HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID# Page of Adverse Event Tracking Log Check box if there were no adverse events to be recorded Insert question to ask participant (e.g. Were there any adverse events? Y/N) N) N) N) of Adverse Event** Start End or or or (Select from Safety Initials Initials Ongoing Outcome1 Grade2 # Date Reported Adverse Event Description Date Date Drug/Device Date Severity/ Serious AE Expected Study Attribution5 Action Attribution5^ PI PI Profiler) Treatment3 Taken4 (Y (Y (Y # - AE indicates the first adverse event documented on the form, 2 = the second, etc. If the adverse event changes in severity, enter it as a separate adverse event row number. “1” on the paper form using the same AE number as the one that ended. **look up corresponding AE at: Action Taken4 Attribution/ Outcome1 Severity/Grade2 AE Treatment3 with Study Intervention Relatedness5 0 Fatal 1 Mild 0 None 0 None 0 Definite – – – – – 1 Not recovered/not resolved 2 Moderate 1 Medication(s) 1 Interrupted 1 Probable – – – – – 2 Recovered w/sequelae 3 Severe 2 Non-medication TX 2 Discontinued 2 Possible – – – – – 3 Recovered w/o sequelae 4 Life Threatening 3 Dose reduced 3 Unlikely – – – – 4 Recovering/Resolving 5 Death (Fatal) 4 Dose increased 4 Unrelated – – – – 5 Not Applicable ^5 Not Applicable (did not receive intervention) – –
HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID# Page of Adverse Event Tracking Log Check box if there were no adverse events to be recorded Insert question to ask participant (e.g. Were there any adverse events? Y/N) # Date Reported Adverse Event Description Adverse Event** (Select from Safety Profiler) Start Date End Date Ongoing (Y or N) Outcome1 Severity/ Grade2 Serious (Y or N) AE Treatment3 Expected (Y or N) Study Attribution5 Action Taken4 Drug/Device Attribution5^ PI Initials Date of PI Initials # - AE number. “1” indicates the first adverse event documented on the form, 2 = the second, etc. If the adverse event changes in severity, enter it as a separate adverse event row on the paper form using the same AE number as the one that ended. Outcome1 Severity/Grade2 AE Treatment3 Action Taken4 with Study Intervention Attribution/ Relatedness5 0 – Fatal 1 – Mild 0 – None 0 – None 0 – Definite 1 – Not recovered/not resolved 2 – Moderate 1 – Medication(s) 1 – Interrupted 1 – Probable 2 – Recovered w/sequelae 3 – Severe 2 – Non-medication TX 2 – Discontinued 2 – Possible 3 – Recovered w/o sequelae 4 – Life Threatening 3 – Dose reduced 3 – Unlikely 4 – Recovering/Resolving 5 – Death (Fatal) 4 – Dose increased 4 – Unrelated 5 – Not Applicable ^5 – Not Applicable (did not receive intervention) **look up corresponding AE at:
Adverse-Event-Tracking-Log_2018.09.05.docx