Compliance In Focus

On October 2, 2014 the FDA issued a guidance that reflects current thinking on management of
 cybersecurity in medical devices. Device manufacturers are encouraged to consider potential threats of hackers and security breaches in the research, design, and development of medical devices. The FDA further recommends incorporating device protection plans into premarket submissions. This has the potential to increase costs in all phases of production.

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.

According to a recent analysis by EP Vantage, there was a 44% reduction in the number of devices approved by the FDA in 2013, as compared to 2012. There are a few key factors that should be considered with respect to this decline.

Monitors that perform their job at a high level can drive the growth and reputation of their company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.

Monitoring clinical trials at a high level requires a unique set of traits, skills, and abilities. While monitors often have diverse backgrounds and experiences, there are specific attributes that characterize great monitors and separate them from the rest of the pack. The following list identifies those attributes and explains why each is instrumental to clinical monitoring. This list is not ranked in any particular order and is not meant to be all inclusive; please share your thoughts!

The relationship between a clinical research monitor and site coordinator can play a major role in ensuring data integrity and compliance with applicable regulations. Positive relationships can foster timely data entry, rapid resolution of queries, and adherence to FDA regulations. On the other hand, strained relationships can delay data entry, prevent resolution of queries and lead to sites being less inclined to follow regulations. The coordinator-monitor relationship is critical to the research process as it serves as a link between sponsors, investigators, and regulatory authorities.

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.

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.