Investigator’s brochure and informed consent form MCQs With Answer

Investigator’s Brochure and Informed Consent Form MCQs With Answer

This quiz collection is designed specifically for M.Pharm students studying Clinical Research (MPP 104T). It focuses on two cornerstone documents in clinical trials: the Investigator’s Brochure (IB), which compiles nonclinical and clinical data about an investigational product for investigators and regulators, and the Informed Consent Form (ICF), which ensures prospective participants receive understandable information to make voluntary decisions. The questions probe regulatory expectations, essential content, responsibilities of sponsors and investigators, versioning and updates, ethical safeguards, special situations (minors, emergencies), and documentation practices—helping students build deep, exam-ready understanding and practical competence for clinical trial conduct and oversight.

Q1. What is the primary purpose of the Investigator’s Brochure (IB)?

• To provide a recruitment script for site staff
• To summarize all clinical and nonclinical data relevant to the study of an investigational product
• To document each subject’s signed consent
• To act as the final clinical study report

Correct Answer: To summarize all clinical and nonclinical data relevant to the study of an investigational product

Q2. Which statement best describes the primary purpose of an Informed Consent Form (ICF)?

• To provide investigators with dosing instructions and lab reference ranges
• To ensure research staff follow protocol-specified procedures
• To provide potential subjects with the information necessary to make an informed decision about participation
• To satisfy sponsor contractual obligations to sites

Correct Answer: To provide potential subjects with the information necessary to make an informed decision about participation

Q3. Which section is typically included in the IB to present human pharmacokinetic information?

• Nonclinical toxicology summary
• Clinical pharmacology and pharmacokinetics
• Investigator qualifications and CVs
• Informed consent templates

Correct Answer: Clinical pharmacology and pharmacokinetics

Q4. Who is primarily responsible for preparing and updating the Investigator’s Brochure?

• The principal investigator at each site
• The study monitors (CRAs)
• The sponsor
• The Institutional Review Board / Ethics Committee

Correct Answer: The sponsor

Q5. When should the Investigator’s Brochure be updated?

• Only when the trial is completed and the final report is issued
• Whenever significant new safety, efficacy, or quality information becomes available
• Only at annual intervals regardless of new data
• When a new investigator requests the update

Correct Answer: Whenever significant new safety, efficacy, or quality information becomes available

Q6. Which of the following is NOT a required element of an informed consent form according to ICH-GCP and most regulations?

• Explanation of the purpose of the research
• A description of reasonably foreseeable risks and discomforts
• Alternative procedures or courses of treatment
• A detailed description of the sponsor’s manufacturing process

Correct Answer: A detailed description of the sponsor’s manufacturing process

Q7. If a prospective subject lacks legal capacity to consent, who may sign the informed consent form on their behalf?

• The study monitor
• The principal investigator
• A legally authorized representative
• The Ethics Committee chair

Correct Answer: A legally authorized representative

Q8. In pediatric research, what does the term “assent” refer to?

• The legal signature of a parent or guardian on the consent form
• A child’s affirmative agreement to participate in research
• A special waiver granted by regulators
• An additional review by the sponsor

Correct Answer: A child’s affirmative agreement to participate in research

Q9. What is the regulatory expectation regarding the language used in an ICF?

• ICFs should use technical clinical terminology only
• ICFs must be written in the language understandable to the subject and be translated when necessary
• ICFs may be provided only in English irrespective of subject language
• ICFs do not require translation if site staff will explain the study

Correct Answer: ICFs must be written in the language understandable to the subject and be translated when necessary

Q10. According to standard regulatory guidance, how long should signed informed consent documents generally be retained?

• At least 30 days after study completion
• For the lifetime of the investigator only
• At least 2 years after the last marketing application approval or as required by applicable regulations
• Only until the ethics committee completes initial review

Correct Answer: At least 2 years after the last marketing application approval or as required by applicable regulations

Q11. Which statement correctly differentiates the IB from the ICF?

• The IB is a legal contract; the ICF is a scientific report
• The IB provides scientific background for investigators; the ICF provides information for potential trial participants
• The IB is signed by subjects; the ICF is signed by sponsors
• The IB contains recruitment adverts; the ICF contains monitoring plans

Correct Answer: The IB provides scientific background for investigators; the ICF provides information for potential trial participants

Q12. Which element should explicitly be included in the informed consent form?

• Detailed sponsor internal financial statements
• Statement describing available alternative procedures or treatments
• Investigator’s unpublished research notes
• Full laboratory raw data from nonclinical studies

Correct Answer: Statement describing available alternative procedures or treatments

Q13. When is re-consent of participants required following an ICF amendment?

• Only when the study is extended beyond its original timeline
• Whenever changes add new information that may affect a subject’s willingness to continue
• Never; initial consent covers all future changes
• Only if the sponsor changes during the trial

Correct Answer: Whenever changes add new information that may affect a subject’s willingness to continue

Q14. Which of the following safety-related items should be summarized in an Investigator’s Brochure?

• List of investigator salaries
• Cumulative safety data, including observed adverse events and known risks
• Site visit schedules
• Recruitment quotas per center

Correct Answer: Cumulative safety data, including observed adverse events and known risks

Q15. What style of language is recommended for the ICF to promote true informed consent?

• Highly technical medical jargon to ensure legal validity
• Concise, lay language appropriate to the subject population
• Extremely brief statements without risk details
• Legal clauses copied from contracts

Correct Answer: Concise, lay language appropriate to the subject population

Q16. Who must review and approve the Investigator’s Brochure and ICF before subject enrollment begins?

• The site pharmacist only
• The Institutional Review Board / Ethics Committee (and investigators and sponsor should also review)
• The study subjects before the sponsor
• Only the regulatory authority without local ethics input

Correct Answer: The Institutional Review Board / Ethics Committee (and investigators and sponsor should also review)

Q17. What document within the IB is used to track changes made across versions?

• Investigator signature page
• Revision history or amendment log
• Subject enrollment log
• Adverse event narrative form

Correct Answer: Revision history or amendment log

Q18. The term “therapeutic misconception” refers to what common misapprehension among trial participants?

• Belief that research participation guarantees medical benefit targeted to the individual
• Assuming the trial has no risks
• Thinking the IB replaces routine medical records
• Confusing the sponsor with the investigator

Correct Answer: Belief that research participation guarantees medical benefit targeted to the individual

Q19. Under what conditions may emergency research proceed without prior informed consent?

• Whenever the sponsor deems it efficient
• Only under specific regulatory provisions, with prior ethics committee approval and additional safeguards
• If the investigator signs on behalf of the subject
• When the IB is not yet finalized

Correct Answer: Only under specific regulatory provisions, with prior ethics committee approval and additional safeguards

Q20. Which is a key responsibility of the investigator regarding IB and ICF?

• Ignoring IB safety updates unless notified by subjects
• Ensuring subjects provide informed consent using the current approved ICF and using the current IB to inform study conduct
• Drafting sponsor financial reports
• Replacing the ICF with a verbal explanation only

Correct Answer: Ensuring subjects provide informed consent using the current approved ICF and using the current IB to inform study conduct

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