The document outlines the guidelines for pharmacovigilance and clinical safety data management, focusing on the definitions and standards for expedited reporting of adverse drug reactions (ADRs). It specifies the criteria for reporting serious, unexpected ADRs and outlines the necessary data elements and timeframes for reporting these events. The aim is to standardize clinical safety reporting to ensure uniform good clinical practices during drug development.

1. ICH GUIDELINESHARMONISING FOR BETTER HEALTH BY T.SATHISH KUMAR PHARMACOVIGILANCE

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

3. CONTENTS INTRODUCTION

4. DEFINITIONS AND TERMINOLOGY

5. STANDARDS FOR EXPEDITED REPORTING

6. DATA ELEMENTS FOR EXPEDITEDREPORTSINTRODUCTIONEnsure uniform Good Clinical Practice standards in drug developmental stage

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

8. For appropriate mechanism for handling expedited (rapid) reporting, in the investigational phaseDEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCEAdverse Event (or Adverse Experience)Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment

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 EXPERIENCEExpected Adverse Drug ReactionAn adverse reaction, the nature or severity of which is consistent with the applicable product information (Investigator's Brochure) Unexpected Adverse Drug ReactionAn 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 EXPERIENCESerious 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

12. STANDARDS FOR EXPEDITED REPORTINGWhat Should be ReportedSingle Cases of Serious, Unexpected ADRs

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

14. Source should be specified always

15. Reasonable suspected causal relationship to the medicinal product qualify as ADRsSTANDARDS FOR EXPEDITED REPORTINGOther Observationslack of efficacy

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

17. Newly completed animal study STANDARDS FOR EXPEDITED REPORTINGReporting Time FramesFatal or Life-Threatening Unexpected ADRShould be notified as soon as possible but no later than 7 calendar days after first knowledge by the sponsor

18. Complete report as possible within 8 additional calendar daysSTANDARDS FOR EXPEDITED REPORTING Reporting Time FramesAll Other Serious, Unexpected ADRs No later than 15 calendar days after first knowledge by the sponsorSTANDARDS FOR EXPEDITED REPORTING Minimum criteria for reportingAn identifiable patient

19. Suspect medicinal product

20. An identifiable reporting source