Clinical Trials Administrator Archives – June 1, 2007
June 1, 2007
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Expert advice to prevent regulatory audit findings and improve compliance
Clinical trial research teams can run into regulatory trouble when there are too few checks and balances established to catch the mistakes and omissions. -
Self-audits will help prevent major problems
Clinical trial sites and investigators should not rely on clinical research organization (CRO) monitors to find systemic problems. Instead, they should be proactive with their own in-depth audits, an expert suggests. -
CR site problems may mean inadequate monitoring
Compliance problems at clinical trial (CT) sites can result in FDA warning letters to sponsors for their lack of adequate follow-up after finding compliance problems, an expert says. -
Approaching research administration: Risk?
Universities in North America face risks in the way they execute research administration, an expert says.