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Allocation Concealment Label Gap Tool

Compare supplied metadata labels; label agreement does not establish allocation concealment.

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Description

Compare a known allocation-concealment label with its expected label.

Clinical research distinguishes supplied protocol metadata, participant/event records, allocation bookkeeping and an analysis target. A local count, permission flag or denominator choice can help reconcile records without establishing valid consent, randomization, regulatory compliance or a reliable treatment-effect estimate.

Compare a known allocation-concealment label with its expected label.

When to use this tool

Use Allocation Concealment Label Gap when checking the stated clinical-research record, allocation, timing, analysis or evidence-basis convention.

How to use the tool and how it works

  1. Enter expectedLabel, recordedLabel, recordKnown. Use the units and conventions below.
  2. Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
  3. Read labelMatches, unresolved. Inspect labelMatches, unresolved before interpreting the associated values.

Compare a known allocation-concealment label with its expected label. labelMatches requires recordKnown and exact label equality, unresolved means recordKnown false.1

Input fieldMeaning and unitsAccepted input
expectedLabelExpected LabelRequired. Text; maximum UTF-16 length 8192.
recordedLabelRecorded LabelRequired. Text; maximum UTF-16 length 8192.
recordKnownRecord KnownRequired. Boolean.
Output fieldInterpretationReturned shape
labelMatchesLabel MatchesRequired. Boolean.
unresolvedUnresolvedRequired. Boolean.
json
{
  "input": {
    "expectedLabel": "masked",
    "recordedLabel": "open",
    "recordKnown": true
  },
  "output": {
    "labelMatches": false,
    "unresolved": false
  }
}

Limitations and assumptions

  • A matching label is not evidence that concealment was maintained; actual implementation, access and selection bias are not assessed.
  • Inputs must satisfy both the field types and the cross-field conditions above. Invalid input causes an error; a successful false flag or documented placeholder is a different result.

Alternative or Complementary methods

Use the complete approved protocol, authenticated source records and qualified clinical/statistical oversight for actual trial design, conduct and interpretation.

References

  1. Calculation and input contract: clinical-trials/allocation-concealment-label-gap — tool.io

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