Monitoring clinical data is a critical part of trial success. Part of doing this effectively is efficiency, so a question being asked more frequently is “why not monitor source data remotely?” This course discusses the feasibility of remote monitoring of source data in compliance with predicate rules, including HIPAA, FDA, as well as mandates outside the US. The course presents 1) the pros and cons for investigational sites, and sponsors, 2) the elements in a quality system that need to be in place at trial sites and sponsors to initiate this successfully, and 3) how to ensure audit readiness for all. Remote monitoring can be more than electronic case report form (eCRF) review and remote meetings between monitors and study coordinators.
Attend this session and you will be able to:
- Identify how to evaluate the feasibility of remote monitoring of site source data
- Promote better remote monitoring practices and documentation
- Clarify what data are accessible remotely from covered entities
- Develop agreements between stakeholders to support remote source review