Scribd
Upload
963 views2 pages

CIOMS Form for Adverse Reaction Reporting

This document is a form for reporting suspect adverse drug reactions. It collects information about the patient, reaction details, suspect and concomitant drugs, and manufacturer and reporter information. The reaction details section allows selection of outcomes like death, hospitalization, disability, life-threatening, congenital anomaly, or other medically important condition. It also records onset and duration of therapy and outcomes of stopping or reintroducing the suspect drug.

Uploaded by

Anusha Denduluri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
963 views2 pages

CIOMS Form for Adverse Reaction Reporting

This document is a form for reporting suspect adverse drug reactions. It collects information about the patient, reaction details, suspect and concomitant drugs, and manufacturer and reporter information. The reaction details section allows selection of outcomes like death, hospitalization, disability, life-threatening, congenital anomaly, or other medically important condition. It also records onset and duration of therapy and outcomes of stopping or reintroducing the suspect drug.

Uploaded by

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

CIOMS FORM

SUSPECT ADVERSE REACTION REPORT

I. REACTION INFORMATION
1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET 8-12 CHECK ALL
(first, last)   Day Month Year Years   Day Month Year APPROPRIATE
TO ADVERSE
REACTION
7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED

INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION

INVOLVED
PERSISTENT OR
SIGNIFICANT
DISABILITY OR
INCAPACITY

LIFE
THREATENING

CONGENITAL
ANOMALY

OTHER
MEDICALLY
IMPORTANT
CONDITION

II. SUSPECT DRUG(S) INFORMATION


14. SUSPECT DRUG(S) (include generic name) 20. DID REACTION
ABATE AFTER
STOPPING DRUG?
YES NO NA
15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 21. DID REACTION
REAPPEAR
AFTER REINTRO-
17. INDICATION(S) FOR USE DUCTION?
YES NO NA

18. THERAPY DATES (from/to) 19. THERAPY DURATION

III. CONCOMITANT DRUG(S) AND HISTORY


22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)

 
23. OTHER RELEVANT HISTORY (e.g. diagnoses, allergies, pregnancy with last menstrual period, etc.)
 

IV. MANUFACTURER INFORMATION


24a. NAME AND ADDRESS OF MANUFACTURER 26-26a. NAME AND ADRESS OF REPORTER (INCLUDE ZIP
CODE)

ORIGINAL REPORT NO. 24b. MFR CONTROL NO.

24c. DATE RECEIVED 24d. REPORT SOURCE


BY MANUFACTURER STUDY LITERATURE
HEALTH PROFESSIONAL
REGULATORY AUTHORITY
OTHER
DATE OF THIS REPORT 25a. REPORT TYPE
INITIAL FOLLOW-UP

You might also like