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SDV is its own axis, not a stage

The monitor works from a queue of unverified data; editing a verified value clears the mark by itself and sends it back to the queue.

Request a demoDocumentation
  • Vital signsRU-001-014 · Visit 3Changed after SDV
  • Adverse eventsRU-001-009 · Visit 2Awaiting SDV
  • DemographicsRU-001-014 · ScreeningVerified
Vital signs · Visit 3RU-001-014V
18 of 24 forms verified

The essentials

An independent status axis

Signing does not require completed SDV, and SDV does not require a signature. The status is computed from coverage, not toggled by hand.

Risk-based

ICH E6 asks to check what is critical, not everything. The monitor verifies by field and by form; coverage is visible per subject, visit and site.

“Changed after SDV” is visible

Editing a verified value is a state of its own, not a silent rollback. The monitor sees what exactly changed and why.

A monitoring visit

  1. 01QueueOnly what is unverified or changed after SDV — by site and visit.
  2. 02VerifyThe value next to its history; mark a field or a whole form.
  3. 03DiscrepancyA query right at the field, the site’s answer in the query register.
  4. 04ReportThe SDV register is produced as an export-log document.

Questions

Related regulations

EAEU GCP RulesRegulatory map

How to set it up — in the documentation

What happens to SDV when a value is edited?

The mark is cleared by the system and the value returns to the monitor’s queue as “changed after SDV”.

Can verification be partial?

Yes: by field or by form; coverage is visible on the subject, visit and site.

Queries and cleaningChecks on save and queries at the value.Audit trailA record that cannot be rewritten.EDC systemThe whole study lifecycle — from design to database lock.

See the system on your own scenario

We walk through the full cycle on a demo study and answer your validation and hosting questions.

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