SC CTSI's Regulatory Science Boot Camp Course Gives an Inside Look at FDA Inspections

The latest in an ongoing series of lectures and workshops about the complex world of FDA regulations shows researchers how to keep studies on track while ensuring their data make the grade.

November 01, 2016

Anyone involved in clinical and translational studies knows that the FDA regulations and the Good Clinical Practice (GCP) guidelines that govern health research are a world unto themselves—extensive, complex and, of course, legally required.

But that's not all: they also keep changing, explained Eunjoo Pacifici, PharmD, PhD, Associate Director of Graduate Programs and Assistant Professor of Clinical Pharmacy at the International Center for Regulatory Science, based at the USC School of Pharmacy. FDA regulations are periodically revised to keep pace with new technology, to better coordinate with international research regulations and standards, to improve data quality and to better protect the participants and patients who make the research possible.

For the past year, Pacifici has organized an ongoing series of Regulatory Science Boot Camps. The most recent of the day-long boot camps was held in early October, at the USC Health Sciences Campus. More than 100 members of the Los Angeles and Southern California research community attended, from principal investigators to research coordinators, representing a broad sampling of health and science specialties, departments and professions.

The courses were created in recognition of the direct link between good command of regulations and better, safer and more efficient studies. Conversely, poor understanding and adherence can endanger participants, derail studies, slow progress and waste money, according to organizers.

The ins and outs of FDA inspections
Each boot camp covers a different aspect of regulatory science. "For this particular boot camp, we focused on activities relating to FDA inspection and Good Clinical Practice, including monitoring, reporting and auditing, quality control and quality assurance," said boot camp co-organizer Nancy Smerkanich, DRSc, MS, Assistant Professor, Clinical Pharmacy at USC School of Pharmacy. "These all go hand in hand to make sure we're protecting our subjects and getting good quality data."

Lecture topics included:

  • Good Clinical Practices (GCP)
  • FDA Inspections and Audit Readiness
  • Auditing GCP Systems for Data Integrity
  • Sponsor Audits

The trainers also guided the boot camp attendees through a detailed workshop in which they conducted a mock GCP audit for a Phase 1 study.

Training for researchers at any point in their career
The goal of the boot camps is two-fold, said Smerkanich: first, to get working (and aspiring) researchers up to speed on rules governing clinical and translational studies, but also to give them a chance to meet, network and learn from each other.

Nicki Karimipour, PhD, a recruitment specialist in Clinical Research Support at SC CTSI, attended the boot camp just as she's starting her career as a clinical research coordinator, focusing on patient recruitment and eligibility. "I wanted to know more about the role of clinical research coordinators in clinical trials," she said, "and also how to prepare for an FDA audits."

Boot camp attendee Tammie Possematto, a Program Data/Clinical Research Coordinator specializing in heart transplant research at the USC Department of Radiology, has worked on many clinical trials. Though familiar with regulatory issues through her previous experience, she said the boot camp provided a useful synthesis of the topic, and valuable materials she'd be able to use for future reference.

"We recruit high numbers of participants in quite a few studies, which makes us a little vulnerable to FDA audits," said Possematto. "I want make sure we have everything we need to complete an audit."

The series is co-sponsored by the USC International Center for Regulatory Science, the Southern California Clinical and Translational Science Institute (SC CTSI), and the Greater Los Angeles CTSA Consortium.

"Regulatory science can be time-consuming, but all of these FDA and other required activities are essential to ensuring the public that the medicines and products they use are safe, effective and high quality," said Pacifici. "The regulations are intended to incorporate redundancies and checks and balances to make sure the data is real and accurate, and that the research participants are well-protected."

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.