Investigator’s Brochure (IB) and New Drug Application (NDA) MCQs With Answer

The Investigator’s Brochure (IB) and New Drug Application (NDA) MCQs With Answer

The Investigator’s Brochure (IB) and New Drug Application (NDA) are core documents in clinical development and regulatory approval that every B.Pharm student should master. The IB summarizes preclinical and clinical safety, pharmacology, toxicology, dosing rationale, and recommended monitoring for investigators. The NDA compiles clinical trial data, efficacy and safety analyses, chemistry, manufacturing and controls (CMC), and proposed labeling for regulatory submission. Understanding IB structure, data interpretation, CTD modules, risk–benefit assessment, investigator responsibilities, and regulatory expectations strengthens competency in clinical research and regulatory affairs. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of the Investigator’s Brochure (IB)?

• To provide investigators with a comprehensive, consolidated summary of clinical and nonclinical data relevant to the trial
• To serve as the final marketing label for the medicinal product
• To replace the clinical protocol in trial conduct
• To register the product for sale in international markets

Correct Answer: To provide investigators with a comprehensive, consolidated summary of clinical and nonclinical data relevant to the trial

Q2. Which CTD module contains Chemistry, Manufacturing and Controls (CMC) information?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 3

Q3. In the Common Technical Document (CTD), which module contains clinical study reports and clinical summaries?

• Module 1
• Module 2 and Module 5
• Module 3
• Module 4

Correct Answer: Module 2 and Module 5

Q4. How often should an Investigator’s Brochure be updated?

• Only at the start of the first clinical trial
• Annually, regardless of new information
• Whenever new and significant safety or efficacy information becomes available
• Only after marketing approval

Correct Answer: Whenever new and significant safety or efficacy information becomes available

Q5. Which of the following is typically NOT a component of an Investigator’s Brochure?

• Summary of nonclinical pharmacology and toxicology
• Detailed site budget and investigator salary information
• Summary of clinical pharmacology and safety data
• Guidance on dose selection and safety monitoring

Correct Answer: Detailed site budget and investigator salary information

Q6. What does the NDA primarily seek from the regulatory authority?

• Permission to start first-in-human studies
• Approval to market the drug for specified indications
• Approval to extend a patent term
• Funding for additional preclinical studies

Correct Answer: Approval to market the drug for specified indications

Q7. Which section of an NDA will contain pivotal Phase III clinical trial results?

• CMC section
• Nonclinical toxicology section
• Clinical efficacy and safety section
• Administrative cover letter only

Correct Answer: Clinical efficacy and safety section

Q8. What type of information in the IB assists investigators in recognizing and managing adverse events?

• Laboratory supply vendor lists
• Detailed safety profile, expected adverse reactions and recommended monitoring
• Marketing and commercial pricing strategies
• Investigator personal CVs

Correct Answer: Detailed safety profile, expected adverse reactions and recommended monitoring

Q9. Which of the following best describes Module 1 of the CTD?

• Region-specific administrative and prescribing information
• Global nonclinical study reports
• Biopharmaceutics summaries
• Clinical trial protocols

Correct Answer: Region-specific administrative and prescribing information

Q10. Which document would typically summarize dose rationale, pharmacokinetics and safety to guide early phase dosing?

• Investigator’s Brochure
• Marketing Authorization Letter
• Manufacturing Batch Record
• Pharmacy dispensing log

Correct Answer: Investigator’s Brochure

Q11. Which element is essential in an NDA to demonstrate product quality?

• Case report forms from a single patient
• Comprehensive CMC data including stability and manufacturing controls
• Investigator travel itineraries
• List of potential prescribers

Correct Answer: Comprehensive CMC data including stability and manufacturing controls

Q12. For a sponsor compiling an IB, what is the role of nonclinical pharmacology studies?

• To define marketing strategy
• To provide mechanistic and dose-response information and identify target organ toxicities
• To substitute for clinical safety data
• To determine investigator payments

Correct Answer: To provide mechanistic and dose-response information and identify target organ toxicities

Q13. Which statement about SUSARs and the IB is correct?

• SUSARs are never reflected in the IB
• SUSARs and other significant new safety information should prompt IB updates
• SUSARs are only relevant after marketing approval
• SUSARs are marketing terms and not used in clinical trials

Correct Answer: SUSARs and other significant new safety information should prompt IB updates

Q14. What is the significance of “benefit–risk assessment” in an NDA?

• It measures the financial profit expected from the drug
• It weighs therapeutic benefits against known risks to support approval decisions
• It is only relevant for over-the-counter drugs
• It compares the product to unrelated drugs

Correct Answer: It weighs therapeutic benefits against known risks to support approval decisions

Q15. Which item is a key responsibility of an investigator with regard to the IB?

• To update the IB content themselves
• To use the IB to inform consent discussions and safety monitoring
• To file the NDA with the regulatory authority
• To manufacture the investigational product

Correct Answer: To use the IB to inform consent discussions and safety monitoring

Q16. Which of the following is typically reviewed under the nonclinical section of an NDA?

