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

Introduction: This quiz collection focuses on the roles and responsibilities of key clinical trial team members — investigator, sponsor, monitor, and CRO — tailored for M.Pharm students studying Clinical Research (MPP 104T). It covers regulatory duties, oversight functions, safety reporting, documentation, monitoring strategies and contractual relationships to deepen understanding beyond basic definitions. Each question is designed to test practical knowledge applicable to site management, trial conduct, quality assurance and sponsor oversight. Use these MCQs for self-assessment, classroom revision, or exam practice; detailed attention to timelines, delegation, and regulatory obligations will help consolidate competencies required for managing or collaborating in clinical trials.

Q1. Which of the following best describes the primary responsibility of the clinical investigator in a trial?

• Designing the overall clinical trial and providing funding
• Ensuring the rights, safety and well‑being of trial subjects and conducting the study according to protocol
• Performing independent audits of sponsor activities
• Managing central data cleaning and statistical analysis for all sites

Correct Answer: Ensuring the rights, safety and well‑being of trial subjects and conducting the study according to protocol

Q2. What is the defining role of the sponsor in a clinical trial?

• To obtain informed consent from trial participants at each site
• To initiate, manage, finance or arrange for the trial and assume overall responsibility for it
• To perform only monitoring visits and site training
• To serve as the independent ethics committee reviewing the protocol

Correct Answer: To initiate, manage, finance or arrange for the trial and assume overall responsibility for it

Q3. Which activity is a primary duty of a clinical monitor (CRA)?

• Writing the clinical study report and performing final statistical analyses
• Performing source data verification, ensuring protocol adherence and protecting subject safety at assigned sites
• Issuing regulatory approvals on behalf of health authorities
• Funding the trial and negotiating site budgets

Correct Answer: Performing source data verification, ensuring protocol adherence and protecting subject safety at assigned sites

Q4. What function does a Contract Research Organization (CRO) typically perform?

• Acts as the ethics committee for multiple investigational sites
• Provides contracted services such as monitoring, data management, and regulatory support on behalf of the sponsor
• Issues investigational product (IP) marketing authorizations
• Replaces the sponsor in all legal responsibilities without a contract

Correct Answer: Provides contracted services such as monitoring, data management, and regulatory support on behalf of the sponsor

Q5. Who is primarily responsible for obtaining local Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval before enrolling subjects at a site?

• Sponsor’s pharmacovigilance department
• Clinical data management team
• Investigator or investigator‑site with support from the sponsor as necessary
• Central laboratory conducting sample analyses

Correct Answer: Investigator or investigator‑site with support from the sponsor as necessary

Q6. Which document provides the comprehensive clinical and nonclinical background to investigators about the investigational product?

• Case Report Form (CRF)
• Investigator Brochure (IB)
• Clinical Trial Agreement (CTA)
• Monitoring Plan

Correct Answer: Investigator Brochure (IB)

Q7. What is the immediate reporting responsibility of the investigator when a serious adverse event (SAE) occurs?

• Document the SAE and wait for the sponsor to detect it during monitoring
• Report the SAE promptly to the sponsor and the IRB/IEC as required by local regulations and the protocol
• Only report SAEs if they are unexpected and related to the investigational product
• Send SAE details only in the final study report

Correct Answer: Report the SAE promptly to the sponsor and the IRB/IEC as required by local regulations and the protocol

Q8. Who typically signs the Clinical Trial Agreement (CTA) between site and sponsor?

• Only the monitor who oversees the site
• The sponsor (or sponsor’s legal representative) and the investigator or the investigator’s institution
• The IRB/IEC chairperson and the data manager
• The central laboratory director and the CRO project manager

Correct Answer: The sponsor (or sponsor’s legal representative) and the investigator or the investigator’s institution

Q9. Which of the following is a monitor’s responsibility related to investigational product (IP)?

