While it’s not a formal regulatory mandate, sites that focus on internal clinical trial quality management increasingly represent “the industry standard,” says Lee Truax-Bellows, MS, FNP, CCRA, RQAP-GCP, TIACR, ACRP-MDP, president and CEO of NCRA.
She warns sites against “relying on sponsors” when it comes to implementing quality policies. “Each sponsor will tell you something different” and the result can be a complex mess, she cautions.
Instead, sites should develop their own internal quality management programs, demonstrate their sagacity to sponsors, and take matters more into their own hands, Truax-Bellows says. “If a site doesn’t have its own plan in place, it will have to jump through hoops” to accommodate the disparate requests of disparate sponsors, she notes.
For example, many sponsors request regulatory forms to be organized and documented in specific, but sometimes widely different, manners. If the site already has a sound program in place, “it’s ridiculous” for sites to have to adjust their system to accommodate the sponsor, Truax-Bellows says.
She allows some sponsors will push back and insist on doing things their way. However, many will bend if sites “can demonstrate they have good, well-written quality management procedures” in place, Truax-Bellows says.
Positive Outcomes in Building a QMS: A Case Study
Join Truax-Bellows and Dr. Marcus Stone of the Spine Institute of Louisiana Foundation at ACRP 2022 as they explore a quality management system (QMS) approach. Sharing a case study of a site that chose to apply a QMS approach, they will explore trials, tribulations, and positive outcomes from their experience and give you the insights you need to employ a QMS approach in your studies.
Remember, Truax-Bellows says, Form 483s (Inspection Observations) from the U.S. Food and Drug Administration will focus on the site if an internal quality issue is in question. “Saying the sponsor told you to do it a certain way is no defense” in the eyes of regulators, she adds. “Sponsor protocol doesn’t include internal site operations.”
“It’s up to sites” to take control of their own operations by developing their own road-tested, defensible internal quality management systems, Truax-Bellows stresses. In addition to attracting new business, she says sites have told her that doing so shows sponsors and others “you have your act together” when it comes to clinical trial operations.
Author: Michael Causey