The formulation of standard operating procedures for electronic data collection and management in traditional Chinese medicine clinical research according to T/CACM 015.4-2017

Scope

Main technical content: Clinical research data are the most important evidence to demonstrate the safety and effectiveness of research drugs, and well-regulated data management is the key to ensuring the quality of clinical research. Clinical research should establish a data quality management system including quality policies and objectives, quality manuals, procedural documents, work instructions, and quality records, and establish an organizational structure compatible with the quality system to ensure the normal operation and continuous development of the quality system and guarantee the data quality of clinical research. Electronic data collection and management is an important tool for clinical research, which has basic features such as multi-role authority maintenance, online data collection and verification, audit traceability, and online electronic signature. Compared with traditional paper-based data management, it has the advantages of cost savings, shortened R&D cycles, and improved data quality, and has become the mainstream form of clinical research data collection and management. At present, drug regulatory authorities in Europe, the United States, and China, as well as international data management industry organizations, have issued a large number of guidelines and management norms related to electronic data collection, computerized system validation, electronic signature, and records. On the basis of following the above guidelines and norms, this specification formulates norms for 17 standard operating procedures commonly used in the process of electronic data collection and management, each of which includes four parts: purpose/scope, responsible persons, relevant processes, and working documents. For an overview of the standard operating procedures (SOPs) for clinical research data management, please refer to Appendix A. At the same time, in view of the characteristics of electronic data collection and management in TCM clinical research, corresp

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