Is Your CAPA System Effective?

A corrective and preventive actions (CAPA) system is an essential component of any quality management system, and is an approach intended to correct and prevent problems from recurring or prevent them from ever happening. This article describes key components of a CAPA system, highlights key elements of a CAPA report, and reviews some methods for […]

Brent Ibata headshot

Research Compliance: Hospital Approval—Non-Delegable Obligations of a Covered Entity

Non-academic hospitals knowingly and unknowingly engage in clinical research every day, and these hospitals have nontransferable obligations, particularly when the research has been reviewed and approved by an external institutional review board (IRB). These studies utilize a wide gamut of hospital services, from outpatient diagnostics to surgical services for implantable investigational devices, and the non-delegable […]

Michael Causey, ACRP Editor-In-Chief

New Opportunities and Threats in the Realm of Informed Consent

Informed consent errors have fallen to sixth from first place as cited in most common clinical investigator findings by the U.S. Food and Drug Administration (FDA) over the past five years. While that suggests clinical researchers and sites have gotten better at handling this critically important set of tasks, it may not tell the whole […]

Informed Consent: Improving the Process

Ensuring individuals are able to make an informed decision when deciding whether or not to enroll in a research study is a cornerstone of conducting ethical research. How do we ensure that the consent is valid, and that the signature on the document represents a truly informed study participant? This article addresses the rational for […]