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  4. SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency - 04/30/2020 - 04/30/2020
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Webcast

Event Title
SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency
April 30, 2020


Date:
April 30, 2020
Time:
1:00 PM - 1:45 PM ET

View Recording  View Slides

 

ABOUT THIS WEBINAR

FDA recognizes that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products and lead to difficulties in meeting protocol-specified procedures. Further, FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures. To provide timely guidance to support continuity and response efforts to this public health emergency, FDA published Guidance on Conducting Clinical Trials of Medical Products during the COVID-19 Public Health Emergency. Although the necessity for, and the impact of, COVID-19 control measures on trials will vary depending on various factors, the guidance provides general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.

LEARNING OBJECTIVES

After this webinar, participants will be able to:

  • Describe general challenges during the COVID-19 public health emergency that can impact the conduct of clinical trials of medical products.
  • Identify key factors that should be considered when sponsors decide whether to suspend or continue an ongoing study, or to initiate a new study, during the COVID-19 public health emergency.
  • Identify key factors that should be considered when sponsors decide whether to modify an ongoing study.
  • Identify steps to help protocol deviations and amendments that result from challenges related to the COVID-19 public health emergency.

INTENDED AUDIENCE

  • Sponsors involved in the management of or conducting clinical trials
  • Healthcare professionals involved in the conduct of clinical trials
  • Researchers/ clinical investigators conducting clinical trials
  • Persons serving on an institutional review board
  • Regulatory affairs professionals involved in the management of clinical trials
  • Clinical research coordinators

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FDA SPEAKERS

Jacqueline Corrigan-Curay, MD, JD
Director
Office of Medical Policy | CDER | FDA

John Concato, MD, MS, MPH
Deputy Director, Office of Medical Policy Initiatives
Office of Medical Policy | CDER | FDA

FDA RESOURCES 

  1. FDA Guidance on Conducting Clinical Trials of Medical Products during the COVID-19 Public Health Emergency
  2. Coronavirus Disease 2019 (COVID-19) FDA page
  3. Coronavirus Treatment Acceleration Program (CTAP) FDA page
  4. For further questions on clinical trial conduct during the COVID 19 public health emergency, please email Clinicaltrialconduct-COVID19@fda.hhs.gov.
  5. Contact information for FDA’s review divisions is as follows:

QUESTIONS

Please contact CDERSBIA@fda.hhs.gov for all technical questions.

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