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 |
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4. Listing of key events identified for a
specific Mode of Action
|
Key Event 1 |
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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) |
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5b. Consistency &
Specificity – Biological Plausibility
|
Key Event 1 |
Key Event 2 |
Key Event 3 |
Key Event 4 |
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Consistency & Specificity |
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Biological Plausibility |
5c. Qualitative and Quantitative human concordance
|
Qualitative
Concordance |
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|
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 |
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|
Key
Event 2 |
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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