Section 1: General SAE information
Diagnosis only (if known), otherwise sign / symptom A separate form should be used for each SAE however if multiple SAEs which are temporarily or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
text
The start date should document the first occurrence of the SAE. This is generally the start date of the signs/symptoms and not necessarily the date that the event met the definition of serious.
date
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 completed the study or becomes lost to follow-up, the outcome must be recorded as “Recovering/Resolving” or “Not recovered/Not resolved”. Also enter “Not recovered/Nor 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 direct cause of death.
integer
If fatal, record date of death Record the date of resolution or the date of death as applicable. Leave blank only if the outcome of the event is “Not resolved” – “ Recovering / resolving”.
date
Record the maximum intensity that occurred over the duration of the event (see protocol for 1-2-3 definition of intensity). Amend the intensity if it increases. Enter X (not Applicable) if grading can not be applied. For example, intensity for ‘broken leg’.
text
If administration of the investigational product was stopped permanently and not restarted enter 1- Investigational product(s) withdrawn and enter the date that investigational product was discontinued in section 9. If administration of the investigational product was not modified and all scheduled doses were given enter 2-Dose not changed. If administration of investigational product was temporarily interrupted but then restarted enter 3- Dose Interrupted. If the subject did not receive investigational product dose at the time of the event or if the subject has received all his doses or if the subject died and there was no prior decision to discontinue investigational product enter X-Not applicable.
text
If Yes, please complete the Study Conclusion form of the subject and tick SAE as reason for withdrawal
boolean
This box is mandatory and has to be completed before faxing the form. 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 pharmacologicallypredicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.
boolean
Refer to protocol for full definition
text
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
boolean
Section 2: Seriousness
In the event of a death determined by the investigator to be related to the vaccination, sending of the fax must be accompanied by phone call to the study contact for reporting SAEs.
boolean
Note: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.
boolean
Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is 'serious'. When in doubt as to whether 'hospitalisation' occurred or was necessary, the AE should be considered 'serious'. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. Record date of admission and discharge Requires hospitalisation or prolongation of existing hospitalisation The following cases are not defined as serious AEs and no SAE report is no to be submitted : · Hospitalization for elective surgery related to a pre-existing condition which did not increase in severity or frequency following initiation of the study (e.g. : aesthetic surgery or surgery planned before subject enrolled), · Hospitalisation for routine clinical procedure or for social reason (e.g. : elderly person had an extension of hospitalization because of room is available in a resting home) that are not the result of an adverse event These latter cases have to be recorded in the CRF only. If the hospitalization arises from a preexisting condition or was planned prior to the first vaccination, it should be recorded in the Medical History section of the CRF. If the hospitalisation was planned after the first vaccination, it should be recorded in the AE pages. In both cases, it should be recorded as “Hospitalisation” (not an adverse event) or “Hospitalisation for social reason” (not an adverse event) or “Elective surgery” (not an adverse event) and the relationship to vaccination will be checked “No”.
boolean
Note: The term disability means a substantial disruption of a person's ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. , sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.
boolean
Congenital anomaly/birth defect in the offspring
boolean
Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.
boolean
Other SAE seriousness specification
text
if hospitalisation is reason of why AE is serious
date
if hospitalisation is reason of why AE is serious
date
Section 3: Demography Data
Date of birth
date
Sex
text
Weight
float
(US only; give ounces in next item)
integer
(US only; give pounds in next item)
integer
Section 4: SAE reccurence
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
text
Section: 5 Possible Causes of SAE Other Than Investigational Product(s)
(not applicable for prophylactic vaccine studies)
boolean
(record in Section 6)
boolean
Lack of efficacy
boolean
Withdrawal of investigational product
boolean
Concomitant medication(s)
boolean
(e.g., procedures)
boolean
please specify in next item
boolean
Specify other SAE causation
text
Section 6: Relevant Medical Conditions
Relevant Medical Conditions
text
Date of onset
date
If no, record date of last occurrence
boolean
Date of Last Occurrence
date
Section 7: Other Relevant Risk Factors
Section 8: Relevant Concomitant Medications
(Trade name preferred)
text
Concomitant Medication Dose
integer
Concomitant Medication Unit
text
Concomitant Medication Frequency
text
Concomitant Medication Route
text
Concomitant Medication Taken Prior to Study?
boolean
Concomitant Medication Start Date
date
Concomitant Medication Stop Date
date
Ongoing Concomitant Medication ?
boolean
Reason for Concomitant Medication
text
Section 9: Details of investigational product(s)
in case of multiple vaccination, please specify if vaccines were administered mixed or separately
text
Dose number
integer
Lot number
integer
Route / site
text
Administration date
date
Randomization code broken
integer
Section 10: Details of Relevant Assessments
Section 11: Narrative Remarks
Section 12: SAE additional / follow-up information
Investigator's signature
Investigator's signature
text
Printed Investigator's name
text
Type of report
integer
Date of investigator's signature
date