Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests

Food, U. S., & Drug Administration, '. (2007). Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.

Type

Unclassified

Intellectual base

Unclassified

Year

2007

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-guidance-reporting-results-studies-evaluating-diagnostic-tests-guidance-industry-and-fda

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Domain-specific

• Diagnostic Method
  • FDA guidance makes the target condition, intended-use population, study population, and reference standard explicit parts of evaluating a clinical diagnostic procedure.

    This sourceDefines target condition, reference standard, sensitivity, specificity, intended-use population, and recommended accuracy reporting.

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