Contingency planning is essential to eCOA deployment to ensure continuous data collection throughout a clinical trial.
Effective strategies start with:
- Clear system requirements and user-centric design
- Robust quality assurance practices and user acceptance testing
- Timely site and participant training
- Quick device replacements and web backup solutions
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.
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 hours a day, 7 days a week, 365 days a year)
- 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
- For unresolved situations, YPrime’s help desk provides access to the web backup version of the handheld device software via a hyperlink sent in email. Site staff can also provide this link to participants, based on 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
- A replacement handheld device is immediately issued
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 displayThe 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.