originally posted as a comment by Janet Lewis, RN, CCRP on LinkedIn group Good Clinical Practice regarding an FDA Warning Letter
Although it may be easy to blame the CRA during and after an audit, it is important to remember that as a site you are the one being audited and not the CRA. You are the one potentially receiving the 483 and not the CRA. In an audit it does absolutely nothing to place blame anywhere but at the site and investigator. It is the site and investigator’s responsibility to follow the protocol and, unfortunately, you cannot always rely on the CRA. In an ideal situation, the CRA would find every error. However, this is not the case, especially with the increasing use of risk-based monitoring. It is now more important than ever that sites audit their own work. It is unfortunate that the sponsor, CRO or monitor did not catch some of these findings. However, it is the investigator who signs the 1572 which says he/she will follow the protocol. One major problem today is that there are some investigators responsible for studies that do not have a clue how to conduct a clinical trial. I am fairly certain that the investigator did not know what he/she was responsible for or how to prepare for an audit. “Missing Files?” I would not be surprised if this was a “for cause” audit. Sites should be prepared in advance and have everything ready and in place for the FDA investigator. What can you do to be prepared and have a successful audit?
- Do not wait until the day of an inspection to get your ducks in a row.
- Sites should complete their work as if every study will be audited.
- Do not take on a research study if you do not understand the protocol.
- If you have not been monitored then ask for monitoring.
- Get it right the first time or fix it if you don’t.
- Everyone makes mistakes. When you make a mistake, correct it, and make a plan so it will not happen again.
It is ultimately the site’s responsibility to properly conduct their clinical trials and produce quality work.
