Clinical regulatory requirements MCQs With Answer

Clinical regulatory requirements MCQs With Answer

Introduction: This set of MCQs on clinical regulatory requirements is designed specifically for M.Pharm students studying Biological Evaluation of Drug Therapy. It covers key regulations, guidelines, and practical responsibilities related to clinical trials, safety reporting, documentation, and regulatory submissions (CTD/eCTD, IND/NDA). Questions emphasize ICH guidelines, Good Clinical Practice, pharmacovigilance, ethics committee processes, and national registry and approval pathways. The questions are crafted to deepen understanding beyond definitions — focusing on timelines, roles, and real-world regulatory expectations — to help students prepare for exams and clinical research roles with clarity and confidence.

Q1. Which document format is internationally harmonized for regulatory submissions to facilitate consistent dossier structure across regions?

• Electronic submission summary (ESS)
• Common Technical Document (CTD)
• Clinical Trial Application (CTA)
• Investigator’s Brochure (IB)

Correct Answer: Common Technical Document (CTD)

Q2. Which ICH guideline provides the unified standard for Good Clinical Practice used internationally?

• ICH E2A – Pharmacovigilance
• ICH E6(R2) – Good Clinical Practice
• ICH E3 – Clinical Study Report
• ICH M4 – Quality Management

Correct Answer: ICH E6(R2) – Good Clinical Practice

Q3. In India, which regulatory authority is primarily responsible for approval of clinical trials and oversight of clinical research?

• Pharmacopoeia Commission of India (PCI)
• Central Drugs Standard Control Organization (CDSCO) / DCGI
• Indian Council of Medical Research (ICMR)
• National Pharmaceutical Pricing Authority (NPPA)

Correct Answer: Central Drugs Standard Control Organization (CDSCO) / DCGI

Q4. According to ICH E2A, within how many days must sponsors report fatal or life‑threatening SUSARs to regulatory authorities?

• 30 calendar days
• 15 calendar days
• 7 calendar days
• 90 calendar days

Correct Answer: 7 calendar days

Q5. What is the primary purpose of the Investigator’s Brochure (IB) in a clinical trial?

• To provide the final marketing label for the product
• To document site budgets and payments
• To summarize clinical and nonclinical data relevant to the study of the investigational product
• To serve as the informed consent form for participants

Correct Answer: To summarize clinical and nonclinical data relevant to the study of the investigational product

Q6. Which clinical trial phase primarily focuses on dose‑ranging and preliminary evidence of efficacy in patients?

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

Correct Answer: Phase II

Q7. What is the official registry for prospective registration of clinical trials in India?

• European Clinical Trials Database (EudraCT)
• ClinicalTrials.gov
• Clinical Trials Registry – India (CTRI)
• WHO Trial Portal

Correct Answer: Clinical Trials Registry – India (CTRI)

Q8. What does eCTD stand for in the context of regulatory submissions?

• electronic Clinical Trial Data
• electronic Common Technical Document
• enhanced Clinical Trial Dossier
• encrypted Clinical Trial Database

Correct Answer: electronic Common Technical Document

Q9. What is the primary intent of an orphan drug designation?

• To accelerate approval for blockbuster drugs
• To provide regulatory incentives for drugs treating rare diseases
• To mandate post‑marketing safety studies for all new drugs
• To classify over‑the‑counter medicines

Correct Answer: To provide regulatory incentives for drugs treating rare diseases

Q10. Who is defined as the sponsor of a clinical trial under ICH‑GCP?

• The principal investigator at the trial site
• An independent ethics committee member
• An individual, company, institution, or organization that takes responsibility for initiating, managing, and financing a clinical trial
• The contract research organization (CRO) conducting the trial operations

Correct Answer: An individual, company, institution, or organization that takes responsibility for initiating, managing, and financing a clinical trial

Q11. According to Good Clinical Practice, when must informed consent be obtained from a participant?

• After the first dose of investigational product
• At the end of the study during closeout
• Prior to any trial‑related procedures or participation
• Only if an adverse event occurs

Correct Answer: Prior to any trial‑related procedures or participation

Q12. ICH E2B guidance is principally concerned with which aspect of pharmacovigilance?

• Clinical trial design and sample size
• Electronic transmission of Individual Case Safety Reports (ICSRs)
• Good Manufacturing Practice (GMP) documentation
• Regulatory inspection procedures

Correct Answer: Electronic transmission of Individual Case Safety Reports (ICSRs)

Q13. What does NDA stand for in the US regulatory pathway?

• New Drug Application
• National Drug Assessment
• Notification of Drug Approval
• Nonclinical Data Appendix

Correct Answer: New Drug Application

Q14. What is the primary responsibility of an Institutional Ethics Committee (IEC) / Institutional Review Board (IRB)?

• To approve marketing materials for a drug
• To protect the rights, safety, and well‑being of trial participants
• To sponsor clinical trials financially
• To manufacture investigational products

Correct Answer: To protect the rights, safety, and well‑being of trial participants

Q15. Pharmacovigilance is best defined as which of the following?

• Regulatory approval of clinical trial protocols
• Detection, assessment, understanding, and prevention of adverse effects or other drug‑related problems
• Marketing and promotion of pharmaceutical products
• Quality control testing of finished drug products

Correct Answer: Detection, assessment, understanding, and prevention of adverse effects or other drug‑related problems

Q16. What does conditional marketing authorization typically allow?

• Full approval without any post‑marketing obligations
• Approval based on less comprehensive data with obligations to provide additional data post‑approval
• Marketing only for pediatric populations
• Unlimited off‑label promotion

Correct Answer: Approval based on less comprehensive data with obligations to provide additional data post‑approval

Q17. Regulatory bioequivalence criteria commonly require which statistical condition for AUC and Cmax?

• Point estimates of ratios equal to 100% exactly
• 90% confidence intervals of the ratio must fall within 80–125%
• 95% confidence intervals of the ratio must fall within 50–150%
• No statistical testing required for bioequivalence

Correct Answer: 90% confidence intervals of the ratio must fall within 80–125%

Q18. According to ICH‑GCP, for how long should a sponsor retain essential clinical trial documents after the last approval of a marketing application in an ICH region?

• 6 months
• 2 years (or longer if required by applicable regulatory requirements)
• 10 years exactly
• Only until the study report is finalized

Correct Answer: 2 years (or longer if required by applicable regulatory requirements)

Q19. What does the acronym SUSAR stand for in clinical safety reporting?

• Standard Unexpected Serious Adverse Reaction
• Suspected Unexpected Serious Adverse Reaction
• Systematic Unscheduled Safety Analytical Report
• Safety Update Summary and Risk

Correct Answer: Suspected Unexpected Serious Adverse Reaction

Q20. What is the primary role of an independent Data Safety Monitoring Board (DSMB) in a clinical trial?

• To recruit study participants at clinical sites
• To independently monitor accumulating safety and efficacy data and recommend continuation, modification, or termination
• To prepare the final regulatory submission dossier
• To provide funding for the clinical trial

Correct Answer: To independently monitor accumulating safety and efficacy data and recommend continuation, modification, or termination

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