EMA clinical trial regulations MCQs With Answer

Introduction: EMA Clinical Trial Regulations MCQs With Answer

This quiz resource is designed specifically for M.Pharm students to deepen understanding of the European Medicines Agency (EMA) framework governing clinical trials. It focuses on the EU Clinical Trials Regulation, key processes in submissions and assessments, safety reporting, transparency, and sponsor/investigator responsibilities. Each question reinforces regulatory principles and practical implications for designing, conducting, and managing clinical trials within the EU. The set covers portal use, timelines, classifications (such as low‑intervention trials), reporting obligations, and oversight roles by Member States and ethics committees. Use these MCQs to test knowledge, prepare for examinations, or consolidate regulatory concepts relevant to pharmaceutical practice and clinical research.

Q1. Which legislative instrument governs clinical trials across the European Union and established the Clinical Trials Information System (CTIS)?

• Directive 2001/20/EC
• Regulation (EU) No 536/2014
• Good Clinical Practice Guideline ICH E6(R2)
• Paediatric Regulation (EC) No 1901/2006

Correct Answer: Regulation (EU) No 536/2014

Q2. When did the EU Clinical Trials Regulation (EU No 536/2014) enter into application, initiating use of CTIS for new submissions?

• 1 January 2016
• 31 January 2022
• 1 May 2018
• 30 June 2020

Correct Answer: 31 January 2022

Q3. What is the primary purpose of the Clinical Trials Information System (CTIS)?

• To store manufacturing batch release documentation
• To provide a single EU portal for submission, assessment and public information on clinical trials
• To replace national ethics committees across Member States
• To manage marketing authorisation applications

Correct Answer: To provide a single EU portal for submission, assessment and public information on clinical trials

Q4. According to EMA-related regulations, who is defined as the sponsor of a clinical trial?

• The clinical investigator responsible for a single trial site
• The authority that grants the marketing authorisation
• The person or organisation that takes responsibility for initiating, managing and financing the trial
• The ethics committee reviewing the trial protocol

Correct Answer: The person or organisation that takes responsibility for initiating, managing and financing the trial

Q5. Under standard EU reporting requirements, within what timeframe must a sponsor report a fatal or life‑threatening SUSAR to regulatory authorities?

• Within 24 hours
• Within 7 days of the sponsor becoming aware
• Within 60 days after the annual safety report
• Within 90 days after trial completion

Correct Answer: Within 7 days of the sponsor becoming aware

Q6. What is a key requirement for the lay summary of clinical trial results under EU rules?

• It should be a technical report aimed only at regulatory authorities
• It must be prepared in non‑technical language and generally made public within one year of trial end (shorter timelines apply for paediatric trials)
• It should be submitted only if the trial leads to a marketing authorisation
• It is optional and only required for oncology trials

Correct Answer: It must be prepared in non‑technical language and generally made public within one year of trial end (shorter timelines apply for paediatric trials)

Q7. How does the EU Clinical Trials Regulation define a “low‑intervention clinical trial”?

• A trial with no investigational medicinal product
• A trial where the medicinal product is used in accordance with the marketing authorisation or with evidence‑based minimal additional risk and procedures pose no more than minimal additional risk
• A study run only by academic institutions with no commercial involvement
• A trial conducted exclusively outside of the EU

Correct Answer: A trial where the medicinal product is used in accordance with the marketing authorisation or with evidence‑based minimal additional risk and procedures pose no more than minimal additional risk

Q8. Which part of a clinical trial assessment is intended to be common across Member States and covers scientific aspects such as trial design and safety data?

• Part I
• Part II
• Part III
• National Annex

Correct Answer: Part I

Q9. In CTIS submissions, what happens if a proposed change to a protocol affects subject safety or trial objectives?

• It can be implemented immediately without notification
• It is classified as a substantial modification and requires approval before implementation
• It is considered non‑substantial and only logged in the annual report
• It must be submitted as a new separate trial application

Correct Answer: It is classified as a substantial modification and requires approval before implementation

Q10. Which committee or authority principally assesses ethical aspects such as informed consent documents and subject compensation under EU trial processes?

