ISO/TC 276/WG 5 - Data processing and integration

This document specifies a common model for generating, maintaining, and provisioning provenance information on objects, such as biological material and data. This document also specifies requirements for provenance information serialization to achieve its interoperability. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: acquiring, collecting, processing, testing, analysing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); generating, collecting, analysing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); generating, collecting, analysing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain); )manufacturing devices or software for the afore mentioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). Customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can use this document in confirming or recognizing the competence of the aforementioned parties. This document does not apply to biological material and data used for medical diagnosis and therapy. NOTE 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations, standards, or requirements can apply to specific topics covered in this document, e.g., for organizations handling human materials procured and used for diagnostic and treatment purposes.

This document specifies a general concept for provenance information of biological material and data, organizational roles, and requirements for provenance information management. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: acquiring, collecting, processing, testing, analysing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); generating, collecting, analysing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); generating, collecting, analysing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain); manufacturing devices or software for the aforementioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). This document can be used by customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others for confirming or recognizing the competence of the aforementioned parties. This document does not apply to biological material and data used for medical diagnosis, treatment and therapy. NOTE 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations, standards, or requirements can apply to specific topics covered in this document, e.g., for organizations handling human materials procured and used for diagnostic and treatment purposes.

This document describes a practical procedure for nucleotide sequence database evaluation and validation. This document describes minimum requirements for the validation of a nucleotide sequence database. This document is applicable only for databases consisting of entries of nucleotide sequences. This document is not applicable to the general evaluation of the entire database quality including the quality of each data entry. EXAMPLE The use of the validated database is for confirming a representative sequence specificity including primers or probes for qualification and quantification of target nucleic acids by conventional polymerase chain reaction (PCR), quantitative polymerase chain reaction (qPCR), digital polymerase chain reaction (dPCR) and microarray technologies.

This document illustrates the workflow of shotgun metagenomic sequence data processing of host-derived microbiome and environmental metagenomes. This document specifies the requirements for quality control of shotgun metagenomic sequence data processing for massively parallel DNA sequencing. This document provides guidelines for data directory, data archive and metadata for shotgun metagenomic sequence data. This document applies to data storage, sharing and interoperability of shotgun metagenomic sequence data. This document applies to shotgun metagenomic sequence data processing and analyses, but excludes functional analysis.

This document specifies requirements for the consistent formatting and documentation of data and corresponding metadata (i.e. data describing the data and its context) in the life sciences, including biotechnology, and biomedical, as well as non-human biological research and development. It provides guidance on rendering data in the life sciences findable, accessible, interoperable and reusable (F-A-I-R). This document is applicable to manual or computational workflows that systematically capture, record or integrate data and corresponding metadata in the life sciences for other purposes. This document provides formatting requirements for both primary experimental or procedural data obtained manually and machine derived data. This document also describes requirements for storing, sharing, accessing, interoperability and reuse of data and corresponding metadata in the life sciences. This document specifies requirements for large quantities of data systematically obtained from automated high throughput workflows in the life sciences, as well as requirements for large-scale and small-scale data sets obtained by other life science technologies and manual data capture. This document is applicable to many domains in biotechnology and the life sciences including, but not limited to: basic/applied research in all domains of the life sciences, and industrial, medical, agricultural, or environmental biotechnology (excluding for diagnostic or therapeutic purposes), as well as methodology-driven domains, such as genomics (including massive parallel sequencing, metagenomics, epigenomics and functional genomics), transcriptomics, translatomics, proteomics, metabolomics, lipidomics, glycomics, enzymology, immunochemistry, synthetic biology, systems biology, systems medicine and related fields.

This document reviews best practices that: a) respect the existing standardization efforts of life sciences research communities; b) normalize key aspects of data description particularly at the level of the biology being studied (and shared) across the life sciences communities; c) ensure that data are “findable” and useable by other researchers; and d) provide guidance and metrics for assessing the applicability of a particular data sharing plan. This document is applicable to domains in life sciences including biotechnology, genomics (including massively parallel nucleotide sequencing, metagenomics, epigenomics and functional genomics), transcriptomics, translatomics, proteomics, metabolomics, lipidomics, glycomics, enzymology, immunochemistry, life science imaging, synthetic biology, systems biology, systems medicine and related fields.

This document specifies requirements for data management and publication in microbial resource centres (MRCs) to enable consistent formatting, and a quality control workflow to improve the overall quality of data. It also provides recommendations for MRCs to improve data sharing and integration of microbial material and associated data. This document is intended to facilitate procedures such as accessioning, acquisition, authentication, preservation, storage, and distribution, and can be used by MRCs, regulatory authorities, organizations, and schemes using peer-assessment to confirm or recognize the competence of MRCs in data management and publication NOTE International, national and/or regional regulations or requirements can also apply to specific topics covered in this document.

This document specifies a general concept for a provenance information model for biological material and data and requirements for provenance data interoperability and serialization. The provenance information model covers any information relevant to the quality and fitness for purpose of the biological material generated throughout the preanalytical phase of the materials life cycle from collection to analysis, data originating from analytical procedures applied to the biological material and results from further mathematical processing of the data. This document is applicable to organizations, authorities and industries that are: a) collecting, processing or distributing biological material for research; b) generating, collecting, analysing or storing data on biological material. This document does not apply to biological material and data used for other than research or in fields that are regulated by national, regional or international laws, such as medical diagnosis and therapy or food production. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.