Suspect Adverse Reaction Report Form (Cioms) - Adamed

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CIOMS FORM
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1.PATIENT
1a COUNTRY
2. DATE OF BIRTH
2a.AGE
3. SEX
4-6 REACTION ONSET
8-12 CHECK ALL
INITIALS
Years
APPROPRIATE TO
(first, last)
ADVERSE REACTION
Day
Month
Year
Day
Month
Year
 PATIENT DIED
7+13 DESCRIBE REACTION(S) (including relevant tests/laboratory data)
 INVOLVED OR
PROLONGED INPATIENT
HOSPITALISATION
 INVOLVED
PERSISTANCE OR
SIGNIFICANT DISABILITY
OR INCAPACITY
 LIFE THREATENING
 CONGENITAL
ABNORMALITIES
 OTHER MEDICALLY
IMPORTANT
II. SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG(S) (include generic name and batch no.)
20. DID REACTION
ABATE AFTER STOPPING DRUG?
 YES  NO  NA
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID REACTION REAPPEAR AFTER
REINTRODUCTION?
 YES  NO  NA
17. INDICATION(S) FOR USE
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. diagnostics, allergics, pregnancy with last month of period, etc.)
IV. MARKETING AUTHORIZATION HOLDER/MANUFACTERER INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER/MARKETING
26. REPORTER’S DETAILS
AUTHORIZATION HOLDER (MAH)
24b. ORIGINAL REPORT NO.
24c. MAH CONTROL NO.
24d. DATE RECEIVED BY MAH
24d. REPORT SOURCE
 STUDY
 LITERATURE
 HEALTH PROFESSIONAL
 COMPETENT AUTHORITIES
25a.DATE OF THIS REPORT
25b. REPORT TYPE
 INITIAL
 FOLLOW UP
Confidential
Page 1 of 1
CIOMS FORM
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1.PATIENT
1a COUNTRY
2. DATE OF BIRTH
2a.AGE
3. SEX
4-6 REACTION ONSET
8-12 CHECK ALL
INITIALS
Years
APPROPRIATE TO
(first, last)
ADVERSE REACTION
Day
Month
Year
Day
Month
Year
 PATIENT DIED
7+13 DESCRIBE REACTION(S) (including relevant tests/laboratory data)
 INVOLVED OR
PROLONGED INPATIENT
HOSPITALISATION
 INVOLVED
PERSISTANCE OR
SIGNIFICANT DISABILITY
OR INCAPACITY
 LIFE THREATENING
 CONGENITAL
ABNORMALITIES
 OTHER MEDICALLY
IMPORTANT
II. SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG(S) (include generic name and batch no.)
20. DID REACTION
ABATE AFTER STOPPING DRUG?
 YES  NO  NA
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID REACTION REAPPEAR AFTER
REINTRODUCTION?
 YES  NO  NA
17. INDICATION(S) FOR USE
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. diagnostics, allergics, pregnancy with last month of period, etc.)
IV. MARKETING AUTHORIZATION HOLDER/MANUFACTERER INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER/MARKETING
26. REPORTER’S DETAILS
AUTHORIZATION HOLDER (MAH)
24b. ORIGINAL REPORT NO.
24c. MAH CONTROL NO.
24d. DATE RECEIVED BY MAH
24d. REPORT SOURCE
 STUDY
 LITERATURE
 HEALTH PROFESSIONAL
 COMPETENT AUTHORITIES
25a.DATE OF THIS REPORT
25b. REPORT TYPE
 INITIAL
 FOLLOW UP
Confidential
Page 1 of 1

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