Clinical Trials Administrator Archives – April 1, 2004
April 1, 2004
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An FDA audit is no reason to panic: These 10 steps can help you prepare
Knowledge is power, and knowing how an audit works can help you sail through, says Erich K. Jensen. Jensen has developed a course designed specifically to highlight what happens during an FDA audit and what can be done to make the process as easy as possible. -
Experts agree: Think recruitment through
Youd think it would be easy to recruit patients for studies just put an ad in the paper or talk to patients at the clinic. Everyone wants to help science advance, right? Maybe, but that doesnt mean they want to be a subject in a clinical trial. -
HIPAA regulations still confuse and confound
Just about a year ago, the Privacy Rule, which is a part of the Health Insurance Portability and Accountability Act (HIPAA) regulations, became enforceable. Already, complaints are coming in and investigations are being launched some against mighty organizations such as Kaiser Permanente. -
Protecting children in clinical drug trials
Federal laws aimed at encouraging drug companies to study how well their products work in children have had the unintended consequence of weakening already vague protections that prevent child research subjects from being exploited, a leading human subjects research advocate claims. -
News brief
On-line university offers controversial course.