Compliance In Focus

Data integrity is a fundamental requirement of medical research and laboratory experimentation. All studies should be conducted according to the protocol guidelines and documented accurately and completely even if the data disproves or challenges the posted hypothesis. As researchers, it is our responsibility to make sure the study is conducted ethically and honestly. The results of the study are used to justify the effectiveness of a procedure, medical device or pharmaceutical. The goal is to improve the overall health and welfare of humans. Lack of data integrity could prove to be a disaster as something originally thought to be safe could cause unexpected pain or death.

After months/years of conducting your clinical trial, you submit a Premarket Approval Application (PMA) to the Food and Drug Administration (FDA) with the expectation that your Class III medical device will be approved. Unexpectedly, you receive a call from the FDA. The FDA requests to inspect one of your sites to ensure that the data is scientifically valid and the welfare of research subjects have been protected. You don’t worry. Later, the FDA issues a Warning Letter revealing serious violations that could jeopardize the validity of the trial and may refuse to approve the application. You then realize, all of this could have been prevented.