ICH GCP and ICMR guidelines in clinical trials MCQs With Answer

Introduction: This quiz collection on ICH GCP and ICMR guidelines is designed specifically for M.Pharm students preparing for Clinical Research (MPP 104T). It highlights core ethical principles, regulatory responsibilities, documentation standards, safety reporting, and operational aspects of clinical trials in both global (ICH GCP) and Indian (ICMR) contexts. Each question probes practical understanding — investigator and sponsor duties, informed consent, ethics committee requirements, trial registration, monitoring strategies, and handling of vulnerable populations. Use these MCQs to test knowledge, identify gaps, and reinforce best practices necessary for conducting ethically sound and scientifically credible clinical research in India and internationally.

Q1. What is the primary objective of ICH GCP?

• To provide a unified standard to ensure protection of human subjects and integrity of clinical trial data
• To regulate pricing and marketing of investigational products
• To replace national regulations for clinical trials
• To provide clinical trial funding guidelines

Correct Answer: To provide a unified standard to ensure protection of human subjects and integrity of clinical trial data

Q2. Which set of ethical principles is emphasized by the ICMR National Ethical Guidelines?

• Respect for persons (autonomy), beneficence, non-maleficence and justice
• Efficiency, profitability, compliance and publicity
• Confidentiality, marketability, transparency and neutrality
• Speed, cost-minimization, competitiveness and innovation

Correct Answer: Respect for persons (autonomy), beneficence, non-maleficence and justice

Q3. Under ICH GCP, which of the following is a primary responsibility of the investigator?

• Ensuring informed consent is obtained and the protocol is followed at the site
• Approving the final marketing authorization for the investigational product
• Providing overall sponsorship and financing for the trial
• Writing national regulations for clinical trials

Correct Answer: Ensuring informed consent is obtained and the protocol is followed at the site

Q4. Which duty is specifically the responsibility of the sponsor according to ICH GCP?

• Overall trial design, safety reporting to regulators, and provision of monitoring oversight
• Obtaining individual informed consent from study participants at each site
• Acting as the independent ethics committee chairperson
• Performing only on-site data entry for all sites

Correct Answer: Overall trial design, safety reporting to regulators, and provision of monitoring oversight

Q5. Which of the following is NOT listed as an essential document in ICH GCP?

• Trial protocol and amendments
• Investigator Brochure
• Informed consent forms and signed consent documentation
• Marketing authorization for the investigational product

Correct Answer: Marketing authorization for the investigational product

Q6. How is a Serious Adverse Event (SAE) defined under GCP?

• An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
• A mild, expected side effect that does not require medical intervention
• An event that occurs only in preclinical animal studies
• An administrative error in documentation

Correct Answer: An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect

Q7. According to ICH GCP, what is the reporting timeline for a SUSAR that is fatal or life‑threatening?

• The sponsor must notify regulatory authorities and investigators within 7 calendar days of becoming aware, with a follow-up within 8 additional days
• Within 30 days of the end of the study
• Only at the time of final study report submission
• Within 60 days after database lock

Correct Answer: The sponsor must notify regulatory authorities and investigators within 7 calendar days of becoming aware, with a follow-up within 8 additional days

Q8. Which element is essential for valid informed consent under both ICH GCP and ICMR guidelines?

• Voluntary participation after adequate information and comprehension, documented by written consent
• Consent obtained only from the treating physician
• Implied consent through participation without documentation
• Consent that can be verbal and undocumented for all interventional trials

Correct Answer: Voluntary participation after adequate information and comprehension, documented by written consent

Q9. Under ICMR guidelines, who is primarily responsible for providing compensation for research-related injury?

• The sponsor is responsible for providing compensation for research-related injury
• Individual study participants must self-insure
• The ethics committee is responsible for paying compensation from its funds
• The investigator bears all financial responsibility personally

Correct Answer: The sponsor is responsible for providing compensation for research-related injury

Q10. Which composition element is required for a registered Ethics Committee (EC) per ICMR recommendations?

• A multidisciplinary membership including a chairperson, medical scientist, clinician, legal expert, social scientist/NGO representative and a lay person
• Only clinicians who are involved in the study
• Only members from the sponsoring organization
• A single person who approves all studies

Correct Answer: A multidisciplinary membership including a chairperson, medical scientist, clinician, legal expert, social scientist/NGO representative and a lay person

Q11. What is the requirement for trial registration in India before enrollment, according to national guidelines?

