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Study Title: Adverse Event Report Form Patient ID: - Patient Initials

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Bouy Sok
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78 views2 pages

Study Title: Adverse Event Report Form Patient ID: - Patient Initials

Uploaded by

Bouy Sok
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Study Title

Adverse Event Report Form

Patient ID: ____ ____ ____ ____ Patient Initials: ____ ____ ____

Date of Report: ___ ___ / ___ ___ / ___ ___ ___ ___ Form completed by (initials): ____ ____ ___
MM DD YYYY

ADVERSE EVENT (Page 1 of 2)

Type of Adverse Event & Adverse Event:


description

(if more than one AE occurred,


fill out a separate form for Adverse Event Description
each)

Date of Onset
Date of onset Date Study team became aware

__ __- __ __- __ __ __ __ __ __- __ __- __ __ __ __


MM DD YYYY MM DD YYYY
Time of Onset
Time of onset Time Study team became aware

__ __: __ __ __ __: __ __
HH MM HH MM
Date / Time of Resolution
Date of Resolution Time of Resolution
OR  Check if ongoing
__ __- __ __- __ __ __ __ __ __: __ __
MM DD YYYY HH MM

ADVERSE EVENT (CONTINUED) (Page 2 of 2)


Most Extreme Intensity 1  Mild 2  Moderate 3  Severe

Study Relationship 1  Not Related 2 Unlikely 4 Possibly 3 Probably 5 Definitely

Feb. 2014
Study Title

Adverse Event Report Form

Patient ID: ____ ____ ____ ____ Patient Initials: ____ ____ ____

Date of Report: ___ ___ / ___ ___ / ___ ___ ___ ___ Form completed by (initials): ____ ____ ___
MM DD YYYY

Drug Relationship 1  Not Related 2 Unlikely 4 Possibly 3 Probably 5 Definitely

Expectedness 1  Expected 2  Unexpected

Treatment Action 1 None 2 Surgery required 3 Medication 4 Hospitalization


Taken 5 Other (specify) __________________________________________
(check all that apply)

1  Resolved 2  Resolved with sequelae (specify in comments section)


Outcome
3  Death 4  Unresolved 5 Unknown

Serious? 0  No 1  Yes
(Defined as fatal, life-
threatening, significant
disability, congenital If yes, please check all that apply:
abnormality, prolonged or 1 Fatal 2 Life-threatening 3  Significant disability
new hospitalization)
4 Prolonged hospitalization 5 New hospitalization

If serious, report to
IRB/FDA per
guidelines

Comments

Feb. 2014

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