• European Medicines Agency (EMA) central ethics office
• National ethics committees and competent authorities at Member State level
• World Health Organization ethics committee
• European Commission legal unit

Correct Answer: National ethics committees and competent authorities at Member State level

Q11. What is the role of the reporting Member State in a multi‑state CTIS assessment?

• It provides a local site investigator for the trial
• It coordinates the consolidated assessment of Part I and prepares the initial assessment report shared with other concerned Member States
• It issues a marketing authorisation for the investigational product
• It audits all sponsor facilities in other Member States

Correct Answer: It coordinates the consolidated assessment of Part I and prepares the initial assessment report shared with other concerned Member States

Q12. What is the Investigator’s Brochure (IB) and why is it important under EMA regulations?

• A marketing leaflet for patients to advertise the trial
• A document summarising preclinical and clinical information relevant to the investigator’s safety assessment and conduct of the trial
• A financial report of investigational medicinal product costs
• A list of all investigators and their CVs

Correct Answer: A document summarising preclinical and clinical information relevant to the investigator’s safety assessment and conduct of the trial

Q13. Where must clinical trials conducted in the EU be registered or receive a unique identifier?

• ClinicalTrials.gov only
• EudraCT/CTIS (EudraCT number and CTIS record)
• Local hospital registries exclusively
• Only in the sponsor’s internal database

Correct Answer: EudraCT/CTIS (EudraCT number and CTIS record)

Q14. To which EU system are SUSARs commonly reported for medicinal products used in clinical trials?

• EudraVigilance (clinical trial module)
• EUROPOL adverse events registry
• WHO pharmacovigilance portal exclusively
• European Data Protection Supervisor database

Correct Answer: EudraVigilance (clinical trial module)

Q15. Which EMA body is responsible for opinions on Paediatric Investigation Plans (PIPs)?

• Committee for Medicinal Products for Human Use (CHMP)
• Paediatric Committee (PDCO)
• Pharmacovigilance Risk Assessment Committee (PRAC)
• Committee for Orphan Medicinal Products (COMP)

Correct Answer: Paediatric Committee (PDCO)

Q16. Which of the following changes to a clinical trial would most likely be classified as a substantial amendment?

• Correction of a typographical error in the investigator letterhead
• Changing the primary efficacy endpoint of the trial
• Updating contact details of the trial monitor
• Adjusting the font size in patient information leaflets

Correct Answer: Changing the primary efficacy endpoint of the trial

Q17. What is the EMA/CTIS position on public access to clinical trial documents and data?

• All documents must remain strictly confidential and never be published
• CTIS increases transparency by making many documents public, with limited deferrals allowed for commercially confidential information
• Only final marketing authorisation dossiers are visible to the public
• Only Member State officials can view any submission documents

Correct Answer: CTIS increases transparency by making many documents public, with limited deferrals allowed for commercially confidential information

Q18. What obligation does a sponsor have regarding insurance or indemnity for trial participants under EU practice?

• No obligation; participants assume all risks
• Sponsors must ensure arrangements are in place to provide compensation and cover for trial participants in accordance with applicable national law
• Only investigators must provide insurance
• Insurance is optional and only for paediatric trials

Correct Answer: Sponsors must ensure arrangements are in place to provide compensation and cover for trial participants in accordance with applicable national law

Q19. Which of the following best describes the handling of safety aggregate reports under the EU system during a clinical trial?

• No periodic safety reporting is required until marketing authorisation
• Sponsors must prepare and submit aggregated safety reports (e.g., DSUR) as required, and ensure expedited reporting of individual SUSARs
• Sponsors only report aggregate safety data at trial end
• Sponsor must only inform ethics committees, not regulatory authorities

Correct Answer: Sponsors must prepare and submit aggregated safety reports (e.g., DSUR) as required, and ensure expedited reporting of individual SUSARs

Q20. What may be a regulatory consequence if a sponsor fails to report a serious breach affecting subject safety?

• No consequences; reporting is voluntary
• Regulatory authorities may require corrective action and can suspend or terminate the trial; sanctions may apply
• The trial will automatically be approved retroactively
• Only a minor administrative note will be recorded with no enforcement

Correct Answer: Regulatory authorities may require corrective action and can suspend or terminate the trial; sanctions may apply

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