REPORTING FORM OF
SERIOUS SUSPECTED UNEXPECTED ADVERSE REACTIONS
Protocol №.
Suspected adverse reaction:
Investigated product:
1. Patient
initials
I. Information about the adverse reaction:
1. Country
2. Birth date
Day
Month
2.a.Age
3.Gender
Year
Notification №
Patient №
4-6 Manifestation of A.R.
Day
Month
Year
8-12
Mark the appropriate
[ ] Death
[ ] Dangerous for life
[ ] Prolongation of the
hospitalization
[ ] Invalidant
[ ] Congenital anomalies/
cancer
[ ] Other important
conditions
7. Description of the reaction (tests included/ relevant laboratory results )
II. Information about the suspected investigated products
14. Name of the product
15. Daily dose
16. Route of administration
20. A.R. disappeared after the interruption
of the administration
[ ] Yes
[ ] No
21. A.R. reappeared after the
readministration of the product
[ ] Yes
[ ] No
17. Indication (s):
18. Period of administration ( from / to)
19. Administration duration:
III. Medicines at the same time and historical
22. Medicines at the same time and the dates of administration (except for the one that is used for the treatment of reaction)
23. Other relevant anamnesis data (for example diagnostics, allergic reactions, pregnancy etc.)
IV Information about the sponsor and the investigator
24.a. Name and the address of the sponsor
24.b. Investigator’s name
24.c. Date of receipt by sponsor
25.a. Type of information
[ ] Initial
[ ] Sequential
25.b.Method of informing of the sponsor
Informing date
Receipt date
[ ] Attached additional information
Sponsor’s signature