SECTION 1: Serious Adverse Event
SECTION 1: Serious Adverse Events Record
Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page. If this was recorded previously as a non-serious event but has progressed to serious, put a line through the Non-Serious AE record and transcribe the details onto the SAE form.
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Day Month Year Record the start date and time of the first occurrence of the event or signs/symptoms of the serious event, not the date and time the event became serious.
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Hr : Min 00:00-23:59 Record the start date and time of the first occurrence of the event or signs/symptoms of the serious event, not the date and time the event became serious.
time
All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.
integer
If fatal, record date of death Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/ Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Record the end time of the SAE.
date
Hr : Min 00:00-23:59 Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/ Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Record the end time of the SAE.
time
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).
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Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).
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If yes, complete Study Conclusion page and tick Adverse event as reason for withdrawal. Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.
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It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.
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SECTION 2: Seriousness
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form
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Seriousness
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Seriousness Specification
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SECTION 3: Demography Data
SECTION 4: Serious Adverse Event Recurrence
SECTION 5: Causes of SAE
Disease under Study
boolean
Medical Condition(s)
boolean
Medical Condition(s) Specification
text
Lack of Efficacy
boolean
Withdrawal of investigational product(s)
boolean
Concomitant medication(s)
boolean
Concomitant medication(s) Specification
text
Activity Related to Study Participation
boolean
Other
boolean
Other Specification
text
SECTION 6: Relevant Medical Conditions
Relevant Medical Conditions
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Day Month Year
text
Condition present at time of the SAE
text
Day Month Year
text
SECTION 7: Other Relevant Risk Factors
SECTION 8: Relevant Concomitant Medications
Include any concomitant medications that may contribute to the occurrence of the SAE Trade name preferred
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Dose
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Unit
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Frequency
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Route
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Taken Prior to Study
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Day Month Year
date
Day Month Year
date
Ongoing Medication
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Indication
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SECTION 9: Details of Investigational Product(s)
Details of Investigational Product
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Treatment Blind Broken
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SECTION 10: Details of Relevant Assessments
SECTION 11: Narrative Remarks
Conclusion
SECTION 12: Additional/Follow-Up Information
use this page to provide any additional details on the SAE not already captured on the previous pages
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confirming that the data on the SAE pages are accurate and complete
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Date
date