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HomeResearch & DevelopmentRemote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 Restrictions

Remote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 Restrictions

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials (GCP Training)/ Coronavirus / COVID-19/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90-Minutes
On-Demand
Includes handouts!
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

The recent COVID-19 outbreak has disrupted clinical trials drastically. Monitors are grounded but data still needs to be monitored. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released new guidance with updates for industry about COVID-19 and patient safety. The question remains – how do we do this without putting our monitors or trial subjects at risk while staying compliant?

This course discusses the real feasibility of remote monitoring of the quality of original source data in compliance with clinical trial predicate rules, including HIPAA and FDA. This is not asking trial sites to be burdened with scanning and redacting documents or, to risk security breaches. The review of source data in a risk-based regulatory environment is centered on the quality of the documentation – not the comparison of the source to the electronic case report form (eCRF). As such, this crisis is an opportunity to propel us further into enhancing a risk-based culture while having the agility to keep trials moving during crises…like the current pandemic.

During this webinar, our expert instructor will present:

  • Application of the FDA and EMA guidance to real case scenarios
  • A simple process for working together as sponsor and site to ensure quality data during forced remote work
  • How to overcome the many barriers of quality data review when remote monitoring
  • The elements in a quality management system (QMS) that need to be in place or updated at trial sites (and within sponsor firms) to initiate successful remote monitoring now and in the future
  • Strategies to ensure audit readiness for all
LEARNING OBJECTIVES

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

WHO SHOULD ATTEND

This course will be of benefit to anyone responsible for clinical operations of those that monitor, audit and coordinate clinical trial subject source data.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Sandra “SAM” Sather
Industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.

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Clear
Duration: 90-Minutes
On-Demand
Includes handouts!

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials (GCP Training) (110)
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Upcoming Live Courses

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