Investigational New Drug (IND) application is a regulatory submission that allows investigational drugs to enter clinical trials. For B. Pharm students, understanding IND application structure and purpose is essential: it integrates preclinical data, clinical protocols, safety assessments, pharmacology/toxicology, and Chemistry, Manufacturing and Controls (CMC) documentation. The IND explains sponsor responsibilities, investigator qualifications, and monitoring plans to meet FDA or national regulatory expectations. Mastery of IND components—investigator brochure, informed consent, adverse event reporting, and protocol design—helps pharmacists contribute to drug development, study conduct, and regulatory compliance. This foundation supports evaluating risk–benefit and ensuring patient safety during early-phase trials. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary regulatory purpose of an IND application?
- To obtain marketing approval for a drug
- To allow investigational drugs to be legally administered to humans in clinical trials
- To register a drug manufacturing facility
- To establish drug pricing and reimbursement
Correct Answer: To allow investigational drugs to be legally administered to humans in clinical trials
Q2. Which section of an IND contains details on drug synthesis, formulation, and stability?
- Investigator Brochure
- Clinical Protocol
- Chemistry, Manufacturing and Controls (CMC)
- Pharmacology/Toxicology
Correct Answer: Chemistry, Manufacturing and Controls (CMC)
Q3. How long does the FDA typically have to review a new IND before the sponsor can begin clinical trials if no hold is issued?
- 7 days
- 30 days
- 90 days
- 180 days
Correct Answer: 30 days
Q4. Which document summarizes animal and prior human data for investigators and is included or referenced in the IND?
- Informed Consent Form
- Investigator Brochure
- Clinical Study Report
- Marketing Authorization Application
Correct Answer: Investigator Brochure
Q5. Which type of IND is submitted by a physician who both initiates and conducts an investigation?
- Commercial IND
- Investigator IND
- Treatment IND
- Generic IND
Correct Answer: Investigator IND
Q6. Which IND section contains the clinical trial design, objectives, inclusion/exclusion criteria, and procedures?
- CMC section
- Clinical Protocol
- Pharmacology/Toxicology
- Financial Disclosure
Correct Answer: Clinical Protocol
Q7. Which element is NOT a typical component of preclinical pharmacology/toxicology in an IND?
- Acute and chronic toxicity studies in animals
- Mutagenicity and carcinogenicity assessments
- Bioequivalence to marketed products
- Pharmacokinetic studies in animals
Correct Answer: Bioequivalence to marketed products
Q8. What is the main objective of Phase 1 clinical trials described in an IND?
- To demonstrate long-term efficacy
- To evaluate safety, tolerability, and pharmacokinetics in humans
- To compare with standard of care in large populations
- To obtain marketing authorization
Correct Answer: To evaluate safety, tolerability, and pharmacokinetics in humans
Q9. Which regulatory report must sponsors submit to report a serious, unexpected suspected adverse reaction?
- IND Annual Report
- Protocol Amendment
- IND Safety Report
- Establishment Inspection Report
Correct Answer: IND Safety Report
Q10. In IND terminology, what does CMC stand for?
- Clinical Monitoring and Compliance
- Chemistry, Manufacturing and Controls
- Clinical, Medical and Clinicaltrials
- Compound, Method and Characterization
Correct Answer: Chemistry, Manufacturing and Controls
Q11. Which electronic format is commonly used for regulatory submissions including INDs?
- PDF only
- eCTD (electronic Common Technical Document)
- CSV datasets
- Plain text email
Correct Answer: eCTD (electronic Common Technical Document)
Q12. What is a clinical hold?
- A marketing approval by FDA
- A notice that prevents a clinical trial from proceeding or continuing
- An expedited approval for emergency use
- A requirement for submission of annual reports only
Correct Answer: A notice that prevents a clinical trial from proceeding or continuing
Q13. Which of the following best describes an investigator brochure’s role?
- To document manufacturing batch records
- To provide investigators with comprehensive, relevant clinical and preclinical data
- To list financial relationships with sponsors
- To provide final efficacy analysis for marketing
Correct Answer: To provide investigators with comprehensive, relevant clinical and preclinical data
Q14. Which section of the IND addresses previous human experience with the drug, including foreign clinical data?
- Nonclinical Pharmacology/Toxicology
- Previous Human Experience
- Marketing Application Annex
- Labeling for Commercial Use
Correct Answer: Previous Human Experience
Q15. What is the usual purpose of an IND amendment?
