eCOA Web Backup

eCOA Web Backup

Contingency planning is essential to eCOA deployment to ensure continuous data collection throughout a clinical trial.

Although typically less than 1% of devices fail, breakage or loss can result in missing data. Electronic backup methods offer superior data quality when compared to traditional paper backup approaches.

 

eCOA Solutions Powered by Advanced Technology

Web Backup: How it Works for Field-Based Data Collection

If a trial participant experiences technical difficulties with a handheld device:

  • Participants contact YPrime’s helpdesk (available 24/7 365)
  • Helpdesk agents will troubleshoot and/or provide a replacement handheld device as quickly as possible
    • 90% of YPrime’s support issues are resolved within a few minutes of the first call
    • When a device issue cannot be resolved remotely, YPrime’s help desk provides access to the web backup version of the handheld device software via a hyperlink sent via encrypted email. Site staff can also provide this link to participants, contingent on role-based permissions
  • The web interface features an emulator, which is an exact replica of the handheld display. The emulator requires the same password, and includes the same functionality as the original physical handheld device, with the same navigation and login experience
  • The participant submits assessments according to the protocol schedule from any computer or tablet with internet access
  • The web back-up is a temporary solution until a replacement handheld device becomes available

Web Backup: How it Works for Site-Based Data Collection

If an investigator site staff member experiences technical difficulty with a tablet device:

  • Site staff contact YPrime’s helpdesk (available 24/7 365)
  • Helpdesk agents will troubleshoot and/or provide a replacement tablet as quickly as possible
  • For unresolved situations, YPrime’s helpdesk enables the web-based tablet backup for the site:
    • A button will appear in the site-specific web portal that enables access to the web-based tablet backup
    • The web interface features an emulator, which is an exact replica of the tablet display
    • The emulator requires the same password and includes the same functionality as the original physical tablet device

Data Integrity and Privacy

When participants require backup solutions, helpdesk agents handle all requests in compliance with applicable confidentiality regulations, and do not save personally-identifying information.  As the web-based backup is intended to be a temporary solution until a replacement device is received, both the site’s backup button in the study portal and the participant’s URL to the web-based backup expire after short durations. Data collected via the web-based backup solution are secured with encrypted authentication. Records created using the web-based backup are clearly identified in the audit trail, and distinguishable from data entries made on the primary device.

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