Electronic Informed Consent for Clinical Trials - Webinar CD/Transcript

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Electronic Informed Consent for Clinical Trials: Best Practices

The simple fact about electronic informed consent is that it's much more than a simple digital handwritten signature. 

Clinical trial sites can now use audio, video and interactivity to educate participants more thoroughly and consistently. These innovations can help you reduce barriers to trial participation, improve patient comprehension and retention and accomplish the same completion goals with fewer patients. 

There’s a tremendously powerful up-side for you in transitioning to electronic consent software.

Dr. Susan Brink, executive vice president, e-consent Products and Services at Enforme Interactive, Inc. presents this learning opportunity.  She has over 25 years of experience in research and development in the area of public health interventions, patient and consumer health information and patient decision­making.

Dr. Brink will bring you up to speed on the FDA and NIH guidances and help you feel more confident about moving your company from pen and paper to the new technology.

Dr. Brink will also talk about other major benefits of employing e-consent software and answer your toughest questions about it, including:

  • How do you know which software is right for your company?
  • What assurances are there that a site-wide system can remain fully compliant as regulations change? 
  • How much training will be needed for your staff to understand and use the new software properly?
  • Can electronic media help keep patients better informed?
  • How much is too much — or too little — to spend on an e-consent system?

And she'll provide you with checklists and guides that will help you make an informed decision about the software that's best for you, as well as prepare you to talk to prospective vendors:

  1. A 5-step overview of the e-consent process
  2. 7 questions you should ask the provider of an e-consent application
  3. A step-by-step workflow for e-consent development
  4. 4 pillars of successful e-consent implementation

Changing over to an e-consent system is probably not far away in your future. Let FDAnews and Dr. Susan Brink guide you in making the best possible decisions for your company. Plan to order the webinar Electronic Informed Consent for Clinical Trials: Best Practices CD and transcript.

  • Compliance officials
  • QA/QC personnel
  • Regulatory affairs professionals
  • Training personnel
  • Procedural document writers
  • Clinical operations personnel
  • Clinical investigators
  • Clinical research coordinators

Susan G. Brink, DrPH
Exec. Vice President, e-consent Products and Services
Enforme  Interactive, Inc.

Susan Brink has over 25 years of experience in research and development in the area   of public health interventions, patient and consumer health information and patient decision­making. Dr. Brink has been involved in the creation of e-consent products for patients and clinical staff since 2003. As the principal investigator on an NIH Clinical Trials Office SBIR grant to develop an electronic approach to informed consent, she provided the initial vision, guidance and research for the development of SecureConsent.