Appendix B

Adverse Event Attributions

 

Documentation of attribution of an adverse event will be based on what the sponsor or IRB requires. Some sponsors may use a 5 option approach or a dichotomized approach (see below). The IRB uses a dichotomized approach of being related or not to the research. Default to the more stringent requirement.

 

Dichotomized Approach

5 Option Approach

Attribution Definition Attribution Definition
Related Reasonable causal relationship between the AE and the intervention/research. Definite AE clearly related to the intervention/research.
Probable Likely related to the intervention/research.
Possible May be related to the intervention/research.
Unrelated No reasonable causal relationship between the AE and the intervention/research. Unlikely Doubtfully related to the intervention/research.
Unrelated Clearly not related to the intervention/research.