When a monitor has a tiny epiphany while working through a difficult compliance issue with a site, or an ‘Ah-ha!’ moment, we call that a ‘Regulation Revelation.’ After reviewing an informed consent that lacked the required statement regarding registration on clinicaltrials.gov (21 CFR 50.25(c)), I discussed it with the sponsor and had an ‘Ah-Ha!’ moment I’d love to share.

This week is FDA Warning Letter Week at IMARC! Have you had a chance to catch up on the first three blogs that aim to help you response to the FDA? This last blog in the series attempts to take the perspective of the agency when reading your response letters.

The FDA Bioresearch Monitoring Program (BIMO) was created to: “Protect the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical trials; Verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and To assess compliance with statutory requirements and FDA's regulations governing the conduct of clinical trials.” But, how exactly does FDA safeguard human subjects, ensure data integrity, and verify compliance with applicable standards?

On December 31, 2012 the guidance, “eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff" was issued as an official guidance document.  The guidance provides step-by-step instructions on how to make submissions for medical devices to FDA using the new eCopy format.  Yet to anyone attempting to issue a submission to FDA after January 1st utilizing a strictly paper format, it was quickly learned that this wasn’t a typical FDA guidance document.  FDA responded to those “paper only” submissions with an eCopy hold notification; in essence, not received.

Informed consent is arguably the most important aspect of patient protection in clinical research. The informed consent process is intended to protect the rights and welfare of subjects by educating them about their potential participation in a clinical trial. Unfortunately, informed consent remains an issue today. In fact, the FDA has sent out many warning letters regarding informed consent over the last few years.

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?

In the clinical research industry many rely on a regulatory strategy, or a regulatory plan. Having a strong foundation to build upon for a research team is vital for success. When regulations are the building blocks the goal of compliance can be more readily achieved- and in the end, keep patients safe. This is the main objective of our industry; how can it be realized?

A project that has long been in the mind of Sandra Maddock’s has come to life.  The challenge was how to translate key events in clinical history into a series of images that depicted both the amazing and tragic events that have impacted medical research.

The FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance is issued with hopes to increase the number of female subjects enrolled in clinical trials.

Jim Dickinson recently published an article on the Medical Device and Diagnostic Industry website about the most recent Health and Human Services Office of the Inspector General (OIG) report.  The report raises the issue of whether or not FDA should be forced to tighten their review process for Sponsor’s to submit complete financial disclosure information on investigators with IND/IDE applications.  The article also mentions that OIG is critical of FDA’s current adverse event reporting review process.  With that being said, OIG will be re-focusing a previous recommendation that FDA obtain complete financial disclosure information, as well as develop more strict device adverse event reporting review requirements.