4/30/2020
Over time, the clinical trial industry has figured out how to coordinate onsite monitoring of a study patient’s electronic health record. This can be through certified copies (very laborious for sites) or increasingly often by providing temporary secure access to source documentation for a particular trial.
Why can’t we do this remotely as well? Before you answer, be sure you have the terminology and requirements straight…There are many over interpretations of the HIPAA Privacy Rule that hinder this possibility and a lack of focus on the essential security and privacy needs of the research site. Also, we have a case study that shows this can be very successful!
This recorded webinar ‘A Case for Sponsor Monitoring Remote Access to EMRs’ presents guest speakers from the Duke Office of Clinical Research within the School of Medicine. It details how a successful program was previously implemented and then leveraged during COVID-19 to support sponsor remote review of EMRs. Learn about a case example of a successful program implementation that avoids site burden and maintains attributability to records. Explore opportunities for sites and sponsors to find similar solutions.
This is an opportunity to finally move the industry into more remote monitoring models, and in many cases, improve quality, improve timeliness of subject safety oversight, and lower the cost of research development.
The course presents:
The essential needs of the site regarding remote monitoring, including remote monitoring of study source documentation.
The feasibility of sponsor monitoring's direct access to EMR (during COVID-19 and during "normal" times), including the challenges, myths and opportunities.
A case study of successful program implementation for sponsor direct access to study subject pertinent source in EMRs remotely.
Purchase the recorded webinar here. Access to the recording is available for 10 days after purchase.
Presenters:
Denise C. Snyder, MS, RD, LDN
After spending time in public health and clinical nutrition, Denise started work at Duke as a research coordinator and project manager in 2000 for NIH funded trials in oncology. In 2009, her Research Management Team in the School of Nursing received support from Duke’s CTSA to leverage the group’s services and launch REDCap for the School of Medicine. For the past 8 years, Denise has been the Associate Dean for Clinical Research for Duke University School of Medicine. In this role, she leads the Duke Office of Clinical Research (DOCR) a support office of expertise in coverage analysis, study logistics, data management, regulatory oversight, workforce innovation and guidance for clinical research operations for Duke as a site.
Maria Manson, BS, CCRC
Maria started her career working for the perioperative services with cardiothoracic, liver, and kidney transplant teams in Argentina. She joined Duke Operative services in 2004 and became a Research Coordinator for the Department of Surgery in 2006. She continued her research career at Duke by moving to the Department of Orthopedic Surgery as their Research Practice Manager. In 2018, she joined the Duke Office of Clinical Research (DOCR).
DOCR is housed within the Duke University School of Medicine and provides navigation, tools, and training to support the conduct of clinical research in which Duke serves as an investigative site.
Sandra “SAM” Sather, MS, BSN, CCRC, CCRA
Sandra “SAM” Sather is the author of the book HIPAA and U.S. Clinical Trials: A Question & Answer Reference Guide and authors the HIPAA Privacy Rule chapter in the annual CHI GCP Q&A Guidebook since 2008 to present. 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 has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, CAPA, RBM, safety, HIPAA, and vendor management).
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 and QRM subject matter expert, training management and development, mentoring, performance improvement systems analysis, staff management and more.
- The Clinical Pathways Team
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