• Clinical trials must be registered in the Clinical Trials Registry – India (CTRI) before enrolment of the first participant
• Registration is optional and can be done at study completion
• Trials should only be registered with international registries, not CTRI
• No registration is required for interventional trials in India

Correct Answer: Clinical trials must be registered in the Clinical Trials Registry – India (CTRI) before enrolment of the first participant

Q12. What data management feature is emphasized by ICH GCP for electronic case report forms (eCRFs)?

• An audit trail that records all edits, timestamps and user identification for any change
• Allowing anonymous bulk edits without logging changes
• Deleting previous entries without trace after database lock
• Only paper records are acceptable; eCRFs are prohibited

Correct Answer: An audit trail that records all edits, timestamps and user identification for any change

Q13. The primary purpose of randomization and blinding in clinical trials is to:

• Minimize selection and observer bias to ensure comparability between treatment groups
• Guarantee that all participants receive the active drug
• Make data entry faster and cheaper
• Allow sponsors to change assignments during the study

Correct Answer: Minimize selection and observer bias to ensure comparability between treatment groups

Q14. How is a protocol deviation generally distinguished from a protocol violation?

• Deviations are minor departures that do not affect safety/data integrity, whereas violations are significant breaches that may affect patient safety or data validity
• Deviations always lead to participant harm while violations do not
• Deviations are intentional and violations are always accidental
• There is no difference; both terms are interchangeable

Correct Answer: Deviations are minor departures that do not affect safety/data integrity, whereas violations are significant breaches that may affect patient safety or data validity

Q15. ICH E6(R2) introduced greater emphasis on which monitoring approach?

• Risk-based monitoring including centralized and remote monitoring techniques
• Only 100% source data verification via exhaustive on-site monitoring
• Eliminating monitoring entirely to reduce costs
• Monitoring solely by independent auditors without sponsor oversight

Correct Answer: Risk-based monitoring including centralized and remote monitoring techniques

Q16. According to ICH GCP, for how long should essential clinical trial documents typically be retained by the sponsor?

• At least 2 years after the last approval of a marketing application in an ICH region or after formal discontinuation of clinical development
• Only until the study database is locked
• One month after the last subject visit
• Indefinitely without any retention policy

Correct Answer: At least 2 years after the last approval of a marketing application in an ICH region or after formal discontinuation of clinical development

Q17. For research involving children, ICMR guidelines require which of the following regarding consent?

• Obtaining consent from a legally authorized representative and assent from the child when appropriate
• No consent is required for minors; parental permission is optional
• Only the child’s consent is sufficient regardless of age
• Consent may be waived for all pediatric studies

Correct Answer: Obtaining consent from a legally authorized representative and assent from the child when appropriate

Q18. What is the primary content of an Investigator Brochure (IB)?

• A compilation of the clinical and non-clinical data on the investigational product relevant to the study of the product in human subjects
• A financial prospectus for marketing the drug after approval
• A site-specific enrollment log with patient identifiers
• A document containing only the informed consent form

Correct Answer: A compilation of the clinical and non-clinical data on the investigational product relevant to the study of the product in human subjects

Q19. Who is generally expected to ensure insurance or indemnity for trial-related injury in accordance with ICMR and GCP principles?

• The sponsor is expected to ensure appropriate insurance or indemnity arrangements to cover trial-related injuries
• The ethics committee must purchase insurance for each study participant
• Investigators must personally pay for all compensation claims
• No insurance is required for clinical trials

Correct Answer: The sponsor is expected to ensure appropriate insurance or indemnity arrangements to cover trial-related injuries

Q20. How do audits differ from regulatory inspections in the context of GCP?

• Audits are conducted by or on behalf of the sponsor to evaluate trial conduct and compliance; inspections are conducted by regulatory authorities with enforcement powers
• Audits are secret and never documented, inspections are always public
• Audits only assess financial records while inspections only assess clinical outcomes
• There is no difference; both are identical processes carried out by the same people

Correct Answer: Audits are conducted by or on behalf of the sponsor to evaluate trial conduct and compliance; inspections are conducted by regulatory authorities with enforcement powers

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