Good Clinical Practice (GCP) obligations for investigators MCQs With Answer

Good Clinical Practice (GCP) defines global standards for designing, conducting, recording, and reporting clinical trials. For B. Pharm students, mastering investigator obligations—obtaining valid informed consent, ensuring protocol compliance, maintaining data integrity, reporting serious adverse events promptly, and protecting participant confidentiality—is vital. This concise, keyword-rich overview covers investigator responsibilities under ICH GCP, ethical conduct, regulatory requirements, source document management, investigational product accountability, delegation of duties, and communication with Institutional Review Boards/Independent Ethics Committees and sponsors. A solid grasp of these topics enables pharmacists to support trial quality, patient safety, and credible clinical data. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Who holds the primary responsibility for protecting the rights, safety, and well‑being of clinical trial subjects?

• The study sponsor
• The trial monitor
• The Institutional Review Board / Independent Ethics Committee
• The investigator

Correct Answer: The investigator

Q2. Who is authorized to obtain informed consent from a prospective subject according to GCP?

• Only the principal investigator personally
• The investigator or a qualified, delegated member of the study team
• The sponsor’s medical monitor
• The trial monitor during site initiation

Correct Answer: The investigator or a qualified, delegated member of the study team

Q3. How should an investigator report a Serious Adverse Event (SAE) to the sponsor?

• Only at study end during final report
• Within one year of occurrence
• Immediately to the sponsor (typically within 24 hours)
• Only if the subject requests it

Correct Answer: Immediately to the sponsor (typically within 24 hours)

Q4. For how long should an investigator retain essential trial documents according to ICH GCP guidance?

• Six months after study completion
• At least 2 years after the last approval of a marketing application for the product
• Indefinitely without any restrictions
• Until the sponsor decides to dispose of them

Correct Answer: At least 2 years after the last approval of a marketing application for the product

Q5. When must the Investigator’s Brochure (IB) be updated?

• Only at the end of the trial
• Yearly, regardless of new data
• Whenever new and significant safety or efficacy information becomes available
• Only when the sponsor requests it

Correct Answer: Whenever new and significant safety or efficacy information becomes available

Q6. Who is primarily responsible for investigational product accountability at the clinical site?

• The study monitor
• The sponsor’s quality assurance team
• The site pharmacist or designee under the investigator’s oversight
• The regulatory authority

Correct Answer: The site pharmacist or designee under the investigator’s oversight

Q7. How should delegation of trial-related duties be documented at the site?

• Not necessary if duties are verbally assigned
• On a delegation log with signatures and documented training
• Only in emails between staff members
• By the sponsor centrally without site records

Correct Answer: On a delegation log with signatures and documented training

Q8. What is the correct handling of a protocol deviation at the investigator site?

• Ignore it if no harm occurred
• Document, explain, and report according to protocol and IRB/sponsor requirements
• Only report if the monitor requests documentation
• Correct it without informing sponsor or IRB

Correct Answer: Document, explain, and report according to protocol and IRB/sponsor requirements

Q9. What are “source documents” in clinical research?

• Only electronic case report forms submitted to the sponsor
• Original records where data are first recorded (e.g., medical records, lab reports)
• Marketing materials for the investigational product
• Monitoring visit summaries only

Correct Answer: Original records where data are first recorded (e.g., medical records, lab reports)

Q10. Who must ensure confidentiality of trial participants’ personal information?

• The sponsor only
• The investigator and site staff
• The study monitor only during visits
• The IRB exclusively

Correct Answer: The investigator and site staff

Q11. What qualifies an investigator to conduct a clinical trial under GCP?

• Having a medical degree only, regardless of experience
• Being appointed by the sponsor without documentation
• Being qualified by education, training, and experience to assume responsibility
• Only being licensed in any country

Correct Answer: Being qualified by education, training, and experience to assume responsibility

Q12. Under what circumstances is unblinding of a subject’s treatment assignment acceptable?

• Whenever the investigator is curious
• Only at the end of the study report
• When necessary for the subject’s safety or medical management, per protocol
• When the sponsor requests it without reason

Correct Answer: When necessary for the subject’s safety or medical management, per protocol

Q13. What financial information must investigators disclose under GCP?

• Nothing; financial interests are irrelevant
• Only salary from the hospital
• Relevant financial interests or arrangements that could affect trial integrity to the sponsor and IRB
• Only personal investments unrelated to clinical research

Correct Answer: Relevant financial interests or arrangements that could affect trial integrity to the sponsor and IRB

Q14. Before enrolling the first subject, what must the investigator obtain?

• Verbal approval from the sponsor
• IRB/IEC approval of the protocol and informed consent form
• A copy of the final study publication
• Only a delegation log

Correct Answer: IRB/IEC approval of the protocol and informed consent form

Q15. Which document is essential to demonstrate that a subject provided informed consent?

