T/GDPHA 002-2023 Data sharing and data quality control specifications for clinical phenotype and bioinformatics data of chronic hepatitis B

Scope

Scope: This document is an auxiliary specification document for the (Precision Medicine Big Data Mining and Integrated Analysis Platform), which defines the data sharing and quality control standards for clinical phenotypes and biomarker data of chronic hepatitis B, and establishes standards for data collection, data entry, data quality control, data sharing, data storage, data use, and data security management. This document aims to standardize all aspects of data collection, processing, sharing, and management of clinical phenotypes and biomarker data of chronic hepatitis B to ensure the accuracy, reproducibility, and comparability of the data, and to provide high-quality data support for research in this field. It is applicable to all stages of data collection, processing, sharing, and management of clinical phenotypes and biomarker data of chronic hepatitis B, with the aim of standardizing the operational processes of data collection, entry, management, and sharing. Main technical content: This document is applicable to units and institutions participating in the construction of the Precision Medicine Big Data Mining and Integrated Analysis Platform, as well as researchers, hospitals, and other stakeholders involved in the interconnection and sharing of clinical phenotype and biomarker data of chronic hepatitis B. When sharing data with the platform, this document must be strictly followed. Compared with ordinary data processing, the data sharing and quality control standards for clinical phenotypes and biomarker data of chronic hepatitis B have the following differences: a) The data must undergo rigorous quality control and data review processes to ensure data accuracy and reproducibility; b) Standardized data formats and biospecimen collection and processing protocols are required to ensure data consistency and comparability; c) Unauthorized data use and illegal dissemination are strictly controlled to safeguard data security and legality; d) A robust securi

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