Advanced Education: Good Clinical Practice (GCP)

Contact

Name

Claudia Maria Wedekind

Secretary´s office

Phone

work
+49 241 80 80092

Email

E-Mail
 

Our GCP courses are constructed in modules and take into consideration the official announcements of the German Medical Association regarding the curricular advanced education of examiners and their representatives and members of the review group for clinical examinations in accordance with the Medicinal Products Acts, AMG and MPG.

Participants receive a certificate of participation for each individual module as well as a certificate for each exam they successfully pass.

 

Dates

If you wish to attend a GCP-Course, you can find the dates in the registration form attached below.

 

Modules - Courses Offered and Content

Basic Module (Module 1)

In the Basic Module (8 instructional units plus exam), participants learn the fundamentals of clinical investigations in accordance with the AMG and MPG. They are as follows:

  • Ethical and methodological fundamentals
  • Planning and preparation of trials in accorrdance with AMG and MPG
  • Particulars about protecting vulnerable groups
  • Consent from trial participants
  • Construction and working with Trial Master File and Investigator’s Site File, essential documents
  • Implementation of inclusive quality-assurance measures
  • Undesired events (including practical exercises)

AMG Advanced Course (Module 2)

The AMG Advanced Course (8 instructional units plus exam) advances the basic knowledge for clinical investigations with medications to include the following topics

  • Management of clinical trials, financing, investigator contracts, insurance
  • Creation of the trial protocol including design, randomization, blinding, dealing with crucial changes
  • Handling investigational products
  • Proposal processes in accordance with AMG (including BfS proposal processes) among ethics committees and higher federal authorities
  • Data management, data protection
  • Evaluation and publication

MPG Advanced Course (Module 3)

The MPG Advanced Course (8 instructional units plus exam) advances the basic knowledge about clinical investigations with medical products:

  • Classification of medical products, requirements of the investigator handbook (including practical exercises)
  • Additional definitions (manufacturers, putting products on the market, notified bodies, etc.) as well as in comparison to the AMG
  • Management of clinical trials, financing, investigator contracts, insurance
  • Creation of the trial protocol including design, randomization, blinding, dealing with crucial changes
  • Handling investigational products
  • Proposal processes (complete process and refraining from authorization) in accordance with the MPG (including BfS proposal processes) among ethics committees and higher federal authorities
  • Data management, data protection
  • Requirements for documentation and registering undesired events in accordance with the MPG in conjunction with the respective legal guidelines, corrective measures
  • Evaluation and publication

Refresher Course

In addition to our basic and advanced modules, we offer a refresher course. This is suitable for anyone who has already completed an at least two-day GCP course.

We recommend taking a Refresher Course at least every two years. Over five hours the most important topics are once again addressed and taught. This helps to make sure everyone knows the fundamentals as a whole and to provide information about any legal changes.