Full Description

BS PD ISO/TS 20428:2017 defines the data elements and their necessary metadata to implement a structuredclinical genomic sequencing report and their metadata in electronic health records particularlyfocusing on the genomic data generated by next generation sequencing technology.

This document defines the composition of a structured clinical sequencing report (see Clause 5), defines the required data fields and their metadata for a structured clinical sequencing report (seeClause 6), defines the optional data (see Clause 7), covers the DNA-level variation from human samples using whole genome sequencing, whole exomesequencing, and targeted sequencing (disease-targeted gene panels) by next generation sequencingtechnologies. Though whole transcriptome sequencing and other technologies are important toprovide better patient care and enable precision medicine, this document only deals with DNA-levelchanges, covers mainly clinical applications and clinical research such as clinical trials and translationalresearch which uses clinical data. However, the necessary steps such as de-identification or consentfrom patient should be applied. The basic research and other scientific areas are outside the scopeof this document, does not cover the other biological species, i.e. genomes of viruses and microbes, and does not cover the Sanger sequencing methods.
Cross References:
ISO/TS 27527:2010
ISO/TS 22220:2011 Ed 2
ISO 11615:2012 ED1


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 07/18/2017 ISBN(s): 9780580953798 Number of Pages: 42 File Size: 1 file , 2.3 MB Same As: ISO/TS 20428:2017 Product Code(s): 30346825, 30346825, 30346825