As clinical trials have moved toward electronic methods for patient recruitment, trial management and data collection, the provision of candidate informed consent has remained a paper-based document that is increasingly outside the trial management process. More and more, the possibility of using electronic formats to enhance the consenting process is being considered. This audio conference examines the FDA guidelines for consent and their relationship to electronic consenting and inspection, as well as the importance of making connections to e-trial management and data capture.

In this presentation, our speaker outlines the steps to using electronic consent and gives examples of how electronic presentation of an informed consent document can increase candidate understanding and access to information. Dr. Brink also provides insight into making the e-consent decision, how to use e-consent to manage trial risk, and FDA guidance regarding e-consenting and its integration into the clinical trial process.

This audio conference covers:

• How electronic consenting assists the candidate, trial site staff and sponsor
• Steps for implementing an electronic consent process
• Current FDA guidance as it relates to the electronic informed consent process
• Considerations when implementing an electronic informed consent document
• How the use of electronic informed consents can assist in managing trial risk

About the speaker:

Dr. Susan Brink founded ConsentSolutions, Inc. in 2005 to create and market innovative, media-based approaches to informed consent for clinical trials. With over 25 years of experience in research and development of patient and consumer health information products, Dr. Brink is a recognized expert in leveraging new technologies to support patient education and decision making. She is also the founder of HealthMark Multimedia, a company that designs and builds multimedia decision support tools for patients and caregivers.

Dr. Brink has published articles about methodologies for increasing the effectiveness of informed consent communications and is regularly invited to speak at national academic conferences. She has also acted as principal investigator on numerous NIH grants exploring technology approaches to patient decision making, and has served on the faculty at the Center for Health Promotion Research and Development at the University Of Texas School of Public Health, Houston, and in the Pediatric Department at the University of Texas Medical Branch, Galveston.

Who should attend?

• Clinical Research & Operations
• Global Clinical Outsourcing
• e-Clinical & Technology Implementation
• Legal Affairs