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Requirements for data submission are defined and managed by the regulatory authorities to whom data are submitted. This section describes general requirements for datasets that may be part of a submission.
However, additional conventions may be defined by regulatory bodies or negotiated with regulatory reviewers. In such cases, additional requirements must be followed. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-608
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