Form cioms-i Suspect Adverse Reaction Report Form

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CIOMS-I 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 AL L
APPROPRIAT E
(first,last)
TO ADVERSE
REACTION
Day
Month
Year
Day
Month
Year
PATIENT DIED
7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data)
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALIZATION
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
LIFE
THREATENING
Narrative: *
II. SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG 1of 1 (include generic name)
20. DID REACTION
ABATE AFTER
STOPPING DRUG?
YES
NO
NA
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID REACT
IO
N
REAPPEAR
AFTER REINTRODUCTION?
17. INDICATION(S) FOR USE
YES
NO
NA
18. THERAPY DATES (from/to)
19. THERAPY DURATION
III. CONCOMITANT DRUGS 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. MANUFACTURER INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER
Spontaneous report
24b. MFR CONTROL NO.
24c. DATE RECEIVED BY
24d. BY MANUFACTURER
MANUFACTURER
STUDY LITERATURE
HEALTH PROFESSIONAL
DATE OF THIS REPORT
25a. REPORT TYPE
INITIAL
FOLLOWUP
Page 1 of 2
NI - No information available at this time. UNK - Information unknown
DRAFT
* Item completed on continuation page(s)
CIOMS-I 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 AL L
APPROPRIAT E
(first,last)
TO ADVERSE
REACTION
Day
Month
Year
Day
Month
Year
PATIENT DIED
7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data)
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALIZATION
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
LIFE
THREATENING
Narrative: *
II. SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG 1of 1 (include generic name)
20. DID REACTION
ABATE AFTER
STOPPING DRUG?
YES
NO
NA
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID REACT
IO
N
REAPPEAR
AFTER REINTRODUCTION?
17. INDICATION(S) FOR USE
YES
NO
NA
18. THERAPY DATES (from/to)
19. THERAPY DURATION
III. CONCOMITANT DRUGS 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. MANUFACTURER INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER
Spontaneous report
24b. MFR CONTROL NO.
24c. DATE RECEIVED BY
24d. BY MANUFACTURER
MANUFACTURER
STUDY LITERATURE
HEALTH PROFESSIONAL
DATE OF THIS REPORT
25a. REPORT TYPE
INITIAL
FOLLOWUP
Page 1 of 2
NI - No information available at this time. UNK - Information unknown
DRAFT
* Item completed on continuation page(s)
CIOMS-I FORM
1. PATIENT INITIALS
24b. MFR CONTROL NO.
(first,last)
CONTINUES PREVIOUS PAGE
7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data)
Page 2 of 2

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