Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

On 2 July 2020 the FDA updated the final guidance for industry, investigators and IRBs.

FDA issued this guidance to provide 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 for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency. A new Q&A (#12) section has been added about the alternative process to obtain informed consent when electronic and paper forms cannot be provided.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /