The TransCelerate eConsent Implementation Guidance
Document provides practical guidance for sponsors and other interested stakeholders to facilitate more efficient and effective implementation of eConsent with two key elements:
- Identification of various potential multi-media components
- Potential internal and external processes and considerations for implementation
eConsent Considerations for Health Literacy
Document provides guidance and considerations to improve the comprehension and readability of eConsent material.
eConsent Considerations for Vulnerable Populations
Document provides guidance and considerations for the use of eConsent with vulnerable populations.
eConsent Emerging Trends
Document provides perspectives on the potential future utility of eConsent and its potential integration with other eClinical technologies/platforms.
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.
eConsent 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).
Patient Advisory Summary Report
Summary report describing the perspectives of an eConsent patient advisory board (PAB) commissioned through the Center for Information and Study on Clinical Research Participation (CISCRP).
CTTI/WHO Operational Examples of eConsent
Set of two operational examples of how various multimedia 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 Whitepaper: "Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption"
The research included in this paper suggests that while the appetite for eConsent is increasing, industry stakeholders must continue to raise awareness, communicate and collaborate to develop appropriate technological capabilities, regulatory pathways, and operational processes to clear the path for mainstream use of eConsent.
