Drug development teams and their functions MCQs With Answer

Introduction

Drug development teams and their functions MCQs With Answer is a focused study tool for B. Pharm students exploring multidisciplinary roles in drug discovery, preclinical studies, clinical trials, formulation development, regulatory affairs, quality control (QC), quality assurance (QA), manufacturing (CMC), pharmacovigilance and project management. This guide explains how medicinal chemists, pharmacologists, toxicologists, clinical research associates, biostatisticians and regulatory specialists collaborate to take a candidate from lab bench to market, following GLP, GMP and ICH guidelines. It emphasizes practical functions such as stability testing, bioavailability studies, IND/NDA submissions and safety reporting. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which team member is primarily responsible for designing and optimizing chemical structures of drug candidates?

• Formulation scientist
• Medicinal chemist
• Clinical research associate
• Regulatory affairs specialist

Correct Answer: Medicinal chemist

Q2. Who ensures compliance with Good Manufacturing Practice (GMP) during production?

• Pharmacovigilance officer
• Quality assurance (QA) specialist
• Clinical project manager
• Medicinal chemist

Correct Answer: Quality assurance (QA) specialist

Q3. Which function is mainly responsible for conducting stability studies and shelf-life determination?

• Regulatory affairs
• Clinical operations
• Quality control (QC) and analytical development
• Pharmacovigilance

Correct Answer: Quality control (QC) and analytical development

Q4. Which team prepares the Investigational New Drug (IND) application for regulatory submission?

• Clinical research associates
• Regulatory affairs team
• Marketing team
• Formulation development only

Correct Answer: Regulatory affairs team

Q5. Who typically writes the clinical study protocol and oversees trial conduct?

• Clinical project manager / principal investigator
• Quality control analyst
• Medicinal chemist
• Regulatory affairs associate

Correct Answer: Clinical project manager / principal investigator

Q6. The primary role of pharmacovigilance team is to:

• Develop drug formulations
• Monitor and report adverse drug reactions
• Conduct GLP toxicology studies
• Perform analytical method validation

Correct Answer: Monitor and report adverse drug reactions

Q7. Which document contains detailed manufacturing steps, specifications and controls for a drug product?

• Investigator’s brochure
• Clinical protocol
• Batch manufacturing record / CMC dossier
• Informed consent form

Correct Answer: Batch manufacturing record / CMC dossier

Q8. Which guideline family outlines international standards for quality, safety and efficacy of pharmaceuticals?

• GCP only
• ICH guidelines
• ISO 9001
• EPA guidelines

Correct Answer: ICH guidelines

Q9. Who in the team is responsible for designing dosage forms and selecting excipients?

• Formulation scientist
• Biostatistician
• Regulatory inspector
• Clinical research associate

Correct Answer: Formulation scientist

Q10. Which team member analyzes and interprets trial data using statistical methods?

• Biostatistician
• Quality assurance officer
• Pharmacologist
• Regulatory affairs manager

Correct Answer: Biostatistician

Q11. During preclinical development, which team performs toxicology and safety pharmacology studies?

• Clinical operations
• Toxicology and nonclinical development team
• Regulatory affairs
• Marketing

Correct Answer: Toxicology and nonclinical development team

Q12. Which function manages interactions with contract research organizations (CROs)?

• Supply chain only
• Clinical project management and outsourcing team
• Analytical chemists
• Pharmacovigilance only

Correct Answer: Clinical project management and outsourcing team

Q13. What is the main purpose of an investigator’s brochure (IB)?

• Describe marketing strategy
• Summarize nonclinical and clinical information for investigators
• List manufacturing batch records
• Provide cost estimates

Correct Answer: Summarize nonclinical and clinical information for investigators

Q14. Which team ensures that analytical methods are validated according to ICH guidelines?

• Clinical operations
• Analytical development / QC
• Pharmacovigilance
• Regulatory compliance only

Correct Answer: Analytical development / QC

Q15. Which phase of clinical trials primarily assesses safety in a small group of healthy volunteers?

