In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

Recently, a clinical site received a call from an inspector on a Thursday notifying the site of a not-for-cause inspection the following Monday. This was a short gap of time between the notification and actual audit conduct. How can sites make sure they are ready if an inspector calls today?

How is auditing different than monitoring?  Why do we need to audit?  Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

As monitors we sort of live by this motto and we always try to remind our sites of this, we do so in order to help protect the subjects, their site, and the Sponsor of the study all at the same time.

Over the past seven years I have traveled all over the United States and Canada and have even been to Japan once.  Due to the great distance, airplane has been the most expedient method for me to travel.  Given that, I have looked out of hundreds of airplane windows and am always enamored with the view.  I never tire of trying to identify where I am, especially as I get closer to Cleveland Hopkins International Airport.  I only live about 25 miles from the airport and really, how hard can it be to find a landmark from the sky?  For whatever reason, I have the hardest time trying to do this.  So you can imagine my aggravation when my husband accompanied me on a trip a few years back and on our decent into the airport he started to rattle off all of these landmarks and our location.  Did I mention my husband has flown in an airplane about six times in his entire life?  After I was done being aggravated at his skill, I really enjoyed finding landmarks, too.  It was so easy once someone gave me a starting point.  Wearing your ‘auditor’s hat’ during your monitoring visits can be just as easy and fun.  You just need to have the right starting point and tools.

In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:

The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from medical device regulatory authorities and the regulated industry. According to the website the purpose of the GHTF is to “encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade. The primary way in which this purpose is accomplished is via the publication and dissemination of harmonized documents on basic regulatory practices.”