Good Laboratory Notebook Practices

被引:0
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作者
King C. Lee
机构
[1] Aton Pharma,
[2] Inc.,undefined
关键词
Laboratory notebook; Good practices; Investigator/scientist;
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摘要
Laboratory notebook practices play a significant role in science, the regulatory approval process, litigation, patent protection, and interference (an administrative law proceeding conducted within the United States Patent and Trademark Office). Good laboratory notebook practices allow an investigator/scientist to use laboratory notebooks to their full potential. Good laboratory notebook practices include: 1. proper construction/formatting of laboratory notebooks (including the proper size, coding, identity, sponsor’s identity, and labeling of the confidentiality, intellectual property, and proprietary natures of laboratory notebooks); 2. proper methods of information entry (related to the table of contents, experiment, investigators, coinvestigators, and other personnel involved with the experiment/study, methodology, materials, instruments, equipment, results, discussion, and conclusion); 3. management of each page of the laboratory notebooks; 4. maintaining the integrity of the laboratory notebooks; and 5. management and archiving of laboratory notebooks, inserts, and supplementary records, and the management of a logbook system related to experiments/studies.
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页码:215 / 219
页数:4
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