NOTE: For instructions on how to fill in the template see Word Doc with instructions.

1.       Problem formulation

2.       Hypothesised Mode of action Statement

3.       Summary of data for use in Mode of Action Analysis

Species

Route/Dose

Incidence

Comments

References

 

 

 

 

 

 

4.       Listing of key events identified for a specific Mode of Action

Key Event 1

Key Event 2

 

5.       Bradford Hill Considerations for Weight of Evidence Analysis of available data/information for Mode of Action Analysis in experimental species

5a. Dose Response Relationships and Temporal Association

Species (name)

Dose (units)

Key Event 1 (time observed and severity)

Key Event 2(time observed and severity)

Key Event 3(time observed and severity)

Key Event 4(time observed and severity)

 

 

 

 

 


5b. Consistency & Specificity Biological Plausibility

Key Event 1

Key Event 2

Key Event 3

Key Event 4

Consistency & Specificity

Biological Plausibility

 

5c. Qualitative and Quantitative human concordance

Qualitative Concordance

 

Key Event (name)

(Evidence in Experimental Species)

(Evidence in Humans)

Quantitative Species Concordance (experimental species and humans)

Quantitative Dose Response

 

Confidence/ Uncertainty

Key Event 1

Key Event 2

 

 

 

 


 

6.       Other potential Modes of Action

Comparative Weight of Evidence Table

Bradford Hill Considerations

Supporting Evidence

Potentially Inconsistent Evidence

Dose Response & Temporal Concordance

Consistency & Specificity

Biological Plausibility

Bradford Hill Considerations

Supporting Evidence

Potentially Inconsistent Evidence

Dose Response & Temporal Concordance

Consistency & Specificity

Biological Plausibility

 

 

 

 

 

7.       Uncertainties/Inconsistencies and Identification of Data Gaps

8.       Conclusions in relation to problem formulation