Compliance In Focus

We’re often asked- What makes a good monitor? What’s involved in the day-to-day of being a CRA? Well, it’s no secret that a good monitor often wears and juggles many hats; from reporter, to auditor, to traveler. And like many with this New Year quickly unfolding there are some resolutions from those that live out the day-to-day of clinical research monitoring:

In order to run a well-controlled compliant study at the site level, one must ensure that the study team has been trained, and is knowledgeable on the rules and regulations. Although it is the Investigator who is responsible for the conduct of the study, there is a larger team at work to complete all the required activities. The research coordinator carries out many of the day-to-day activities and touches nearly every study milestone.

IMARC monitors are all over North America on a weekly basis traveling to a wide range of sites from the small community hospital to the large medical center that also serves as a teaching institution. What makes a periodic monitoring visit a Good Visit? To those in the medical field, they may determine a good visit by the notability or prestigiousness of the facility itself. To the general population in the outside world, they may say - destination. After all, who wouldn’t want to be monitoring at the site next to the sunny, beautiful beach in southern Florida versus next to the corn field out in no man’s land? If you ask an insider, a monitor, the response would sound something like- “That visit was great. The research coordinator – she (he) was a ROCK STAR!” 

As a former research coordinator of five years, I am well aware of the extremely busy and highly demanding nature of the job. In addition to balancing multiple trials, subjects, physicians, sponsors, and monitors; coordinators are often required to perform a diverse set of tasks that go beyond the scope of subject visit conduct. This may include regulatory submission and maintenance, laboratory processing and shipping, subject recruiting, and source document creation among others. Furthermore, coordinators often work to facilitate trials across multiple locations and must ensure that studies are conducted in accordance with applicable federal regulations, the investigator agreement or 1572, the protocol, and the rules of the IRB (FAIR SHAKE). Given the multitude of responsibilities, some coordinators may be spread too thin.

There are many factors that go into a successful clinical study start-up.  Having the proper team assembled can be a critical factor in the success of any study. Choosing the right site is another factor that can make or break a successful study start-up.  Having a research coordinator and principal investigator that are engaged is important too.

At the site level, having a great working relationship between monitors and research coordinators can really make a difference in the performance of the site.  To do this, monitors walk a fine line between being personable and relatable, but also being respected and trusted.