Download Serious Adverse Event form

Serious Adverse Event / SUSAR Reporting Form
When completing this form please refer to:
“SOP Guidance on Adverse Event Recording, Reporting & Reviewing for Researchers”
1. Project Identifiers:
Sponsor R&D No:
Sponsor SAE ref Number:
(To be completed by Sponsor only):
OTHER:
EudraCT No:
Project Title:
2. Site details:
Reporting Site:
Reported By:
Reporters Contact
Details:
Date of Report:
Address:
__ __ / __ __ / __ __ __ __
dd / mm / yyyy
Tel:
Email:
Fax:
3.. Subject Identifiers:
Initials:
Unique Study Identifier: Date of Birth:
__ __ / __ __ / __ __ __ __
dd / mm / yyyy
Ethnicity:(delete as appropriate)
Asian / Black / Caucasian
Other: please specify;
Sex:
Male

Female 
4. Event/Reaction Information:
Date of Onset of Event: __ __ / __ __ / __ __ __ __
dd / mm / yyyy
Time of Onset of Event: ____ __: __ __ 24h clock
Date Deemed Serious: __ __ / __ __ / __ __ __ __
dd / mm / yyyy
Time Deemed Serious: ____ __: __ __ 24h clock
Event / Reaction:
Description of Event: e.g. Lab Tests/Results, Signs & Symptoms related to Diagnosis
5. Serious Criteria (tick all that apply)
Death

Life Threatening

Hospitalisation/Prolongation of hospitalisation 
Persistent or Significant Disability or Incapacity 
Congenital anomaly or birth defect

Other (maybe protocol specific)
 - Specify:____________________________________
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6. Causality:
Detail all possible and suspected causes:
7. Relationship of the Reaction to the Investigational Medicinal Product?
Definite 
Probable 
Possible 
Not Related 
8. If related to the Medicinal Product was the reaction unexpected (Suspected Unexpected Serious Adverse
Reaction - SUSAR)?
Yes 
No 
Not Applicable 
9. Classification of Event:
CTIMPs:
Non CTIMPS
SAE: serious – not related to IMP

SAR related to IMP – not unexpected

SUSAR – Suspected Unexpected Serious Adverse Reaction

SAE – Serious - Not related to trial treatment

SAE – Serious, Related to trial treatment AND unexpected

10. Investigational Medicinal Product Information – Detail all IMPs:
IMP Name
Dose
Route
Date of first
(include
1.oral
administration*
units)
2.IV
3.SC
4.Other:
specify
Start date of latest
Date of Last
IMP administration** Administration***
__ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __
__
dd / mm / yyyy
dd / mm / yyyy
dd / mm / yyyy
__ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __
__
dd / mm / yyyy
dd / mm / yyyy
dd / mm / yyyy
__ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __
__
dd / mm / yyyy
dd / mm / yyyy
dd / mm / yyyy
__ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __
__
dd / mm / yyyy
dd / mm / yyyy
dd / mm / yyyy
__ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __
__
dd / mm / yyyy
dd / mm / yyyy
dd / mm / yyyy
*Date of first administration; when the IMP was given/taken for the 1 st time
**Start date of latest administration; if the drug is given in cycles, enter the start date of the latest cycle, if drug
has been continuous since date of first administration- please mark as ‘continuous’
***Date of last administration; when the drug was last given/taken
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Serious Adverse Event / SUSAR Reporting Form
11. Action Taken:
Detail treatment and any action taken:
dates of treatment and/or best estimate of treatment duration;
None 
Dose reduction  details:
IMP Treatment delayed  details:
IMP Treatment delayed and dose reduced  details:
IMP Treatment permanently discontinued  details:
Other  details:
12. Event Outcome: Tick One
a) Resolved:  date of recovery: __ __ / __ __ / __ __ __ __
dd / mm /
yyyy
b) Ongoing:  
If yes, details:
c) Recovered with sequelae:  
If yes, date:__ __/ __ __ / __ __ __ __
dd / mm /
yyyy
Details:
d) Subject Died:  
If yes, date of death: __ __ / __ __ /__ __ __ __
dd / mm /
yyyy
e) Unknown:  
13. Principal Investigator
Name of Principal Investigator at reporting site:
PLEASE PRINT
Signature:
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Date:
__ __ / __ __ / __ __ __ __
dd / mm / yyyy
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Serious Adverse Event / SUSAR Reporting Form
14. Chief Investigator
Chief Investigator:
PLEASE PRINT
Confirm Classification:
Yes  No  if no state reason and re-classify:
Reason:
Re-classification:
CTIMPs:
Non CTIMPS
SAE: serious – not related to IMP

SAR related to IMP – not unexpected

SUSAR – Suspected Unexpected Serious Adverse Reaction

SAE – Serious - Not related to trial treatment

SAE – Serious, Related to trial treatment AND unexpected

Signature:
Serious Adverse Event Report - Page 4 of 4
Date:
__ __ / __ __ / __ __ __ __
dd / mm / yyyy
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Serious Adverse Event / SUSAR Reporting Form
REPORTING INSTRUCTIONS
Send Copy to R&D within 24hrs from becoming aware of the by either:
1. email a copy to: [email protected]
or
2. Fax a copy to: 0115 8493295
Any queries please contact a member of staff in the Research & Innovations department:
Telephone: 0115 9709049 or 0115 9249924 ext 70659 or 70660
A copy should also be sent to the Chief Investigator & Retain form in the Investigator Site File
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