Compliance In Focus

How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?

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?

You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?

At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit. It is helpful for a site to know what the FDA auditor will use during their review. In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations.

I am often asked by industry colleagues that if I had to pick just one “favorite” federal regulation what would it be?  The answer is easily 21 CFR 812.100, as this regulation embodies 95% of the investigational site non-compliances  I observe as I conduct clinical investigator audits. Let me elaborate.

21 CFR 812.100 falls under Subpart E- Responsibilities of Investigators of the IDE Regulations.  This regulation succinctly details investigator responsibilities in just two sentences.

You’ve received “the call” from the FDA auditor.  After an understandable quick moment of panic, what should your next steps be?

At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit.  It is helpful for a site to know what the FDA auditor will use during their review.  In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations. 

A medical device company files a marketing application with FDA and awaits a determination on whether or not its clinical trial data is sufficient to support product approval and/or clearance.

I had an interesting question come up today from a research manager whose site has recently switched to an EPIC EMR system.  She asked if copies of data that she had printed out of EPIC for source document verification for an upcoming visit would be adequate for purposes of source document verification. 

We all know that source documents are the gold standard for data verification.  Monitors and auditors ideally should be granted direct access to this information in order to verify study data; however with the plethora of concern surrounding private health information and individual privacy it seems to be getting more difficult to access this information easily.