3/22/2020
Background:
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.
The Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. It clarifies how to proceed with alternative methods of assessments that maintain subject safety and are in compliance with Good Clinical Practice (GCP), while minimizing risks to data integrity.
Additionally, the Office for Civil Rights (OCR) released a Notification of Enforcement Discretion on telehealth and HIPAA. This allows covered health care providers subject to HIPAA to provide telehealth services through remote communication that may not comply with HIPAA Rules during the COVID-19 public health emergency. They also released a frequently asked questions guidance to clarify when and how the Enforcement Discretion may be followed in good faith.
Clinical Pathways is offering a live, interactive webinar that discusses the real feasibility of remote monitoring of the quality of the original source data. It ties in compliance with clinical trial predicate rules, including HIPAA and FDA, and the newly released guidances. The webinar is updated to support more examples of approaches with expanded sections on remote monitoring and help for sites when communicating.
Webinar Course Title: Remote Monitoring Operations & Maintaining HIPAA, GCP, and COVID-19 Restrictions
Dates and Times:
24 March 2020 at 7:00 am EDT
24 March 2020 4:00 pm EDT
26 March 2020 at 7:00 am EDT
26 March 2020 4:00 pm EDT
Duration: 90 Minutes
Cost: $25
Location: Live, interactive training on your computer!
Purchase here
Description:
Learn how to navigate remote monitoring operations while maintaining HIPAA, GCP, and COVID-19 restrictions in the interactive, live webinar.
The course presents:
myths of remote review 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 this and future crisis, and
how to ensure audit readiness for all.
Attend this interactive live session and you will be able to:
Clarify what data are accessible remotely from HIPAA covered entities
Develop agreements between stakeholders to support remote source review
Identify how to evaluate the feasibility of remote monitoring of the quality of site source data without threat of security breach
Promote better remote monitoring practices and documentation
Who Should Attend:
This course will be of benefit to anyone responsible for clinical operations or those that monitor, audit, and coordinate clinical trial subject source data.
Attendees will receive a handout and will have access to a recording of the webinar for 10 days after their participation.
- The Clinical Pathways Team
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