FDA Inspections Shift Focus to CAPAs, Could Come at Any Time

While matters related to how informed consent is obtained at study sites remain at or near the top of most U.S. Food and Drug Administration (FDA) inspectors’ checklists, they’ve also shown an increasing interest in corrective and preventive action (CAPA) programs, says Dr. DeAnn Cary, director of research with Sharp Healthcare in San Diego, Calif. […]

Katrina Quidley

Site Quality Devils are in the Daily (and Weekly and Monthly) Details

Dogged dedication to reviewing documents and keeping training on the cutting edge at study sites are keys to an effective quality assurance (QA) program, says Katrina Quidley, regulatory manager with IACT Health in Columbus, Ga. “We review every interim monitoring visit letter as it comes in,” Quidley says of her efficient shop. Letters are sorted […]

Are Clinical Trial Sites Leaving Billable Items on the Table?

A growing number of billable items are not automatically included in contract agreements between study sites and sponsors, says Bonnie Segal, vice president of Segal Institute for Clinical Research. The upshot? Sites often leave money for a number of billable activities on the negotiating table, she says. “When it comes to negotiating a contract on […]

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

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 […]

More Carrot, Less Stick: How to Effectively Drive Adoption of ‘eResearch’ Methods

Even the most change averse clinical trial practitioners can warm up to managing clinical trials in new electronic environments if the benefits are demonstrated early and often, says Lenis Sosa, MSN, RN, CCRC with the Houston Methodist Research Institute in Texas. It’s a big challenge because transitioning from paper to electronic files in clinical research […]