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
4.2 Data life cycle elements
4.2.1 Data capture
4.2.2 Relevant metadata, including audit trails
4.2.3 Review of data and metadata
4.2.4 Data corrections
4.2.5 Data transfer, exchange and migration
4.2.6 Finalisation of data sets prior to analysis
4.2.7 Retention and access
4.2.8 Destruction
Published with Nuclino