eConsent Assets

The TransCelerate eConsent Initiative aims to create general awareness of eConsent and enable broad, voluntary implementation. To this end, our Initiative has developed practical guidance and tools to aid sponsors and other interested parties. In this process, the eConsent Initiative has collaborated with Patient and Site Advocates, Health Authorities (HAs) and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), and Clinical Research Organizations (CROs).

Download the materials below to explore the team’s insights, which incorporates inputs and feedback from our collaborative efforts.

Name Description
The TransCelerate eConsent Implementation Guidance Document which provides practical guidance for sponsors and other interested stakeholders to facilitate more efficient and effective implementation of eConsent with several key elements:

  • Identification of various potential multi-media components and operational considerations
  • Potential internal and external processes and considerations for implementation
  • Additional eConsent implementation considerations for application of health literacy principles and use of eConsent with vulnerable populations
  • Perspectives on eConsent emerging trends and future considerations
Site-Facing Tools:

Tools designed to be used by sites/sponsors when implementing eConsent, developed through a collaboration with an eConsent site advocacy group (SAG) commissioned through the Society for Clinical Research Sites (SCRS).
CTTI / WHO Operational Examples of eConsent Set of two operational examples of how various multi-media components could be used, based on two publicly available informed consent form templates — from Clinical Trials Transformation Initiative (CTTI) and the World Health Organization (WHO).
eConsent Landscape Assessment:

Series of documents with the aggregated, blinded survey data on global experience with eConsent. The survey was sent to pharmaceutical companies, clinical research organizations (CROs), and eConsent vendors in December 2016.
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