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Approved: 09Nov2018SUBJECT INFORMATION AND CONSENT FORM AND HIPAA AUTHORIZATION Study Title:A 26Week, Phase 3, Open Label Study with a 12Week, PlaceboControlled, Randomized Withdrawal Period Followed
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Development and validation refer to the process of creating and testing a new product or system to ensure it meets requirements.
Any company or individual involved in the creation and testing of a new product or system is required to file development and validation documentation.
Development and validation documentation can be filled out by providing detailed information about the development process, testing procedures, and results.
The purpose of development and validation is to ensure that the product or system meets requirements, is safe to use, and functions as intended.
Information such as development plans, testing protocols, test results, and any issues or concerns encountered during the process must be reported on development and validation documentation.
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