CTA Regulatory Submissions & Approvals 3 — Questions and Answers
Question 1: A protocol amendment requiring prior FDA approval before implementation would most likely involve:
- An increase in radiation exposure to subjects (Correct answer)
- A change in the study coordinator's contact information
- Addition of a new investigational site in the same country
- An updated version of the investigator's CV
Correct answer: An increase in radiation exposure to subjects
Amendments that increase risk to subjects, such as increased radiation exposure, require FDA approval before implementation.
Question 2: What is the primary purpose of a Safety Reporting Expedited Report (SUSAR) submitted to regulatory authorities?
- To notify authorities of a suspected unexpected serious adverse reaction not previously identified in the IB (Correct answer)
- To report all adverse events observed during the trial
- To summarize annual trial safety data for ongoing IND review
- To document deviations from the protocol that affected safety
Correct answer: To notify authorities of a suspected unexpected serious adverse reaction not previously identified in the IB
A SUSAR is submitted when a serious adverse reaction is both unexpected (not in the IB) and possibly related to the investigational product.
Question 3: Which of the following best describes a Pre-Submission meeting (formerly Pre-IDE or Q-Sub) with the FDA?
- An optional early meeting where sponsors seek FDA feedback before submitting a formal application (Correct answer)
- A mandatory meeting required before any Phase 1 study can begin
- A meeting to discuss post-marketing surveillance commitments
- A formal step in the NDA review process requiring FDA scheduling
Correct answer: An optional early meeting where sponsors seek FDA feedback before submitting a formal application
Pre-Submission meetings allow sponsors to obtain FDA feedback on study designs, data requirements, and regulatory strategies before formal submission.
Question 4: In the EU Clinical Trials Regulation (EU CTR 536/2014), which system is used for submitting clinical trial applications?
- CTIS (Clinical Trials Information System) (Correct answer)
- EudraVigilance
- XEVMPD
- EMVO
Correct answer: CTIS (Clinical Trials Information System)
CTIS is the EU portal and database where all clinical trial applications under EU CTR 536/2014 must be submitted.
Question 5: What does a Pediatric Study Plan (PSP) require a sponsor to submit to the FDA for most new drug applications?
- Plans for conducting studies to assess safety and effectiveness in pediatric populations (Correct answer)
- A summary of adult pharmacokinetic data only
- Post-market commitment to conduct adult safety studies
- Evidence of orphan drug designation for the pediatric population
Correct answer: Plans for conducting studies to assess safety and effectiveness in pediatric populations
Under PREA, sponsors must submit a PSP describing how they will study their drug in relevant pediatric age groups.
Question 6: Which term describes the FDA review goal under Priority Review designation?
- 6 months (Correct answer)
- 10 months
- 12 months
- 3 months
Correct answer: 6 months
Priority Review shortens the FDA's target review time from the standard 10 months to 6 months for drugs addressing serious conditions.
Question 7: When must a sponsor submit an IND safety report for a fatal or life-threatening unexpected serious adverse reaction?
- Within 7 calendar days (Correct answer)
- Within 15 calendar days
- Within 30 calendar days
- At the next annual report
Correct answer: Within 7 calendar days
Fatal or life-threatening unexpected serious adverse reactions must be reported to the FDA within 7 calendar days of the sponsor's awareness.
CTA Regulatory Submissions & Approvals 3
A protocol amendment requiring prior FDA approval before implementation would most likely involve: