CCRA Certified Clinical Research Associate 2

Question 1

During a routine monitoring visit, the CRA discovers that the site has been enrolling subjects who do not meet the inclusion criteria. What is the FIRST action the CRA should take?

Accepted Answer

Document the finding and discuss it with the investigator during the visit

Answer

The CRA should document the protocol deviation and discuss it with the investigator to understand the root cause before escalating per the monitoring plan.

Question 2

Which ICH E6(R2) principle requires that each individual involved in conducting a trial should be qualified by education, training, and experience?

Accepted Answer

Principle 3 — qualified personnel

Answer

ICH E6(R2) Principle 3 specifies that all trial personnel must be qualified by education, training, and experience to perform their tasks.

Question 3

A subject's source document shows a glucose value of 450 mg/dL, but the CRF records 45 mg/dL. How should this discrepancy be handled?

Accepted Answer

Issue a data query to the site to correct the CRF entry with a documented explanation

Answer

Transcription errors between source documents and CRFs must be resolved through a formal data query so the correction is auditable.

Question 4

Under FDA 21 CFR Part 312, the sponsor must notify the FDA of an IND safety report (IND Safety Report) within how many calendar days for unexpected fatal or life-threatening SUSARs?

Accepted Answer

7 calendar days

Answer

Fatal or life-threatening unexpected serious adverse reactions must be reported to the FDA within 7 calendar days of the sponsor's first knowledge.

Question 5

Which document is considered the primary source for verifying that informed consent was obtained before any study procedures were performed?

Accepted Answer

The signed and dated informed consent form

Answer

The signed and dated informed consent form is the primary document confirming that consent was obtained prior to study participation.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Certified Clinical Research Associate 2