reasonable possibility means that there is a cause and effect relationship between the investigational product, study device and/or study procedure and the AE.
reasonable possibility means that there is a potential cause and effect relationship between the IP, study device and/or study procedure and the AE.
reasonable possibility means that there is a cause and effect relationship between the investigational product, study device and/or study procedure and the AE. The investigator answers yes/no when making this assessment.
More Definitions of reasonable possibility
reasonable possibility means that there is a cause and effect relationship between the investigational product, PET tracers and/or study procedure and the AE.
reasonable possibility means there is evidence to suggest a causal relationship between the investigational product and the adverse event.
reasonable possibility means that there is evidence to suggest a causal relationship between the study drug and the adverse event. Within the reporting requirements, the following examples illustrate the types of evidence that would suggest a causal relationship:
reasonable possibility means there is evidence to suggest a causal relationship between the drug and the adverse event. Suspected Adverse Reaction is further defined in 21 C.F.R. 312.32. [COMMENT: Check to make sure Suspected Adverse Reaction is the same definition as in the Protocol.]
reasonable possibility means there is evidence to suggest a causal relationship between the drug and adverse event.
reasonable possibility means that there is evidence to suggest a causal relationship between the study product/intervention and the AE. This does NOT mean that the relationship cannot be ruled out. Examples of types of evidence that would suggest a causal relationship between the study product and AE are the following:
reasonable possibility means that there is evidence to suggest a causal relationship between the investigational product and the AE.