EANM guideline on quality risk management for radiopharmaceuticals.

Eur J Nucl Med Mol Imaging · 2022 · PMC9308578 · PMID 35385986

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an adverse trendno p-value reported

The initiation of an assessment may be triggered by several events, such as: Deviations: A deviation (either planned or unplanned) from an established procedure An out of specification (OOS) result An adverse trend An unusual event or abnormal result, which does not necessarily represent a deviation but needs to be assessed and investigated.

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