An article in the Journal of Clinical Research Practices titled Regulatory Myths in Clinical Research highlights the intricacies and confusion surrounding regulatory requirements in clinical research. Some of the myths addressed include details about the 1572, consents, protocols, IRBs and enrolling subjects. The conclusion states:
It’s impossible to know how much time is wasted complying with the regulatory myths listed above and countless others. So, what can we do about it? To start with, periodically reread the main regulations. Second, maintain a healthy level of skepticism when someone says something is an FDA requirement. Ask to see the regulation. When in doubt, look it up.
This quote from the article is very true! As a company, we agree that so much time is wasted on regulatory “myths”. Before blindly following a supposed FDA requirement follow the above quote’s advice and look it up. One myth we see over and over again is that the investigator must print his or her name on a consent along with their signature. This is false, the investigator is only required to sign their name. – Janet Lewis, RN, CCRP
