Jim Kremidas, ACRP Executive Director

Executive Director’s Message: It’s Time to Tackle Ethics

Google makes it so easy to find a simple definition of ethics. Take your pick: “A branch of philosophy considering the rightness and wrongness of actions and the goodness or badness of the motives and ends of such action.” “Systematic rules or principles governing right conduct.” “Rules or standards governing the conduct of a person […]

Designing Clinical Trials for New Drugs: Ethics, Governance, and Reputational Challenges

Much has been written about the ethics of healthcare innovation and the role of pharmaceutical companies in innovation. Rightly or wrongly, the scholarship and media coverage has been disparaging. Many commentators fear that the biopharmaceutical sector no longer serves patients’ interests; they see it as more focused on shareholders’ financial interests. For instance, such commentators […]

Proposed Revisions to the Informed Consent and IRB Regulations

In September 2015, the U.S. Department of Health and Human Services (HHS) released a Notice of Proposed Rulemaking (NPRM) to significantly revise the human subject protection and informed consent regulations known as the “Common Rule.”1 If enacted, it will be the first substantial change to these regulations since 1981. Including HHS, the NPRM would affect […]

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 […]