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The skill's code, runtime instructions, and requirements are consistent with a local protocol-deviation classification tool and do not request credentials or external installs, but you should validate... [内容已截断]
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"changelog": "Initial release of protocol-deviation-classifier.\n\n- Automatically classifies protocol deviations in clinical trials as \"major\" or \"minor\" based on GCP\/ICH E6 standards.\n- Assesses impact of deviations on subject safety, data integrity, and scientific validity.\n- Provides CLI and Python API for single or batch classification, with report generation.\n- Includes clear deviation classification standards and examples for both major and minor categories.\n- Generates structured JSON results with confidence scores and regulatory basis references.\n- Pure Python implementation with no third-party dependencies; supports Chinese clinical trial scenarios.",
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