T/CGCPU 012-2020 Standard for Archive Management of Clinical Trial Institutions

Scope

Scope: This standard specifies the requirements for the standardized management of archives in clinical trial institutions, covering spatial conditions, facilities and equipment, clinical trial archivists, management systems and standard operating procedures, key aspects and requirements of clinical trial archives management, etc. This standard applies to the management of archives in drug clinical trial institutions and medical device clinical trial institutions. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 3.1 Source documents 3.2 Source data 3.3 Documentation 3.4 Essential documents 3.5 Certified copies 4. Basic requirements 5. Management rules 5.1 Spatial conditions 5.2 Equipment and facilities 5.3 Requirements and qualifications for clinical trial archivists 5.4 Management systems and standard operating procedures 5.5 Management requirements for common archives on other media (except paper archives) 5.6 Archive management requirements for specialized departments 5.7 Key aspects and requirements of clinical trial archives management 5.7.1 Generation of archival materials 5.7.2 Archiving and filing of archival materials 5.7.3 Storage and use of archival materials 5.7.4 Destruction or transfer of archival materials to third-party custody 5.7.5 Special requirements for electronic archive management

Development Information

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