Clinical trial control - Good clinical practice

Question 1

Number of GCP principles

Answer 1

13

Question 2

Relevant rules in Health Products (Clinical Trials) Regulations for Informed Consent

Answer 2

r16 to r20

Question 3

Labelling requirements for investigational products and auxiliary products are stated in which rule and section of the Health Products (Clinical Trial) Regulations

Answer 3

Rule 26, elaborated in Second Schedule

Question 4

If the USADR results in death, or is life threatening to the trial subject,
Initial report must be furnished to HSA no later than ____ after the sponsor first becomes aware of the event.

The follow-up report for this event must be submitted within ____ after the first report.

Answer 4

7 days; 8 days

Question 5

Any USADR that does not result in death or is not life threatening must be reported to HSA within ____ after the sponsor first becomes aware of the event.

Answer 5

15 days