FDAnews Management Report: Implementing e-Consent for Clinical Trials

The challenges of e-consent fall into two categories: technical and regulatory. If done right, adopting e-consent technology will yield tremendous benefits.

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Implementing e-Consent for Clinical Trials

Implementing e-Consent for Clinical Trials

Falls Church, VA (PRWEB) December 12, 2013

Implementing e-Consent for Clinical Trials:
Pitfalls and Practical Considerations
**FDAnews Management Report**
http://www.fdanews.com/CTeconsent

Long, dense clinical trial informed consent documents may satisfy the lawyers, but they don’t satisfy anyone else. They’re difficult for study subjects to understand. Time consuming for investigators to deliver. Arduous to audit and monitor. And, as changes to study documents take place, the forms are a version control nightmare.

All that is why some sponsors and CROs are looking toward electronic consent. The benefits are readily apparent: faster enrollment, more reliable communication of risks, and reduced compliance headaches. But there are some things they need to know before taking the jump to e-consent…

The challenges of e-consent fall into two categories: technical and regulatory. If done right, adopting e-consent technology will yield tremendous benefits. In this management report, learn how the technology of e-consent can:

  •     Overcome language and literacy barriers
  •     Simplify data gathering and remote monitoring
  •     Maintain version control and audit trails
  •     Speed up trial enrollment
  •     Improve investigator compliance

In addition, the report offers a step-by-step approach to making sure e-consent processes align with regulatory requirements. It shows:

  •     How to work with the IRB when initiating e-consent
  •     Essential features that every e-consent system must have for compliance
  •     Optional features to look for to get the most out of the e-consent process
  •     Tips for monitoring and auditing e-consents, and
  •     Some key compliance pitfalls to avoid during the transition to e-consent

Implementing e-Consent for Clinical Trials:
Pitfalls and Practical Considerations
**FDAnews Management Report**
http://www.fdanews.com/CTeconsent

FORMAT: Print or PDF
PRICE: $397

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Online:     http://www.fdanews.com/CTeconsent
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