Source Data Review (SDR) vs. Source Data Verification (SDV) – A Site Monitoring Best Practices Update
Is there a difference between source data verifying (SDV) and source data reviewing (SDR)? The use of the abbreviation SDV is very common, but does not have consistent expectations from group to group (sponsor/ CRO, site). Some studies show that “SDV” is not a critical activity in monitoring quality data, but source data review is. However, many defend that source data verification includes verifying data quality and compliance vs. accuracy alone. If this is the case, is SDV being performed as assumed? This lack of clear expectations leads to data quality issues, even with SDV being defined as monitoring for data quality.
This course will outline the best practices for designing and implementing SDV AND SDR programs, focusing on a risk-based approach. Best practices are outlined in detail, and tools provided will help you find the right blend for your site monitoring activities. Questions such as, “Can SDV/SDR be done remotely?” will be answered, and other common points of confusion will be addressed.
Come to this interactive, live 90-minute session and you will be able to:
- Define the differences between SDV and SDR and determine the right data monitoring path for you
- Perform a risk-based gap analysis of interpretation of the definition of SDV and SDR within current practice
- Update terminology to support cross-functional teams performing remote monitoring activities like source data review remotely and on-site
This course will be of benefit to anyone responsible for monitoring activity planning, monitoring plan development, and cross-functional coordination of study oversight. Additionally, those looking to become conversant in risk-based monitoring approaches to clinical trials will find this course highly useful.
Sandra “SAM” Sather's current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience: 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. Clinical Pathways’ services include development and updates to clinical monitoring operations, compliance and auditing services, GCP subject matter expert, training management and development, mentoring, performance improvement systems analysis, staff management and more. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and 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).