The Annals of Internal Medicine published a guideline, entitled “The Standard Protocol Items: Recommendations for Interventional Trials” or SPIRIT 2013 to address the clinical practice quality issues surrounding current trials, as reported by an article on Outsourcing-Pharma.com. The guideline is composed of a 33-item checklist of recommendations, designed to aid in the drafting of high-quality protocols. The guideline is not directed at specific countries or drug regulators, but it does include parts from international and US guidelines. To read the full article from Outsourcing-Pharma.com, click here.
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