• Signed and dated informed consent form retained in the site file
• Randomization code list
• Vendor invoice for study supplies
• Monitor’s visit log only

Correct Answer: Signed and dated informed consent form retained in the site file

Q16. What is the investigator’s responsibility during monitor visits?

• Refuse monitor access to any study records
• Allow monitors access to source documents and facilitate verification of data
• Only provide summaries, not original records
• Exclude any records related to adverse events

Correct Answer: Allow monitors access to source documents and facilitate verification of data

Q17. How should an investigator implement a protocol amendment?

• Implement immediately without notification
• Submit to IRB and sponsor and implement only after IRB approval, except to eliminate immediate hazards
• Ask subjects for permission before IRB review
• Wait until study end to apply amendments

Correct Answer: Submit to IRB and sponsor and implement only after IRB approval, except to eliminate immediate hazards

Q18. Who is responsible for initial assessment of the causality between an adverse event and the investigational product?

• The monitor alone
• The investigator
• The IRB only
• The packaging vendor

Correct Answer: The investigator

Q19. Where should source data supporting case report form entries be recorded?

• Only in the investigator’s memory
• In original source documents at the clinical site (e.g., medical records, lab reports)
• Only in external sponsor databases
• In press releases

Correct Answer: In original source documents at the clinical site (e.g., medical records, lab reports)

Q20. Which of the following lists contains essential documents an investigator must maintain?

• Only the final publication and invoices
• Signed consent forms, delegation log, investigator CVs/licenses, IRB approvals, and source data
• Only monitoring visit schedules
• Advertising materials for subject recruitment only

Correct Answer: Signed consent forms, delegation log, investigator CVs/licenses, IRB approvals, and source data

Q21. Who is responsible for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory authorities?

• The investigator alone
• The subject who experienced the event
• The sponsor
• The trial monitor only

Correct Answer: The sponsor

Q22. What must an investigator ensure regarding investigational product storage?

• No documentation of storage conditions is required
• Storage conditions are maintained, documented, and product accountability records kept
• Products are stored with personal medications
• Temperature records can be kept only by the sponsor off-site

Correct Answer: Storage conditions are maintained, documented, and product accountability records kept

Q23. Is it acceptable to enroll subjects before obtaining IRB approval or signed informed consent?

• Yes, for the first subject only
• No, subjects must not be enrolled before IRB approval and informed consent
• Yes, if the investigator signs a note afterward
• Only if the sponsor gives verbal permission

Correct Answer: No, subjects must not be enrolled before IRB approval and informed consent

Q24. Who may audit site records and facilities under GCP?

• Only the site staff
• Sponsor, monitors, and regulatory authorities with appropriate authorization
• Any member of the public
• Only the IRB Chair without notice

Correct Answer: Sponsor, monitors, and regulatory authorities with appropriate authorization

Q25. If a significant noncompliance is discovered at a site, the investigator must notify:

• No one; handle it internally only
• The sponsor and the IRB/IEC and take corrective actions as required
• Only the trial subjects
• The monitor after study completion

Correct Answer: The sponsor and the IRB/IEC and take corrective actions as required

Q26. How should potential conflicts of interest for an investigator be managed?

• Hide them to avoid scrutiny
• Disclose them to the sponsor and IRB and follow management plans
• Only disclose if the monitor asks
• Resolve them with study subjects directly

Correct Answer: Disclose them to the sponsor and IRB and follow management plans

Q27. In what language must informed consent information be presented?

• Only in English, regardless of subject language
• In a language and terms understandable to the subject or legally authorized representative
• Only in the investigator’s native language
• Only using technical medical terminology

Correct Answer: In a language and terms understandable to the subject or legally authorized representative

Q28. If a subject withdraws consent during the trial, the investigator should:

• Continue all study procedures regardless of withdrawal
• Respect the withdrawal, stop further protocol interventions, and document the withdrawal
• Delete all previously collected data immediately
• Force the subject to continue for data integrity

Correct Answer: Respect the withdrawal, stop further protocol interventions, and document the withdrawal

Q29. Who should sign the clinical trial protocol or protocol signature page at the site?

• The sponsor’s CEO only
• The investigator (and sub-investigators as applicable) to confirm understanding and agreement
• The monitor only
• The IRB Chair only

Correct Answer: The investigator (and sub-investigators as applicable) to confirm understanding and agreement

Q30. What is the investigator’s responsibility regarding the quality of trial data from their site?

• Ensure accuracy, completeness, and timeliness of data reported
• Only the sponsor is responsible for data quality
• Quality is irrelevant if the sample size is large
• Delegate all responsibility permanently to external vendors

Correct Answer: Ensure accuracy, completeness, and timeliness of data reported

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