T/CQAP 3013-2023
Key points for quality inspection of clinical trial data management (English Version)

Standard No.
T/CQAP 3013-2023
Language
Chinese, Available in English version
Release Date
2023
Published By
Group Standards of the People's Republic of China
Latest
T/CQAP 3013-2023
 

Introduction

The Clinical Trial Data Management Quality Verification Points, published on October 10, 2023 and implemented from January 10, 2024 under the standard number T/CQAP 3013-2023, aims to provide a comprehensive guideline for ensuring high-quality data management in clinical trials. This Chinese national group standard focuses on establishing clear criteria for verifying the quality of data throughout various stages of clinical research, including planning, execution, monitoring, and reporting phases.

The standard emphasizes the importance of maintaining data integrity and accuracy through rigorous verification processes. It outlines specific requirements related to data collection methodologies, validation procedures, and documentation practices that are critical in ensuring the reliability and validity of clinical trial results. Furthermore, it provides detailed recommendations on how to handle potential issues such as missing or inconsistent data entries.

This standard is crucial for all stakeholders involved in conducting and managing clinical trials, including researchers, sponsors, regulatory authorities, and healthcare providers. By adhering to these guidelines, the quality of clinical research can be significantly enhanced, thereby contributing to more reliable outcomes that benefit patients and advance medical science.

T/CQAP 3013-2023 history

  • 2023 T/CQAP 3013-2023 Key points for quality inspection of clinical trial data management

Topics on standards and specifications

Standard and Specification




Copyright ©2025 All Rights Reserved