ObjectiveThrough researching the "Automated Production Quality Management Specification 5th Edition" (GAMP5) promulgated by the International Society for Pharmaceutical Engineering, combined with domestic and foreign guidelines and regulatory requirements, to explore the practical methods for the verification of the central randomization system of clinical trials.MethodsThe GAMP5 verification process and specifications of the clinical trial central randomization system was established according to the GAMP5 guideline and domestic and foreign computerized system verification guidelines and regulations in combination with the characteristics of the clinical trial central randomization system, and the existing clinical trials central randomization system was used as an example to show the verification results.ResultsThe verification framework and process of the central randomization system met the requirements of the relevant regulations of clinical trials that had been constructed. For the existing system, a verification team was established, a verification plan was developed, and a computerized system verification was conducted in accordance with the V model to form a set of standardized verification documents.ConclusionsThe verification process of the central randomization system proposed by this research follows the GAMP5 specification and has high operability and reference value.
Epigenetics refers to the modification effect of external and internal environmental factors on genes under the premise of the unaltered genetic sequence, leading to changes in gene expression level or function, and thereby affecting various phenotypes or disease outcomes. In recent years, epigenetics has attracted increasing attention. Among them, DNA methylation has been shown to be closely related to human development and the development of disease. However, the high-dimensional omics data generated by genome-wide methylation detection can comprehensively reflect the overall and local epigenetic modifications at the genome level, which has become one of the main research contents in this field. Based on genome-wide methylation chip data, this paper summarized the quality control process of this omics data, common epigenetic omics correlation statistical analysis methods and ideas, and visualization realization of main results based on SAS JMP Genomics 10 software, so as to provide reference for similar studies.