Introduction: This quiz set on Sponsor–CRO–Investigator responsibilities is designed for M.Pharm students preparing for advanced clinical research and regulatory roles. It focuses on practical, regulatory and quality aspects of clinical trial conduct, clarifying who is responsible for trial oversight, safety reporting, documentation, monitoring, delegation and interactions with ethics committees and regulatory authorities. The questions draw on ICH-GCP principles and common regulatory expectations to deepen your understanding of sponsor oversight, CRO delegation and investigator duties in multicentre and single-centre trials. Use these MCQs to test and consolidate knowledge needed for protocol compliance and ethical, regulatory trial conduct.
Q1. What is the primary regulatory responsibility of the sponsor in a clinical trial?
- Design and conduct all site-level trial activities personally
- Provide overall trial oversight including financing, trial design, and ensuring regulatory compliance
- Obtain informed consent from every subject
- Monitor all trial subjects daily at the site
Correct Answer: Provide overall trial oversight including financing, trial design, and ensuring regulatory compliance
Q2. When a sponsor delegates trial tasks to a CRO, which statement is true regarding ultimate responsibility?
- The CRO becomes the regulatory sponsor and bears all legal responsibilities
- The investigator assumes sponsor responsibilities automatically
- The sponsor retains ultimate responsibility for trial quality and regulatory compliance even when tasks are delegated
- The contract transfers all liabilities to the contract research organization
Correct Answer: The sponsor retains ultimate responsibility for trial quality and regulatory compliance even when tasks are delegated
Q3. According to ICH-GCP, which document must record which delegated tasks are performed by site staff and by the CRO?
- Protocol Synopsis
- Investigator Site File
- Delegation Log (or Sponsor/CRO delegation of duties log)
- Case Report Form (CRF)
Correct Answer: Delegation Log (or Sponsor/CRO delegation of duties log)
Q4. Which of the following is a core responsibility of the principal investigator at a study site?
- Ensuring subject recruitment only after approval of any protocol amendments by the IEC/IRB
- Issuing the marketing authorization for the investigational product
- Preparing the clinical study report for regulatory submission
- Performing central statistical analysis for the entire trial
Correct Answer: Ensuring subject recruitment only after approval of any protocol amendments by the IEC/IRB
Q5. Who is responsible for maintaining the Trial Master File (TMF) and ensuring it is complete and accessible?
- Each investigator separately without sponsor involvement
- The sponsor (or sponsor-designated party such as a CRO) is responsible for the TMF
- The ethics committee/IRB is required to maintain the sponsor’s TMF
- The regulatory authority maintains the TMF on behalf of the sponsor
Correct Answer: The sponsor (or sponsor-designated party such as a CRO) is responsible for the TMF
Q6. What is the sponsor’s obligation when it subcontracts work to a CRO?
- No oversight is needed once a CRO is selected
- To ensure the CRO has adequate qualifications, resources and to document oversight arrangements
- To allow the CRO full authority to change protocol and consent forms
- To delegate regulatory submissions without any written agreement
Correct Answer: To ensure the CRO has adequate qualifications, resources and to document oversight arrangements
Q7. Which party is primarily responsible for immediate reporting of serious adverse events (SAEs) from the site to the sponsor?
- The sponsor’s medical monitor
- The investigator (or designated site staff)
- The regulatory authority
- The contract laboratory
Correct Answer: The investigator (or designated site staff)
Q8. For suspected unexpected serious adverse reactions (SUSARs), what are the typical sponsor reporting timelines to regulatory authorities under ICH GCP?
- 7 calendar days for fatal or life‑threatening SUSARs and 15 calendar days for other SUSARs
- 30 days for all SUSARs
- Immediately within 24 hours for all SUSARs
- 90 days after database lock
Correct Answer: 7 calendar days for fatal or life‑threatening SUSARs and 15 calendar days for other SUSARs
Q9. Which document defines the responsibilities of sponsor and CRO and forms the basis for oversight?
- Site Monitoring Visit Log
- Study Protocol
- Written Contract/Services Agreement specifying scope, responsibilities and deliverables
- Investigator’s Brochure
Correct Answer: Written Contract/Services Agreement specifying scope, responsibilities and deliverables
Q10. Who is responsible for ensuring investigational medicinal product (IMP) is stored, handled and administered appropriately at the site?
