2016

FDA IRB inspections: What, why, and how

Friday, January 1, 2016

Has your institutional review board (IRB) been inspected by the FDA for compliance with IRB regulations? These inspections focus on IRB operations and responsibilities. If your IRB reviews and approves FDA-regulated clinical trials, this article will provide you a guide for what to expect during an IRB inspection.

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Understanding feasibility for faster clinical trials

Friday, January 1, 2016

Do you hate to be late? Most people do, but CenterWatch surveys of investigative sites show the majority have delays. A root cause is increasing eligibility cri­teria (up 58% in the last decade). It is no wonder that sites say recruit­ment is the biggest cause of delay; with more criteria, fewer patients qualify.

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Regulatory Update, January 2016

Friday, January 1, 2016

FDA Seeks Comments on ICH’s GCP Guideline Update

In Sept. 29’s Federal Register, the FDA announced the availability of a draft guidance titled “Guideline for Good Clinical Practice” E6 (R2). The draft is an update of the International Conference on Harmonisation’s (ICH) “Guideline for Good Clinical Practice” E6 (R1), in which new information is integrated into the original document. The changes are intended to encourage improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also to update standards regarding electronic records and essential documents. The draft also is intended to improve clinical trial quality and efficiency while maintaining human subject protection. The FDA made the draft guidance available for public comment on the sections added to ICH E6 (R1) and marked as “ADDENDUM.”

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