CCA CATO Associate Ethics & Good Clinical Practice (GCP) 4

Question 1

Under 21 CFR Part 50, a 'short form' written consent document may be used when:

Accepted Answer

The IRB determines that oral presentation of consent elements is appropriate and a witness is present

Answer

A short form may be used when the IRB approves oral presentation of consent elements to the participant, with a witness signing the document.

Question 2

A monitor conducting a site visit cannot access source documents due to patient privacy restrictions at the site. GCP requires the monitor to:

Accepted Answer

Report the access issue to the sponsor and document the inability to verify data

Answer

If source document access is denied, the monitor must document the limitation and notify the sponsor, who must address the regulatory access rights per the trial agreement.

Question 3

The principle of 'equipoise' in clinical research means that:

Accepted Answer

There is genuine uncertainty in the expert community about the comparative merits of the treatments being tested

Answer

Equipoise justifies a randomized controlled trial by confirming that there is honest, professional uncertainty about which treatment is superior.

Question 4

An investigator site file (ISF) must contain all of the following EXCEPT:

Accepted Answer

Sponsor's internal financial audit reports

Answer

The ISF contains study conduct documents; internal sponsor financial audits are confidential sponsor records, not required in the ISF.

Question 5

Which GCP guideline specifically governs statistical principles for clinical trials, complementing ICH E6?

Accepted Answer

ICH E9

Answer

ICH E9 provides statistical principles for clinical trials, including randomization, blinding, and analysis population definitions.

(CCA) CATO Certified Associate Practice Test

(CCA) CATO Certified Associate Practice Test

CCA CATO Associate Ethics & Good Clinical Practice (GCP) 4