Causality Assessment. The Investigator is to assess the causal relationship (causality) between an adverse event and the investigational product and/or the clinical trial procedure according to the following definitions (Decision of 25 November 2013 on Guideline on Annex I to Regulation (EC) No 1223/2009 (2013/674/EU) - Causality assessment of undesirable effect caused by cosmetic products): • Very likely • Likely • Not clearly attributable • Unlikely • Excluded Medical judgment should be used to determine the relationship, considering all relevant factors including the pattern of reaction, temporal relationships, positive de-challenge or re-challenge, relevant medical history, and confounding factors such as co-medication or concurrent diseases.
Appears in 3 contracts
Sources: Investigator Agreement, Investigator Agreement, Investigator Agreement