ICH E2A GUIDELINE

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)

3. CONTENTS INTRODUCTION DEFINITIONS AND TERMINOLOGY STANDARDS FOR EXPEDITED REPORTING DATA ELEMENTS FOR EXPEDITED REPORTS

4. INTRODUCTION Ensure uniform Good Clinical Practice standards in drug developmental stage The development of standard definitions and terminology for key aspects of clinical safety reporting For appropriate mechanism for handling expedited (rapid) reporting, in the investigational phase

5. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE Adverse 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

6. 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

7. 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)

8. 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

9. STANDARDS FOR EXPEDITED REPORTING What Should be Reported Single Cases of Serious, Unexpected ADRs Reports from spontaneous sources and from any type of clinical or epidemiological investigation Source should be specified always Reasonable suspected causal relationship to the medicinal product qualify as ADRs

10. STANDARDS FOR EXPEDITED REPORTING Other Observations lack of efficacy Increase in the rate of occurrence of an expected serious ADR Newly completed animal study

11. STANDARDS FOR EXPEDITED REPORTING Reporting Time Frames Fatal or Life-Threatening Unexpected ADR Should be notified as soon as possible but no later than 7 calendar days after first knowledge by the sponsor Complete report as possible within 8 additional calendar days

12. STANDARDS FOR EXPEDITED REPORTING Reporting Time Frames All Other Serious, Unexpected ADRs No later than 15 calendar days after first knowledge by the sponsor

13. STANDARDS FOR EXPEDITED REPORTING Minimum criteria for reporting An identifiable patient Suspect medicinal product An identifiable reporting source And an event or outcome (SUSAR)

14. STANDARDS FOR EXPEDITED REPORTING How to Report The CIOMS-I is standard for expedited adverse event reporting Reports must be sent to regulatory or other official parties requiring them in countries where the drug is under development Informing investigators and ethics committees/ institutional review boards of new safety information

15. KEY DATA ELEMENTS FOR EXPEDITED REPORTS OF SERIOUS ADVERSE DRUG REACTIONS Patient Details Initials Other relevant identifier (clinical investigation number, for example) - Gender - Age and/or date of birth - Weight - Height

16. KEY DATA ELEMENTS FOR EXPEDITED REPORTS OF SERIOUS ADVERSE DRUG REACTIONS Suspected Medicinal Product(s) Brand name as reported International Non-Proprietary Name (INN) Indication(s) for which suspect medicinal product Dosage form and strength Route of administration Other Treatment(s) concomitant medicinal products

17. KEY DATA ELEMENTS FOR EXPEDITED REPORTS OF SERIOUS ADVERSE DRUG REACTIONS Details of Suspected Adverse Drug Reaction Start date (and time) of onset of reaction Stop date (and time) or duration of reaction Dechallenge and rechallenge information Outcome

18. KEY DATA ELEMENTS FOR EXPEDITED REPORTS OF SERIOUS ADVERSE DRUG REACTIONS Other details Details on Reporter of Event  Administrative and Sponsor/Company Details

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