Adr-En

SUSPECT ADVERSE REACTION REPORT
ID CASE NUMBER (Distributor)
ID CASE NUMBER (Bioindustria)
ID CASE NUMBER (Authority Reference number)
1.REACTION INFORMATION
PATIENT INITIALS
COUNTRY
DATE OF BIRTH
MM slash DD slash YYYY
AGE
SEX
REACTION ONSET
MM slash DD slash YYYY
DESCRIBE REACTION(S) (including relevant test/lab data)
CHECK ALL APPROPRIATE TO ADVERSE REACTION
- PATIENT DIED
- INVOLVED OR PROLONGED INPATIENT HOSPITALISATION
- INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY
- LIFE THREATENING
- CONGENITAL ANOMALY
- OTHER MEDICALLY IMPORTANT CONDITION
2. SUSPECT DRUG(S) INFORMATION
SUSPECT DRUG (S) (include generic name)
DAILY DOSE(S)
ROUTE(S) OF ADMINISTRATION
INDICATION(S) FOR USE
THERAPY DATES (from/to)
THERAPY DURATION
DID REACTION ABATE AFTER STOPPING DRUG?
- Yes
- No
- N/A
DID REACTION REAPPEAR AFTER REINTRODUCTION?
- Yes
- No
- N/A
3. CONCOMITANTS DRUGS AND HISTORY
CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period,etc)
4. MANUFACTURER INFORMATION
NAME AND ADDRESS OF MANUFACTURER
MFR CONTROL No.
DATE RECEIVED BY MANUFACTURER
MM slash DD slash YYYY
DATE OF THIS REPORT
MM slash DD slash YYYY
NAME AND ADDRESS OF REPORTER (INCLUDE ZIP CODE)
Address City Zip Country
REPORT SOURCE
- STUDY
- LITERATURE
- HEALTH PROFESSIONAL
- REGULATORY AUTHORITY
- OTHER
REPORT TYPE
- INITIAL
- FOLLOW UP