SOCRA FDA Regulations and Compliance 2 — Questions and Answers
Question 1: Under 21 CFR Part 312, which IND application type is used when a sponsor wants to conduct a clinical investigation using a legally marketed drug for a new indication?
- Investigator IND (Correct answer)
- Emergency IND
- Treatment IND
- Research IND
Correct answer: Investigator IND
An Investigator IND is submitted when a physician-investigator initiates and conducts a study using a marketed drug for a new indication not on the label.
Question 2: What is the FDA's regulatory definition of a 'serious adverse event' (SAE) under 21 CFR Part 312.32?
- Any AE that requires dose reduction
- Any AE resulting in death, hospitalization, disability, or congenital anomaly (Correct answer)
- Any Grade 3 or higher toxicity per CTCAE
- Any AE that causes a protocol deviation
Correct answer: Any AE resulting in death, hospitalization, disability, or congenital anomaly
21 CFR 312.32 defines SAEs as those resulting in death, life-threatening events, inpatient hospitalization, persistent disability, congenital anomaly, or requiring medical intervention to prevent one of these outcomes.
Question 3: A sponsor must notify FDA of an unexpected fatal or life-threatening SUSAR within how many calendar days of first receiving information?
- 7 calendar days (Correct answer)
- 10 calendar days
- 15 calendar days
- 30 calendar days
Correct answer: 7 calendar days
Per 21 CFR 312.32(c)(2), unexpected fatal or life-threatening suspected unexpected serious adverse reactions must be reported to FDA within 7 calendar days.
Question 4: Which FDA regulation specifically governs the obligations of clinical investigators in conducting clinical trials?
- 21 CFR Part 50
- 21 CFR Part 54
- 21 CFR Part 312 Subpart D (Correct answer)
- 21 CFR Part 314
Correct answer: 21 CFR Part 312 Subpart D
21 CFR Part 312 Subpart D (Responsibilities of Sponsors and Investigators) outlines the specific obligations of clinical investigators under FDA regulations.
Question 5: What does FDA require regarding the delegation of protocol tasks to study staff not listed on the FDA Form 1572?
- All tasks must be performed only by the principal investigator
- Sub-investigators must be added to Form 1572; other staff appear on a delegation log (Correct answer)
- Any licensed healthcare professional may perform tasks without documentation
- Tasks may be delegated verbally without additional documentation
Correct answer: Sub-investigators must be added to Form 1572; other staff appear on a delegation log
FDA requires that sub-investigators performing significant protocol tasks be listed on Form 1572, while other staff delegated tasks must appear on a site delegation log signed by the PI.
Question 6: Under FDA regulations, a CRO that assumes sponsor obligations must do which of the following?
- Obtain approval from the IRB before assuming responsibilities
- Submit a CRO registration to FDA before conducting any trial activities
- Ensure that any uncanceled obligations revert back to the sponsor (Correct answer)
- File an amendment to the IND listing the CRO as co-sponsor
Correct answer: Ensure that any uncanceled obligations revert back to the sponsor
Per 21 CFR 312.52, when a sponsor transfers obligations to a CRO, any obligations not covered by the CRO agreement revert to the sponsor.
Question 7: Which of the following best describes FDA's 'clinical hold' authority under 21 CFR 312.42?
- An order to pause subject enrollment pending safety review
- A request for additional preclinical data before IND approval
- An FDA order to delay or suspend a clinical investigation for safety or compliance reasons (Correct answer)
- A temporary suspension of IND review while FDA requests more information
Correct answer: An FDA order to delay or suspend a clinical investigation for safety or compliance reasons
A clinical hold under 21 CFR 312.42 is an FDA order to delay initiation or suspend an ongoing clinical investigation when safety or compliance concerns exist.
