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Informed consent in clinical trials
Course Summary
Informed consent in clinical research is an ethical and regulatory requirement. A research participant must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Prospective participants must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential participants must agree, in writing, to participate. In this course we set out the underlying principles and ICH GCP expectations and provide examples of practical issues confronting healthcare professionals and participants.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s)โfor a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
โข Discuss the ethical principles underlying ICH GCP expectations for informed consent of trial participants
โข Describe the consent process
โข Specify information to be provided in discussion between healthcare professional and participant, in the informed consent form, and in any supporting document
โข Discuss practical issues for healthcare professionals and participants regarding informed consent
โข Describe circumstances in which third parties may act as proxies for prospective participants in the informed consent process
Who will benefit from this course
This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.
Module Outline
Roles
Research, Regulatory, Compliance
CPD Points
No
Region
Level
Foundation
Course Study Time
Approx 15 minutes
USA, Europe, Other