Good clinical practice (GCP) E6 (R2) Training with Certification

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.

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 the 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.

Why Should You Complete ICH Good Clinical Practice (GCP) 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 GCPtraining prior to conducting research?

120

Each Module Will Take Approximately 120 Minutes to Complete

Some feedback from our online participants on the ‘best aspects’ of this ICH Good Clinical Practice (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.”

 

Rebecca Kuzminski from Telethon Kids Institute (TKI)

“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.”

 

Krist Ewe from Perth Children’s Hospital (PCH)

It was easy to navigate through the course and the use of “real people” involved in research is clever.”

Christelle Schofield from Edith Cowan University (ECU)

“The ability to download and have access to legislation and governance documents. The clear nature of the information presented made learning easy.”

 

Duncan Wright from Fiona Stanley Hospital

“The different methods of delivering the information kept it interesting and helped to maintain concentration. I also liked the YouTube videos.”

 

Laura Laing from Telethon Kids Institute (TKI)

“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.”

 

Colin Keogh from St John of God Health Care (SJGHC)

Other Online Modules