IND Regulation Mastery & Office Hours Materials
Total Time Commitment: 3.5-4 hours
This week's homework reinforces IND regulation mastery through applied learning, realistic scenarios, and timeline practice. Total estimated time: 3.5-4 hours (spread across the week).
Estimated time: 45 minutes
As you read 21 CFR 312.50-312.70, type your notes addressing:
Q: What are the THREE primary responsibilities of sponsors per 312.50?
Q: What specific steps must sponsors take to ensure investigator qualifications? Can this be fully delegated to a CRO?
Q: List the FOUR KEY commitments an investigator makes on Form 1572. Which can be delegated, and which cannot?
Q: Per 312.56, what is the standard for sponsor monitoring frequency? Is there a specific number of monitoring visits required?
Q: How long must sponsors maintain IND records per 312.57(b)? From what date is the 2-year period calculated?
Q: What is the same AND what is different between sponsor (312.57) and investigator (312.62) record retention requirements?
Q: Who reports to whom per 21 CFR 312.64? How does this differ from FDA reporting (312.32)?
Q: Per regulatory guidance, can a sponsor transfer regulatory accountability to a CRO? What's the distinction?
Estimated time: 60 minutes
Create a VISUAL DECISION TREE flowchart that walks through the logic of determining safety reporting requirements per 21 CFR 312.32.
Use if/then statements to draft your logic here.
Estimated time: 75 minutes
Facts: XYZ-101 (antihypertensive). IB lists "bradycardia (<50 bpm)". Event: Subject develops PVCs w/ chest discomfort. Sponsor aware March 15. Possibly related. No hospitalization.
Facts: ABC-789 (antibiotic). IB lists "rash". Event: Anaphylaxis (life-threatening), O2 sat 91%. Sponsor learns April 8. Treated in ED, discharged after 4 hours. Suspected related.
Facts: DEF-999 (oncology). London subject sepsis. US sponsor receives notification May 12. Classified: Serious, unexpected, suspected related.
Facts: GHI-555 (diabetes). IB lists "Elevated ALT in <2%". Phase 2: 15% have ALT elevations (3 subjects >3x ULN). Sponsor discovery: April 20. Trend is unexpected.
Facts: Initial 15-day report (Jan 20) for possible sepsis. Follow-up data (Jan 28) shows positive blood culture for Staph. aureus. Causality reassessed as UNLIKELY related.
Facts: Subject severe hypotension (SBP 78). Investigator immediately stops drug and gives IV fluids (emergency deviation). Outcome: Hospitalization overnight. Sponsor notified April 5. Serious, possibly related.
Facts: JKL-333. IB lists "Dizziness... mild-to-moderate". Event: Subject severe vertigo w/ vomiting, dehydration, hospitalization. Sponsor learns Feb 14.
Facts: MNO-777 (anticoagulant). Subject develops appendicitis (unrelated). Hospitalized 2 days. Investigator decides not to report to sponsor as it's unrelated.
Facts: Serious, unexpected, suspected adverse reaction reported to sponsor on December 27.
Facts: Sponsor aware of THREE events on March 15: A (Serious, unexpected, related), B (Fatal, unexpected, related), C (Serious, EXPECTED, related).
Estimated time: 45 minutes
Enter notes on key fields: Sponsor contact, emergency contact, monitoring person, safety review person, clinical phase.
In your own words, what does each commitment mean?
For EACH, identify: What you're committing to, why it matters, and one example of a violation.
What would require disclosure? What are consequences of false/incomplete disclosure?