CliniGA CRO

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Separating provisional information from verified facts in inspection responses

State what has been verified, what remains an assumption and which questions are still under investigation.

Representative research photograph: Separating provisional information from verified facts in inspection responses
Photo: Bill Branson (Photographer) · License: Public domain · Cropped and resized.
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Pressure to answer an inspection question quickly can turn an unverified explanation into an apparently established fact. Reliability is not determined by speed alone. Teams need to distinguish what they know, what they are investigating and which conclusions cannot yet be supported.

Scope of the decision

An initial response can present source-verified facts and the scope of the investigation. Label assumptions as provisional. If later information changes an earlier explanation, correct the difference visibly. Quietly replacing the text can weaken the trace of how the assessment developed.

Worked review

For example, a shipment delay is initially thought to involve the courier. Instead of stating that as the confirmed cause, the first response gives known delivery dates and explains the open investigation. A delayed site-release approval is later found. The update describes both stages and the limitations of the original assumption.

Practical checks

  • Review important statements as sourced facts, assessments or pending information.
  • Avoid declaring a final cause or impact boundary before completing the relevant review.
  • Explain how new evidence affects the previous response.

Acceptance and limits

Accept a response when the basis of its facts and ownership of open questions are understandable. Honest uncertainty does not replace investigation; follow-up remains necessary. An authorised reviewer should also assess whether the response addresses the question and applicable local response requirements.

Frequently asked questions

Is saying we do not know sufficient?
Not alone. Explain the investigation, responsible owner and route for providing further information.
Should an incorrect initial explanation be hidden?
No. Make changed facts and their effect on the conclusion visible.

Sources

  1. EMA — ICH E6 good clinical practice
  2. MHRA — GxP data integrity