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- Published
- Updated
Target and actual enrolment become meaningful at different stages of a trial. Updating public fields is more than replacing one number with another. Sponsors should establish which period and participant definition a value represents so that readers understand the size of the research accurately.
Decision framework
Examine how the platform defines anticipated and actual enrolment. Do not confuse screening, consent and enrolment totals. Verify the information source and data-cut date with the relevant owner. Where a numerical change affects study design, appropriate scientific and regulatory processes remain necessary alongside maintenance of the public record.
Worked example
For example, the target is two hundred participants while site reports show three hundred screened candidates. The record owner does not copy the screening total into actual enrolment. The team reconciles the relevant definition and reporting cut. If recruitment ends below target, it explains the actual position consistently rather than adjusting the number to fit a commercial objective.
Implementation checks
- Verify every reported count against its definition, source and data-cut date before updating the relevant public field.
- Treat a revised target and an update to actual enrolment as different events requiring their respective supporting information.
- Check that differences from public results and other trial records can be explained using the underlying definitions and reporting periods.
Acceptance and boundaries
Accept review when the counts describe consistent concepts and any differences are justified. This example imposes no particular enrolment definition; applicable platform and trial definitions govern the record. Numerical consistency alone does not prove scientific adequacy, which remains a matter for appropriate specialist assessment.
Frequently asked questions
- Is the number screened the same as enrolment?
- Not always. Verify the trial definition and the meaning of the registry field.
- Can a missed target be hidden?
- Public information should reflect the actual position through the appropriate definition and explanation.