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Development and validation of a clinical prediction tool
for estimating the risk of 1year mortality
among hospitalized patients with dementia Michael Bonanza thesis submitted in conformity with the
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What is development and validation of?
Development and validation refers to the process of creating and confirming the reliability and accuracy of a methodology, system, or product, ensuring it meets specified requirements and functions as intended.
Who is required to file development and validation of?
Entities involved in research and development activities, such as pharmaceutical companies, biotech firms, and any organization seeking regulatory approval for new commodities or processes typically are required to file development and validation documentation.
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To fill out development and validation documentation, one must follow specified guidelines which typically include providing detailed information about the development process, methodologies used, results obtained, and how validation was conducted, ensuring all required sections are completed with accurate data.
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The purpose of development and validation is to ensure that a method or system is sound, effective, and capable of producing results that are consistent, reliable, and reproducible for intended uses.
What information must be reported on development and validation of?
The information reported usually includes objectives of the development, description of methods, validation protocols, experimental data, results, discussions of findings, and any conclusions drawn about the consistency and reliability of the approach.
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