Compliance In Focus

What is a guidance document and how should they be used? A guidance document represents the FDA’s current thinking on a topic. Per FDA’s website, guidance documents “do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternate approach if the approach satisfies the requirements of the applicable statues and regulations.” Guidance documents usually discuss FDA’s interpretation of their policy on a regulatory issue.

When is emergency use of unapproved devices acceptable?  The Federal Regulations explicitly state how an unapproved device should be used in an emergency situation by a physician. The FDA website also provides a training presentation on this topic.

According to the regulations for clinical trials, the PI is personally responsible for conducting and supervising the conduct of human subjects research by “protecting the rights, safety, and welfare of subject’s under the investigator’s care”.  The PI also has to ensure that all the research he is responsible for is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB. So what exactly is “oversight”?  Oversight is defined in the Merriam-Webster’s online dictionary as “management by overseeing the performance or operation of a person or group; watchful care, superintendence, general supervision”. As you can imagine, this can be quite an undertaking.

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:

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 difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)? Who makes the decision, why do they make the decision and how can it effect a clinical trial? Based on the FDA’s guidance for medical device studies and the Regulations, a SR device:

On Thursday, September 6th, BioEnterprise hosted an event at Corporate College in Cleveland, Ohio. The training event focused on the differences between investigational drug and medical device clinical trials.  Featured speakers for the event were Sandra Maddock, CEO and President of IMARC Research and Brandy Smith, Chief of Clinical Operations for IMARC Research.

According to the regulations for clinical trials, the PI is personally responsible for conducting and supervising the conduct of human subjects research by “protecting the rights, safety, and welfare of subject’s under the investigator’s care”.  The PI also has to ensure that all the research he is responsible for is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB. So what exactly is “oversight”?  Oversight is defined in the Webster’s online dictionary as “management by overseeing the performance or operation of a person or group; watchful care, superintendence, general supervision”. As you can imagine, this can be quite an undertaking.