During a training module this week, a group of monitors were discussing the importance of back-up coverage. Monitors that are conducting visits in the field know that juggling schedules can be very challenging. To provide thorough and consistent monitoring, experienced monitors are assigned to a clinical trial or a study team. Next, training is extended into the therapeutic area of research and sponsor specific trainings including SOPs and monitoring plans.  But what about back-up coordinators- are they trained and ready?

As monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself. Before your next monitoring visit, consider asking yourself these five questions:

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:

Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study.  What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC).  Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked.  Some of the major responsibilities of the CRC are:

Regardless if you are reading this from a sponsor, site, monitor or IRB perspective, we have all worked on a protocol with a medical test that really seems unnecessary or obsolete, not to mention, difficult to obtain with in the time window specified by the protocol.

I love the straightforward definition this website provides on CAPA. “Simply put, Corrective Action is based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Both are similar procedurally, but with the focus as described. Together, Corrective and Preventive Actions are integral parts of a continuous improvement program.”

In clinical research this phrase is used to emphasize the importance of complete and accurate documentation to site staff.  Still, every year we see that FDA issues multiple warning letters which cite, “You failed to maintain adequate and accurate records.”

Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study.  What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC).  Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked.  Some of the major responsibilities of the CRC are:

Have you ever worked at a site where they follow a practice just because “that is how they have always done it?”  At IMARC, we like to apply the FAIR Shake™ to these scenarios. What is the FAIR Shake™?

Most of us have been there before.  In an attempt to get that last item completed before the end of another long day on the job in the field of clinical research we inadvertently scribe the wrong date on the research record we are completing.  We are all human after all, and mistakes do happen from time to time.  Sometimes we know instantly and can correct ourselves, and others someone else points out the discrepancy that we may have over looked.  It’s how we respond after we are made aware that we have made the mistake that I want to focus on for this blog post because there are multiple different options one can take.