Mastering the Event Reporting Cycle Understanding Your

Impact on Patient Safety Exam

What does the ICH E2A guideline describe? - Answer Safety information that arises

during clinical development. Covers all phases of development.

Adverse Event ICH GCP Definition - Answer Any untoward medical occurrence in a

patient or clinical investigation subject administered a pharmaceutical product and which

does not necessarily have to have a causal relationship with this treatment.

Untoward medical occurrence - Answer ny unfavorable and unintended sign, symptom,

or disease that occurs in one or more subjects

per protocol analysis - Answer only the information for those subjects who have taken

the product will be included in the analysis

'intention to treat' analysis - Answer includes information on anyone who was intended to

have the product administered, whether it actually happened or not

Pre-approval definition of ADRs - Answer any adverse event that is reasonably related to

use of a medicinal product. If an adverse event is possibly, probably, or definitely related

to use of a medicinal product, it's an ADR.

Severity - Answer describes its intensity. Severity is typically reported as being mild,

moderate, or severe.

seriousness - Answer based on the patient or event outcome, usually posing a threat to a

patient's life or ability to function. (The seriousness serves as a guide for determining

expedited reporting requirements. In short, if it's serious, it needs reporting as soon as

possible)