Abstract:The quality of data is related to the evaluation of clinical trial results, and standardized data recording is an important basis for ensuring the traceability of clinical trial data. Clinical trial data management in China is currently in a stage where both paper and electronic documents are used.This article analyzes the current status of clinical trial data management in China, as well as the requirements for document management in relevant laws, regulations, and guidelines for clinical trial quality management. Based on practical management experience, it outlines the process of controlled management for paper documents related to clinical trials. The aim is to further standardize clinical trial data management from the perspective of document management and provide reference for clinical trial institutions.