Clinical Trial Site QA Management Programs Prevent Operational Pain Down the Road


David Morin, director of research at The Holston Medical Group

It’s easy for overwhelmed sites to get off-track and overlook critical gaps in their quality training programs, says David Morin, director of research at The Holston Medical Group in Kingsport, Tenn. “We’re all so busy and resources are so tight,” he acknowledges. That said, high-quality, proactive training is key to better site management and bolstering quality assurance (QA) performance throughout a site.

Some sites look at QA in too narrow a manner, Morin adds. “Many use it to focus on a review of a single problem or a way to be proactive” about a specific task or situation, he says. That’s all well and good, of course, yet it fails to recognize that QA should apply to operations across the board, he adds.

Adequate QA programs should include strong training, hiring, and ongoing competency verification methodologies, Morin says. He advocates using mentors to help clinical research coordinators (CRCs) and others perform their tasks adequately. He also strongly believes in establishing other ways to ensure that an employee continues to grow in the job and learn new skills to address new challenges as their position evolves (e.g, internal testing with clear explanations of roles and responsibilities).

“Explain why something is done a certain way,” he suggests. “Make certain they understand the concept behind it.” Give them a stake in site operations, too. Synchronize root cause analysis and corrective and preventive action (CAPA) responsibilities with clear job descriptions, Morin adds.

“Errors tend to happen early” in the process, he notes. Vigilant, well-designed, site quality management programs can make all the difference.

Learn More

To learn more about site quality management, check out Site Quality Management Tools: SOPs, Metrics, and Training.

And check out ACRP’s CRC ‘Boot Camp’ if you need to rapidly develop competent and effective early-stage CRCs. This immersive and experiential one-week training program puts CRCs through a mix of didactic learning and practical simulations of real-life scenarios to aid learning retention and immediately develop the competencies required of high-quality, early-stage CRCs.

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