Protocol writing and essential trial documents MCQs With Answer

Introduction

Writing a clear, compliant clinical trial protocol and maintaining essential trial documents are fundamental skills for M.Pharm students entering clinical research. This blog provides focused multiple-choice questions that cover protocol components, ethical and regulatory requirements, investigator responsibilities, documentation standards, safety reporting, and practical aspects like amendments and version control. The questions emphasize ICH-GCP principles, sponsor versus investigator duties, informed consent, CRFs, monitoring and archiving — helping you build competency for academic exams and real-world trial conduct. Use these MCQs to test understanding, identify gaps, and reinforce best practices in preparing and managing clinical trial documentation.

Q1. Which section of a clinical trial protocol provides the scientific rationale, objectives, and primary and secondary endpoints?

• Background and Rationale
• Study Objectives and Endpoints
• Statistical Analysis Plan
• Safety Monitoring Plan

Correct Answer: Study Objectives and Endpoints

Q2. Which document summarizes key trial information in a concise form, often used for ethics committee review and regulatory submission?

• Investigator Brochure
• Protocol Synopsis
• Case Report Form
• Monitoring Plan

Correct Answer: Protocol Synopsis

Q3. According to ICH-GCP, which of the following is an essential document demonstrating that informed consent was obtained from each trial subject?

• Delegation Log
• Signed Informed Consent Form (ICF)
• Trial Master File Index
• Source Data Verification Report

Correct Answer: Signed Informed Consent Form (ICF)

Q4. Which essential trial document is primarily used to record data required by the protocol for each trial subject?

• Investigator Agreement
• Case Report Form (CRF)
• Site Regulatory File
• Serious Adverse Event Form

Correct Answer: Case Report Form (CRF)

Q5. What is the primary purpose of the Investigator’s Brochure (IB)?

• To list site staff and their roles
• To describe preclinical and clinical information relevant to the trial
• To provide the final clinical study report
• To document financial agreements with the sponsor

Correct Answer: To describe preclinical and clinical information relevant to the trial

Q6. Which of the following best describes a protocol amendment?

• A change to the protocol that is made before ethics approval only
• A minor administrative update that never requires documentation
• A written change to the protocol requiring approval by sponsor and usually review by the ethics committee and regulator
• An informal agreement between monitor and investigator during a visit

Correct Answer: A written change to the protocol requiring approval by sponsor and usually review by the ethics committee and regulator

Q7. Which document demonstrates that a site is qualified to conduct the trial and includes CVs, medical licenses, and training records?

• Participant Diary
• Site Qualification File
• Investigator Site File/Regulatory File
• Monitoring Log

Correct Answer: Investigator Site File/Regulatory File

Q8. Which essential document is retained by the sponsor to show the accountability of investigational medicinal products (IMP)?

• Drug Accountability Log
• Ethics Committee Approval Letter
• Case Report Form
• Protocol Signature Page

Correct Answer: Drug Accountability Log

Q9. What is the correct immediate action when a serious adverse event (SAE) occurs at a trial site?

• Wait until the next monitoring visit to report
• Report the SAE promptly to the sponsor and document in the source and CRF as required
• Notify participants’ families only
• Publish the event before notifying authorities

Correct Answer: Report the SAE promptly to the sponsor and document in the source and CRF as required

Q10. Which of the following indicates proper version control for a protocol document?

• Using date only, without version number
• Maintaining a version number, revision history, and effective date on each document version
• Replacing old versions without archiving
• Allowing multiple uncontrolled drafts at sites

Correct Answer: Maintaining a version number, revision history, and effective date on each document version

Q11. Which document outlines the procedures for monitoring, frequency of visits, and responsibilities of monitors?

• Data Management Plan
• Monitoring Plan
• Statistical Analysis Plan
• Informed Consent Form

Correct Answer: Monitoring Plan

Q12. In the context of essential documents, what is the purpose of the Trial Master File (TMF)?

• To store only financial records related to the trial
• To provide a complete collection of all essential documents that permit evaluation of the conduct of a trial
• To replace the need for individual site files
• To record only adverse events

Correct Answer: To provide a complete collection of all essential documents that permit evaluation of the conduct of a trial

Q13. Which party is primarily responsible for obtaining ethics committee approval and ensuring subject protection at a clinical site?

• Sponsor
• Regulatory Authority
• Principal Investigator
• Contract Research Organization

Correct Answer: Principal Investigator

Q14. What is the main goal of a protocol’s statistical analysis plan (SAP)?

• To describe the drug manufacturing process
• To pre-specify statistical methods, handling of missing data, and analysis populations
• To list contact details for monitors
• To serve as the informed consent document

Correct Answer: To pre-specify statistical methods, handling of missing data, and analysis populations

Q15. Which document evidences that site staff delegated trial responsibilities have appropriate training and authorization?

• Source Documents
• Delegation Log
• Participant Informed Consent
• IMP Shipment Records

Correct Answer: Delegation Log

Q16. For blinding and randomization integrity, which essential document is critical at the site?

• Randomization list and blind maintenance procedures
• Drug accountability log only
• Ethics approval letter only
• Investigator’s personal notes

Correct Answer: Randomization list and blind maintenance procedures

Q17. Which of the following is NOT usually considered an essential document during trial conduct?

• Subject Screening Log
• Financial Disclosure Forms
• Advertisements for subject recruitment that are active and approved
• Internal draft protocol versions never distributed to sites

Correct Answer: Internal draft protocol versions never distributed to sites

Q18. How should protocol deviations be documented and managed?

• Ignore minor deviations; only report major ones retrospectively
• Document each deviation, assess its impact on subject safety and data integrity, and report per SOPs
• Only record deviations if the sponsor requests them
• Erase deviations from source documents to avoid audit findings

Correct Answer: Document each deviation, assess its impact on subject safety and data integrity, and report per SOPs

Q19. Which document provides instructions on how to collect, access, and maintain trial data, including CRF completion guidelines?

• Data Management Plan
• Investigator Brochure
• Protocol Signature Page
• Ethics Committee Minutes

Correct Answer: Data Management Plan

Q20. What archival requirement is typically expected for essential clinical trial documents after study completion?

• Destroy all documents within one month
• Retain essential documents for a specified period (often many years) as per regulatory and sponsor policy
• Keep documents only electronically without backups
• Store documents at investigator discretion with no record

Correct Answer: Retain essential documents for a specified period (often many years) as per regulatory and sponsor policy

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