ICH GUIDELINES HARMONISING FOR BETTER HEALTH BY T.SATHISH KUMAR PHARMACOVIGILANCE
CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (E2A)
CONTENTS
INTRODUCTION
DEFINITIONS AND TERMINOLOGY
STANDARDS FOR EXPEDITED REPORTING
DATA ELEMENTS FOR EXPEDITEDREPORTS
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
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
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
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)
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
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
STANDARDS FOR EXPEDITED REPORTING Other Observations
lack of efficacy
Increase in the rate of occurrence of an expected serious ADR
Newly completed animal study
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
STANDARDS FOR EXPEDITED REPORTING Reporting Time Frames All Other Serious, Unexpected ADRs
No later than 15 calendar days after first knowledge by the sponsor
STANDARDS FOR EXPEDITED REPORTING Minimum criteria for reporting
An identifiable patient
Suspect medicinal product
An identifiable reporting source
And an event or outcome (SUSAR)
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
KEY DATA ELEMENTS FOR EXPEDITEDREPORTS 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
KEY DATA ELEMENTS FOR EXPEDITEDREPORTS 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
KEY DATA ELEMENTS FOR EXPEDITEDREPORTS 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
KEY DATA ELEMENTS FOR EXPEDITEDREPORTS OF SERIOUS ADVERSE DRUG REACTIONS Other details
