This is a professionally developed, interactive and engaging, online informed consent course. This course will give you an understanding of the background and practical implications of the valid Informed Consent process. The knowledge and understanding gained from this course, coupled with practical examples, are intended to give you the confidence to take a proactive role in the Informed Consent process within in your own workplace.
The course includes topics such as; Introduction to Informed Consent, What is Informed Consent? The Five Steps of the Informed Consent Process, The Informed Consent Form (ICF) and Patient Information Sheet (PIS), and the Challenges of the Informed Consent Process. It has also been recently updated to include information on electronic informed consent (or eICF) which, due to advances in technology is becoming much more widely used. We have also included changes which are part of the new ICH GCP E6 R3 update that is due to be released soon.
This course is suitable for anyone working within clinical research involved in the informed consent process. It was created by our subject matter expert who has worked in clinical research for over 30 years and has delivered training globally in all elements of informed consent.
- To understand the definition of Informed Consent (IC)
- To identify the reasons why Informed Consent is necessary
- To explore the process of gaining Informed Consent
- To have knowledge of what information should be contained in an Informed Consent Form (ICF) and in a Patient Information Sheet (PIS)