Category Archives: InSites

InSites: Multiple IRB Reviews of Multicenter Clinical Trials

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry. On 3 December 2014, the National Institutes of Health (NIH) published a Draft NIH Policy on the Use … Continue reading

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InSites: Accelerated Clinical Trial Agreements

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry. Albert Einstein proffered the notion that insanity is doing the same thing over and over again and expecting … Continue reading

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InSites: New FDA Guidance on Informed Consent

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry. On July 16th, FDA released its: Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors. When finalized … Continue reading

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InSites: Insurance Coverage Analysis in Clinical Trials

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry. As we approach the fourteenth anniversary of the effective day of the final rule for Medicare coverage of … Continue reading

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