Serious Adverse Event
SECTION 1
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.
text
Record the start date of the first occurrence of the SAE.
date
Record the start date of the first occurrence of the SAE.
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
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’.
date
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).
text
Investigational product(s) withdrawn = Dose reduced = Dose increased = Dose not changed = Dose interrupted = Not applicable = Administration of investigational product(s) was permanently discontinued. Dose is reduced for one or more investigational product(s). Dose increased for one or more investigational product(s). Investigational product(s) continues even though an adverse event has occurred. Administration of one or more investigational product(s) was temporarily interrupted but then restarted. 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).
text
Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes: Complete Study Conclusion page and check Adverse event as reason for withdrawal.
text
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.
text
Section 2: Seriousness
SAE results in death
boolean
SAE is life-threatening
boolean
SAE requires hospitalisation
boolean
SAE results in disability/incapacity
boolean
Congenital anomaly/birth defect
boolean
Óther SAE
boolean
Other SAE specificationn
text
SECTION 3: Demography Data
SECTION 4
Section 5
Possible Causes of SAE Other Than Investigational Product(s)
text
If
text
If "Concomitant medication(s)", specify:
text
If "Other", specify:
text
SECTION 6: RELEVANT Medical Conditions
Relevant Medical Conditions
text
Date of onset
date
continuation SAE
text
Date of Last Occurrence
date
Section 7
SECTION 8 RELEVANT Concomitant Medications
Drug Name
text
Dose
integer
Unit
text
Frequency
text
Route
text
Taken Prior to Study?
boolean
Start Date
date
Stop Date
date
Ongoing Medication?
boolean
Reason for Medication
text
Section 9 - Investigational Product
Section 10
SECTION 11 Narrative Remarks
Investigator's signature
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
Investigator signature date
date
Investigator name
text