CCRA Introduction to Certified Clinical Research Associate 2

Question 1

Which organization administers the CCRA certification examination in the United States?

Accepted Answer

The Association of Clinical Research Professionals (ACRP)

Answer

ACRP (Association of Clinical Research Professionals) administers the CCRA certification exam and sets the competency standards for clinical research associates.

Question 2

A CRA notices that a site has been enrolling subjects without obtaining updated ICF signatures after a protocol amendment. What is the CRA's immediate obligation?

Accepted Answer

Document the finding as a protocol deviation and report it to the sponsor

Answer

Failure to obtain updated consent after an amendment is a protocol deviation that must be documented and reported to the sponsor per GCP guidelines.

Question 3

What does the term 'source document verification (SDV)' refer to in clinical monitoring?

Accepted Answer

Comparing CRF data to original source documents to confirm accuracy

Answer

SDV is the process of comparing data recorded in the CRF against original source documents to ensure data accuracy and integrity.

Question 4

Under 21 CFR Part 312, an Investigational New Drug (IND) application must be submitted to the FDA before:

Accepted Answer

Initiating a clinical investigation of a new drug in humans

Answer

An IND must be in effect before a sponsor ships an investigational drug across state lines or begins clinical studies in humans.

Question 5

Which ICH E6(R2) principle states that clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification?

Accepted Answer

Data integrity

Answer

ICH E6(R2) emphasizes that all clinical trial data must be handled and stored to allow accurate reporting, interpretation, and verification.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Introduction to Certified Clinical Research Associate 2