SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency (04/30/2020)

The 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. Protocol modifications may be required and 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. This 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.

This recorded webinar discusses the FDA guidance and discusses community solicited questions including: 

  • What is the most important aspect of study consult to be concerned about during COVID-19? (29:36)
  • Reporting of protocol deviation(s) as a result of COVID-19? (30:12)
  • When do immediate changes to a protocol that is implemented a the sites and then approved by the IRB actually need to be submitted to the FDA?  (32:04)
  • Additional documentation of COVID-19 as an AE? (34:51)
  • How to conduct source data verification for remote site audits? (36:39)
  • Changes to the statistical plan? (39:08)  
  • Screening of participants for COVID-19 infection? (40:31)
  • Changes to the statistical plan? (39:08)  

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