CCA CATO Associate Ethics & Good Clinical Practice (GCP) 2

Question 1

Which ethical principle requires that the anticipated benefits of clinical research must justify the risks to participants?

Accepted Answer

Beneficence

Answer

Beneficence obligates researchers to maximize benefits and minimize harms so that the study's potential benefits justify the risks.

Question 2

A sponsor discovers a serious unexpected adverse drug reaction mid-trial. Under GCP, the expedited reporting window to regulatory authorities is typically:

Accepted Answer

7 calendar days for fatal/life-threatening events

Answer

Fatal or life-threatening SUSARs must be reported to regulators within 7 calendar days; other SUSARs within 15 calendar days.

Question 3

An IRB/IEC must retain its records of approved studies for at least how long after study completion under ICH E6(R2)?

Accepted Answer

As required by applicable regulations, but no less than 3 years

Answer

ICH E6(R2) states that IRB/IEC records should be retained as required by applicable regulations, with a general minimum of 3 years post-completion.

Question 4

During site selection, a clinical monitor finds that the principal investigator has insufficient time to conduct the study. GCP requires the sponsor to:

Accepted Answer

Not initiate the site

Answer

GCP requires sponsors to select only sites where the investigator has adequate time and resources; a site should not be initiated if those conditions are not met.

Question 5

The Declaration of Helsinki's requirement for a 'post-study provision' means that:

Accepted Answer

Participants should have access to beneficial interventions identified in the study

Answer

The Declaration of Helsinki states that participants who benefited from study interventions should have access to them after the study ends.

(CCA) CATO Certified Associate Practice Test

(CCA) CATO Certified Associate Practice Test

CCA CATO Associate Ethics & Good Clinical Practice (GCP) 2