There’s been lots of talk about how the clinical research enterprise will need to address new informed consent challenges raised in relation to eConsent, genomics, vulnerable populations, and more. Each issue requires new ways of guaranteeing everyone’s eyes are wide open during the conduct of informed consent. Ultimately, however, it’s still the human factor that […]
"If we hold our employees accountable, we have to hold ourselves accountable," says industry pathfinder David Morin, MD, RPh, FACP, CPI. As Director of Clinical Research at Holston Medical Group, he's worked hard with his team to come up with a robust accountability program designed to improve overall performance -- not to point fingers. Working […]
Left floundering in a communications vacuum, any risk-based monitoring program simply won’t ever get off the ground, says Mike Caswell, vice president for clinical evaluation at the Consumer Product Testing Company. It’s critical to seek out and incorporate comments from “different stakeholders,” including sponsors, principal investigators, research staff, and financial officers. Without a clear understanding […]
The Joint Task Force (JTF) for Clinical Trial Competency Framework will share important feedback from more than 2,500 survey respondents at the ACRP 2016 Meeting & Expo, according to JTF Co-Chair Stephen Sonstein, PhD, director of Clinical Research Administration at Eastern Michigan University in Fort Myers, Fla. "We'll talk about definitions and perceptions of core […]
Clinical researchers who fail to adequately document corrective and preventive action (CAPA) programs are missing out on a number of important benefits to save time and money, says Beth D. Harper, MBA, president of Clinical Performance Partners, Inc. "It's not just a compliance tool," she stresses. Instead, CAPA can be leveraged to dig deeper and […]
