基于真实世界研究项目电子源数据存储库的审核查验路径和要点研究

Research on Audit Inspection Paths and Key Points Based on the Electronic Source Data Repository of Real World Study Projects

临床研究在药物研发和医学领域中的作用越来越重要,其中数据质量与科学性是重要环节之一。为了提高数据准确性,我国监管机构积极推进临床研究监管改革,并强调源数据的可追溯性和准确性。电子源数据记录(ESR)技术在提高数据质量和降低成本方面具有重要作用。研究团队围绕源数据质量进行探索,提出建立基于临床研究项目的电子源数据存储库(ESDR)的研究流程以及对应的审核查验要点等解决方案。基于ESDR源数据管理系统的工作流程覆盖了从研究项目源数据采集、治理到研究数据库输出等各个环节,同时对临床研究的数据管理过程操作留痕,具有完备的稽查轨迹,有利于高效地进行审核查验工作。

Clinical research plays an increasingly important role in drug development and the medical field,with data quality and scientific rigor being crucial aspects.In order to enhance data accuracy,regulatory agencies in China are actively promoting reforms of clinical research supervision,emphasizing the traceability and accuracy of source data.Electronic source record(ESR)technology plays a vital role in improving data quality and reducing costs.This research team explores the quality of source data and proposes possible solutions,such as a research workflow for establishing an electronic source data repository(ESDR)based on clinical research projects,along with corresponding audit and inspection points.The ESDR workflow,which relies on the electronic information system,covers the entire process from source data collection and governance to data output,leaving a comprehensive audit trail.This feature makes it convenient for efficient audit and inspection work in the data management process of clinical research.