All AE Reports Require Investigator Review, FDA Guidance Stresses
In an update to the FDA’s guidance on conducting trials during the pandemic, the agency has reminded investigators of their responsibility to review all adverse events (AE) and report to their IRBs any potential risk to trial participants.
First released in March and updated in April, May and July, the guidance uses a question-and-answer format to address issues unique to conducting a trial during the COVID-19 outbreak. The guidance has grown to 25 questions from the original 10 published in March.
According to the latest update, investigators must review all AE reports they receive from sponsors, even ones a sponsor says do not require changes to the trial’s investigator’s brochure, informed consent form or protocol.
The agency acknowledges that trials with COVID-19 patients may have a higher volume of AEs, some of which may not be directly related to the investigational drug, pointing out that any unexpected AE may indicate a previously unanticipated risk to participants.
The review of all safety reports is “critical to fulfilling investigators’ responsibility to protect the safety of trial participants,” the guidance stresses.
The addition to the guidance is “a timely reminder to the investigator community,” says WCG Clinical Vice President of IRB Compliance David Borasky, “and affirms that nothing about this requirement changes in circumstances where study subjects have COVID.”
To read the updated guidance, click here: https://bit.ly/30qemjt.