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This professionally developed Good Documentation Practice (GDocP) and Essential Documents course explores data integrity and document requirements in detail and demonstrates how GDocP can be implemented into a number of roles.
Good Documentation Practice is mandatory to ensure that documentation (and ultimately products) meet industry standards and other legal responsibilities in the pharmaceutical sector.
Learning Objectives
- To understand what GDocP is and why it is important
- To understand the various types of essential documents
- To explore which essential documents are required at which stage of the clinical trial process
- To examine ICH GCP E6 R2 and its requirements in regards to essential documents, and how to archive essential documents according to ICH GCP standards
- To know about different types of documents
- To understand different types of data
- To understand the importance of data integrity and ALCOA+ and be able to implement these in your role
- To understand the role of security and data protection in GDocP
