These include the Data Sharing Policy, 68 Fed. Reg. 37369 (2003); Genomic Data Sharing Policy, 79 Fed. Reg. 51345 (2014); and NIH Policy on the Dissemination of NIH-Funded Clinical Trials Information, 81 Fed. Reg. 64922 (2016).Google Scholar

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“Scientific Data: The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens.” Id. at 68896-68897 (Section II).Google Scholar

“Data Management: The process of validating, organizing, protecting, maintaining, and processing scientific data to ensure the accessibility, reliability, and quality of the scientific data for its users.” Id. at 68897 (Section II).Google Scholar

“Data Sharing: The act of making scientific data available for use by others (e.g., the larger research community, institutions, the broader public), for example, via an established repository).” Id. (Section II).Google Scholar

“Data Management and Sharing Plan (Plan): A plan describing the data management, preservation, and sharing of scientific data and accompanying metadata.” Id. (Section II).Google Scholar

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