ICH Clinical Safety Data Management: (E2A)

Question 1

What is ICH E2A?

Answer 1

A guideline that defines safety data management standards and outlines expedited reporting requirements for adverse events in clinical trials.

Question 2

What is the purpose of ICH E2A?

Answer 2

To ensure the timely detection and reporting of serious, unexpected, and related adverse events to protect participant safety.

Question 3

What is an Adverse Event (AE)?

Answer 3

Any unwanted medical occurrence in a participant, regardless of whether it is related to the study drug.

Question 4

What is a Serious Adverse Event (SAE)?

Answer 4

An AE that results in one or more of the following:
- Death
- Life-threatening situation
- Hospitalization or prolonged hospitalization
- Significant disability or permanent damage
- Congenital anomaly or birth defect
- Any important medical event requiring intervention to prevent these outcomes.

Question 5

What is a Suspected Unexpected Serious Adverse Reaction (SUSAR)?

Answer 5

A serious adverse reaction that is both unexpected and possibly related to the study drug.

Question 6

What is the timeline for reporting SAEs?

Answer 6

• Fatal or life-threatening SAEs: Report within 7 calendar days.
• Non-fatal/non-life-threatening SAEs: Report within 15 calendar days.

Question 7

What is the purpose of expedited reporting?

Answer 7

To inform regulatory authorities and stakeholders about serious, unexpected, and related safety issues as quickly as possible.

Question 8

Who is responsible for expedited reporting?

Answer 8

The sponsor must submit expedited safety reports to regulatory authorities, investigators, and ethics committees.

Question 9

What is the role of the investigator in SAE reporting?

Answer 9

• Report SAEs to the sponsor immediately.
• Provide detailed follow-up information as needed.

Question 10

What types of events do NOT require expedited reporting?

Answer 10

• Non-serious adverse events.
• Serious events that are already described in the Investigator’s Brochure (unless severity increases).

Question 11

Why is ICH E2A important in clinical trials?

Answer 11

It standardizes safety reporting practices, ensuring participant safety and improving the reliability of clinical trial data.