Reduce Audit Findings while Increasing the Quality of Your Consent Process
Advarra eConsent is a mobile friendly electronic consenting system that keeps participants engaged, enhances their understanding, simplifies compliance oversight, and optimizes the overall quality of the consenting process.
About eConsent
Reduce audit risk and boost participant retention with simple, interactive multimedia (text, video, hints, multi-language) to keep participants engaged, while the system tracks progress and conducts knowledge assessments to verify participant comprehension during the consenting process. By simplifying this process for staff with detailed analytics, remote access, and real-time alerts, sites gain significant improvements in consenting efficiency and a boost in ICF data quality.
Why eConsent?
Boost Participant Engagement
- Ease participants through steps
- Provide a multimedia experience
- Allow participant device of choice
Enhance Consenting Compliance
- Standardize the eSignature process
- HIPAA and CFR Part 11 compliant
- Allow participants to opt-out any time
Ensure Consent Process Efficiency
- Standardize regulatory and personal forms
- Provide consent versioning and audit trails
- Automate reconsenting reminders
Increase Participant Enrollment
- Comprehension focused consenting
- Intuitive form templates
- Complete process oversight
Improve Participant Comprehension
- Automate knowledge assessments
- Provide hints for missed questions
- Track progress and provide analytics
Start Visit Procedures Faster
- Quality checks during consenting
- Increase patient comprehension
- Controlled eSignature workflows
Paper Versus eConsent: A Comparison
There are many benefits of eConsent versus a paper-based system, especially when it comes to your study team being able to efficiently manage participant recruitment, maximize retention, mitigate the risk of data loss, and increase overall ROI.
| Paper | eConsent | |
|---|---|---|
| Participant Engagement | Sites need to apply greater effort to ensure participant understanding of the forms they are handed. | Participant is engaged in an interactive process through video and Q&A, which helps achieve participant engagement and comprehension with less effort. |
| Audit Trail | No audit trail and manual file system needed. | Complete audit trail for all signatures, initials saved in a secure digital system. |
| Version Control | Version control must be maintained manually, which is prone to error. | Strict version control with automatic verification of most current version, patient delivery, and signature need notification. |
| Reconsenting | Difficult to know which participants need to be reconsented on which documents. Increased chance of errors. | System can capture which documents require reconsent and update the status of patients needing reconsent. |
| Site Monitoring | Monitor travels to site. | Remote monitoring can be facilitated via system export or a video screenshare session between the site staff and the monitor. |
| Storage | Numerous binders kept in a storage facility. | All data is accessible and backed up on secure web portal. |
| Patient Comprehension | Cumbersome for adapting content to trial and participant needs, requiring emailing or mailing materials to off-site participants. No ability to track progress remotely. | eConsent can support video, built-in glossary definitions, and knowledges assessments with oversight from any location. This helps facilitate comprehension for participants with different learning styles. Also available in multiple languages. |
| Readiness of Site Consent Forms | Manual process for confirming readiness of forms. | Online summary viewing and reporting of all consent documentation facilitates audit or monitoring readiness. |
