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COVID-19 Resources for Clinical Research Professionals

To assist you in staying on top of the latest developments around COVID-19 impact on clinical trials, Barnett will continuously compile industry resources and post them here as they become available. Please check back regularly for updates.

Following are industry resources that have been identified to date:

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards, issued December 2020

FDA Guidance Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic May 2020

EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 1 (20/03/2020)

Association of Clinical Research Organizations (ACRO): Considerations to Support Clinical Trial Monitoring Oversight During COVID-19, 13 March 2020

Gov.UK Guidance Managing clinical trials during Coronavirus (COVID-19) How investigators and sponsors should manage clinical trials during COVID-19, Published 19 March 2020, Last updated 24 March 2020

OHRP Guidance on COVID-19, issued April 2020

COVID MyStudies Application (App)

Tools for Managing Clinical Trials During the COVID-19 Pandemic

In response to the unprecedented challenges that COVID-19 has created in the field of clinical research, Barnett is developing a number of courses addressing the unique challenges of managing trials in the era of COVID-19.

Our initial Interactive Web Seminar courses include:

Strategies for Remote Auditing of Investigative Sites

Strategies for Effective Remote Monitoring