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.
Why Should You Complete ICH GCP Modules?
Some feedback from our online participants on the ‘best aspects’ of this ICH GCP training:
“It was well laid out which made it easy to follow. It was good that it had the quizzes spaced out as this acted as a break type activity and meant I could really focus in on what I had just been reading and solidify that knowledge.”
“Contains a broad overview of good clinical practice but also surprisingly detailed information. This is by far one of the best online course I’ve done in a long time.”
” It was easy to navigate through the course and the use of “real people” involved in research is clever.”
“The ability to download and have access to legislation and governance documents. The clear nature of the information presented made learning easy.”
“The different methods of delivering the information kept it interesting and helped to maintain concentration. I also liked the YouTube videos.”
“It Provides a very good overview and the parts make sense when seen in a logical way. There are many prompts to more detailed references on the topics and they can be followed up for more information. Building in breaks was a good idea.”