FDAnews Announces — Electronic Informed Consent for Clinical Trials: Best Practices Webinar, Sept. 15, 2015

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The simple fact about electronic informed consent is that it's much more than a simple digital handwritten signature. This webinar, led by Dr. Susan Brink, will bring manufacturers up to speed on the FDA and NIH guidances and help them feel more confident about moving from pen and paper to the new technology.

Electronic Informed Consent for Clinical Trials:
Best Practices
**FDAnews Webinar**
Sept. 15, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/electronicinformedconsent

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 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 in transitioning to electronic consent software.

And that's why FDAnews is pleased to present Electronic Informed Consent for Clinical Trials: Best Practices on Tuesday, Sept. 15, 2015.

The webinar will be led by Dr. Susan Brink, executive vice president, e-consent Products and Services at Enforme Interactive, Inc. 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 manufacturers up to speed on the FDA and NIH guidances and help them feel more confident about moving from pen and paper to the new technology.

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

  •     How to know which software is right for a company?
  •     What assurances are there that a site-wide system can remain fully compliant as regulations change?
  •     How much training will be needed for 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 attendees with checklists and guides that will help them make an informed decision about the software that's best for them, as well as prepare them to talk to prospective vendors:

1.    A 5-step overview of the e-consent process

2.    7 questions to 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 future. Plan to attend the webinar Electronic Informed Consent for Clinical Trials: Best Practices on Sept. 15, 2015.

Meet the Presenter:
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.

Who Will Benefit:

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

Conference Details:
Electronic Informed Consent for Clinical Trials:
Best Practices
**FDAnews Webinar**
Sept. 15, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/electronicinformedconsent

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/electronicinformedconsent
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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