Digital Source Verification - What Remote Monitoring Enables (and Doesn’t)

Let’s take a practical look at how source data verification (SDV) has changed. Not theoretically, but in the actual day-to-day reality of trials now supported by remote tools.

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What’s New

Source verification no longer means someone flying out to a site and flipping through paper. With remote-capable systems, monitors can:

• Review entries in real time
• Flag issues within an electronic platform
• Log queries without sending back scanned notes
• Cross-check timestamps and signatures digitally

This model speeds up the process. Instead of long cycles of site visits followed by follow-up calls, many queries are handled within a few days.

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But Some Things Still Require Context

Digital access helps, but it does not replace everything. Some limitations remain:

• You cannot “observe” workflow issues the same way on a screen
• Clinical nuance is hard to interpret without conversation
• Certain paper records (e.g. site logs or lab notebooks) may not be digitised

Also, not every discrepancy can be resolved with a screenshot. Monitors still need context, judgement, and human communication.

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Think in Layers

Instead of trying to replicate old monitoring practices digitally, it helps to layer your verification strategies:

1. Digital platform alerts - catch missing fields or logic breaks automatically
2. Remote review - monitor core data points early and frequently
3. Scheduled check-ins - use calls or video to discuss context and workflow
4. On-site verification (if needed) - for documents or tasks that cannot be confirmed remotely

This approach spreads effort over time, instead of clustering it at specific points.

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Tools That Help (and Hurt)

Helpful:

• Audit trails with clear timestamps
• Access logs and role-based permissions
• Forms that restrict out-of-range or conflicting entries

Problematic:

• Systems with no version history
• Shared login accounts
• Platforms that export into PDFs with no metadata

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Your verification strategy is only as strong as the tools you use. Remote source verification works best when you think less about replacing site visits and more about redesigning your information flow. It is not just about watching from a distance. It is about building systems that let you verify what matters, when it matters.