Clinical trial team roles: investigator, coordinator, sponsor, CRO MCQs With Answer

Introduction: This quiz set focuses on the key roles and responsibilities within clinical trials—investigator, study coordinator, sponsor, and Contract Research Organization (CRO)—designed for M.Pharm students specializing in Clinical Research and Pharmacovigilance. Understanding who does what in a trial is essential for ensuring participant safety, data integrity, and regulatory compliance. These 20 multiple-choice questions explore practical and regulatory aspects such as delegation of duties, informed consent oversight, safety reporting timelines, monitoring vs auditing, investigational product accountability, and contractual obligations. Each question is crafted to deepen your comprehension of team interactions and real-world responsibilities critical to conducting high-quality clinical research.

Q1. Which individual is ultimately responsible for the overall conduct of a clinical trial at a trial site?

• The study coordinator who manages day-to-day activities
• The sponsor who funds the trial
• The principal investigator who oversees trial conduct at the site
• The Contract Research Organization (CRO) monitoring the study

Correct Answer: The principal investigator who oversees trial conduct at the site

Q2. Which of the following is a primary responsibility of the sponsor in a clinical trial?

• Obtaining informed consent from each participant
• Ensuring trial design, funding, and regulatory submissions are performed
Preparing source documents at the site
• Executing randomization and drug dispensing only at site level

Correct Answer: Ensuring trial design, funding, and regulatory submissions are performed

Q3. What is the main role of a clinical research coordinator (CRC) at a trial site?

• Issuing investigational product manufacturing licenses
Coordinating subject visits, maintaining source documents, and ensuring protocol adherence
• Approving protocol amendments on behalf of the sponsor
• Performing regulatory inspections of other sites

Correct Answer: Coordinating subject visits, maintaining source documents, and ensuring protocol adherence

Q4. Which activity is typically contracted out by a sponsor to a CRO?

• Ethics Committee approval at the site
• Centralized monitoring, data management, and statistical analysis
• GCP training of site staff (sole responsibility of PI)
• Final sign-off of investigator’s site files

Correct Answer: Centralized monitoring, data management, and statistical analysis

Q5. Under ICH-GCP, who must ensure that all study staff are adequately informed about the protocol?

• The Contract Research Organization as sole custodian
• The sponsor’s legal department only
• The principal investigator
• The trial monitor exclusively

Correct Answer: The principal investigator

Q6. Which document lists delegation of tasks from the principal investigator to other study personnel?

• Investigator Brochure
• Master Trial File
• Delegation log (or signature and delegation log)
• Case report form

Correct Answer: Delegation log (or signature and delegation log)

Q7. Which of the following best describes the sponsor-investigator?

• A CRO employee who performs monitoring visits
• An investigator who also takes on sponsor responsibilities for the trial
• The ethics committee chair who oversees safety reporting
• A site pharmacist responsible for IMP accountability

Correct Answer: An investigator who also takes on sponsor responsibilities for the trial

Q8. Who is responsible for expedited reporting of SUSARs (Suspected Unexpected Serious Adverse Reactions) to regulatory authorities?

• The site pharmacist
• The sponsor (or sponsor-investigator), often via the CRO if delegated
• The study coordinator only
• The monitor during routine visits

Correct Answer: The sponsor (or sponsor-investigator), often via the CRO if delegated

Q9. Which task is within the principal investigator’s responsibility related to investigational product (IP)?

• Manufacturing the IP for the entire trial
• Ensuring IP is stored, dispensed, and accounted for at the site
• Designing the randomization algorithm for the sponsor
• Performing central laboratory testing for all sites

Correct Answer: Ensuring IP is stored, dispensed, and accounted for at the site

Q10. What is a primary role of a sponsor’s quality assurance (QA) function in relation to a CRO?

