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

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  • 18 March 2021
  • Author: Webmaster1
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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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Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

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