4/18/2020
Date: April 27, 2020
Time: 11 a.m. – 12 p.m. EDT
Cost: $25
Register: Here
Description:
Sponsor monitoring of the ORIGINAL source documents has been a challenge since the increased use of electronic medical records (EMRs) by the healthcare industry. But over time, the clinical trial industry has figured out how to coordinate this, and increasingly often by providing monitors temporary secure direct access to source documentation for a particular trial. This has been while the monitor is onsite.
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!
A silver lining? The global COVID-19 pandemic has increased the need for remote monitoring and for sites to support a sponsor’s review of source documents remotely [FDA COVID-19 Guidance 16-APR-2020]. 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.
Join this live, interactive webinar with guest presenters from the Duke Office of Clinical Research within the School of Medicine for ‘A Case for Sponsor Monitoring Remote Access to EMRs.’ This session presents how a successful program was implemented prior to COVID-19 and then leveraged during COVID-19 to support sponsor remote review of EMRs while maintaining control and security of the subjects’ data and maintaining subjects’ privacy based on the HIPAA authorization. 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. The webinar concludes with a question and answer session.
A recording if the webinar will be available to attendees for 10 days.
Objectives:
Recognize the essential needs of the site regarding remote monitoring, including remote monitoring of study source documentation
Discuss the feasibility of sponsor monitoring's direct access to EMR (during COVID-19 and during "normal" times), and what are the challenges, myths, and opportunities?
Review a case study of successful program implementation for sponsor direct access to study subject pertinent source in EMRs remotely.
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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