Reduce Audit Findings While Increasing the Quality of Your Consent Process
Advarra eConsent is an electronic consenting module for research sites, designed to keep participants engaged, simplify compliance oversight, and optimize the overall quality of the consenting process.
About eConsent
Advarra eConsent helps your site reduce audit risk and keep participants engaged, while tracking consenting progress across your portfolio. 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 informed consent form (ICF) data quality. eConsent is available as a module within Advarra’s eRegulatory Management System.
Why eConsent?
Boost Participant Engagement
- Ease participants through steps
- Allow participant device of choice
Enhance Consenting Compliance
- Standardize the eSignature process and maintain HIPAA and 21 CFR Part 11 compliance
- Allow participants to opt-out any time
Ensure Consent Process Efficiency
- Standardize regulatory and personal forms
- Provide audit trails
Increase Participant Enrollment
- Intuitive form templates
- Complete process oversight
Accelerate Consent Processes
- Controlled eSignature workflows
- Simplified remote monitoring
Integrate Across Your Organization
- Ensure your team is using the most up-to-date ICF by integrating with Advarra’s CIRBI platform
- Easily populate protocol information with OnCore and Clinical Conductor interfaces
Paper Versus eConsent: A Comparison
There are many benefits of eConsent versus a paper-based system. Study teams can efficiently manage participant recruitment, maximize retention, mitigate the risk of data loss, and increase overall return on investment (ROI).
| Paper | eConsent | |
|---|---|---|
| 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 |
| Storage | Numerous binders kept in a storage facility | All data is accessible and backed up on secure web portal |
| 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 |
