ICH-Good Clinical Practice (GCP) E6 (R2) for Investigators – eLearning

Reasons to attend

You are a principal investigator, sub-investigator, study coordinator within clinical research; or other staff; then you need to comply with the International Council of Harmonisation Good Clinical Practice (ICH-GCP) guideline, including the recently released ICH-GCP E6 (R2) Addendum 2016.

Authorities as well as scientific journals imply compliance to ICH-GCP for all research with human subjects. This international standard is specifying conduct, performance, monitoring, documentation and reporting of the results of clinical research. Without training, or without experience in clinical trials, you might not fully grasp what it means to work according to GCP. This e-learning will give you the training as required by most of the European Regulators. 

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion
• This course has been mutually recognised by TransCelerate BioPharma
• This course has been reviewed by the Belgian GCP Inspectorate.

Course schedule

• Course credit: 3h (3 months period to complete course)
• Complete the course at anytime, anywhere!

Course Description

This 3 hour course will allow professionals, active in clinical research, to understand GCP-roles of everyone involved. All GCP duties of the investigator and his/her team according to chapter 4 of ICH-GCP will be elucidated.

In addition, the implementation of GCP is explained and illustrated using examples from practice. You will receive hands-on information about mandatory elements such as approval for clinical trials, informed consent, safety reporting and trial specific documentation. You will learn to link your clinical research tasks with ICH-GCP requirements.

Note that the complete and most recent 2016 version of the ICH-GCP is covered by this training. Secondly, our ICH-GCP training meets all the Criteria for ICH GCP Investigator Site Personnel Training as identified by TransCelerate BioPharma, which makes this course recognized by most sponsors.