/ SAE Report Form
FTM ECF-014-03

Instruction to the Investigator: To notify the Ethics Committee of the Faculty of Tropical Medicine of any serious adverse events, please provide the information needed below. You may use this Form to report a follow-up when more information regarding the SAE is available.

Project Title: / Project ID: / Location:
Project information
Participant identifier: / Investigational product: / Report type:
Initial
Follow-up
Adverse event information
Date of birth
(dd/mmm/yyyy): / Age (year): / Sex:
Male
Female / Height (cm): / Weight (kg): / Event onset
(dd/mmm/yyyy):
Adverse event in MEDICAL TERMS:
Expedited report criteria
(check all applicable to event)
 Participant died
Date: …………….
(dd/mmm/yyyy) /  Life-
threatening /  Prolonged
hospitalization / Significant
disability /  Congenital
anomaly /  Other SAE
……………….
Description:
Project Title: / Project ID: / Location:
Suspected trial product information
Suspected product: / Daily dose at onset of event: / Route of administration:
Indication for use:
Therapy dates: from (dd/mmm/yyyy) ….…………………….. to (dd/mmm/yyyy) ……………………….
Therapy duration until onset (hh/dd/mmm): …………………………………..……………………………
Did the event abate after stopping product? /  No /  Yes /  N/A
Concomitant drug(s)
Relevant concomitant drugs and dates of administration
If yes, then list the name(s) and detail(s) /  No /  Yes
Drug name / Dose / Unit / Date started
(dd/mmm/yyyy) / Continue
1 = No
2 = Yes / Date
discontinued
(dd/mmm/yyyy) / Reason for use
Route / Schedule
Project Title: / Project ID: / Location:
Other relevant history, laboratory findings and action taken
Other relevant history:
Relevant test/laboratory findings:
Laboratory test / Unit / Date
(dd/mmm/yyyy) / Value / Comments on laboratory finding
Action taken by investigator:
 None /  Concomitant drug discontinued
 Trial dosage change /  New drug therapy added
 Trial drug discontinued /  Prolonged hospitalization
 Non-drug therapy
Outcome:
 Completely recovered on (dd/mmm/yyyy) ……………………………………………………….
 Recovered with sequel /  Condition deteriorated
 Condition improving /  Death, autopsy done (attach summary)
 Condition still unchanged /  Death, autopsy not done
Causality assessment by investigator (Is there any relationship with test product?):
 Not related /  Doubtful
 Possible /  Probable
 Very likely
Project Title: / Project ID: / Location:
Information source
Name, address, telephone and email address of the investigator:
Tel: ………………………………………………… / Email: …………………………………….
Signature of investigator reporting event: ………………..…………………………………………
Reporting date (dd/mmm/yyyy): ……………………………………………………………………
Sponsor information
Name and address of reporting sponsor/manufacturer:
Name: ……………………………………………………………………………………………..
Address: ……………………………………………………………………………………………..
……………………………………………………………………………………………...
……………………………………………………………………………………………...
Date received by sponsor (dd/mmm/yyyy): / Date of this report (dd/mmm/yyyy):
Signature:

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