SUSAR Reporting Form

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SUSAR Reporting Form
Please complete this form as fully as possible and insert additional rows where
needed. Once complete, please send to Trust.R&[email protected] 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
Subject ID
Weight
Height
Years
Kilograms
Feet Inches
Disease History (not being treated as part of trial):
Disease
Start Date
End Date
Continuing
Please use MedDRA terminology
Disease
Start Date
End Date
Continuing
Please use MedDRA terminology
☐Yes ☐No
OR
☐Yes ☐No
Drug History (not taken as part of trial):
Drug
Start Date
End Date
Continuing
☐Yes ☐No
Drug
Start Date
End Date
SUSAR Reporting Form, version 2.0, February 2014
1
Continuing
☐Yes ☐No
Drug
Start Date
End Date
Continuing
☐Yes ☐No
Reaction:
Narrative
Outcome
Enter details of reaction using MedDRA terminology where
appropriate
☐ Recovered
☐ Recovering
☐ Recovered with SEQUELAE
☐ Not Recovered
☐ Fatal
☐ Unknown
Start Date
End Date
Seriousness
If fatal please detail date of death
☐ Death
☐ Life Threatening
☐ Hospitalisation
☐ Disabling
☐ Congenital Abnormality
☐ Other
Narrative
Outcome
Enter details of reaction using MedDRA terminology where
appropriate
☐ Recovered
☐ Recovering
☐ Recovered with SEQUELAE
☐ Not Recovered
☐ Fatal
☐ Unknown
Start Date
End Date
Seriousness
If fatal please detail date of death
☐ Death
☐ Life Threatening
☐ Hospitalisation
☐ Disabling
☐ Congenital Abnormality
☐ Other
SUSAR Reporting Form, version 2.0, February 2014
2
Test
Result
Unit
Test Date
Name of test
Value/Outcome/Scan Result
Test
Result
Unit
Test Date
Name of test
Value/Outcome/Scan Result
Medication details – all medication taken in last 3 months (including
concomitant medication):
Drug Name
Characterisation
Enter name as detailed in CTA
☐ Suspect
☐ Concomitant
Drug Dosage
Dosage Interval
Form
Route of Administration
Indication
Start Date
End Date
Action Taken
Drug Name
Characterisation
Enter name as detailed in CTA
☐ Suspect
☐ Concomitant
Drug Dosage
Dosage Interval
Form
Route of Administration
Indication
Start Date
End Date
Action Taken
Drug Name
Characterisation
Enter name as detailed in CTA
☐ Suspect
☐ Concomitant
Drug Dosage
Dosage Interval
Form
Route of Administration
Indication
Start Date
End Date
Action Taken
Drug Name
Characterisation
Enter name as detailed in CTA
☐ Suspect
☐ Concomitant
Drug Dosage
Dosage Interval
SUSAR Reporting Form, version 2.0, February 2014
3
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 2014
4
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