Making Your Consent Forms Readable: The Why and the How - Q&A

By Dr. Wendy Tate | Director, Data Analytics, Nimblify, Inc.
June 29th, 2016

Summary: In this Q&A, Dr. Wendy Tate of Nimblify, Inc. answers attendee questions from her webinar "Making Your Consent Forms Readable: The Why and the How." Question topics include NPRM, federal regulations, cost language, central IRBs and more.

Estimated reading time: 1 minutes

Dr. Wendy Tate of Nimblify, Inc. answers attendee questions following her recent webinar “Making Your Consent Forms Readable: The Why and the How.” In her webinar, Wendy focused on the HHS and FDA requirements regarding the content of an informed consent form, and provided tips for making consent forms more understandable to the general study population. Questions she answers in this Q&A include:

  1. What is the impact of NPRM (Notice of Proposed Rulemaking) on consent forms?
  2. Do you have any tips for sites working with a central IRB in multi-site studies?
  3. What is the best way to present risks if there are multiple drugs in a study?
  4. What are the federal regulations on consent forms?
  5. Writing cost language can be very difficult. Do you have tips for simplifying it?
  6. Do you have any tips on consenting pediatric subjects?

Use the playlist below to navigate through each question and hear Dr. Tate’s response.

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About the Author

Wendy Tate is Director of Data Analytics at Nimblify, Inc, a clinical trials technology company. In her current role she collaborates with institutions to develop and validate meaningful and quality metrics regarding various aspects of clinical trial operations. Prior to Nimblify, Wendy worked at the University of Arizona for 15 years, where she spent 2 years at the University of Arizona Cancer Center in clinical trials administration and 6 ½ years at the IRB where she focused her efforts on operational metrics, process improvement, and compliance. She has a master’s degree in Applied Biosciences and recently received her PhD in Pharmaceutical Economics, Policy, and Outcomes, with a minor in Epidemiology.

Website: Nimblify, Inc.

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