Research Practitioner articles from January 2004

Research Practitioner archives from January 2004

From the editors.
January 1, 2004... The article by Hanna in this issue of Research Practitioner provides an in-depth look at registries and their interface with research. Increasingly, investigators are submitting to Institutional Review Boards (IRB), their proposals for...

The LA Times and the NIH.(In the News)
January 1, 2004... On December 7, the Los Angeles Times published a 4-page article claiming that several senior National Institutes of Health (NIH) scientists earned millions of dollars in outside income from drug companies over a decade. The article opened...

FDA bans ephedra supplements.(In the News)
January 1, 2004... On December 30, the U.S. Food and Drug Administration (FDA) announced a new rule that will ban sales of dietary supplements containing ephedra. The agency issued a Consumer Alert stating that "dietary supplements containing ephedra present an...

Research and registries: addressing privacy concerns.
January 1, 2004... Over the past 10 years the number of health and medical registries has significantly increased. These collections of patients and information about their health at various points in time can provide valuable resources for researchers,...

Sponsor inspections: what, why, and how.
January 1, 2004... Sponsors of clinical research are obligated to ensure that clinical studies are conducted properly end according to federal regulations and that the rights and welfare of subjects enrolled in the studies are protected. If a sponsor has...

Exam for continuing education: Research Practitioner 5.1.
January 1, 2004... Research and registries: Addressing privacy concerns 1.5 CE hours 1.5 CME hours 1. Disease registries can be considered observational studies that follow patterns in disease diagnosis, treatment, and survival patterns over time....

Standard operating policy and procedure for FDA inspections.(Issues In Research Management)
January 1, 2004... Introduction A sponsor should have a standard operating procedure (SOP) for managing an FDA inspection. The SOP should address pre-inspection preparation. Because sponsor inspections typically are unannounced, all staff should know what...

Pre-IND consultation program.(Regulatory Update)
January 1, 2004... FDA's Office of Drug Evaluation IV (ODE IV) has a pre-IND (investigational new drug) consultation program that should be of interest to potential sponsors of certain new therapeutics for the treatment of bacterial infections, human...

Guidance on submitting responses to clinical holds.(Regulatory Update)
January 1, 2004... A provision of the 1997 FDA Modernization Act required that when a sponsor of a clinical investigation submits a written request to FDA asking that a clinical hold be removed, FDA has 30 calendar days to send the requestor a written decision,...

FWA still voluntary; MPA/SPA persist.(Regulatory Update)
January 1, 2004... The Office for Human Subject Protections (OHRP) recently announced that existing Multiple Project Assurances (MPA) and Cooperative Project Assurances (CPA) will remain in effect until further notice. OHRP also said it will continue to accept...

GAO report on conflict of interest.(Regulatory Update)
January 1, 2004... The General Accounting Office (GAO) issued a November 2003, report titled "University Research: Most Federal Agencies Need to Better Protect Against Financial Conflicts of Interest (GAO-04-31)." GAO did this study because federal agencies...

FDA warning letter to a sponsor-investigator.(Regulatory Update)
January 1, 2004... This Warning Letter was issued on Dec. 11, 2003, to Dr. Stephen H. Caldwell, University of Virginia Health Systems Division of Gastroenterology and Hepatology in Charlottesville, VA, by FDA's Center for Devices and Radiological Health. FDA...