ICH E11- Clinical Investigation of Medicinal Products in the Pediatric Population

Question 1

What is the age classification of Term newborn infants?

Answer 1

0-27 days

Question 2

What is the age classification of Infants and toddlers?

Answer 2

28 days to 23 months

Question 3

What is the age classification of Children?

Answer 3

2-11 Years

Question 4

What is the age classification of Adolescents?

Answer 4

12 to 16-18 years (dependent on region)

Question 5

Who consents a pediatric subject to a study?

Answer 5

Pediatric study participants are dependent on their parent(s)/legal guardian to assume responsibility for their participation in clinical studies. Therefore, fully informed consent should be obtained from the legal guardian in accordance with regional laws or regulations.

Question 6

When should assent be signed?

Answer 6

Where appropriate, participants should assent to enroll in a study (age of assent to be determined by IRB’s/IEC’s or be consistent with local legal requirements).

Question 7

T/F In all cases, participants should be made aware of their rights to decline to participate or to withdraw from the study at any time.

Answer 7

True