Hireb | Hamilton Integrated Research Ethics Board



Step 1: To assess relatedness of the adverse reaction to a drug / device / study procedure (intervention), answer the following questions to determine the pertinent score(s). In the score column, indicate the value associated with your answer of “yes” or “no” to each question. Add the scores to arrive at a total score.Please answer the following questions:YesNoDo NotKnowScore1. Are there any previous reports from any source on this reaction indicating possible, probably or definite relationship to drug/device/procedure (intervention) required by the protocol?+100Click here to enter text.2. Did the adverse event appear after the suspected drug/device/intervention was administered?+2-10Click here to enter text.3. Did the adverse reaction improve when thedrug/device/intervention was discontinued, or a specific antagonist was administered?+100Click here to enter text.4. Did the adverse reaction reappear when the drug/device/intervention was re-administered?+2-10Click here to enter text.5. Are there alternative causes (other than the drug/device/intervention) that could on their own have caused the reaction?-1+20Click here to enter text.6. Did the reaction reappear when a placebo was given?-1+10Click here to enter text.7. Was the drug/device detected in the blood (or other fluids) in concentrations known to be toxic?+100Click here to enter text.8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?+100Click here to enter text.9. Did the patient have a similar reaction to the same or similar drug/device/intervention in any previous exposure?+100Click here to enter text.10. Was the adverse event confirmed by objective evidence?+100Click here to enter text.11. Total Score:Click here to enter text. ................
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