CCRA Site Initiation, Qualification, and Close-Out Procedures 2

Question 1

Which regulatory submission is typically required in the US BEFORE initiating a Phase I clinical trial with a new investigational drug?

Accepted Answer

Investigational New Drug (IND) application

Answer

An IND application must be submitted to the FDA and allowed to proceed (no clinical hold issued within 30 days) before initiating Phase I trials with a new investigational drug in the US.

Question 2

During a site close-out visit, the CRA identifies 15 unused blister packs of investigational product. What is the CORRECT course of action?

Accepted Answer

Return or destroy the product per the sponsor's instructions and document the reconciliation

Answer

All unused investigational product must be accounted for and either returned to the sponsor or destroyed per documented procedures to maintain the drug accountability record.

Question 3

Which of the following is NOT typically reviewed during a Site Qualification Visit?

Accepted Answer

Final data lock and statistical analysis outputs

Answer

Data lock and statistical analysis occur after study completion, not during a pre-study qualification visit assessing site feasibility.

Question 4

When must a Financial Disclosure Form (FDA Form 3454 or 3455) be obtained from clinical investigators?

Accepted Answer

Before the investigator begins participating in the covered clinical study

Answer

Per 21 CFR Part 54, financial disclosure information must be obtained before the investigator's participation begins to identify potential conflicts of interest.

Question 5

Which of the following items is the CRA responsible for confirming is in place at site initiation before the first subject is enrolled?

Accepted Answer

IRB approval, signed protocol, delegation log, trained staff, and available investigational product

Answer

Before first enrollment, the CRA must verify all regulatory approvals, site agreements, staff training, delegation of authority, and product availability are in place.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Site Initiation, Qualification, and Close-Out Procedures 2