Implementing a Patient-Centered Informed Consent Process

Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language.

An effective informed consent process involves more than simply reviewing a document with a potential participant and applying signatures.  This critical process lays the foundation for a subject’s participation in a clinical trial and directly impacts regulatory compliance and site performance with respect to the ability to meet recruitment requirements, achieve and maintain subject compliance, and retain trial subjects.

This course is essential for those who are directly involved in and responsible for conducting informed consent discussions and developing informed consent forms. Use the included job aids to immediately take positive actions for your next informed consent discussion.

Upon completion of this training program, participants should be able to:

• Describe the three critical elements of patient-centered care, which are integral to the consent process.
• List the ways to ensure understanding during the consent process.
• Develop a personal action plan to improve your organizational policies and procedures around the consent process.

This course helps physicians and nurses engaged in the care of patients within a clinical trial, as well as other site personnel, build competency in Clinical Trials Operations (GCPs), Communication and Teamwork, and Ethical and Participant Safety Considerations. Explore Competencies >

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date