5/03/2020

Date: May 7, 2020

Time: 1:00 – 2:30 PM EDT

Live or available as recorded session

Register: Here

Background: The Food and Drug Administration’s (FDA’s) finalized guidance document includes evolving frequently asked questions 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.

The Office for Civil Rights’ (OCR’s) Notification of Enforcement Discretion on telehealth and HIPAA 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.

The European Medicines Agency (EMA) recently updated their Guidance on the Management of Clinical Trials During the COVID-19 Pandemic.

Learn about the latest updates on these guidance documents on the conduct of clinical trials during the pandemic during the webinar, and ask your questions during the question and answer session at the end.

Description: The recent COVID-19 outbreak has disrupted clinical trials drastically. Monitors are grounded but data still needs to be monitored. Despite the FDA, OCR, and EMA guidance, the question remains – how do we do this without putting our monitors or trial subjects at risk while staying compliant?

Learning objectives:

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

- The Clinical Pathways Team

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