Target Audience: This course would be suitable for Research Nurses, Trial Coordinators, Research Administrators, Principal Investigators and any other healthcare professional involved in research
Aims and Objectives: To understand the:
- Historical context of archiving
- Importance of archiving
- Regulatory & legal frameworks
- Archiving challenges
- Meeting archiving challenges
Course Summary: 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