GCP E6 Revision 3 AcademyGCP
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ICH GCP E6 (R3) Good Clinical Practice revision 3 Draft copy
III Anex 1
4. Data governance – investigator and sponsor
4.3 Computerised systems
4.3 Computerised systems
4.3.1 Procedures for the use of computerised systems
4.3.2 Training
4.3.3 Security
4.3.4 Validation
4.3.5 System release
4.3.6 System failure
4.3.7 Technical support
4.3.8 User management
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