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Clinical Endpoint Adjudication Label

Render a recorded endpoint-adjudication state and reviewer code without adjudicating a clinical outcome.

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Description

Label an endpoint's supplied adjudication status and reviewer.

Statistical record calculations depend on risk-set boundaries, cluster assumptions, missingness codes and exposure definitions. Entry can be excluded while exit inclusion is a policy choice, and one design-effect formula assumes equal cluster sizes. A local flag or contribution does not fit a model or establish a clinical result.

Label an endpoint's supplied adjudication status and reviewer.

When to use this tool

Use Clinical Endpoint Adjudication Label when you already have endpointId, status, reviewerCode and need to label an endpoint's supplied adjudication status and reviewer.

How to use the tool and how it works

  1. Enter endpointId, status, reviewerCode. 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 label. Use the output convention below.

Require endpointId/reviewerCode nonempty and status pending/confirmed/not-confirmed/indeterminate; append them.1

Input fieldMeaning and unitsAccepted input
endpointIdEndpoint IdRequired. Text; minimum UTF-16 length 1; maximum UTF-16 length 8192.
statusStatusRequired. Text; one of "pending", "confirmed", "not-confirmed", "indeterminate"; maximum UTF-16 length 8192.
reviewerCodeReviewer CodeRequired. Text; minimum UTF-16 length 1; maximum UTF-16 length 8192.
Output fieldInterpretationReturned shape
labelLabelRequired. Text; maximum UTF-16 length 8192.
json
{
  "input": {
    "endpointId": "E17",
    "status": "pending",
    "reviewerCode": "R3"
  },
  "output": {
    "label": "E17 [pending; reviewer=R3]"
  }
}

Limitations and assumptions

  • No endpoint, evidence, reviewer identity, adjudication, diagnosis or analysis classification is verified.
  • 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 study design, data and statistical model for inference. Check censoring, clustering, visit windows, exposure and missingness conventions before combining these terms, and assess uncertainty with the full analysis.

References

  1. Calculation and input contract: biostatistics/clinical-endpoint-adjudication-label — tool.io

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