be easily forgotten. At the same time, a refresher course should not place unnecessary time burden on trial staff. Most German ethics committees require proof of completion of a four-hour refresher course, which is why we have designed our course accordingly

Accredited and Certified GCP Online Training

This refresher training corresponds to a “refresher course” for investigators and medical members of an investigation team for clinical trials, performance studies, or other clinical investigations in accordance with European Regulations (EU) No. 536/2014 (human medicinal products), No. 2017/745 (medical devices), and No. 2017/746 (in vitro diagnostic medical devices).

The content and scope of the GCP online training meet all requirements established on July 3, 2025, by the Executive Board of the German Medical Association and approved on June 6, 2025, by the Working Group of Medical Ethics Committees in the Federal Republic of Germany. The Bremen Medical Association has accredited our refresher training with eight (8) continuing medical education (CME) credits. The Bremen Medical Association's assessment is recognized by the medical associations of other federal states. The eLearning quality criteria of the German Medical Association apply.

After completing the refresher training, participants can conveniently download and print their GCP certificate. The certificate details the content and scope of the training, thereby meeting the documentation requirements of German ethics committees' requirements.

Description and Content of the Training Course

This GCP/MPDG refresher course was designed by Dr. Andreas Grund, based on 18 years of professional experience in clinical trials. The result is a highly practical training program. It covers the ethical, legal, and administrative principles necessary for clinical trials and addresses common misconceptions in professional clinical research practices. We continuously update our training content to ensure it always complies with current legislation (without guarantee).

Refresher Training Modules

Our AMG/MDPG refresher course consists of four modules, each lasting approximately 30-45 minutes, which can be accessed online:

1. Basics – Ethical Foundation
2. Planning and Preparation – Responsibility, Resource Planning, and Task Allocation within the Team
3. Implementation
   1. Screening, Inclusion and Exclusion Criteria, and the Information and Consent Process
   2. Treatment of Patients, Risk Mitigation Measures, and the Proper Handling of Investigational Medicinal Products
   3. Practical Exercise: Safety-Related Events
   4. Monitoring Clinical Trials and Changes During the Course of the Study
4. Focus Module: ICH GCP E6 (R3) – Summary of Essential Changes

All modules are designed in accordance with the following current standards: ICH-GCP E6(R3), ISO14155, ISO20916, (EU) 536/2014 (CTR), (EU) 2017/745 (MDR), (EU) 2017/746 (IVDR), AMG, MPDG, and GDPR. 

Refresher Training Procedure – Download your Certificate Online

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

The tests consist of ten randomized questions. Participants have three attempts to successfully complete each test. The questions are randomized each time a test is taken. Participants must answer at least 80% of the questions correctly to continue with the GCP/MPDG refresher course. Answering the questions takes approximately 10 minutes.

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

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

Advantages of an Online GCP/MPDG Refresher Training Course

Take your refresher course online with us! With our online training, you can learn independently wherever and whenever it suits you best. All you need is a computer or tablet with stable internet access and an up-to-date internet browser. Once you receive your login details, you can access the training at any time within two months.