GCP-CERTIFICATES AND OTHER TRAININGS
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 | ||
| Implementation | ||
| Investigational Medical Products (IMP`s) | Definition, storage, dispensation | |
| Screeening and recruitment | Strategies | |
| Inclusion and exclusion criteria | ||
| Randomization | ||
| 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 | |
| Filing | ||
| 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?
SPEAKER AT YOUR SYMPOSIUM
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?
