Compliance In Focus

As industry begins conducting more and more device trials globally, now more than ever it is crucial to understand the important differences that exist between the FDA’s regulations and the international standards of ISO 14155.  IMARC Research has created a new whitepaper that highlights these differences.

We recently took a poll within the company regarding the following topic:  What is your favorite regulation, and why?  Here are some selected responses and the reasoning behind them:

Clinical research trials have a multitude of stakeholders.  For the monitor, though, our first and most important priority is the human research subjects who have altruistically volunteered to participate in these trials.  Our goal is to ensure that the rights, safety, and well-being of clinical trial subjects are being maintained.  We remember the ethical principles as outlined in the Belmont Report- respect for persons; beneficence, and justice- as we travel all around the world to investigative sites conducting clinical research trials to ensure that they are being conducted appropriately.

In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

While working on a recent project involving researching FDA warning letters, it astonished me the number of investigators and investigative sites who had issues with informed consent.  I was surprised at the seemingly little familiarity study staff had regarding Federal Regulations when it came to the informed consent and the consenting process.

This blog was written by a newer monitor with IMARC Research.  This is her experience, and certainly not representative of all research coordinators and monitors.  We thank her for sharing this, and hope others who have made the similar transition will chime in with their experiences!