Going “E” With Informed Consent for Clinical Trials
Want to increase enrollment, retain more participants, reduce compliance risk and speed your product to market? Heck, yes!
Then read on…
As consent forms get longer and more complex, participant enrollment and retention rates fall.
Innovative pharma/device sponsors and CROs have started making consent forms more visual, not just lines of text.
This audio CD/Transcript gives attendees straightforward advice and guidance. Attendees learn the benefits of e-consenting, which include:
- How a more visual format overcomes language and literacy barriers
- Why electronic consent makes data gathering and remote monitoring easier on sponsors and subjects
- How version control and audit trails are easier to maintain and reduces the risk of non-compliance
- Why e-consenting speeds up trial enrollment and gets products to market faster
Clinical trial specialists Dr. Susan Brink and Sherri Bracy answer these questions:
- What should you ask your IRB when initiating e-consent — how will they view the process and will it affect trial approval and monitoring?
- How does a site/CRO or sponsor determine which e-consent application is the best fit for their organization?
- What are the features that every e-consent application must have (e.g., revision control, audit trails)?
- Tips and tricks for monitoring and auditing e-consents
- Tales from the trenches — what are some of the common impacts an e-system has on the IRB process?
Dr. Susan Brink is the President and CEO of Consent Solutions, Inc. Dr. Brink co-founded Consent Solutions in 2005 to further the development of media-based approaches to informed consent for clinical trials. Dr. Brink previously served as the principal investigator on numerous NIH grants exploring technology approaches to patient decisionmaking. She has more than 25 years of experience in research and development in patient and consumer health.
Sherri Bracy is the founder and director of Bracy Consulting, LLC. Ms. Barcy spent the past 28 years working for Alcon Laboratories, where she started as a biostatistician and eventually ended her career as the Associate Director for R&D Quality Product Improvement. For 10 years, she served as the R&D Learning Director responsible for R&D-wide learning systems and programs, global clinical training, and library information science departments. She has extensive experience providing practical solutions for pharmaceutical and device clinical development.
Here’s a suggested list of potential participants from your organization:
- Compliance officials
- QA/QC personnel
- Regulatory affairs professionals
- Training personnel
- Procedural document writers
- Clinical operations personnel
- Clinical investigators
- Clinical research coordinators
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600