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. When FDA conducts a 'for cause' inspection following a complaint about a drug product, the inspection authority derives from: → Section 704 of the FD&C Act, which grants FDA broad inspection authority
3. 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
4. How does maintaining proper credentials demonstrate regulatory compliance? → It proves the practitioner has met all requirements for legal practice
5. Which FDA regulation governs the labeling of over-the-counter (OTC) and prescription drug products? → 21 CFR Part 201
6. Which FDA regulation requires that design controls for medical devices include risk analysis as part of the design process? → 21 CFR Part 820.30
7. What should guide all regulatory submissions? → Factual and honest information
8. 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
9. What is the maximum review period for a Standard Review NDA under PDUFA VII goals? → 10 months
10. Under 21 CFR 820, the Device History Record (DHR) must contain or reference all of the following EXCEPT: → Personnel performance review scores
11. What does 'submission tracking' ensure? → Timely submission and regulatory updates
12. Australia's TGA uses which application pathway specifically for medicines that have been approved by a comparable overseas regulator? → Category 3 AUST R application
13. Which FDA office is responsible for regulating direct-to-consumer (DTC) prescription drug advertising? → FDA Office of Prescription Drug Promotion (OPDP)
14. In the ICH CTD structure, where is the Drug Substance section located? → Module 3.2.S
15. Under FDA's 21 CFR Part 11, which of the following electronic records practices is required for GMP compliance? → Audit trails must be computer-generated, time-stamped, and protected from alteration
16. A company is conducting a benefit-risk analysis for a new drug submission. Which framework does FDA recommend for structured benefit-risk assessment? → FDA's Benefit-Risk Framework with five-factor analysis in Module 2.5
17. A RAP is asked by their employer to submit data that selectively omits unfavorable clinical results. The most appropriate response is to: → Refuse and explain the legal and ethical obligations to present complete data
18. Which global standard defines requirements for Quality Management Systems in medical device manufacturing? → ISO 13485
19. What is the most important principle in professional Certified Regulatory Affairs Professional practice? → Maintaining competence through continuous learning and adherence to standards
20. A Corrective and Preventive Action (CAPA) plan is deemed ineffective during a follow-up audit. What should happen next? → Escalate to senior management and revise the CAPA with root cause re-analysis
21. Which action best describes a 'Good Documentation Practice' (GDP) when correcting a handwritten entry? → Draw a single line through the error, write the correction, and add date and initials
22. Which risk acceptability principle states that a risk should be reduced as far as reasonably practicable, even if it is already below the acceptable threshold? → ALARP (As Low As Reasonably Practicable)
23. In pharmaceutical GMP, 'secondary data' differs from 'raw data' in that it: → Is derived or transformed from raw data through calculation or data processing
24. Which document supports drug safety during submissions? → Clinical study reports
25. In the context of combination products in the US, what determines the regulatory pathway (drug, device, or biologic) for a combination product? → The primary mode of action (PMOA)
26. What makes a report effective for stakeholder communication? → Clear visualization of relevant metrics aligned with business objectives
27. Which federal agency is primarily responsible for regulating medical devices in the United States? → FDA
28. What is the significance of professional networking in the Certified Regulatory Affairs Professional field? → It facilitates knowledge exchange, referrals, and collaborative problem-solving
29. Which of the following constitutes a breach of confidentiality for a regulatory affairs professional? → Disclosing a client's proprietary formulation to a competitor during contract negotiations
30. Under ICH Q10, the concept of 'knowledge management' in pharmaceutical quality systems primarily supports continuous improvement by: → Capturing and leveraging product and process understanding throughout the lifecycle