ICH Good Clinical Practice (GCP) E6 R2 training modules cover key components of GCP including responsibilities, approvals, informed consent, documents, data management, safety and adverse events. This training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. A certificate of completion is awarded at the completion of this training.
All human research conducted in the WA public health system (WA Health) should be undertaken in accordance with the principles contained in the ICH GCP Guideline. As such, health and medical researchers conducting research within WA are encouraged to undertake ICH GCP training.
Does your Health Service Provider/site currently mandate that researchers undertake ICH GCP training prior to conducting research?
GOOD CLINICAL PRACTICE (GCP) TRAINING MODULES
GCP training M1: ORIGINS AND PRINCIPLES
This module will cover the principles of GCP and the need to continually update skills as well as identify the set of guidelines which govern human research.
GCP training M2: RESEARCHERS RESPONSIBILITIES AND ESSENTIAL DOCUMENTS
In this module you will learn the roles of the research study team and record management requirements related to essential documents.
GCP training M3: INFORMED CONSENT
This module will cover the definition of the informed consent process; considerations for developing an informed consent form; the Human Research Ethics approval process for consent, etc.
GCP training M4: SAFETY REPORTING
This module covers: the importance of safety reporting, the classification of different adverse events and reactions and reporting requirements for specific staff (e.g. Investigator, Sponsor, Institution/Study Site)
GCP training M5: SOURCE DATA AND DATA MANAGEMENT.
This module will cover the processes of effective data management through an understanding of important topics such as source data; data collection monitoring.