Suspect Adverse Reaction Report Form - Cioms

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CIOMS FORM
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
4-6. REACTION ONSET
2. DATE OF BIRTH
1a. COUNTRY
1.PATIENT INITIALS
2a. AGE
3. SEX
Day
Month
Year
8-13 CHECK ALL
Day
Month
Year
APROPRIATE TO
ADVERSE
REACTION
7+13 DESCRIBE REACTION(S) (including relevant tests/lab.data)
RECOVERY
WITHOUT
CONSEQUENCES
RECOVERY
WITH
CONSEQUENCES
ADVERSE
REACTION
ONGOING
DEATH
THREAT TO LIIFE
UKNOWN
13. CAUSAL LINK BETWEEN ADVERSE REACTION AND SUSPECT MEDICINAL PRODUCT
1. Certain 2. Most likely 3. Possible 4. Not likely 5. Can not be classified
II. SUSPECT DRUG(S) INFORMATION
20. DID REACTION
14. SUSPECT DRUG(S) (incl.generic name, proprietary name, pharmaceutical form and strength)
ABATE AFTER
STOPPING DRUG?
YES
NO
N/A
15. SINGLE AND DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION
OF THE DRUG?
17. INDICATION(S) FOR USE
YES
NO
N/A
18. THERAPY DATES
19. THERAPY DURATION
III. CONCOMITANT DRUGS AND HISTORY
22. CONCOMITANT DRUGS AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
23. OTHER RELEVANT HISTORY ( e.g. diagnostics, allergic, pregnancy etc.)
IV. SOURCE INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER
26. REPORTER
HEALTHCARE INSTITUTION:
24b.
24c. DATE OF THIS REPORT
BATCH NO.
NAME OF THE HEALTHCARE PROFESSIONAL, SPECIALITY
25. REPORT TYPE
24d. REPORT SOURCE
ADDRESS:
SPONTANEOUS
HOSPITAL
FROM CLINICAL STUDY
CONTACT TEL:
NON HOSPITAL SOURCE
TARGET MONITORING OF
GENERAL PRACTICIONER
THE MEDICINAL PRODUCT
E-MAIL:
SPECIALIST
TOLERABILITY
OTHER
SIGNATURE:
CIOMS FORM
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
4-6. REACTION ONSET
2. DATE OF BIRTH
1a. COUNTRY
1.PATIENT INITIALS
2a. AGE
3. SEX
Day
Month
Year
8-13 CHECK ALL
Day
Month
Year
APROPRIATE TO
ADVERSE
REACTION
7+13 DESCRIBE REACTION(S) (including relevant tests/lab.data)
RECOVERY
WITHOUT
CONSEQUENCES
RECOVERY
WITH
CONSEQUENCES
ADVERSE
REACTION
ONGOING
DEATH
THREAT TO LIIFE
UKNOWN
13. CAUSAL LINK BETWEEN ADVERSE REACTION AND SUSPECT MEDICINAL PRODUCT
1. Certain 2. Most likely 3. Possible 4. Not likely 5. Can not be classified
II. SUSPECT DRUG(S) INFORMATION
20. DID REACTION
14. SUSPECT DRUG(S) (incl.generic name, proprietary name, pharmaceutical form and strength)
ABATE AFTER
STOPPING DRUG?
YES
NO
N/A
15. SINGLE AND DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION
OF THE DRUG?
17. INDICATION(S) FOR USE
YES
NO
N/A
18. THERAPY DATES
19. THERAPY DURATION
III. CONCOMITANT DRUGS AND HISTORY
22. CONCOMITANT DRUGS AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
23. OTHER RELEVANT HISTORY ( e.g. diagnostics, allergic, pregnancy etc.)
IV. SOURCE INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER
26. REPORTER
HEALTHCARE INSTITUTION:
24b.
24c. DATE OF THIS REPORT
BATCH NO.
NAME OF THE HEALTHCARE PROFESSIONAL, SPECIALITY
25. REPORT TYPE
24d. REPORT SOURCE
ADDRESS:
SPONTANEOUS
HOSPITAL
FROM CLINICAL STUDY
CONTACT TEL:
NON HOSPITAL SOURCE
TARGET MONITORING OF
GENERAL PRACTICIONER
THE MEDICINAL PRODUCT
E-MAIL:
SPECIALIST
TOLERABILITY
OTHER
SIGNATURE:

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