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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