How Can We Work Together to Monitor Quality Source Data Amid COVID-19 Restrictions? Webinar

3/19/2020

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.

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 guidance.

Webinar Course Title: Remote Monitoring Operations & Maintaining HIPAA, GCP, and COVID-19 Restrictions

Dates and Times:

  • 20 March 2020 at 4:00 pm EDT

  • 24 March 2020 at 7:00 am EDT

  • 24 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:

  1. myths of remote review of source data,

  2. a simple process for working together as sponsor and site to ensure quality data without being at site,

  3. how to overcome the barriers of quality data review,

  4. 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

  5. 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 after their participation.


- The Clinical Pathways Team

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