Logo

FDA Divulges Guidance for Conducting Clinical Studies During COVID-19 Pandemic

Share this

FDA Divulges Guidance for Conducting Clinical Studies During COVID-19 Pandemic

Shots:

  • The US FDA has issued guidance to aid sponsors & IRBs for assuring the safety of participants in clinical studies- maintaining compliance with GCP and to reduce the risk to trial integrity during the COVID-19 pandemic
  • FDA recommended alternative methods for assessments i.e. contacting patients by phone or virtual visits and offering additional safety monitoring for candidates who may not have access to the investigational therapy or trial site
  • The FDA plans to keep clinical research going and is offering a level of flexibility to work with sponsors to manage how clinical studies may be impacted by changing conditions

Source 1- Source 2 ­to­ read full press release/ article | Ref: FDA- FDA | Image: FDA


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions