The eConsent Initiative will create a model approach for the electronic consenting of patients using an array of digital elements and process efficiencies to increase insight into patients’ understanding, increase regulatory compliance, and reduce quality risks. As of December 2021, this initiative is complete. No new solutions or updates are planned.


While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials has been historically paper-based. Given the inefficiencies in the traditional process and the increasing complexity of clinical studies, the current approach at times may raise challenges with respect to quality, compliance, patient understanding and trial retention.

The development of enabling technologies are ongoing to address these issues; however, there is limited guidance currently available to facilitate effective implementation. The eConsent Initiative will develop practical guidance on efficient processes and potential multimedia components that are available to sponsors to facilitate broad, voluntary adoption of patient eConsent. Successful industry adoption of eConsent will transform the informed consent process by using an array of patient-focused multi-media components to empower patients and their caregivers to make better, informed decisions and create process efficiencies for sites, Health Authorities, IECs/IRBs and sponsors.


  • Provide patients clear and easy-to-understand clinical trial information so that they are truly informed when making a decision to participate
  • Improve patient compliance by offering sites the tools to get insight into patient’s understanding and reduce complex and time-consuming explanations, paperwork and quality risks
  • Reduce inspection findings and establish submission considerations for Health Authorities and Ethics Committees to improve review/approval process
  • Enable process efficiencies (e.g., re-consent, remote monitoring, integration with other eClinical systems), reduce corrective actions for audit/inspection consent findings, improve patient recruitment process and reduce dropout rates

Available Solutions

The eConsent Initiative team has collaborated with patient and site advocates, Health Authorities and institutional review boards (IRBs)/independent ethics committees (IECs) to develop the following assets:

  • A framework that describes the potential multi-media components available to sponsors for use in implementing eConsent
  • A toolkit to aid sponsors by identifying potential processes that may facilitate more efficient and effective implementation of eConsent

Related Initiatives


The eLabels Initiative will support TransCelerate Member Companies in establishing an innovative information channel: Electronic Labels (eLabels). This initiative will work to enhance label utility for patients.

Clinical Data Standards

Clinical data are reported by individual trials in various ways which may cause a labor intensive process to gain data insights. The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI- EVS (National Cancer Institute – Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies), aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and metadata, while improving patient safety and clinical trial outcomes.