- To request marketing approval
- To update the IND with changes such as protocol revisions or new CMC data
- To report patient enrollment numbers only
- To close the IND permanently
Correct Answer: To update the IND with changes such as protocol revisions or new CMC data
Q16. Which party is primarily responsible for preparing and submitting the IND?
- Clinical site coordinator
- Sponsor
- Institutional Review Board (IRB)
- Contract Research Organization (CRO) only
Correct Answer: Sponsor
Q17. Which of the following is an example of data included in the CMC section?
- Animal LD50 values
- Stability data under specified storage conditions
- Investigator CVs
- Patient informed consent wording
Correct Answer: Stability data under specified storage conditions
Q18. What is the role of the Institutional Review Board (IRB) in IND clinical trials?
- To manufacture investigational drug
- To review and approve the ethical conduct of the clinical protocol and informed consent
- To submit the IND to FDA
- To perform nonclinical toxicology studies
Correct Answer: To review and approve the ethical conduct of the clinical protocol and informed consent
Q19. Which type of IND is intended to provide an investigational drug to patients with serious or life‑threatening conditions outside clinical trials?
- Commercial IND
- Treatment IND / Expanded access IND
- Bioequivalence IND
- Generic IND
Correct Answer: Treatment IND / Expanded access IND
Q20. Which document in the IND package provides the investigator’s qualifications and experience?
- Protocol
- Investigator’s Brochure
- Investigator’s Curriculum Vitae and medical licenses
- CMC section
Correct Answer: Investigator’s Curriculum Vitae and medical licenses
Q21. What must the sponsor demonstrate about the investigational product in the IND before clinical trials?
- That it already has marketing approval in all countries
- That there is sufficient information on safety and quality to support initial human exposure
- That it is less expensive than existing therapies
- That it is manufactured only in academic labs
Correct Answer: That there is sufficient information on safety and quality to support initial human exposure
Q22. Which report is typically submitted annually to update the FDA on progress of the IND?
- Annual IND Report
- Quarterly Profit Report
- Monthly Enrollment Notice
- Final Marketing Report
Correct Answer: Annual IND Report
Q23. In the context of IND safety reporting, what does “15‑day report” usually refer to?
- Annual submission timeline
- Timeframe to report serious, unexpected suspected adverse reactions
- Time allowed for FDA review of an IND
- Duration of Phase 1 studies
Correct Answer: Timeframe to report serious, unexpected suspected adverse reactions
Q24. Why is a well‑designed informed consent form important in IND studies?
- It provides manufacturing details to patients
- It documents that participants understand risks, benefits, and study procedures
- It replaces the investigator brochure
- It is used to submit CMC data
Correct Answer: It documents that participants understand risks, benefits, and study procedures
Q25. Which element helps regulators assess the integrity and reproducibility of drug manufacturing?
- Clinical endpoint definitions
- CMC documentation including batch records and specifications
- Investigator conflict of interest statements
- Patient case report forms
Correct Answer: CMC documentation including batch records and specifications
Q26. What is the significance of pharmacokinetic (PK) data in an IND?
- It determines marketing price
- It informs dose selection, safety monitoring, and study design in humans
- It is only relevant after approval
- It replaces toxicology testing
Correct Answer: It informs dose selection, safety monitoring, and study design in humans
Q27. Which regulatory concept ensures that investigational sites follow the protocol and regulatory requirements?
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- Pharmacovigilance only
- Good Manufacturing Practice (GMP) only
Correct Answer: Good Clinical Practice (GCP)
Q28. What information about impurities is typically required in the IND CMC section?
- No information is required about impurities
- Identification, qualification, and acceptable limits of impurities and degradants
- Only the color of impurities
- Only the supplier name
Correct Answer: Identification, qualification, and acceptable limits of impurities and degradants
Q29. When can FDA place an IND on clinical hold?
- If the IND has excessive paperwork only
- If there are concerns about subject safety, protocol design, or CMC adequacy
- Only after a Phase 3 trial finishes
- FDA cannot place clinical holds
Correct Answer: If there are concerns about subject safety, protocol design, or CMC adequacy
Q30. For B. Pharm students, why is understanding IND structure and purpose important for future pharmacy roles?
- It is only relevant for marketing teams
- It enables pharmacists to contribute to clinical trial design, safety monitoring, regulatory submissions, and patient counseling
- It replaces the need for clinical pharmacology knowledge
- It is only useful for manufacturing engineers
Correct Answer: It enables pharmacists to contribute to clinical trial design, safety monitoring, regulatory submissions, and patient counseling
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.
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