CPI Study Guide 2026
Everything you need to pass the CPI exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📋 CPI Exam Format at a Glance
📚 CPI Topics to Study (21)
✍️ Sample CPI Questions & Answers
1. How long must drug accountability records typically be retained after study completion under FDA regulations?
Under 21 CFR 312.62, investigators must retain records for 2 years after a marketing application is approved or, if no application is filed, 2 years after the investigation is discontinued and FDA is notified.
2. What is a data management plan in clinical research?
A data management plan (DMP) is essential in clinical research for systematically organizing and handling all data generated during a study. It outlines procedures for data collection, entry, storage, quality control, security, and eventual analysis, ensuring data integrity, accessibility, and compliance with regulatory requirements.
3. What is a clinical research protocol?
A clinical research protocol is a detailed document that serves as the blueprint for a clinical study. It meticulously describes the study's rationale, objectives, design, methodology, statistical considerations, and organizational aspects, ensuring consistency, safety, and scientific integrity throughout the research.
4. Which of the following best describes 'blinded drug kits' used in a double-blind trial?
Blinded drug kits are manufactured so that active drug and placebo are indistinguishable to both the subject and site staff, preserving the blind and preventing bias in outcome assessment.
5. Which of the following scenarios represents a serious breach of investigational product accountability that must be reported to the sponsor immediately?
Unexplained missing investigational product represents a potential diversion, safety hazard, or fraud that requires immediate sponsor notification and investigation to protect trial integrity and subject safety.
6. What are record retention policies in CPI practice?
Retention policies establish consistent guidelines based on legal requirements and business needs.