- The sponsor only
- The investigator or delegated site staff for site-level IMP accountability
- The regulatory authority conducts daily checks
- The CRO is always responsible for on-site IMP handling
Correct Answer: The investigator or delegated site staff for site-level IMP accountability
Q11. Which of the following best describes the difference between monitoring and auditing in clinical trials?
- Monitoring is independent and retrospective; auditing is routine and ongoing
- Monitoring is site-focused oversight to ensure compliance and data quality; auditing is an independent evaluation of study conduct and quality systems
- Monitoring only checks drug storage; auditing only reviews informed consent forms
- They are the same function with different names
Correct Answer: Monitoring is site-focused oversight to ensure compliance and data quality; auditing is an independent evaluation of study conduct and quality systems
Q12. In a multicentre trial, who must ensure consistent protocol training and qualification of investigators?
- The individual investigator at each site without sponsor support
- The sponsor or sponsor-designated CRO through investigator training and qualification processes
- The IEC/IRB is responsible for operational training of site staff
- The clinical laboratory provides training on protocol procedures
Correct Answer: The sponsor or sponsor-designated CRO through investigator training and qualification processes
Q13. Which of the following is a sponsor responsibility related to safety signal detection?
- Rely only on published literature for safety signals
- Establish pharmacovigilance systems to detect, evaluate and report safety signals throughout the trial
- Require investigators to handle all signal evaluation without sponsor input
- Only evaluate safety at the end of the trial
Correct Answer: Establish pharmacovigilance systems to detect, evaluate and report safety signals throughout the trial
Q14. Which action is the investigator required to take if a serious protocol deviation occurs that may affect subject safety?
- Keep the deviation confidential and not inform anyone
- Report the deviation promptly to the sponsor and the IEC/IRB and take immediate corrective action
- Wait until study close-out to report the deviation
- Allow the sponsor to decide whether it is reportable without informing the IEC/IRB
Correct Answer: Report the deviation promptly to the sponsor and the IEC/IRB and take immediate corrective action
Q15. What must a sponsor ensure before initiating a clinical trial at a new investigational site?
- That the investigator receives no training to avoid bias
- That the site has adequate facilities, qualified staff, signed agreements and regulatory/ethics approvals
- That the site begins recruitment immediately to speed up timelines
- That all site documents are mailed at study end only
Correct Answer: That the site has adequate facilities, qualified staff, signed agreements and regulatory/ethics approvals
Q16. Who is responsible for ensuring informed consent is obtained prior to any trial-specific procedure?
- The sponsor’s legal department
- The investigator or authorized delegated staff who obtain consent
- The CRO’s central office without site involvement
- The trial participants themselves without documentation
Correct Answer: The investigator or authorized delegated staff who obtain consent
Q17. What is the role of a Data Safety Monitoring Board (DSMB) in relation to sponsor and investigator responsibilities?
- The DSMB replaces the sponsor and conducts all regulatory submissions
- The DSMB independently reviews accumulating safety and efficacy data and advises the sponsor; it does not replace sponsor or investigator responsibilities
- The DSMB performs site monitoring visits on behalf of the investigator
- The DSMB signs informed consent forms for subjects
Correct Answer: The DSMB independently reviews accumulating safety and efficacy data and advises the sponsor; it does not replace sponsor or investigator responsibilities
Q18. Which document is typically submitted by the sponsor to regulatory authorities to obtain approval to start a clinical trial?
- Investigator’s CV only
- Clinical Trial Application (CTA) or Investigational New Drug (IND) application including protocol, IB and supporting data
- Delegation log from each site
- Final clinical study report
Correct Answer: Clinical Trial Application (CTA) or Investigational New Drug (IND) application including protocol, IB and supporting data
Q19. How long should essential trial records typically be retained, according to ICH-GCP principles?
- Until database lock only
- For at least 2 years after the last marketing authorization in an ICH region or as required by applicable regulatory requirements
- No retention is necessary after study close-out
- Forever at the sponsor’s discretion with no minimum
Correct Answer: For at least 2 years after the last marketing authorization in an ICH region or as required by applicable regulatory requirements
Q20. When a sponsor receives an allegation of serious non-compliance at a site, what is the sponsor’s appropriate action?
- Ignore the allegation until study completion
- Investigate promptly, notify regulatory authorities and IEC/IRB as required, take corrective and preventive actions and consider suspending the site
- Immediately terminate the entire study without investigation
- Request the investigator to delete the relevant records
Correct Answer: Investigate promptly, notify regulatory authorities and IEC/IRB as required, take corrective and preventive actions and consider suspending the site
