CRAP Cheat Sheet 2026

The 30 highest-yield CRAP facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. What is residual risk? → The risk remaining after mitigation measures have been applied
2. Why is staying current with industry developments important for Certified Regulatory Affairs Professional professionals? → To provide the best possible service using current knowledge and practices
3. How does maintaining proper credentials demonstrate regulatory compliance? → It proves the practitioner has met all requirements for legal practice
4. Which FDA regulation governs the labeling of over-the-counter (OTC) and prescription drug products? → 21 CFR Part 201
5. What should guide all regulatory submissions? → Factual and honest information
6. Under 21 CFR Part 314.81, what is the required timeframe for an NDA holder to submit an expedited 15-day alert report? → 15 calendar days
7. What does 'submission tracking' ensure? → Timely submission and regulatory updates
8. Which FDA office is responsible for regulating direct-to-consumer (DTC) prescription drug advertising? → FDA Office of Prescription Drug Promotion (OPDP)
9. What is the most important principle in professional Certified Regulatory Affairs Professional practice? → Maintaining competence through continuous learning and adherence to standards
10. Which document supports drug safety during submissions? → Clinical study reports
11. What makes a report effective for stakeholder communication? → Clear visualization of relevant metrics aligned with business objectives
12. What is the significance of professional networking in the Certified Regulatory Affairs Professional field? → It facilitates knowledge exchange, referrals, and collaborative problem-solving
13. A supplier qualification program in a QMS typically requires which of the following as a minimum? → Evaluation of supplier capability to meet specified requirements
14. Which metric is most useful for evaluating the effectiveness of a CAPA system? → Recurrence rate of nonconformities after CAPA closure
15. What is the primary purpose of a Periodic Safety Update Report (PSUR)? → To provide a cumulative benefit-risk analysis of a drug at defined intervals post-approval
16. In a QMS, a Management Review must include evaluation of: → Quality policy, objectives, and audit results
17. What is the regulatory classification of a product whose label contains false or unauthorized claims? → The product is considered misbranded
18. An FDA Form 483 observation during a QMS inspection indicates: → Inspectional observations of conditions that may constitute regulatory violations
19. Under 21 CFR Part 820, the FDA's Quality System Regulation, which element is required to ensure that purchased components meet specified requirements? → Purchasing controls
20. What is the ethical response to discovering falsified data? → Report the issue to appropriate authority
21. What is a professional’s duty when faced with a compliance violation? → Report to supervisor or compliance office
22. Under 21 CFR Part 314.500 (Subpart H), what post-market commitment is required for drugs granted accelerated approval? → Confirmatory trial to verify the anticipated clinical benefit
23. What is the purpose of a staging environment? → To test configurations and changes before deploying to production
24. Why is change management important during implementation? → It ensures smooth transitions and user adoption of new systems
25. Which region uses the TGA for regulatory approvals? → Australia
26. Which of the following best describes a Design History File (DHF) in the context of FDA QSR? → A compilation of records that describes the design history of a finished device
27. What is the first stage in product development? → Concept and feasibility
28. What is the appropriate retention period for professional records? → As specified by state/federal law and professional licensing requirements
29. What is the primary purpose of system monitoring? → To detect issues proactively and maintain system health
30. How should a Certified Regulatory Affairs Professional professional handle situations beyond their expertise? → Refer to a qualified specialist and communicate transparently with the client