Clinical trial documentation: protocol and investigator brochure MCQs With Answer

Introduction

This quiz set focuses on clinical trial documentation with emphasis on the protocol and the Investigator’s Brochure (IB), tailored for M.Pharm students specializing in Clinical Research and Pharmacovigilance. It reviews the purpose, essential components, regulatory expectations and practical aspects of drafting, reviewing and maintaining these core documents. Questions cover protocol design elements, safety reporting, amendments, version control, IB content (preclinical and clinical data synthesis), risk–benefit assessment, and responsibilities of sponsors and investigators. The aim is to reinforce conceptual understanding and application of Good Clinical Practice (GCP) principles so students can critically evaluate and contribute to high-quality trial documentation.

Q1. What is the primary purpose of the clinical trial protocol?

• To provide marketing information for the investigational product
• To describe the scientific rationale and detailed plan to conduct the study
• To replace informed consent forms for subjects
• To document only safety events occurring during the trial

Correct Answer: To describe the scientific rationale and detailed plan to conduct the study

Q2. Which section of a protocol contains detailed inclusion and exclusion criteria and rationale?

• Statistical Analysis Plan
• Safety Reporting Plan
• Study Population and Eligibility Criteria
• Investigator Brochure Summary

Correct Answer: Study Population and Eligibility Criteria

Q3. Which element is essential in the protocol to ensure unbiased allocation of treatments?

• Randomization and allocation concealment procedures
• Therapeutic drug monitoring schedule
• Publication policy
• Investigator financial disclosures

Correct Answer: Randomization and allocation concealment procedures

Q4. The statistical assumptions for sample size calculation are usually found in which protocol section?

• Data Management Plan
• Statistical Methods and Sample Size Justification
• Informed Consent Process
• Trial Insurance and Indemnity

Correct Answer: Statistical Methods and Sample Size Justification

Q5. Which of the following best describes the Investigator’s Brochure (IB)?

• A regulatory submission form for ethics committees only
• A compilation of clinical and nonclinical data on an investigational product relevant to its study
• An informed consent template for investigators
• A financial agreement between sponsor and investigator

Correct Answer: A compilation of clinical and nonclinical data on an investigational product relevant to its study

Q6. Which IB section summarizes pharmacology, toxicology and pharmacokinetics from nonclinical studies?

• Clinical Trial Protocol Appendix
• Nonclinical/Preclinical Data Summary
• Marketing Authorization Dossier
• Investigator CVs and Qualifications

Correct Answer: Nonclinical/Preclinical Data Summary

Q7. In protocol governance, what is considered a “substantial amendment”?

• An editorial correction of typographical errors
• A change that affects participant safety, scientific validity or conduct of the trial
• An update to the sponsor’s contact details
• A routine extension of administrative deadlines not impacting subjects

Correct Answer: A change that affects participant safety, scientific validity or conduct of the trial

Q8. Which document should be consulted for describing expected adverse reactions and guidance on management during a study?

• Investigator’s Brochure
• Study budget file
• Trial monitoring log only
• Ethics committee meeting minutes

Correct Answer: Investigator’s Brochure

Q9. For expedited safety reporting, which timeline is most commonly required for reporting serious unexpected suspected adverse reactions (SUSARs) to regulators?

• Within 7 or 15 days depending on fatality/severity
• Within 90 days after trial completion
• Only in annual safety reports
• After site close-out

Correct Answer: Within 7 or 15 days depending on fatality/severity

Q10. Which part of the protocol explains procedures for handling protocol deviations and violations?

• Data Safety Monitoring Board charter
• Protocol Compliance and Deviations
• Investigator Brochure nonclinical section
• Statistical Analysis Plan

Correct Answer: Protocol Compliance and Deviations

Q11. When updating the IB, what principle should guide inclusion of new clinical data?

• Include only positive efficacy data
• Timely, balanced and comprehensive presentation of new safety and efficacy information
• Wait until regulatory approval before updating
• Remove older negative studies to simplify the IB

Correct Answer: Timely, balanced and comprehensive presentation of new safety and efficacy information

Q12. Which protocol element provides details on subject withdrawal and follow-up procedures?

• Study Objectives and Endpoints
• Safety Reporting Timelines
• Discontinuation/Withdrawal Criteria and Follow‑up
• Randomization Schedule

Correct Answer: Discontinuation/Withdrawal Criteria and Follow‑up

Q13. What is the role of a Data Safety Monitoring Board (DSMB) as described in protocol documentation?

• To recruit participants at all trial sites
• To independently review accumulating safety and efficacy data and recommend actions
• To draft the Investigator’s Brochure
• To manage the trial’s financial accounts

Correct Answer: To independently review accumulating safety and efficacy data and recommend actions

Q14. Version control in the protocol and IB is critical because:

• It prevents the need for ethics committee review
• It ensures all stakeholders use the same, current document and maintains audit trail
• It allows investigators to choose preferred versions
• It eliminates the need for informed consent updates

Correct Answer: It ensures all stakeholders use the same, current document and maintains audit trail

Q15. Which item is NOT usually part of the Investigator’s Brochure?

• Summary of efficacy and safety data from clinical trials
• Nonclinical toxicology and pharmacology reports
• Commercial pricing strategy for the investigational product
• Known drug interactions and contraindications

Correct Answer: Commercial pricing strategy for the investigational product

Q16. Which protocol section describes procedures for data collection, CRF completion and source documentation?

• Data Management and Source Data Documentation
• Investigator Brochure Preface
• Clinical Laboratory Normal Ranges Appendix only
• Financial Disclosure Section

Correct Answer: Data Management and Source Data Documentation

Q17. An investigator notices an unexpected safety signal during the study. According to typical protocol/IB guidance, what is the investigator’s immediate duty?

• Wait for annual report before taking action
• Report the event per the protocol’s expedited reporting procedures to sponsor and ethics committee
• Publish the finding immediately
• Unblind the treatment code for all subjects

Correct Answer: Report the event per the protocol’s expedited reporting procedures to sponsor and ethics committee

Q18. Which component of the protocol provides justification for selected primary and secondary endpoints?

• Study Rationale and Objectives
• Drug accountability log
• Investigator signature page
• Monitoring visit schedule

Correct Answer: Study Rationale and Objectives

Q19. For first‑in‑human trials, what specific IB information is indispensable?

• Comprehensive preclinical pharmacology, toxicology, pharmacokinetics and margin of safety data
• Marketing plans and commercial forecasts
• Only human efficacy data from other indications
• Site-specific investigator bank details

Correct Answer: Comprehensive preclinical pharmacology, toxicology, pharmacokinetics and margin of safety data

Q20. Which practice enhances the scientific validity of protocol endpoints and minimizes bias?

• Using unvalidated surrogate endpoints without justification
• Predefining endpoints, measurement methods and blinding procedures in the protocol
• Allowing investigators to change endpoints mid‑study for convenience
• Omitting the statistical analysis plan to simplify documentation

Correct Answer: Predefining endpoints, measurement methods and blinding procedures in the protocol

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