SUSAR Reporting Form, Version 2.0, February 20141

SUSAR Reporting Form, version 2.0, February 20141

SUSAR Reporting Form

Please complete this form as fully as possible and insert additional rows where needed. Once complete, please send to Trust.R&including “SUSAR Report” in the subject line along with the R&D reference.

Trial Details:

Trial Name
R&D Reference
EudraCT

Patient Information:

Initials
Gender
Age at Time of Reaction / Years
Subject ID
Weight / Kilograms
Height / Feet Inches

Disease History (not being treated as part of trial):

Disease / Please use MedDRA terminology
Start Date
End Date
Continuing / ☐Yes ☐No
Disease / Please use MedDRA terminology
Start Date
End Date / OR
Continuing / ☐Yes ☐No

Drug History (not taken as part of trial):

Drug
Start Date
End Date
Continuing / ☐Yes ☐No
Drug
Start Date
End Date
Continuing / ☐Yes ☐No
Drug
Start Date
End Date
Continuing / ☐Yes ☐No

Reaction:

Narrative / Enter details of reaction using MedDRA terminology where appropriate
Outcome / ☐ Recovered
☐ Recovering
☐ Recovered with SEQUELAE
☐Not Recovered
☐Fatal
☐Unknown
Start Date
End Date / If fatal please detail date of death
Seriousness / ☐Death
☐Life Threatening
☐Hospitalisation
☐Disabling
☐Congenital Abnormality
☐Other
Narrative / Enter details of reaction using MedDRA terminology where appropriate
Outcome / ☐ Recovered
☐ Recovering
☐ Recovered with SEQUELAE
☐Not Recovered
☐Fatal
☐Unknown
Start Date
End Date / If fatal please detail date of death
Seriousness / ☐Death
☐Life Threatening
☐Hospitalisation
☐Disabling
☐Congenital Abnormality
☐Other
Test / Name of test
Result / Value/Outcome/Scan Result
Unit
Test Date
Test / Name of test
Result / Value/Outcome/Scan Result
Unit
Test Date

Medication details – all medication taken in last 3 months (including concomitant medication):

Drug Name / Enter name as detailed in CTA
Characterisation / ☐Suspect
☐Concomitant
Drug Dosage
Dosage Interval
Form
Route of Administration
Indication
Start Date
End Date
Action Taken
Drug Name / Enter name as detailed in CTA
Characterisation / ☐Suspect
☐Concomitant
Drug Dosage
Dosage Interval
Form
Route of Administration
Indication
Start Date
End Date
Action Taken
Drug Name / Enter name as detailed in CTA
Characterisation / ☐Suspect
☐Concomitant
Drug Dosage
Dosage Interval
Form
Route of Administration
Indication
Start Date
End Date
Action Taken
Drug Name / Enter name as detailed in CTA
Characterisation / ☐Suspect
☐Concomitant
Drug Dosage
Dosage Interval
Form
Route of Administration
Indication
Start Date
End Date
Action Taken
Name of reporter
Date of report
Contact telephone

SUSAR Reporting Form, version 2.0, February 20141