Clinical trial and investigational requirements in India MCQs With Answer

Clinical trial and investigational requirements in India MCQs With Answer — Introduction

This quiz collection is designed for M.Pharm students preparing for exams on regulations and legislation related to clinical trials in India. It covers key topics such as the regulatory framework (CDSCO/DCGI and the New Drugs and Clinical Trials Rules, 2019), trial registration (CTRI), ethics committee requirements, investigator and sponsor responsibilities, Good Clinical Practice (GCP), essential study documents, phases of clinical development, and device/biological rules. Each question focuses on practical regulatory knowledge you must master for safe and compliant conduct of clinical research in India. Use these MCQs to test understanding, reinforce concepts, and identify areas needing further study.

Q1. Which is the primary regulatory authority responsible for approval and oversight of clinical trials in India?

• Central Drugs Standard Control Organization (CDSCO) under the Drugs Controller General of India (DCGI)
• Indian Council of Medical Research (ICMR)
• World Health Organization (WHO)
• Ministry of Finance

Correct Answer: Central Drugs Standard Control Organization (CDSCO) under the Drugs Controller General of India (DCGI)

Q2. Which set of rules currently governs clinical trials and investigational new drugs in India?

• New Drugs and Clinical Trials Rules, 2019
• Schedule Y, 2005
• Medical Devices Rules, 2017
• Indian Patent Act, 1970

Correct Answer: New Drugs and Clinical Trials Rules, 2019

Q3. What is the requirement for registering a clinical trial in the Clinical Trials Registry – India (CTRI)?

• Registration in CTRI is mandatory before enrolling the first participant
• CTRI registration is optional and may be done after trial completion
• Registration is required only for multinational trials
• Registration is mandatory only for Phase IV studies

Correct Answer: Registration in CTRI is mandatory before enrolling the first participant

Q4. What is the correct sequence of clinical trial phases during drug development?

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

Correct Answer: Phase I → Phase II → Phase III → Phase IV

Q5. Under Indian regulations, does an Institutional Ethics Committee (IEC/EC) need to be registered for conducting clinical trials?

• Yes, Ethics Committee registration with the regulator is mandatory
• No, Ethics Committees do not require registration
• Only Ethics Committees in private hospitals require registration
• Registration is required only for multi-center trials

Correct Answer: Yes, Ethics Committee registration with the regulator is mandatory

Q6. What is the investigator’s immediate reporting responsibility when a serious adverse event (SAE) occurs in a trial participant?

• Report the SAE to the sponsor and the Ethics Committee immediately (typically within 24 hours)
• Wait until the next scheduled monitoring visit to report the SAE
• Report the SAE only in the annual safety report
• Inform only the participant’s family and no formal report is needed

Correct Answer: Report the SAE to the sponsor and the Ethics Committee immediately (typically within 24 hours)

Q7. Which of the following is a core responsibility of the clinical trial sponsor under Indian regulations?

• Ensuring adequate financing, overall trial oversight, and safety reporting
• Only hiring investigators, with no responsibility for safety
• Approving Ethics Committee minutes
• Maintaining patient bedside care during trial visits

Correct Answer: Ensuring adequate financing, overall trial oversight, and safety reporting

Q8. Which organization maintains the Clinical Trials Registry – India (CTRI)?

• Indian Council of Medical Research (ICMR) – National Institute of Medical Statistics (NIMS)
• Central Drugs Standard Control Organization (CDSCO)
• World Health Organization (WHO)
• Ministry of Finance

Correct Answer: Indian Council of Medical Research (ICMR) – National Institute of Medical Statistics (NIMS)

Q9. Which file contains essential documents that demonstrate the conduct of a clinical trial and compliance with regulatory requirements?

• Trial Master File (TMF)
• Patient medical chart only
• Pharmacy stock ledger only
• Clinical Operations Manual only

Correct Answer: Trial Master File (TMF)

Q10. How is an “adverse event” (AE) different from an “adverse drug reaction” (ADR)?

• An AE is any untoward medical occurrence; an ADR is an AE with a reasonable causal relationship to the investigational product
• An AE is always caused by the drug; an ADR is unrelated to the drug
• An AE refers only to lab abnormalities; ADR refers only to clinical symptoms
• There is no difference; the terms are interchangeable

Correct Answer: An AE is any untoward medical occurrence; an ADR is an AE with a reasonable causal relationship to the investigational product

Q11. What key information is contained in the Investigator’s Brochure (IB)?

• Comprehensive preclinical and clinical data on the investigational product
• Only manufacturing batch records
• Only Ethics Committee approvals
• Investigator salary details

Correct Answer: Comprehensive preclinical and clinical data on the investigational product

Q12. Which international guideline is widely accepted as the global standard for Good Clinical Practice?

• ICH E6 Good Clinical Practice (GCP)
• ISO 9001
• FDA CFR Title 21 only
• World Trade Organization (WTO) guidelines

Correct Answer: ICH E6 Good Clinical Practice (GCP)

Q13. Who grants permission for import of investigational medicinal products into India for clinical trials?

• Licensing Authority / DCGI (under CDSCO)
• Institutional Ethics Committee only
• State Pollution Control Board
• Ministry of Finance

Correct Answer: Licensing Authority / DCGI (under CDSCO)

Q14. In which year were the Medical Devices Rules, which reclassified many devices under regulatory control, notified in India?

• 2017
• 2010
• 2019
• 2005

Correct Answer: 2017

Q15. What is the primary objective of a Phase III clinical trial?

• To confirm efficacy and monitor adverse reactions in large patient populations
• To assess initial human safety in healthy volunteers
• To conduct exploratory dose-ranging in a small group
• To carry out post-marketing surveillance only

Correct Answer: To confirm efficacy and monitor adverse reactions in large patient populations

Q16. Who is required to approve substantial protocol amendments for a clinical trial conducted in India?

• Ethics Committee (EC/IEC) and the Licensing Authority (DCGI) as applicable
• The Sponsor alone
• The Contract Research Organization (CRO) only
• The trial monitor only

Correct Answer: Ethics Committee (EC/IEC) and the Licensing Authority (DCGI) as applicable

Q17. What is the primary purpose of registering a clinical trial in a public registry like CTRI?

• To promote transparency, public accountability and avoid unnecessary duplication of trials
• To obtain direct funding from the registry
• To replace Ethics Committee approval
• To certify GMP for the investigational product

Correct Answer: To promote transparency, public accountability and avoid unnecessary duplication of trials

Q18. Which document is specifically used to record a participant’s voluntary agreement to take part in a clinical trial?

• Informed Consent Form (ICF)
• Case Report Form (CRF)
• Investigator’s Curriculum Vitae (CV)
• Monitoring Visit Log

Correct Answer: Informed Consent Form (ICF)

Q19. If a sponsor delegates certain trial activities to a Contract Research Organization (CRO), who retains overall responsibility for the trial?

• The sponsor retains ultimate responsibility for trial conduct and compliance even when delegated to a CRO
• The CRO becomes solely responsible and the sponsor has no obligations
• The Institutional Ethics Committee becomes responsible
• The trial sites are solely responsible

Correct Answer: The sponsor retains ultimate responsibility for trial conduct and compliance even when delegated to a CRO

Q20. Which of the following is considered an essential document as per ICH GCP that must be available before starting a clinical trial?

• Protocol, Investigator’s Brochure, and Informed Consent Form
• Only financial agreements
• Only promotional materials for the drug
• Only staff payroll records

Correct Answer: Protocol, Investigator’s Brochure, and Informed Consent Form

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