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AUD-TR-03

Evidence source and scope

TR-03 · unverified temporal prespecification

Classification and audit outcome: unverified temporal prespecification; supported provenance qualification.

Finding

“Prespecified” modifies the full-group RFD interaction. The published Methods describe that analysis, but the current registry lists only the UPDRS outcome and no dated RFD analysis plan was recovered. Numerical p=.064 and subgroup p=.049 are supported.

Current amendment or qualification

Delete “prespecified” or provide a dated protocol/statistical analysis plan substantiating advance specification. Do not label the analysis post hoc without evidence.

Integration note: No dated analysis plan was established in this QA. Remove unsupported prespecified adjective or obtain dated plan; current registry absence does not prove post hoc analysis.

Remaining limitation: No dated analysis plan was established in this QA. Remove unsupported prespecified adjective or obtain dated plan; current registry absence does not prove post hoc analysis.

Evidence and provenance

Malling Methods/Statistics; ClinicalTrials.gov NCT02125032 current outcomesModule.

Affected reports

Original audit locator(s): P0178

Audit corrections describe the report only where that classification is explicit. A disagreement within a study, missing protocol, statistical query, access upgrade or optional addition is not silently converted into a report error or a new clinical threshold.

Audit register · Unresolved evidence queue

Linked knowledge pages

Located in this vault

Mapping status: exact. An exact location match is not an additional empirical verification.