Brain Teasers on GCP

Question 1

A serious breach is a breach during a clinical trial which is likely to affect to a significant degree in

Accepted Answer

the safety/ physical/ mental integrity, of any subject of a clinical trial, the scientific value of the clinical trial

Question 2

How should you response to the following situation?

Accepted Answer

Push for finalisation of the storage administrative arrangement ASAP, Inform the CRA of your constraint and ask to have the IP delivered later

Question 3

Referring to the following scenario, who else should be present at the consent taking process?

Accepted Answer

A translator, An impartial witness

Question 4

You are assigned to a Randomised double-blinded trial as the unblinded CRC. How do you protect the blind of the trial?

Accepted Answer

A, C

Question 5

What should you do in the following scenario?

Accepted Answer

Inform the PI and withdraw the subject immediately, Report to HSA as serious breach, Report to IRB as Protocol deviation

Question 6

Referring to the following scenario, who else should be present at the consent taking process?

Accepted Answer

The PI

Question 7

Should this event be reported as a SAE?

Accepted Answer

Yes

Questions 7