RT Journal Article SR Electronic T1 Communicating Regulatory High Throughput Sequencing Data Using BioCompute Objects JF bioRxiv FD Cold Spring Harbor Laboratory SP 2020.12.07.415059 DO 10.1101/2020.12.07.415059 A1 Charles Hadley S. King IV A1 Jonathon Keeney A1 Nuria Guimera A1 Souvik Das A1 Brian Fochtman A1 Mark O Walderhaug A1 Sneh Talwar A1 Janisha Patel A1 Raja Mazumder A1 Eric Donaldson YR 2020 UL http://biorxiv.org/content/early/2020/12/09/2020.12.07.415059.abstract AB For regulatory submissions of next generation sequencing (NGS) data it is vital for the analysis workflow to be robust, reproducible, and understandable. This project demonstrates that the use of the IEEE 2791-2020 Standard, (BioCompute objects [BCO]) enables complete and concise communication of NGS data analysis results. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data. Two separate, independent analyses were then carried out using BCOs as the tool for communication of analysis: one to simulate a pharmaceutical regulatory submission to the FDA, and another to simulate the FDA review. The two results were compared and tabulated for concordance analysis: of the 118 simulated patient samples generated, the final results of 117 (99.15%) were in agreement. This high concordance rate demonstrates the ability of a BCO, when a verification kit is included, to effectively capture and clearly communicate NGS analyses within regulatory submissions. BCO promotes transparency and induces reproducibility, thereby reinforcing trust in the regulatory submission process.Competing Interest StatementThe authors have declared no competing interest.