As a Master’s of Public Health student at Emory University, one of the most intriguing ideas I encountered was that of upstream prevention. This concept is often illustrated by a metaphor involving drowning bodies in a river; a panic ensues at the riverfront as rescuers eagerly jump in to save the drowning victims. Although many people are saved, the rescue team can’t keep up with the sheer number of victims. One member of the rescue team (the public health expert) decides to travel upstream to find the cause of the problem. Although this member of the team is harshly criticized for abandoning the immediate rescue effort, he is later praised for identifying the source of the problem and preventing many deaths.

Recently, my inbox has been inundated with training opportunities for Risk-Based Monitoring.  Since the FDA’s release of its latest guidance on monitoring in August 2011, the pharmaceutical and device industries have made this a hot topic of discussion.  It seems the term, Risk-Based Monitoring, in spite of the guidance, has become an obstacle.  What is Risk-Based Monitoring?  And what is causing the confusion?  Perhaps the clearest definition for Risk-Based Monitoring was given by a presenter at the Global ACRP Conference this year in Tampa.  She referred to it as “Intelligent Monitoring”.  That says it all, doesn’t it?  Visually, I see the AT&T Commercial (It’s Not Complicated “Infinity”) with all the kids sitting around a table discussing big numbers with a grown-up.  When a little girl responds “Infinity times infinity” the grown man responds by motioning that his head just burst.

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank. 

It just depends!

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:

Deviations from the protocol, or non-compliances, are inevitable across a multi-centered study. Some deviations can be prevented by the investigational site study staff, such as in exclusionary criteria noted in the medical history. Other deviations, such as missed visits due to the subject’s schedule, can not be avoided. According to 21 CFR 812.46(a), it is the responsibility of the sponsor to ensure that the selected investigators are compliant with any conditions of approval of the reviewing IRB. The investigator, according to 21 CRF 812.110 (b), is responsible for conducting the trial in compliance with the conditions of approval of the reviewing IRB. Additionally, investigators are responsible for maintaining records relating to deviations, including dates of and reasons for, according to 21 CFR 812.140(a)(4).

Recently, a team of IMARC monitors traveled to a sponsor’s clinical research headquarters to meet face-to-face, study team to study team, to kick off a new medical device study. The two teams joined together with a heavy agenda to get the study’s ducks in a row prior to our monitors hitting the road for the on-site initiation visits scheduled in the upcoming weeks. While this is not always the case at study start-up, with tight timelines and limited budgets, there are many advantages to getting the teams together at the beginning of the study to help prepare for a successful study. Additionally, the teams can process through potential study challenges before they become potentially larger issues. Read on to learn five reasons why the sponsor should meet with and include the CRO in study start up!

IMARC clinical monitors are constantly on the go monitoring in the field, from California to Connecticut, Vancouver to Miami.  The monitors are no strangers to airport security lanes and the Transportation Security Administration agents (TSA).  Some may even creatively compare monitors to TSA agents. Both groups of people are required to be familiar with federal regulations. The regulations exist to allow for monitors and TSA agents to execute their primary role; ensuring safety. Monitors ensure the safety of subjects in clinical trials and ensure compliance to 21 CFR 812 (device) or 21 CFR 312 (drug). TSA agents ensure safety of travelers and flight staff as well as ensure compliance with FAA regulations.

What is the ultimate goal for every clinical trial?  High-Quality Data that proves safety and/or efficacy endpoints while safeguarding clinical trial participants. How can data integrity be ensured? This requires a combination of a few key players during the course of a study.

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset of those on a clinical research team.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank to facilitate running a well controlled, compliant clinical trial.