Feedback form for experts

1. Patient initials

2. History number

3. Birthday

4. Gender

5. Consequence of adverse reaction / lack of efficacy

recovery
recovers
without changes
unknown

recovery with consequences
death is not from an adverse reaction
death possibly from an adverse reaction
death as a result of a side reaction

6. Beginning of the adverse reaction / lack of efficacy (date, time)

7. End of adverse reaction (date, time)

9. Category of adverse reaction / lack of efficacy

death of the patient
threat to life
ambulatory patient hospitalization
prolongation of hospitalization

long-term disability
congenital malformations
other important medical evaluation
none of the above

10. SD (trade name, dosage form)

11. Manufacturer, country

12. Serial number

13. Indications for prescribing

14. Single dose

15. Multiplicity of reception

16. Method of administration

17. The beginning of SD therapy

18. End of SD therapy

ІІІ. Information on concomitant drugs (with the exception of drugs that have been used to correct the effects of adverse reactions)

19. Concomitant drugs (trade name, dosage form, manufacturer)

21. Single dose

22. Multiplicity of reception

23. Method of administration

24. Initiation of therapy

25. End of therapy

26. Other important information (diagnoses, allergies, pregnancy with duration, etc.)

Was the SD canceled with the disappearance of adverse reaction?

Yes No

Repeated assignment of SD

Has the resumption of an adverse reaction been noted after re-appointment of the SD?

Yes No

Change the dosage mode of the SD (decrease / increase, specify how much) :

Has an update of the adverse reaction been noted after dosing SD?

Yes No

There was no correction of adverse reaction / lack of efficacy

Drug therapy for adverse reaction / lack of efficacy (indicate drug, dosage regimen, duration of appointment):

27. Name of the notifier, tel / fax, email

28. Notification provides

29. The name and location of the health care institution or the applicant of the disease / ambulatory card

30. Source of notification (paragraph 30-32 only for the applicant)

doctor
research

patient
literature

other

31. Notification number assigned by the applicant

32. Date of receipt by the applicant

33. Type of notification

primary
next
final

34. Date of completion