• Phase IV
• Phase I
• Phase II
• Phase III

Correct Answer: Phase I

Q16. Who prepares the dossier for New Drug Application (NDA) or Marketing Authorization Application (MAA)?

• Quality control technicians
• Regulatory affairs team in collaboration with CMC and clinical teams
• Clinical trial subjects
• Sales representatives

Correct Answer: Regulatory affairs team in collaboration with CMC and clinical teams

Q17. What is the role of a clinical research associate (CRA)?

• Perform batch release testing
• Monitor clinical trial sites for protocol compliance
• Write chemical synthesis routes
• Approve marketing materials

Correct Answer: Monitor clinical trial sites for protocol compliance

Q18. Which team ensures adverse events are assessed, coded and reported to regulators?

• Formulation development
• Pharmacovigilance / drug safety
• Manufacturing operations
• Quality control only

Correct Answer: Pharmacovigilance / drug safety

Q19. What does CMC stand for and which team handles it?

• Clinical Monitoring Committee — clinical team
• Chemistry, Manufacturing and Controls — formulation and manufacturing teams
• Central Medical Committee — regulatory only
• Cost, Marketing and Compliance — business team

Correct Answer: Chemistry, Manufacturing and Controls — formulation and manufacturing teams

Q20. Which document is essential for obtaining informed consent from trial participants?

• Case report form (CRF)
• Informed consent form (ICF)
• Batch manufacturing record
• Stability protocol

Correct Answer: Informed consent form (ICF)

Q21. What is a SUSAR in pharmacovigilance terms?

• Standard Use Safety Assessment Report
• Suspected Unexpected Serious Adverse Reaction
• Supply Update Safety And Review
• Systematic User Safety Audit Report

Correct Answer: Suspected Unexpected Serious Adverse Reaction

Q22. Who is responsible for setting release specifications for drug substance and product?

• Regulatory affairs alone
• Analytical development and quality control in collaboration with formulation and regulatory teams
• Clinical operations
• Marketing department

Correct Answer: Analytical development and quality control in collaboration with formulation and regulatory teams

Q23. Which team typically conducts bioavailability and bioequivalence studies?

• Nonclinical toxicology
• Clinical pharmacology / CROs specializing in clinical PK
• Quality assurance
• Regulatory affairs only

Correct Answer: Clinical pharmacology / CROs specializing in clinical PK

Q24. What is the main responsibility of the manufacturing/production team during scale-up?

• Design clinical protocols
• Develop reproducible, scalable processes and ensure batch consistency
• Evaluate safety signals
• Write investigator brochures

Correct Answer: Develop reproducible, scalable processes and ensure batch consistency

Q25. Which committee provides independent safety oversight during clinical trials?

• Ethics committee only
• Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB)
• Regulatory affairs committee
• Quality control board

Correct Answer: Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB)

Q26. Which team prepares standard operating procedures (SOPs) for lab and clinical activities?

• Human resources
• Quality assurance in collaboration with technical teams
• Sales and marketing
• Clinical trial participants

Correct Answer: Quality assurance in collaboration with technical teams

Q27. Which role evaluates drug–drug interactions and pharmacokinetic profiles?

• Clinical pharmacologist / pharmacokinetics team
• Quality control analyst
• Regulatory reviewer only
• Formulation packing team

Correct Answer: Clinical pharmacologist / pharmacokinetics team

Q28. During regulatory review, which dossier section contains clinical trial results and interpretations?

• Module 3 (Quality)
• Module 5 (Clinical study reports)
• Module 1 (Administrative)
• Module 4 (Nonclinical)

Correct Answer: Module 5 (Clinical study reports)

Q29. What is the primary objective of Phase II clinical trials?

• Confirm long-term safety in thousands of patients
• Evaluate efficacy and dose-ranging in patients
• Market the product
• Conduct initial animal safety tests

Correct Answer: Evaluate efficacy and dose-ranging in patients

Q30. Which team would most directly interact with ethics committees and institutional review boards (IRBs)?

• Clinical operations and regulatory affairs teams
• Manufacturing technicians only
• Analytical chemistry only
• Procurement department

Correct Answer: Clinical operations and regulatory affairs teams

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