Compliance In Focus

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 the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a new whitepaper that discusses the principles of risk management and their application to clinical research.

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?

IMARC Research believes history provides important examples of clinical research misconduct  that have helped establish a foundation for understanding the principles that guide modern clinical research.  If you visit our offices, you will see artwork that is featured in our history of clinical research timeline hanging on our walls that depict critical events in history that have helped shape and improve modern clinical research for the well-being of human subjects.

When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Sponsored IDE (PS-IDE). Chaos can sometimes ensue when one begins down the path of a PS-IDE. This whitepaper will attempt to make sense of that chaos by providing a brief overview of initiating a PS-IDE, the responsibilities of the investigator, the additional sponsor responsibilities assumed by the Sponsor-Investigator, and a thoughtful discussion on the records and reports of the Sponsor-Investigator.  Relevant FDA warning letter findings issued to Sponsor-Investigators and some suggestions to ensure a well-controlled clinical study are reviewed.

There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program.  In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.

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. 

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.