CCRA Site Initiation, Qualification, and Close-Out Procedures 2 — Questions and Answers
Question 1: Which regulatory submission is typically required in the US BEFORE initiating a Phase I clinical trial with a new investigational drug?
- New Drug Application (NDA)
- Investigational New Drug (IND) application (Correct answer)
- Biologics License Application (BLA)
- Abbreviated New Drug Application (ANDA)
Correct answer: Investigational New Drug (IND) application
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?
- Leave the product at the site for potential future studies
- Return or destroy the product per the sponsor's instructions and document the reconciliation (Correct answer)
- Allow the investigator to keep the product for personal use
- Donate the product to a local hospital pharmacy
Correct answer: Return or destroy the product per the sponsor's instructions and document the reconciliation
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?
- Subject recruitment potential and patient population
- Availability and qualifications of site staff
- Final data lock and statistical analysis outputs (Correct answer)
- Facility infrastructure including storage and laboratory capabilities
Correct answer: Final data lock and statistical analysis outputs
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?
- Only after the study is completed and data are analyzed
- Before the investigator begins participating in the covered clinical study (Correct answer)
- Only if the investigator is being paid more than $25,000
- At the same time as the database lock
Correct answer: Before the investigator begins participating in the covered clinical study
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?
- IRB approval, signed protocol, delegation log, trained staff, and available investigational product (Correct answer)
- Completed study report, database lock, and regulatory approval of the final label
- Phase IV commitments, post-approval studies, and marketing authorization
- Subject payment schedules and insurance documentation only
Correct answer: IRB approval, signed protocol, delegation log, trained staff, and available investigational product
Before first enrollment, the CRA must verify all regulatory approvals, site agreements, staff training, delegation of authority, and product availability are in place.
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?
- 1 year after study completion
- 2 years following marketing approval or discontinuation of the IND (Correct answer)
- 5 years after the last subject visit
- 10 years from database lock
Correct answer: 2 years following marketing approval or discontinuation of the IND
Per 21 CFR 312.62, investigators must retain records for 2 years following the date of FDA marketing approval or the date the IND is withdrawn or the investigation discontinued.
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?
- The Informed Consent Form (ICF)
- The Delegation of Authority Log (DOA Log) (Correct answer)
- The Protocol Amendment Log
- The Serious Adverse Event Report
Correct answer: The Delegation of Authority Log (DOA Log)
The Delegation of Authority Log documents which tasks the PI has assigned to specific qualified staff members, ensuring accountability and GCP compliance.
CCRA Site Initiation, Qualification, and Close-Out Procedures 2
Which regulatory submission is typically required in the US BEFORE initiating a Phase I clinical trial with a new investigational drug?