Enhanced Workforce Training Key to Tackling Chronic FDA Inspection Citations

Stephani Hulec, MS, CCRA, Associate Director of Clinical Monitoring Services, IMARC Research

It’s a classic good news/bad news scenario. The bad news? U.S. Food and Drug Administration (FDA) officials keep finding the same operational problems over and over again during clinical trial site inspections, as evidenced by public Warning Letter reports. The good news? “Sponsors and sites are more open to the idea that we need more workforce training” to turn the tide, says Stephani Hulec, MS, CCRA, associate director of clinical monitoring services with IMARC Research.

“There are a lot of moving parts in a clinical trial,” Hulec notes, and “everyone is really busy doing things outside the study.” It’s no wonder problems slip through the cracks, she adds.

The list of common FDA inspection findings is woefully familiar, including:

  • Failure to follow investigational plan/agreement and/or regulations
  • Inadequate record keeping
  • Inadequate subject protection, including informed consent issues and failure to report adverse events
  • Inadequate investigational product accountability
  • Inadequate communication with the institutional review board
  • Investigational product represented as safe/effective

No one is criticizing the clinical trial workforce. “They are often not doing the job they were [originally] hired to do,” says Meghan Kulaszekwski, BS, CCRP, lead clinical research associate with IMARC Research. Tasks are added on an ad hoc basis, and when a study coordinator leaves his or her post, often those duties are spread around to existing staff. She’s observed this particularly in orthopedic studies.

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It’s a formula for trouble and it’s not fair to clinical trial professionals, Hulec and Kulaszekwski agree. “Training and certification can be big factors,” Hulec says. The workforce deserves more education and help in understanding the bigger picture of clinical trials and “why [we are] doing something a certain way,” she adds.

Carrying out one’s duties shouldn’t be about robotically checking a box. Instead, the clinical trial practitioner should understand the underlying logic and rationale for the task, Hulec says.

“As a monitor, we are the eyes and ears of the sponsor [at the study site] and play a vital role in assisting them with securing compliance—the end goal is to ensure study data have integrity and to protect the patients involved in clinical trials,” Kulaszekwski says.

Author: Michael Causey