Classification and control of investigational drugs MCQs With Answer is a focused review designed for B. Pharm students to master regulatory and quality aspects of investigational medicinal products. This introduction covers classification (IND/IMP, placebo, comparator, orphan drugs), essential control measures (GMP, GLP, GCP, stability testing, analytical method validation), documentation (IB, IMP dossier, CMC), labeling, storage, release testing, and pharmacovigilance requirements. Emphasis is on practical control points, regulatory submissions, and quality systems that ensure patient safety during clinical trials. Clear understanding of these topics is critical for roles in QC, QA, regulatory affairs, and clinical supply management. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which document primarily summarizes the quality, preclinical, and clinical data of an investigational drug for initial regulatory review?
- Investigator Brochure (IB)
- Common Technical Document (CTD)
- Investigational Medicinal Product Dossier (IMPD)
- Clinical Study Report (CSR)
Correct Answer: Investigational Medicinal Product Dossier (IMPD)
Q2. Under regulatory classification, an IMP refers to:
- Any marketed drug dispensed in hospitals
- An investigational medicinal product used in clinical trials
- A nutritional supplement used in studies
- A placebo only
Correct Answer: An investigational medicinal product used in clinical trials
Q3. Which regulatory submission is required in the United States before initiating human clinical trials?
- Marketing Authorization Application (MAA)
- Investigational New Drug (IND) application
- Clinical Trial Application (CTA)
- New Drug Submission (NDS)
Correct Answer: Investigational New Drug (IND) application
Q4. Which quality system specifically addresses laboratory study conduct and data integrity for nonclinical studies?
- GMP (Good Manufacturing Practices)
- GCP (Good Clinical Practice)
- GLP (Good Laboratory Practice)
- GDP (Good Distribution Practice)
Correct Answer: GLP (Good Laboratory Practice)
Q5. A stability-indicating method is defined as an analytical method that:
- Measures only the active pharmaceutical ingredient without detecting degradants
- Separates and quantifies the API in presence of degradation products
- Measures excipient purity only
- Is used only for biological products
Correct Answer: Separates and quantifies the API in presence of degradation products
Q6. Which label element is essential on an investigational drug container for a blinded phase II clinical trial?
- Dosage form only
- “For Investigational Use” with trial identifier
- Full SPC (Summary of Product Characteristics)
- Marketing authorization number
Correct Answer: “For Investigational Use” with trial identifier
Q7. Which parameter is NOT typically part of release testing for an IMP batch?
- Assay of active substance
- Sterility (if applicable)
- Marketing price
- Related substances/degradation products
Correct Answer: Marketing price
Q8. In clinical trials, the term “IMP accountability” refers to:
- Tracking production costs of the IMP
- Documenting receipt, dispensing, return, and destruction of IMP
- Pharmacovigilance reporting only
- Laboratory storage validation
Correct Answer: Documenting receipt, dispensing, return, and destruction of IMP
Q9. Which agency is primarily responsible for drug regulation in India?
- FDA (Food and Drug Administration)
- EMA (European Medicines Agency)
- CDSCO (Central Drugs Standard Control Organization)
- MHRA (Medicines and Healthcare products Regulatory Agency)
Correct Answer: CDSCO (Central Drugs Standard Control Organization)
Q10. Which concept ensures that manufacturing processes consistently produce IMPs meeting predefined quality attributes?
- Randomization
- Quality by Design (QbD)
- Double-blinding
- Placebo control
Correct Answer: Quality by Design (QbD)
Q11. Which test is critical for parenteral investigational products to ensure safety?
- pH only
- Microbial limits/sterility testing
- Color measurement only
- Viscosity only
Correct Answer: Microbial limits/sterility testing
Q12. A Suspected Unexpected Serious Adverse Reaction (SUSAR) must be reported to regulatory authorities within what context?
- Only after study completion
- Expedited reporting timelines per regulation
- At annual safety report submission only
- Never required for placebo subjects
Correct Answer: Expedited reporting timelines per regulation
Q13. Which section of the regulatory dossier describes manufacturing process, controls, and specifications for the IMP?
- Clinical overview
- Preclinical pharmacology
- CMC (Chemistry, Manufacturing, and Controls)
- Biostatistics plan
Correct Answer: CMC (Chemistry, Manufacturing, and Controls)
Q14. For temperature-sensitive IMPs, which control measure is most important during shipment?
