THIS IS ICH E2A GUIDELINE -CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

1. ICH GUIDELINES HARMONISING FOR BETTER HEALTH BY T.SATHISH KUMAR PHARMACOVIGILANCE

2. CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (E2A)

4. DEFINITIONS AND TERMINOLOGY

5. STANDARDS FOR EXPEDITED REPORTING

7. The development of standard definitions and terminology for key aspects of clinical safety reporting

9. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE Adverse Drug Reaction (ADR) In the pre-approval clinical experience : All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions

10. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE Expected Adverse Drug Reaction An adverse reaction, the nature or severity of which is consistent with the applicable product information (Investigator's Brochure) Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (Investigator's Brochure)

11. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE Serious Adverse Event or reaction A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose - results in death - is life-threatening - requires inpatient hospitalisation or prolongation of existing hospitalisation - results in persistent or significant disability/incapacity - congenital anomaly/birth defect

13. Reports from spontaneous sources and from any type of clinical or epidemiological investigation

14. Source should be specified always

16. Increase in the rate of occurrence of an expected serious ADR

19. Suspect medicinal product

20. An identifiable reporting source

22. Reports must be sent to regulatory or other official parties requiring them in countries where the drug is under development

24. Other relevant identifier (clinical investigation number, for example) - Gender - Age and/or date of birth - Weight - Height

26. International Non-Proprietary Name (INN)

27. Indication(s) for which suspect medicinal product

28. Dosage form and strength

30. Stop date (and time) or duration of reaction

31. Dechallenge and rechallenge information

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