CTA Site Management & Monitoring 2 — Questions and Answers
Question 1: During a routine monitoring visit, the CRA discovers that a site has enrolled a subject who did not meet an inclusion criterion. What is the FIRST action the CRA should take?
- Immediately withdraw the subject from the study
- Document the protocol deviation and notify the sponsor and IRB per protocol requirements (Correct answer)
- Instruct the site to destroy the subject's data
- Wait until the next scheduled visit to address the issue
Correct answer: Document the protocol deviation and notify the sponsor and IRB per protocol requirements
Protocol deviations must be documented and reported to the sponsor and IRB according to the protocol's deviation management plan.
Question 2: Which document serves as the master reference for the rights and responsibilities of the sponsor, investigator, and institution at a clinical trial site?
- The Informed Consent Form
- The Clinical Study Report
- The Clinical Trial Agreement (CTA) (Correct answer)
- The Investigator's Brochure
Correct answer: The Clinical Trial Agreement (CTA)
The Clinical Trial Agreement outlines the legal obligations, responsibilities, and financial terms between the sponsor and the site/institution.
Question 3: A site coordinator calls to say the temperature in the investigational product storage refrigerator exceeded the acceptable range overnight. What should the CRA advise?
- Dispose of all affected product immediately
- Continue using the product if it looks undamaged
- Quarantine the affected product and notify the sponsor for disposition instructions (Correct answer)
- Re-run temperature logs to verify the excursion
Correct answer: Quarantine the affected product and notify the sponsor for disposition instructions
Excursed investigational product must be quarantined and the sponsor's pharmacovigilance or supply team consulted before any use or disposal.
Question 4: In clinical trial monitoring, what does 'source data verification (SDV)' specifically confirm?
- That the protocol was reviewed by the IRB
- That data entered in the CRF matches the original source records (Correct answer)
- That the investigational product was manufactured correctly
- That all subjects signed the consent form before dosing
Correct answer: That data entered in the CRF matches the original source records
SDV ensures the accuracy and completeness of CRF data by comparing it directly against original source documents such as medical records.
Question 5: A monitoring visit report (MVR) should be completed and sent to the sponsor within which timeframe, per ICH E6 GCP guidance?
- 24 hours after the visit
- One week after the visit
- A defined timeframe in the monitoring plan, typically within 5–10 business days (Correct answer)
- 30 days after the visit
Correct answer: A defined timeframe in the monitoring plan, typically within 5–10 business days
ICH E6(R2) requires the CRA to document monitoring activities promptly; the specific timeframe is defined in the sponsor's monitoring plan, usually within 5–10 business days.
Question 6: When a site investigator is temporarily unavailable, which action is acceptable under GCP?
- Any site staff member may assume investigator duties
- A qualified sub-investigator listed on the FDA Form 1572 may perform delegated duties (Correct answer)
- The CRA may act as the investigator until the PI returns
- The sponsor's medical monitor automatically assumes all investigator responsibilities
Correct answer: A qualified sub-investigator listed on the FDA Form 1572 may perform delegated duties
Only qualified individuals listed on the delegation log and, in the US, on FDA Form 1572 may perform investigator-delegated duties.
Question 7: Which of the following best describes a 'for-cause' monitoring visit?
- A visit scheduled at regular intervals per the monitoring plan
- An unannounced visit triggered by a specific concern, data signal, or complaint (Correct answer)
- A visit conducted solely to perform SDV of all CRFs
- A visit required by the FDA before a New Drug Application submission
Correct answer: An unannounced visit triggered by a specific concern, data signal, or complaint
For-cause visits are triggered by a specific issue such as data anomalies, safety signals, or regulatory concerns, unlike routine periodic visits.
CTA Site Management & Monitoring 2
During a routine monitoring visit, the CRA discovers that a site has enrolled a subject who did not meet an inclusion criterion.
What is the FIRST action the CRA should take?