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Verifying links between trial records and scientific publications

A functioning link is not enough to verify a publication added to a trial record.

Representative research photograph: Verifying links between trial records and scientific publications
Photo: U.S. Army photo by Pvt. Samuel Signor · License: Public domain · Cropped and resized.
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A functioning link is not enough to verify a publication added to a trial record. The paper may describe the same protocol, a narrower population or a secondary analysis. Sponsors should help readers distinguish primary results from related publications and reach the correct information without misunderstanding their relationship.

Decision framework

Compare the publication identifier, trial number and description of the study. Distinguish main results, methods articles, secondary analyses and protocol publications. Check how the platform uses publication links. Do not assume that adding a paper automatically replaces structured result information or other applicable forms of public disclosure for the trial.

Worked example

For example, a paper presents an analysis from one country but the record labels it as the main publication for the whole study. The team corrects the description and explains its relationship to the main report where available. This does not diminish the paper's value; it prevents readers misunderstanding its population and result scope.

Implementation checks

  • Verify that the title, persistent publication identifier and study number point to the same research before linking the record.
  • Explain whether the paper reports primary results, secondary findings or methodological information rather than using an ambiguous label.
  • Arrange reassessment of public links when a correction, withdrawal or new publication version changes the information available to readers.

Acceptance and boundaries

Accept the link when readers can understand the paper's relationship to the trial. Journal publication does not automatically complete other disclosure obligations; assess applicable platform and country conditions separately. Scientific inconsistencies in the article should be handled through appropriate scientific and publication processes.

Frequently asked questions

Is every linked paper the main results publication?
No. It may describe a protocol, methods or a secondary analysis.
Does a working link establish scientific accuracy?
No. Identity, scope and content still require suitable assessment.

Sources

  1. WHO — Trial Registration Data Set
  2. EMA — ICH E3 clinical study reports