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Conflicting source evidence in remote monitoring findings

Avoid premature closure when screenshots, explanations and source records describe different situations.

Representative research photograph: Conflicting source evidence in remote monitoring findings
Photo: Rhoda Baer (Photographer) · License: Public domain · Cropped and resized.
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A screenshot supplied during remote review may suggest that an activity is complete while another record suggests otherwise. Establish which event and time each item represents before deciding. Resolving a conflict simply by accepting the latest email can produce an incorrect closure.

Scope of the decision

A screenshot or summary shows only part of a source. Do not draw a firm conclusion without understanding its production date, scope and context. Where needed, examine the original through an authorised access route. Review needs do not justify sharing more personal information than is necessary.

Worked review

For example, a site sends a printout showing a critical assessment, but the monitoring list still shows it as outstanding. Investigation reveals that the printout concerns another visit. The team requests evidence for the correct visit and retains an explanation of the mismatch rather than treating the wrong document as resolution.

Practical checks

  • Match participant, visit and time context for every item of evidence.
  • Explain separately which question each conflicting record answers.
  • Plan authorised source review while limiting personal data to what is needed.

Acceptance and limits

Close the finding when sufficient, consistent evidence explains the relevant event. Keep the open question and decision owner visible if conflict remains. If source access is unavailable, state the verification limit instead of making an unsupported definitive compliance judgement.

Frequently asked questions

Is an email explanation sufficient on its own?
That depends on the issue. For critical activities, identify the record supporting the explanation.
Should the incorrect document be deleted?
Follow controlled record procedures and preserve how the mismatch was detected and corrected.

Sources

  1. FDA — Risk-based monitoring questions and answers
  2. MHRA — GxP data integrity