CIOMS FORM
CASE ID
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS 1a. COUNTRY 2. DA TE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET 8-12 CHECK ALL
(first, last)
DayI I
Mont h Year Years Day I I
Month Year APPROPRIATE
TO ADVERSE
REACTION
7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data)
□PATIENT DIED
□INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION
□INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
□LIFE
THREATENING
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
I AFTER REINTRO-
17. INDICATION(S) FOR USE DUCTION?
□YES □NO □NA
18. THERAPY DATES (from/to) 19. THERAPY DURATION
I
Ill. 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. diagnostics, allergies, pregnancy with last month of period, etc.)
IV. MANUFACTURER INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER
24b. MFR CONTROL NO.
24c. DATE RECEIVED 24d. REPORT SOURCE
BY MANUFACTURER □ STUDY□ LITERATURE
□HEALTH PROFESSIONAL
DATE OF THIS REPORT 25a. REPORT TYPE
□INITIAL □FOLLOWUP
