(1) Scope This standard provides guidelines for the construction of a quality management system for drug clinical trial sponsors. (2) Normative reference documents The normative reference documents of this standard include: GB/T19000 Quality Management System Basics and Terminology. (3) Terms and definitions define drug clinical trial quality, quality issues, etc. (4) The Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors provide guidance on policies, organizations and systems, quality issue management, risk management, process management, product and/or service provider management, and continuous improvement. (5) References: Relevant laws, regulations and normative documents referred to by this standard.
T/SHQAP 001-2023 history
2023T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors