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The document offers comprehensive guidance for organizations involved in clinical trials, focusing on the retention and archiving of records to ensure compliance with Good Clinical Practice (GCP). It serves both Sponsors and Investigators, as well as organizations providing contract archive services for electronic and physical records. While primarily targeted at GCP-regulated entities, the advice may also benefit those dealing with records from other regulatory frameworks, such as Good Manufacturing Practice (GMP).
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Gcp - A Guide to Archiving, Chris Jones
- Language
- Released
- 2014
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- Title
- Gcp - A Guide to Archiving
- Language
- English
- Authors
- Chris Jones
- Publisher
- Scientific Archivists Group Limited
- Publisher
- 2014
- Format
- Paperback
- Pages
- 54
- ISBN13
- 9780955765940
- Category
- Nature in general
- Description
- The document offers comprehensive guidance for organizations involved in clinical trials, focusing on the retention and archiving of records to ensure compliance with Good Clinical Practice (GCP). It serves both Sponsors and Investigators, as well as organizations providing contract archive services for electronic and physical records. While primarily targeted at GCP-regulated entities, the advice may also benefit those dealing with records from other regulatory frameworks, such as Good Manufacturing Practice (GMP).