The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to provide insight into patients’ understanding, increase regulatory compliance, and reduce quality risks. Currently, there is increasing complexity in clinical trial consent language and longer paper forms leading to an overall lack of patient comprehension, reduced protocol compliance, and potential withdrawal from the study. Data from eConsent pilots suggests that patients prefer multimedia content and on-demand access to consent tools via the web or mobile device over the traditional paper process. Successful industry adoption of eConsent will empower patients, the families that love them, and the providers that care for them.
- Provide patients clear and easy-to-understand clinical trial information so that they are truly informed to make a decision to participate
- Offer sites the tools to get insight into patient’s understanding and reduce complex & time-consuming explanations, paperwork and quality risks
- Establish a consistent and aligned process for Health Authorities and Ethics Committees to improve review/approval process & reduce inspection findings
- Reduce or eliminate on-site consent monitoring activities and corrective actions for audit/inspection consent findings for sponsors; improve patient recruitment and reduce dropout rates for complex studies
The eConsent team plans to collaborate with Patient and Site Advocates, Health Authorities, IRBs/IECs institutional review boards (IRBs)/ independent ethics committees (IECs) to develop the following assets:
- Framework that describes the eConsent components.
- Toolkit for Sponsors that outlines internal and external eConsent procedures.
Please check back for more information.
The TransCelerate eLabels initiative will help the industry progress on the journey to digitally supported, patient-centric clinical supply chains.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
Clinical Trial Diversification
The Clinical Trial Diversification Initiative has achieved its goal of developing better practice materials for Site and Sponsors to improve engagement and recruitment of minority patient populations.