Good Clinical Practice (v.3)
ICH E6 (R2) + TransCelerate Approved
GCP 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 the human research.
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.
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.
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)
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.
Some feedback from our online participants on the ‘best aspects’ of this course
“I enjoyed the slide organisation and how information was presented. Particularly enjoyed the links to additional information/videos in the historical section.”
“Clear and concise.”
“Easy links, achievable modules, varied display.”
“Frequent quizzes were helpful for revising as I went along.”
” Presentation was extremely clear, as was the distinction between international standards, Australian requirements and laws relevant to Western Australia.”