According to the Pharmaceutical Products Act (12th amendment of the PPA), principal investigators must submit their GCP certificates to the ethics commission already at the beginning of a clinical study. Since the order of the German Medical Association in April 2013, principal investigators in all studies must prove to have completed a GCP training according to the PPA and MPA. 

We carry out GCP courses which are individually tailored to your study (PPA or MPA). This can be carried out in a joint event of all principal investigators in a study – for example also in the course of an investigator meeting. Alternatively, the GCP training can also be carried out as in-house training and can be combined with an initiation – thus, the effort for principal investigator and study nurse is manageable and at the same time all GCP guidelines are adhered to.

The contents of our GCP trainings strictly comply with the regulations of the Pharmaceutical Products Act:


Content    Description
Methodical basics    Delimitations pharmaceuticals / medicinal products / foodstuff / cosmetics
     Definition clinical investigation, NIS and safety assessment
     Phases of pharmaceuticals development (I - IV)
     Types of studies, study design
     Biometric basics
Ethical principles    Historical development of clinical research
     Declaration of Helsinki
     Vulnerable groups
Legal basics    EU law, federal law
     Authorization procedures (higher federal authority, assessment by Ethics Commission - Ethics Commission vote)
Planning and preparation    Relevant documents: investigation plan, investigator´s brochure, patient information, CRF, etc.
     Responsibilities (sponsor, CRO, monitor, investigator)
     Resource planning
     Allocation of tasks within the team
     Investigation contract
Investigational Medical Products (IMP`s)    Definition, storage, dispensation
Screeening and recruitment    Strategies
     Inclusion and exclusion criteria
Information and consent     
Regular implementation    Prüfplankonformer Studienablauf, Abbruchkriterien, Dokumentation, Queries, Archivierung
Monitoring, audits, inspections     
Adverse Events, security    Definition AE, SAE, SAR, SUSAR, etc. , causality assessment
     Reporting obligation and reporting deadlines
Finalisation of clinical investigation    Close Out Visit
     Final report and publication
Assessment of learning success     


Additionnally, we offer training to following other subjects:

  • Introduction to data management
  • Principles of statistical evaluations
  • Explaining eCRF – instructions to all relevant programmes
  • Carrying out literature research and introduction to Endnote
  • Compiling Powerpoint presentations

Depending on our agreement, the trainings can take place in our training rooms, on your premises as in-house training or via internet.

Upon request further individual trainings are possible.

Which training do your team needs for your study?

training medical study


We want to help you make your symposium symposium a great success! Here, we also gladly take on lectures and presentations on topics regarding clinical studies and statistics. Of course, the presentations can be held in German or English.

What is your symposium about?