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.
Causality Assessment. Trial investigators are required to provide an assessment of causality, for all adverse events observed during this trial. This assessment will provide a determination of whether, in the investigators’ judgment, there exists a reasonable possibility that the investigational product caused or contributed to an adverse event. For this assessment, investigators must categorize the causality as either “related” or “not related.” For an adverse event to be considered “related” to the trial treatment, there should be evidence that the event follows a reasonable temporal sequence from the administration of trial treatment, or that the event follows a known response pattern to the drug. Causality would be further confirmed by improvement in an adverse event upon stopping the trial treatment, and reappearance of the event upon rechallenge.
Causality Assessment. Generally the reporter's causality assessment will be accepted. Supplier and Teva may however express another opinion. The most conservative opinion will determine further reporting.
Causality Assessment. The investigator or designee is responsible for assessing the relationship between AEs and the study drug. Additionally, the investigator or designee is responsible for providing appropriate treatment for the event and for adequately following the event until resolution. The clinical investigator or responsible designee should determine the study device relationship using the following explanations: Probable / Likely Event or laboratory test abnormality, with reasonable time relationship to medical device use and unlikely to be attributed to disease or other interventions. Response to withdrawal is clinically reasonable. Re-challenge not required. Possible Event or laboratory test abnormality, with reasonable time relationship to medical device use and that could also be explained by disease or other interventions. Information on withdrawal may be lacking or unclear.
