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A dark blue mind map with light blue lines connecting white text labels and icons around the central theme "REGULATORY READINESS." Concepts like QA, Archival, Training Plan, Primary Endpoints, Bias, and Sensitivity Analyses are shown.

A dark blue mind map with light blue lines connecting white text labels and icons around the central theme "REGULATORY READINESS." Concepts like QA, Archival, Training Plan, Primary Endpoints, Bias, and Sensitivity Analyses are shown.
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Provide a creative graphic representing the following: "Regulatory: Ready Reporting Checklist. Reader training/qualification plan and evidence of calibration. Case selection strategy (incl. borderline %), randomization, and washout. Primary endpoints (κ/ICC/OPA) + confidence intervals; McNemar for bias. Weighting rationale and sensitivity analyses; complete R/SAS appendices. Archival of inputs/outputs; QA via formula auditing and double-checks." See more

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