ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Attribution is the process of deciding the likelihood that the adverse event is related to (or resulting from) the research. The PI must determine whether an adverse event is “unrelated”, “possibly related”, “probably related”, or “definitely related” to the study intervention or treatment. Attribution must be determined by the reporting investigator and verified by the principal investigator (The reporting investigator may, or may not be, the principal investigator).

Publication Source: Committees on Human Research

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