• Replacing the CRO in day-to-day monitoring visits
• Ensuring CRO activities meet contractual and regulatory quality standards
• Writing the informed consent form for each site without PI input
• Performing site-level enrollment tasks

Correct Answer: Ensuring CRO activities meet contractual and regulatory quality standards

Q11. Which of the following best describes monitoring by a CRO?

• Auditing financial accounts of the sponsor
• Verifying participant safety, data accuracy, and compliance at the site
• Approving ethics committee submissions
• Manufacturing investigational product

Correct Answer: Verifying participant safety, data accuracy, and compliance at the site

Q12. If a study task is delegated to a CRO, who retains ultimate responsibility under ICH-GCP?

• The CRO, with no sponsor involvement
• The ethics committee
• The sponsor retains ultimate regulatory responsibility
• The study coordinator automatically becomes responsible

Correct Answer: The sponsor retains ultimate regulatory responsibility

Q13. Which document is the investigator required to maintain to demonstrate trial conduct and compliance at the site?

• Investigator’s Site File (or Essential Documents/ISF)
• The sponsor’s corporate policy manual only
• The CRO’s project plan exclusively
• A copy of all sponsor invoices

Correct Answer: Investigator’s Site File (or Essential Documents/ISF)

Q14. During a monitoring visit, which deficiency is the monitor expected to identify and report to the sponsor?

• Missed source documents, inconsistent CRF entries, and protocol deviations
• Internal company salary structures of the sponsor
• Medical decisions made by the ethics committee
• Manufacturing batch records unrelated to the clinical site

Correct Answer: Missed source documents, inconsistent CRF entries, and protocol deviations

Q15. What is the CRO’s responsibility regarding data management when contracted by a sponsor?

• Only physical storage of paper CRFs, without database management
• Designing the database, cleaning data, and preparing datasets per agreed specifications
• Approving the final clinical study report on behalf of the sponsor
• Performing site-level informed consent procedures

Correct Answer: Designing the database, cleaning data, and preparing datasets per agreed specifications

Q16. Which of the following is a regulatory obligation of the investigator after obtaining informed consent?

• Submit the protocol to the central ethics committee without site-specific documents
• Ensure that consent is documented, that consent forms are version-controlled, and that participants receive a copy
• File SUSARs directly to the sponsor’s shareholders
• Authorize CRO payments to site staff

Correct Answer: Ensure that consent is documented, that consent forms are version-controlled, and that participants receive a copy

Q17. In a multinational trial, who typically holds the investigational product import/export responsibilities?

• The ethics committee in each country
• The sponsor or their named logistics vendor/CRO, per regulatory requirements
• The principal investigator at each site without sponsor oversight
• The study coordinator handling customs clearance personally

Correct Answer: The sponsor or their named logistics vendor/CRO, per regulatory requirements

Q18. Which activity is considered a sponsor responsibility that cannot be fully delegated to a CRO?

• Retention of ultimate responsibility for ensuring participant safety and regulatory submissions
• Operational monitoring at the site
• Laboratory sample analysis
• Data entry into the EDC system

Correct Answer: Retention of ultimate responsibility for ensuring participant safety and regulatory submissions

Q19. What should the principal investigator do if a serious adverse event (SAE) occurs at their site?

• Ignore it until the next scheduled monitoring visit
• Report the SAE to the sponsor and ethics committee per protocol and applicable regulations and ensure appropriate medical care
• Send the SAE report only to the study coordinator
• Publicly publish the SAE details immediately

Correct Answer: Report the SAE to the sponsor and ethics committee per protocol and applicable regulations and ensure appropriate medical care

Q20. Which contractual element is important when a sponsor engages a CRO for clinical operations?

• Ambiguous scope of work to allow flexibility
• Clear statement of work, deliverables, timelines, data ownership, and liability provisions
• Exclusion of audit rights for the sponsor
• Payment terms that delay reporting obligations

Correct Answer: Clear statement of work, deliverables, timelines, data ownership, and liability provisions

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