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ICH E2A

QuestionAnswer
What does the ICH E2A Cover Adverse Events and Reporting
Are the ICH E2A the same as 21 CRF 314.80 No, they have different definitions and time frames
What is an Adverse Event Any outword medical occurrence in a pt. or subject administered study drug does not necessarily have to have a casual relation with treatment. Therefore by any unfavorable and unintended sign that is temporally associated with the use of the study drug
Adverse Drug Reaction (ADR) Is all noxious and unintended responses to medical product related to any dose
Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of whih is not consistent with the applicable product information (Investigator Drug Brochure)
What does "severe" mean Used to describe the intensity (severity) of a specific event (mild, moderate, or severe). Not the same as a serious adverse event
What does "serious" mean Is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functions. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations.
A Serious Adverse Event or Reaction is any of the following: Results in death, life threatening, requires inpatient hospitalization or prolong hospitalization, persistent disability/incapacity or congential anomaly/birth defect
What is the purpose of expedited reporting To make regulators, investigators, and other appropriate people aware of new, important information on serious reactions.
Reporting of Serious, Unexpected ADRs (Fatal or Life-Threatening) Notified within 7 calendar days after first knowledge by the sponsor, followed by a complete report as possible within an additional 8 calendar days
Reporting of Serious, Unexpected ADRx (Not Fatal or Life Threatening) Filled no later than 15 calendar days after first knowledge by the sponsor
What is CIOMS-I Is a standard form for expedited adverse event reporting.
Created by: kkolsch
 

 



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