• Human pharmacokinetic study reports only
• Animal toxicology and pharmacology study reports
• Investor relations statements
• Market access strategies

Correct Answer: Animal toxicology and pharmacology study reports

Q17. What should be included in an IB regarding pregnancy and reproductive toxicity?

• Only commercial pregnancy testing kits
• Summary of relevant animal reproductive studies and any known clinical data
• Detailed obstetric protocols for all hospitals
• Pricing information for contraception

Correct Answer: Summary of relevant animal reproductive studies and any known clinical data

Q18. Which regulatory document typically contains the proposed product label that will be used after approval?

• Investigator’s Brochure
• New Drug Application (NDA)
• Clinical trial protocol only
• Good Manufacturing Practice certificate

Correct Answer: New Drug Application (NDA)

Q19. During NDA review, what is the role of pooled safety analyses?

• To replace the need for any individual patient data
• To aggregate safety data across trials to assess overall risk profile
• To determine manufacturing yield
• To set price ceilings for the product

Correct Answer: To aggregate safety data across trials to assess overall risk profile

Q20. Which of the following best describes an investigator brochure’s section on “known and potential risks”?

• It lists marketing messages for the sales team
• It summarizes observed adverse reactions and theoretical risks from nonclinical data
• It provides financial disclosures for investigators
• It explains how to manufacture the drug substance

Correct Answer: It summarizes observed adverse reactions and theoretical risks from nonclinical data

Q21. What is the importance of including pharmacokinetic (PK) data in the IB?

• PK data is irrelevant to dosing decisions
• PK data supports dosing, sampling schedules and understanding of exposure–response relationships
• PK data only matters for topical products
• PK data should only be in marketing materials

Correct Answer: PK data supports dosing, sampling schedules and understanding of exposure–response relationships

Q22. Which document would a regulatory reviewer consult to evaluate the manufacturing process for impurities?

• Clinical study consent form
• Module 3 (CMC) of the NDA
• Investigator curriculum vitae
• Investigator’s Brochure appendix only

Correct Answer: Module 3 (CMC) of the NDA

Q23. When compiling an NDA, which type of clinical trial is most critical to demonstrate efficacy?

• Exploratory pilot studies with no controls
• Adequate and well-controlled pivotal trials
• Animal efficacy studies only
• In vitro laboratory assays

Correct Answer: Adequate and well-controlled pivotal trials

Q24. What role does the IB play in informed consent?

• The IB is confidential and never used for informed consent
• Investigators use IB content to provide accurate safety and risk information during consent
• The IB replaces the informed consent form
• The IB only contains recruitment templates

Correct Answer: Investigators use IB content to provide accurate safety and risk information during consent

Q25. In regulatory submissions, what is the significance of ‘bridging’ data often discussed in the NDA?

• It is used to link nonclinical manufacturing steps
• It supports extrapolation between studies, populations or formulations to justify approval decisions
• It documents investigator payments
• It specifies shipping routes for study drug

Correct Answer: It supports extrapolation between studies, populations or formulations to justify approval decisions

Q26. What is an appropriate action if a new serious adverse event related to the investigational product is identified?

• Ignore it until marketing approval
• Report according to local regulations and update the IB and safety reporting documents as needed
• Publish it only in marketing materials
• Wait for competitor data

Correct Answer: Report according to local regulations and update the IB and safety reporting documents as needed

Q27. Which of the following best explains the difference between an IND (or CTA) and an NDA?

• IND/CTA are for preclinical manufacturing only; NDA is for investigator training
• IND/CTA authorize initiation of clinical trials; NDA seeks marketing approval after sufficient clinical evidence
• IND/CTA are marketing documents; NDA authorizes clinical trials
• There is no difference; they are interchangeable terms

Correct Answer: IND/CTA authorize initiation of clinical trials; NDA seeks marketing approval after sufficient clinical evidence

Q28. Why is historical control data sometimes discussed in NDA submissions?

• To serve as a direct substitute for randomized controlled trials in all cases
• To provide contextual information when concurrent control trials are limited or infeasible
• To replace CMC data requirements
• To determine investigator eligibility

Correct Answer: To provide contextual information when concurrent control trials are limited or infeasible

Q29. What is a key quality expectation for clinical study reports included in Module 5 of the NDA?

• They should be brief summaries without patient-level data
• They should be comprehensive, with methods, results, and access to patient-level listings when required
• They should focus only on recruitment numbers
• They should omit adverse event listings to protect privacy

Correct Answer: They should be comprehensive, with methods, results, and access to patient-level listings when required

Q30. How does the IB support risk mitigation in multicenter trials?

• By listing investigator salaries to standardize pay
• By providing consistent safety information, monitoring recommendations and dose guidance across sites
• By replacing site-specific training entirely
• By defining marketing territories

Correct Answer: By providing consistent safety information, monitoring recommendations and dose guidance across sites

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com