Aims and Objectives: To understand the historical context of archiving, importance of archiving, regulatory & legal frameworks, archiving challenges and meeting archiving challenges
- Reasons for Archiving
- Responsibilities – who should be doing what?
- How the EU directive on clinical trials has influenced the requirements for retention and the required documents.
- The difference between archiving and storage
- How electronic records fit into the archiving requirements.
- Training requirements for personnel