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

New Drug Application (NDA)

Answer

Biologics License Application (BLA)

Answer

Abbreviated New Drug Application (ANDA)

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

Leave the product at the site for potential future studies

Answer

Allow the investigator to keep the product for personal use

Answer

Donate the product to a local hospital pharmacy

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

Subject recruitment potential and patient population

Answer

Availability and qualifications of site staff

Answer

Facility infrastructure including storage and laboratory capabilities

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

Only after the study is completed and data are analyzed

Answer

Only if the investigator is being paid more than $25,000

Answer

At the same time as the database lock

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

Completed study report, database lock, and regulatory approval of the final label

Answer

Phase IV commitments, post-approval studies, and marketing authorization

Answer

Subject payment schedules and insurance documentation only

Question 6

At close-out, what is the required minimum document retention period for clinical trial records at an investigational site in the US under FDA regulations?

Accepted Answer

2 years following marketing approval or discontinuation of the IND

Answer

1 year after study completion

Answer

5 years after the last subject visit

Answer

10 years from database lock

Question 7

Which document is used at site initiation to formally define the delegation of trial-related duties from the Principal Investigator to site staff?

Accepted Answer

The Delegation of Authority Log (DOA Log)

Answer

The Informed Consent Form (ICF)

Answer

The Protocol Amendment Log

Answer

The Serious Adverse Event Report