- Using any available courier
- Validated cold chain packaging with temperature monitoring
- Labeling as “do not refrigerate”
- Increasing batch size
Correct Answer: Validated cold chain packaging with temperature monitoring
Q15. Blinding integrity is threatened when:
- IMP and placebo are identical in appearance and packaging
- Different manufacturers produce visually distinct study treatments
- Emergency unblinding procedures are in place
- Randomization codes are securely stored
Correct Answer: Different manufacturers produce visually distinct study treatments
Q16. Which analytical validation parameter evaluates the method’s ability to produce consistent results over time?
- Specificity
- Precision
- Limit of detection
- Robustness
Correct Answer: Precision
Q17. The Investigator Brochure (IB) primarily provides investigators with:
- Detailed GMP manufacturing instructions
- Nonclinical and clinical safety and efficacy summary
- Shipping manifests for IMP supply
- Marketing strategies
Correct Answer: Nonclinical and clinical safety and efficacy summary
Q18. Which control is essential to manage protocol deviations affecting IMP handling at a trial site?
- Ignoring minor deviations
- Documenting deviations, root cause analysis, and corrective actions
- Destroying all remaining IMP immediately
- Transferring responsibility to another site without records
Correct Answer: Documenting deviations, root cause analysis, and corrective actions
Q19. Which document lists critical quality attributes and acceptance criteria for the investigational product?
- Investigator’s CV
- Specification sheet
- Patient informed consent
- Trial protocol synopsis
Correct Answer: Specification sheet
Q20. In clinical supply management, “reconciliation” refers to:
- Comparing planned vs actual patient recruitment
- Accounting for IMP quantities: received, dispensed, returned, and destroyed
- Resolving ethical committee comments
- Pharmacokinetic sample analysis
Correct Answer: Accounting for IMP quantities: received, dispensed, returned, and destroyed
Q21. Which parameter is most relevant when selecting a primary container for a liquid investigational drug?
- Container color matching marketing samples
- Container-closure compatibility to prevent leachables and adsorption
- Vendor logo visibility
- Country of manufacture only
Correct Answer: Container-closure compatibility to prevent leachables and adsorption
Q22. What is the primary purpose of batch release testing before supplying an IMP to clinical sites?
- To calculate manufacturing costs
- To ensure each batch meets predefined quality and safety criteria
- To obtain marketing approval
- To randomize patients
Correct Answer: To ensure each batch meets predefined quality and safety criteria
Q23. Which action is required when a temperature excursion occurs during IMP storage at a trial site?
- Continue use without documentation
- Quarantine affected stock, document event, and follow sponsor assessment
- Discard entire site inventory immediately without assessment
- Blame courier and resume normal use
Correct Answer: Quarantine affected stock, document event, and follow sponsor assessment
Q24. Which term describes the marketed product used as a comparator in a clinical trial?
- Placebo
- Reference medicinal product
- Investigational buffer
- Blank control
Correct Answer: Reference medicinal product
Q25. Which element is mandatory in an informed consent regarding investigational drug risks?
- Guaranteed therapeutic benefit
- Description of foreseeable risks and adverse effects
- Manufacturer’s profit margin
- Exact mechanism of drug synthesis
Correct Answer: Description of foreseeable risks and adverse effects
Q26. Which of the following is a key component of pharmacovigilance in clinical trials?
- Drug marketing campaigns
- Active and passive adverse event collection and signal detection
- Only preclinical toxicity monitoring
- Shipment scheduling
Correct Answer: Active and passive adverse event collection and signal detection
Q27. For method validation, “specificity” demonstrates that the method:
- Produces the same result regardless of operator
- Can measure the analyte distinctly in presence of other components
- Is unaffected by temperature changes
- Has a low limit of detection only
Correct Answer: Can measure the analyte distinctly in presence of other components
Q28. Which regulatory concept ensures that labelling and packaging information protects blinded studies?
- Full disclosure of identity on outer packaging
- Use of coded labelling and trial identifiers
- Advertising labels on IMP
- Including marketing claims
Correct Answer: Use of coded labelling and trial identifiers
Q29. The primary role of GMP in investigational drug manufacture is to:
- Ensure promotional claims are accurate
- Ensure consistent product quality, safety, and traceability
- Replace the need for clinical monitoring
- Control patient randomization
Correct Answer: Ensure consistent product quality, safety, and traceability
Q30. Which document should describe procedures for emergency unblinding of an IMP for a subject?
- Investigator Brochure (IB) only
- Protocol and unblinding SOP
- Marketing Authorization
- Shipping manifest
Correct Answer: Protocol and unblinding SOP
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