Blog — Clinical Pathways

Now Available! ICH E6(R3) Comparison Tool. Includes Final Principles, Annex 1, and draft Annex 2. Click here to purchase.

HIPAA

Live Webinar: A Case for Sponsor Monitoring Remote Access to a Site’s EMR!

4/18/2020

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Join this live, interactive webinar with guest presenters from the Duke Office of Clinical Research within the School of Medicine for ‘A Case for Sponsor Monitoring Remote Access to EMRs.’ This session presents how a successful program was implemented prior to COVID-19 and then leveraged during COVID-19 to support sponsor remote review of EMRs while maintaining control and security of the subjects’ data and maintaining subjects’ privacy based on the HIPAA authorization. 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. The webinar concludes with a question and answer session.

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

3/29/2020

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Date: April 2, 2020

Time: 1:00 – 2:30 PM EDT

Live or available as recorded session

Register: Here

Background: 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.

FDA Framework for Use of Real-World Evidence

11/05/2019

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The U.S. Food and Drug Administration (FDA) released a Framework in December 2018 for the use of real-world evidence, which is not routinely collected during the course of a clinical trial. Under the 21st Century Cures Act, the FDA was to establish a program to evaluate the use of real-world evidence to help support a new indication for an approved drug or to satisfy post approval requirements. RWE evidence has been used by the FDA for some time to monitor drug safety, but its use to determine effectiveness has been limited.

Very Helpful Resource: Good Clinical Practice: A Question & Answer Reference Guide 2018

10/12/2018

Our own Sandra “SAM” Sather is a contributing author for the HIPAA Privacy Rule and FDA Regulated Clinical Trials chapter, which extensively answers questions about protection of privacy during clinical research. The reference guide answers more than 1000 common questions related to US and international Good Clinical Practice (GCP) for clinical trials.