We recently took a poll within the company regarding the following topic: What is your favorite regulation, and why? Here are some selected responses and the reasoning behind them:
- 21 CFR 812.100: “This regulation lets the investigator know what all they are responsible for.”
- 21 CFR 812.46(a): “Covers the responsibilities of sponsors when monitoring investigations…especially the part about securing compliance. To me this regulation embodies them all!”
- 21 CFR 812.150 (a)(4)) “There is something exhilarating to be said for saving a life and figuring the rest out later. What a neat concept that sometimes the clinical research studies we monitor really are the most cutting edge treatments in the world!”
- 21 CFR 812.110 (b) - the basis for our FAIR Shake: “Compliance: An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.” “Aside from the handy FAIR acronym, I love how this one regulation summarizes very simply a whole philosophy of research compliance. A computer programmer might elegantly say, if you are out of compliance with any area (the protocol, the IRB, the agreement, or specifics from the regulations themselves), then you are not in compliance with the federal regulations. It is the law!”
We pose the same question to you. What is your favorite regulation, and why?
Photo Credit: redmeg8