10/22/2020
Clinical Pathways offered two very popular webinars related to remote monitoring during the pandemic, one related to the sponsor/CRO monitor and the other related to the site. Our introductory price is available through the end of October.
1. In the rapidly changing environment of COVID-19 restrictions, how can monitors and investigators ensure subjects and their personal health information remain protected and data remains high-quality? The ongoing challenge of site closures, travel restrictions, and social distancing has many unsure of how to proceed.
Remember redacting information does Not meet HIPAA de-identification. And why would you do this if you (the sponsor/CRO) are not keeping the documents?
Our sponsor/CRO monitor webinar “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions” prompted many important questions. The companion FAQ document compiles answers to these actual questions and will help guide your remote monitoring efforts during the crisis.
Learn how to work together with sites to review source in a risk-based regulatory environment while being mindful not to overburden sites or put data at risk of security breach.
The course presents:
Myths of remote review and access of source data
A simple process for working together as sponsor and site to ensure quality data without being at site
How to overcome the barriers of quality data review
The elements in a quality management system that need to be in place or updated at trial sites and sponsors to initiate this successfully for now and future crisis
How to ensure audit readiness for all
Purchase the recorded webinar here. Access to the recording is available for 10 days after purchase.
2. 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 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.
- The Clinical Pathways Team
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