Just when you thought you knew how to manage informed consent (IC), new questions arise about how to best manage the IC issues to ensure human subject protections are supported, data integrity is maintained, and documentation supports effective compliance management for audit readiness. This session focuses on applying a critical thinking technique to confidently address the hard questions regarding informed consent process management.
This 90-minute course will give you practical answers to frequently-asked best practice questions related to monitoring informed consent by applying GCP and critical thinking techniques. These questions include:
- What should the site do to adequately address the investigator dating the consent document for the subject?
- What plan of action should the monitor facilitate with the site when the subject source documentation does not support consent prior to study procedures?
- What corrective and preventive action should be done when a subject has altered the content of an informed consent before signing?
Attend this interactive live session and you will be able to:
- Apply critical thinking techniques for effective IC problem solving
- Verify a subject’s informed consent process meets applicable GCP requirements, no matter the situation
- Identify and solve problems and issues regarding informed consent