• Manufacturing and quality testing of the IP
• Performing drug accountability checks and verifying storage conditions at the site
• Issuing marketing authorization for the IP
• Preparing the Investigator Brochure

Correct Answer: Performing drug accountability checks and verifying storage conditions at the site

Q10. What is recorded in the delegation log maintained at an investigational site?

• Study budget details and payment schedules
• Names and signatures of staff to whom study tasks have been delegated, with dates and scope
• All raw laboratory instrument output files
• Details of central monitoring algorithms

Correct Answer: Names and signatures of staff to whom study tasks have been delegated, with dates and scope

Q11. Under ICH‑GCP, who is responsible for ensuring adequate monitoring of the trial?

• The investigator alone
• The monitor alone
• The sponsor, who may delegate monitoring to a CRO but retains ultimate responsibility
• The journal that will publish the trial results

Correct Answer: The sponsor, who may delegate monitoring to a CRO but retains ultimate responsibility

Q12. Which of the following tasks would a CRO most likely be contracted to perform?

• Grant marketing authorization to the investigational product
• Set up and manage electronic data capture (EDC), monitoring logistics and statistical programming
• Act as the institutional review board for sites
• Perform the role of treating physician for all study subjects

Correct Answer: Set up and manage electronic data capture (EDC), monitoring logistics and statistical programming

Q13. What is the primary purpose of risk‑based monitoring (RBM) as applied by sponsors or CROs?

• To eliminate the need for any on‑site visits
• To focus monitoring resources on critical data and processes that impact participant safety and data integrity
• To replace ethics committee review with centralized analytics
• To ensure 100% source data verification at every site

Correct Answer: To focus monitoring resources on critical data and processes that impact participant safety and data integrity

Q14. Who is responsible for submitting the Investigational New Drug (IND) application or clinical trial application (CTA) to regulatory authorities?

• The monitor conducting site visits
• The sponsor or sponsor’s legal representative
• The study coordinator at each site
• The central laboratory performing assays

Correct Answer: The sponsor or sponsor’s legal representative

Q15. What term describes an individual who both initiates and conducts a clinical trial, taking on sponsor and investigator responsibilities?

• Sub‑investigator
• Sponsor‑investigator
• Contract monitor
• Data safety monitor

Correct Answer: Sponsor‑investigator

Q16. Which party usually conducts formal quality assurance (audit) activities to independently assess compliance with GCP?

• The clinical monitor during routine monitoring visits
• The sponsor’s QA/audit unit or an independent auditing group (sometimes contracted)
• The institutional review board (IRB) staff
• The site’s clinical pharmacist only

Correct Answer: The sponsor’s QA/audit unit or an independent auditing group (sometimes contracted)

Q17. For a Suspected Unexpected Serious Adverse Reaction (SUSAR) that is fatal or life‑threatening, what is the standard initial reporting timeframe for sponsors to regulatory authorities in many jurisdictions?

• Within 30 calendar days
• Within 7 calendar days for initial notification
• Only in the annual safety report
• After database lock and study closeout

Correct Answer: Within 7 calendar days for initial notification

Q18. Which of the following is considered an essential document that the investigator must maintain in the investigator site file (ISF)?

• All sponsor internal procurement contracts unrelated to the trial
• Signed informed consent forms and source documents for participants
• Raw output from the sponsor’s central statistical programming only
• Non‑study unrelated patient medical records

Correct Answer: Signed informed consent forms and source documents for participants

Q19. Which activity is NOT typically a monitor’s responsibility?

• Reviewing source documents and CRFs for consistency
• Conducting site initiation, interim and close‑out visits
• Performing independent data analysis and generating the final statistical report for submission
• Verifying IP storage conditions and accountability

Correct Answer: Performing independent data analysis and generating the final statistical report for submission

Q20. If an investigational product requires destruction at the site, who ensures appropriate destruction and documentation?

• The central laboratory without site involvement
• The investigator/site, usually under procedures and instruction provided by the sponsor
• The IRB/IEC conducts the destruction
• The monitor destroys the product personally during each visit

Correct Answer: The investigator/site, usually under procedures and instruction provided by the sponsor

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