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Public Release: Electronic Informed Consent Implementation Guide Practical Considerations Version 1.0

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  • 18 March 2021
  • Author: Webmaster
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Public Release: Electronic Informed Consent Implementation Guide  Practical Considerations  Version 1.0

The EUCROF and eClinical Forum Electronic Informed Consent (eConsent) Joint Task Force are pleased to announce the publication of the eConsent Implementation Guide (version 1). The joint task force was formed in 2019 with a view to look at some of the barriers to adoption of eConsent considering the benefits to stakeholders. eConsent offers remote electronic options for informing and consenting trial participants of a clinical trial, this being a particularly useful capability especially during the pandemic period when site visits are reduced.

The eConsent Implementation Guide provides an overview and practical considerations when implementing eConsent within a clinical trial.

The eConsent Implementation Guide includes:

  • An overview of eConsent, definitions including; discussion around the interactive education and signature components and remote and on-site options
  • Stakeholder perspectives: How eConsent can improve patient experience and advance the consent process for sponsors, sites, CRO’s third parties, authorities.
  • How COVID-19 has accelerated the use of eConsent, and demonstrated its value
  • Detailed guidance and a roadmap for the practical consideration’s implementation eConsent
  • Stakeholder perspectives, regulatory acceptance and country positions on eConsent

The eConsent Task Force team also acts as a go to group for specific questions when considering implementing eConsent.

We’d like to thank EUCROF and eClinical Forum contributors for their invaluable support in the development of this document.

For more information please contact... info@eclinicalforum.org and/or eConsent Task Force Implementation Co-chairs Fiona Maini (fmaini@medidata.com) and Mika Lindroos (mika.lindroos@signanthealth.com)

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BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 
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