Corrective Action/ Preventive Action

According to the American National Standard of the American Society for Quality, the definition of "Preventive Action" is: "Action to eliminate the cause of a potential nonconformity or other undesirable potential situation." The definition of "Corrective Action" is: "Action to eliminate the cause of a detected nonconformity or other undesirable situation."
Karen Hopkins, RN, BS, MS
Acting Director, GCP Operations
ClinAudits, LLC

New Trend in IRB Site Safety Report Requirements

Since the issuance of the FDA Guidance, "Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs -Improving Human Subject Protection" in January 2009, I have noticed that more and more IRBs seem to be interpreting this guidance to mean that they don't need to require Principal Investigators to submit all IND Safety Reports for their review. This is not what the guidance allows. I am just wondering if anyone else is seeing this or has any comments on it.
Karen Hopkins, RN, BS, MS
Acting Director, GCP Operations
ClinAudits, LLC

ClinAudits Offers Expanded Services

Based on the experience and skill of it’s GCP auditing, CRO and clinical trial monitoring services, ClinAudits now offers auditing and consulting services geared toward GMP manufacturing and laboratory testing, GLP laboratories, both animal and in-vitro and in-vivo and Regulatory Affairs submission and review services. Says ClinAudits President, Cheri Wilczek, “the offering of services geared toward GMP, QSR, Regulatory Affairs and GLP arenas is a logical step for ClinAudits, drawing on its reputation providing quality auditing and consulting services and the talent and experience of its seasoned staff.”

For more information about these and other services, contact Cheri Wilczek at (973) 492-8108 or information@clinaudits.com.