Question

"Under the FDA Bioresearch Monitoring Program, if a clinical trial investigator receives an official action indicated after an inspection and chooses to ignore it, he will be issued a warning letter. What is not true of an OAI?"

-FDA requires a response from the investigator within 15 days
-OAI is the least common outcome of an FDA's inspection of a clinical trial site
-Can lead to throwing out of the investigator's clinical data
-Issued by FDA investigators after an inspection when only minor violations are observed
-Can result to disqualification of an investigator from future clinical research

Answer 1

An Official Action Indicated (OAI) issued by the FDA after an inspection of a clinical trial site is the most serious outcome and can result in serious consequences for the investigator and their trial. It is issued when significant violations are observed and may lead to the throwing out of clinical data.

Step-by-step explanation:

The statement that is not true of an Official Action Indicated (OAI) issued by the FDA after an inspection of a clinical trial site is: Issued by FDA investigators after an inspection when only minor violations are observed. An OAI is actually issued when significant or major violations are observed during an inspection. It is the most serious outcome of an FDA inspection and can lead to serious consequences for the investigator and their clinical trial.

An OAI can result in the throwing out of the investigator's clinical data if there are significant violations that compromise the integrity and validity of the data. The FDA requires a response from the investigator within 15 days of receiving an OAI, and failure to respond or address the violations adequately can lead to further regulatory actions and potential disqualification of the investigator from future clinical research.