Hello Lamiaa, you have brought up a very good point. In my personal case, I have not dealt with any of those problems, however a close friend who works in the accounting department of a company mentioned to me that they missed a receipt for a minor purchase in the inventory and the government found out about it and they penalized him with a fine of approximately $1500. On the same way, one of my professors told me a story about how one of his coworkers in the industry was applying certain dose into patients for a study involved to ECG signals. The FDA had provided permission to apply 100 grams/ml (I can’t remember the correct unit of the variable) for the study, everything was working well with the dose of a 100, so the engineer decided to change it to 150. This change was not a major change when related to the study, however the FDA found out about it and it almost cost the Engineer his job, career and he also had to go to multiple auditions because of this. I completely agree that every detail of what is being done in a study must be submitted to the FDA, this provides very good control of what’s happening and it helps to go back as a reference when any issue occurs.

Let me know what you think.

Sincerely,
Roberto Pineda.