Common Technical Document (CTD) format and modules MCQs With Answer

Introduction

The Common Technical Document (CTD) is an internationally harmonized dossier format used for regulatory submissions of pharmaceutical products. Understanding CTD format and modules (Modules 1–5), eCTD electronic submission, and module-specific contents—such as Module 3 quality data, Module 4 nonclinical study reports, and Module 5 clinical study reports—is essential for B. Pharm students pursuing regulatory affairs, quality assurance, and drug development roles. This collection covers detailed concepts including 3.2.S and 3.2.P sections, Module 2 summaries, region-specific Module 1 items, stability data, analytical validation, and dossier organization. Focused MCQs with clear answers will reinforce practical knowledge of dossier compilation and regulatory expectations. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of the Common Technical Document (CTD)?

• To standardize the format and content of regulatory submissions across regions
• To replace clinical trials with summary reports
• To define manufacturing batch sizes for all products
• To list marketing prices of pharmaceutical products

Correct Answer: To standardize the format and content of regulatory submissions across regions

Q2. Which ICH guideline introduced the CTD structure used worldwide?

• ICH M4
• ICH Q1
• ICH E6
• ICH S2

Correct Answer: ICH M4

Q3. Which CTD module contains the Quality (Chemical, Pharmaceutical) documentation?

• Module 3
• Module 1
• Module 4
• Module 5

Correct Answer: Module 3

Q4. Which module is region-specific and typically contains application forms, labeling, and regional administrative information?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 1

Q5. Clinical study reports and clinical trial data are found primarily in which module?

• Module 5
• Module 2
• Module 3
• Module 4

Correct Answer: Module 5

Q6. In CTD Section 3.2, what does the designation “3.2.S” refer to?

• Drug Substance (active pharmaceutical ingredient) information
• Safety and pharmacovigilance plans
• Summary of clinical efficacy
• Sales and marketing strategy

Correct Answer: Drug Substance (active pharmaceutical ingredient) information

Q7. What is described in CTD subsection “3.2.P”?

• Drug Product (finished product) information
• Statistical analysis plans
• Sales projections
• Supply chain vendor lists

Correct Answer: Drug Product (finished product) information

Q8. Where in the CTD would you normally find long-term stability study reports for the marketed formulation?

• Module 3 (drug product stability section)
• Module 4 (nonclinical pharmacology)
• Module 1 (regulatory forms)
• Module 5 (clinical efficacy)

Correct Answer: Module 3 (drug product stability section)

Q9. Which part of Module 2 provides an integrated overview of nonclinical studies and their implications?

• Nonclinical Overview (Module 2.4)
• Quality Overall Summary (Module 2.3)
• Clinical Summary (Module 2.7)
• Module 1 cover letter

Correct Answer: Nonclinical Overview (Module 2.4)

Q10. Where are nonclinical (toxicology and pharmacology) study reports submitted in the CTD?

• Module 4
• Module 3
• Module 1
• Module 2

Correct Answer: Module 4

Q11. What does eCTD stand for and why is it used?

• Electronic Common Technical Document; for standardized electronic regulatory submissions
• Extended Clinical Trial Dossier; for longer clinical reports
• Electronic Clinical Trial Database; for storing raw data
• Emergency CTD Template; for urgent approvals

Correct Answer: Electronic Common Technical Document; for standardized electronic regulatory submissions

Q12. In Module 3, which subsection typically describes the manufacturing process for the finished dosage form?

• 3.2.P.3 (Manufacture)
• 3.2.S.1 (General information)
• 3.2.P.5 (Control of excipients)
• 3.2.P.8 (Stability)

Correct Answer: 3.2.P.3 (Manufacture)

Q13. What is the main goal of Module 2 summaries within the CTD?

• To present concise, integrated overviews that facilitate regulatory review and link detailed data in Modules 3–5
• To replace Module 3 with a short summary
• To provide marketing claims for the product
• To list vendors and contractors

Correct Answer: To present concise, integrated overviews that facilitate regulatory review and link detailed data in Modules 3–5

Q14. Where in the CTD would you locate the drug product specifications (e.g., assay, impurities limits)?

• Module 3 — Control of Drug Product (3.2.P.5)
• Module 4 — Toxicology summaries
• Module 1 — Application form
• Module 5 — Clinical trial protocols

Correct Answer: Module 3 — Control of Drug Product (3.2.P.5)

Q15. What is the correct sequential order of CTD modules?

• Module 1, Module 2, Module 3, Module 4, Module 5
• Module 5, Module 4, Module 3, Module 2, Module 1
• Module 3, Module 2, Module 1, Module 4, Module 5
• Module 2, Module 1, Module 4, Module 3, Module 5

Correct Answer: Module 1, Module 2, Module 3, Module 4, Module 5

Q16. Which ICH guideline is most relevant for stability testing information included in the CTD?

