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This white paper provides guidance on validating define.xml documents against the define.xml XML schemas. The goal is to foster more consistent validation results in order to facilitate regulatory submissions and interchange of define.xml documents. The scope of this white paper is limited to providing guidance on define.xml schema validation. It does not provide guidance on other important areas of define.xml validity including: full compliance with the published define v1.0 specification, accuracy of content versus the SDTM datasets and other related documents and any aspects of quality beyond what XML schema can define. This white paper proposes practices and tools to improve define.xml schema validation.
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