TransCelerate Releases Assets for eConsent


TransCelerate Biopharma Inc. has released a set of eConsent Assets as part of its eConsent Initiative.


  • Clinical trials have become more complex, with longer and more detailed Consent Forms.
  • Moving from paper-based Consent Forms to electronic Consent Forms (eConsent) attempts to address challenges such as 1) subject comprehension, 2) subject compliance, and 3) study retention.


  • The eConsent Initiative has been developed to guide industry into widespread voluntary adoption of eConsent utilizing an array of assets.
  • The assets are tools, templates, and guidance documents designed to direct stakeholders, sponsors or other organizations, in adopting and implementing eConsents.



The newly released TransCelerate eConsent Assets contain an array of tools and guidelines designed to assist stakeholders in widespread adoption of eConsent. While developing the Assets, TransCelerate worked with Clinical Research Organizations, Ethics Committees / Institutional Review Boards, Patient Advocates, Site Advocates, and Health Authorities to address concerns and differences from various stakeholders in clinical research. Adoption and implementation of eConsent should provide a solution for complex paper consent forms and streamline clinical trials from regulatory and Ethics Committee review and approval through the informed consent process.


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-The Clinical Pathways Team