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撰写标准操作规程的十项简单规则。

Ten simple rules on how to write a standard operating procedure.

机构信息

Potsdam University, Potsdam, Germany.

SB Science Management UG (haftungsbeschränkt), Berlin, Germany.

出版信息

PLoS Comput Biol. 2020 Sep 3;16(9):e1008095. doi: 10.1371/journal.pcbi.1008095. eCollection 2020 Sep.

Abstract

Research publications and data nowadays should be publicly available on the internet and, theoretically, usable for everyone to develop further research, products, or services. The long-term accessibility of research data is, therefore, fundamental in the economy of the research production process. However, the availability of data is not sufficient by itself, but also their quality must be verifiable. Measures to ensure reuse and reproducibility need to include the entire research life cycle, from the experimental design to the generation of data, quality control, statistical analysis, interpretation, and validation of the results. Hence, high-quality records, particularly for providing a string of documents for the verifiable origin of data, are essential elements that can act as a certificate for potential users (customers). These records also improve the traceability and transparency of data and processes, therefore, improving the reliability of results. Standards for data acquisition, analysis, and documentation have been fostered in the last decade driven by grassroot initiatives of researchers and organizations such as the Research Data Alliance (RDA). Nevertheless, what is still largely missing in the life science academic research are agreed procedures for complex routine research workflows. Here, well-crafted documentation like standard operating procedures (SOPs) offer clear direction and instructions specifically designed to avoid deviations as an absolute necessity for reproducibility. Therefore, this paper provides a standardized workflow that explains step by step how to write an SOP to be used as a starting point for appropriate research documentation.

摘要

如今,研究出版物和数据应该在互联网上公开,并且理论上可供所有人用于进一步的研究、产品或服务的开发。因此,研究数据的长期可访问性是研究生产过程的经济基础。然而,数据的可用性本身是不够的,还必须验证其质量。确保可重复使用和可再现性的措施需要包括整个研究生命周期,从实验设计到数据生成、质量控制、统计分析、结果的解释和验证。因此,高质量的记录,特别是为了提供可验证数据来源的一系列文件,是至关重要的要素,可以作为潜在用户(客户)的证书。这些记录还提高了数据和流程的可追溯性和透明度,从而提高了结果的可靠性。在过去十年中,研究人员和组织(如研究数据联盟(RDA))的基层倡议推动了数据采集、分析和文档编制的标准,然而,在生命科学学术研究中,仍然非常缺乏复杂常规研究工作流程的商定程序。在这里,精心编制的文档,如标准操作程序(SOP),提供了明确的方向和说明,专门设计用于避免偏差,这是可重复性的绝对必要条件。因此,本文提供了一个标准化的工作流程,逐步解释如何编写 SOP,作为适当研究文档的起点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b42/7470745/13d92029be40/pcbi.1008095.g001.jpg

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