ICH Clinical Safety & Data Management (E2A)

Question 1

What’s the purpose of the E2A guidelines?

Answer 1

To provide standard definitions and terminology for key aspects of clinical safety reporting
And
To give guidance on mechanisms for handling expedited reporting of adverse drug reactions during trials.

Question 2

Is there currently standard international nomenclature to describe the degree of causality (attributability) between a medicinal product and an event?

Answer 2

No

Question 3

In addition to serious, unexpected adverse drug reactions, what are three examples of cases that may require expedited reporting?

Answer 3

1) An increase in the rate of occurrence of an “expected” serious adverse drug reaction
2) A significant hazard to the patient population (i.e. lack of efficacy with a product used for a life-threatening disease)
3) A major safety finding from a newly completed animal study

Question 4

Per ICH E2A expedited reporting guidelines, serious, unexpected adverse drug reactions (that are NOT fatal or life-threatening) must be filed within ______ ___________ days after Sponsor determines that the case meets reporting criteria.

Answer 4

15 CALENDAR

Question 5

What are the minimum criteria for an initial expedited report according to ICH E2A guidelines?

Answer 5

1) Identifiable patient
2) Name of a suspect medicinal product
3) Identifiable reporting source
4) Event or outcome that can be identified as serious, unexpected, and with suspected causal relationship

Question 6

What form is widely accepted as the standard for expedited adverse event reporting?

Answer 6

The CIOMS-I form