Remote Monitoring of Clinical Source Data – Why Not?
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 interactive live 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
This course will be of benefit to anyone responsible for site management, monitoring, quality assurance, site selection, and monitoring plan development. Additionally, those involved with developing risk-based approaches to trial operations and others involved in the general trial efficacy process will benefit greatly from this course.
Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).