This professionally developed Good Documentation Practice (GDocP) course explores data integrity and document requirements in detail and will show how GDocP can be implemented into a number of roles.
Good Documentation Practice is mandatory to ensure that documentation (and ultimately products) meets industry standards and other legal responsibilities in the pharmaceutical sector.
This is a professionally developed, interactive and engaging online course essential for anyone working in Clinical Research. It is suitable for all levels of experience.
Learning Objectives
- To understand what GDocP is and why it is important
- To examine ICH GCP E6 R2 and its requirements in regards to documents, and how to archive documents according to ICH GCP standards
- To know about different types of documents and data
- To understand the regulations surrounding electronic signatures
- 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