• ICH Q1 (Stability)
• ICH S4 (Carcinogenicity)
• ICH E9 (Statistical principles)
• ICH M4 (CTD structure)

Correct Answer: ICH Q1 (Stability)

Q17. Which of the following is typically included in Module 1 of a marketing authorization dossier?

• Prescribing information (labeling) and regional application forms
• Detailed analytical method validation data
• Full nonclinical study raw data
• Clinical study individual patient listings

Correct Answer: Prescribing information (labeling) and regional application forms

Q18. Which subsection of Module 2 is dedicated to the clinical summary?

• Module 2.7
• Module 2.3
• Module 2.4
• Module 2.1

Correct Answer: Module 2.7

Q19. The Quality Overall Summary (QOS) is placed in which part of the CTD?

• Module 2 (Quality Overall Summary — 2.3)
• Module 3 (Drug Substance overview)
• Module 4 (Nonclinical summary)
• Module 5 (Clinical reports)

Correct Answer: Module 2 (Quality Overall Summary — 2.3)

Q20. Where would you find detailed pharmacokinetic and toxicokinetic study reports?

• Module 4 (Nonclinical study reports)
• Module 3 (Quality documentation)
• Module 1 (Administrative data)
• Module 2 (Overviews only)

Correct Answer: Module 4 (Nonclinical study reports)

Q21. Process validation data for a finished product batch should be included in which CTD section?

• Module 3 (Manufacture and process validation)
• Module 4 (Toxicology)
• Module 1 (Application forms)
• Module 5 (Clinical efficacy)

Correct Answer: Module 3 (Manufacture and process validation)

Q22. What is a key difference between CTD and eCTD?

• CTD defines dossier content and organization; eCTD is the electronic format for submitting that dossier
• CTD is only for clinical data while eCTD is only for quality data
• CTD is used only in Europe while eCTD is global
• CTD replaces regulatory review while eCTD replaces manufacturing

Correct Answer: CTD defines dossier content and organization; eCTD is the electronic format for submitting that dossier

Q23. Which module would contain the full study report of a pivotal Phase III clinical trial?

• Module 5
• Module 2
• Module 3
• Module 4

Correct Answer: Module 5

Q24. If a regulatory agency requests the impurity profile justification for the drug substance, where should this be provided?

• Module 3 — Drug Substance (3.2.S) impurity characterization and justification
• Module 4 — Nonclinical impurity studies
• Module 1 — Administrative documents
• Module 5 — Clinical adverse event listings

Correct Answer: Module 3 — Drug Substance (3.2.S) impurity characterization and justification

Q25. Where is the Risk Management Plan (region-specific) usually placed within a CTD submission?

• Module 1 (region-specific safety and pharmacovigilance documents)
• Module 2 (Quality summary)
• Module 3 (Stability)
• Module 4 (Toxicology overview)

Correct Answer: Module 1 (region-specific safety and pharmacovigilance documents)

Q26. Which of the following statements about Module 1 is TRUE?

• Module 1 contains only regional administrative information and is not part of the harmonized CTD core
• Module 1 contains the Quality Overall Summary
• Module 1 is identical in all regions and part of ICH core
• Module 1 contains full clinical study reports

Correct Answer: Module 1 contains only regional administrative information and is not part of the harmonized CTD core

Q27. Where should analytical method validation reports for the drug substance be placed?

• Module 3 — Drug Substance (3.2.S) analytical procedures and validation
• Module 5 — Clinical analytical methods
• Module 1 — Administrative documents
• Module 4 — Nonclinical analytical methods

Correct Answer: Module 3 — Drug Substance (3.2.S) analytical procedures and validation

Q28. A bioequivalence study report for a generic immediate-release tablet should be included in which CTD module?

• Module 5 (clinical study reports)
• Module 3 (quality control)
• Module 1 (regional forms)
• Module 4 (nonclinical)

Correct Answer: Module 5 (clinical study reports)

Q29. Which of these is a major advantage of using the CTD format in submissions?

• Harmonization reduces duplication and streamlines regulatory review across participating regions
• It eliminates the need for clinical trials
• It guarantees faster approval in all countries
• It requires only Module 1 for all submissions

Correct Answer: Harmonization reduces duplication and streamlines regulatory review across participating regions

Q30. The subsection 3.2.P.8 in Module 3 refers to which type of information?

• Stability information for the drug product
• Pharmacology study reports
• Clinical efficacy summaries
• Application cover letters

Correct Answer: Stability information for the drug product

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