CRP Risk Management & Quality Assurance 2

Question 1

Which risk management technique involves assigning numerical probabilities to potential research outcomes to quantify expected losses?

Accepted Answer

Quantitative risk analysis

Answer

Quantitative risk analysis assigns numerical probabilities and impact values to calculate expected monetary value or other numeric risk measures.

Question 2

A research sponsor requires a DSMB (Data Safety Monitoring Board) for a clinical trial. What is the primary function of the DSMB?

Accepted Answer

Provide ongoing review of accumulating safety and efficacy data

Answer

A DSMB independently monitors accumulating data to protect participant safety and ensure study integrity, with authority to recommend stopping the trial early.

Question 3

In quality assurance, what does a 'process audit' specifically evaluate?

Accepted Answer

Adherence to procedures and protocols during research activities

Answer

A process audit examines whether research activities are being carried out according to defined procedures, SOPs, and protocols.

Question 4

What is the purpose of a 'risk register' in research project management?

Accepted Answer

Record identified risks, their likelihood, impact, and mitigation strategies

Answer

A risk register is a centralized document cataloging identified risks along with their assessed probability, potential impact, and planned responses.

Question 5

Which GCP principle requires that research be conducted in accordance with a protocol approved by an IRB/IEC?

Accepted Answer

Principle of protocol adherence

Answer

GCP requires strict adherence to the approved protocol, and any deviations must be documented and reported to the IRB/IEC.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Risk Management & Quality Assurance 2