Clinical Trials Administrator Archives – April 1, 2006
April 1, 2006
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Adaptive protocol design challenges researchers to think outside the box
Imagine conducting clinical trials that provide a greater possibility of personal benefit to participants and reach conclusions in a faster and more efficient manner. -
Special Coverage: AAHRPP conference 2006: Stanford’s COI policy covers gray areas
Stanford University (Stanford, CA) has an extensive human subjects research conflict of interest (COI) policy that covers details that sometimes are overlooked at research institutions. -
Special Coverage: AAHRPP conference 2006: Getting through the accrediting process
Seeking accreditation for research institutions human subjects research protection programs is becoming an increasingly popular choice. -
International sites must pay attention to detail
CTA: How should a site be prepared to maintain a trial audit capability, and what are some details on how these audits should take place? -
Compliance Corner: Follow an expert’s advice in reporting to regulators
Clinical trial sites and institutions could improve compliance if they have a clearly defined process for reporting to regulatory authorities, an expert says. -
Going beyond reporting adverse events to IRBs
Investigators often find it difficult determining what types of information should be reported to an IRB, and they may report too many incidents or omit important information.