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Separating site status from whole-trial status in public records

Completion of recruitment at one site does not mean enrolment has ended throughout a trial.

Representative research photograph: Separating site status from whole-trial status in public records
Photo: MaynardClark · License: CC BY 4.0 · Cropped and resized.
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Completion of recruitment at one site does not mean enrolment has ended throughout a trial. Follow-up may also continue after recruitment closes. Sponsors should verify which geographical and operational level a public status describes; otherwise people searching for research opportunities may receive misleading information about where activity remains available.

Decision framework

Examine how the platform defines whole-study and site-level fields. Distinguish recruitment, intervention, follow-up and overall completion events. Connect the operational source of status information to the registry owner. An email from one site manager should not automatically serve as evidence for the state of the entire multinational study.

Worked example

For example, recruitment finishes in one country while others continue. The overall record is mistakenly changed to a nonrecruiting status. The team reconciles country and site information and corrects the whole-study field according to the applicable definition. Participants in follow-up and sites still seeking new participants are not hidden under one ambiguous label.

Implementation checks

  • Specify whether each status change concerns a site, country or the whole trial before updating a public field.
  • Verify the information source and effective date so that outdated local information is not transferred into the overall record.
  • Test whether public enquiry staff can route questions according to current recruitment information using a realistic example.

Acceptance and boundaries

Accept the record when statuses at different levels are understandable and any differences can be explained. Similar platform labels may have different meanings, requiring separate checks. This example does not define legal trial completion; authorised trial arrangements and applicable local processes remain the relevant basis for that assessment.

Frequently asked questions

Is a trial complete when recruitment ends?
Not necessarily. Follow-up, analysis or other responsibilities may continue.
Does one open site mean every country is open?
No. Site and country statuses require separate verification.

Sources

  1. WHO — Trial Registration Data Set
  2. EMA — ICH E6 good clinical practice