Case report forms and clinical study report preparation MCQs With Answer

Introduction: This quiz collection on Case Report Forms (CRFs) and Clinical Study Report (CSR) preparation is designed for M.Pharm students specializing in Clinical Research and Pharmacovigilance. It focuses on practical and regulatory aspects of CRF design, data capture, validation, query management, source data verification, and assembly of the CSR in line with ICH guidelines. Questions emphasize real-world processes such as eCRF vs paper CRF, audit trails, coding of safety and medication data, database lock, and responsibilities of investigators and sponsors. Use these MCQs to reinforce understanding of documentation quality, data integrity, and compliance required for reliable clinical study reporting.

Q1. What is the primary purpose of a Case Report Form (CRF) in a clinical trial?

• To serve as the official published article for trial results
• To collect standardized participant data required by the protocol
• To replace source documents at the investigator site
• To provide regulatory authorities with raw laboratory files

Correct Answer: To collect standardized participant data required by the protocol

Q2. Which guideline specifically provides structure and content recommendations for the Clinical Study Report (CSR)?

• ICH E6 (Good Clinical Practice)
• ICH E9 (Statistical Principles)
• ICH E3 (Structure and Content of Clinical Study Reports)
• ICH M4 (Common Technical Document)

Correct Answer: ICH E3 (Structure and Content of Clinical Study Reports)

Q3. Which of the following best describes the difference between source data and data entered into a CRF?

• Source data are the final transcribed values in the CRF
• CRF entries are primary records and source data are copies
• Source data are original records (e.g., hospital notes) that support CRF entries
• There is no difference; both terms are interchangeable

Correct Answer: Source data are original records (e.g., hospital notes) that support CRF entries

Q4. Which feature is essential for an electronic CRF (eCRF) to comply with regulatory expectations?

• Ability to export data only in PDF format
• Integrated audit trail that records who changed data and when
• Open editing by any site user without logging
• Automatic deletion of historical data upon entry correction

Correct Answer: Integrated audit trail that records who changed data and when

Q5. In CRF design, which approach helps minimize data queries and improve data quality?

• Collecting every conceivable data point irrespective of protocol relevance
• Implementing targeted edit checks and logical skip patterns
• Keeping free-text fields for all critical variables
• Delaying validation rules until after database lock

Correct Answer: Implementing targeted edit checks and logical skip patterns

Q6. What does SDV (Source Data Verification) typically involve during monitoring visits?

• Comparing CRF entries against source documents to verify accuracy
• Automatically reconciling all laboratory instruments with the sponsor database
• Rewriting source medical records to match CRF data
• Deleting inconsistent entries without documentation

Correct Answer: Comparing CRF entries against source documents to verify accuracy

Q7. Who is primarily responsible for ensuring CRFs are complete and accurate at the investigator site?

• The sponsor’s medical monitor
• The site investigator
• The contract research organization (CRO) data manager
• The regulatory authority

Correct Answer: The site investigator

Q8. Which section of the CSR typically contains detailed Tables, Figures, and Listings (TFLs)?

• Main body summary without appendices
• Appendices to the CSR
• Cover letter to the regulatory authority
• Protocol synopsis

Correct Answer: Appendices to the CSR

Q9. For adverse event coding in regulatory submissions, which dictionary is most commonly used for preferred term classification?

• ATC (Anatomical Therapeutic Chemical)
• MedDRA (Medical Dictionary for Regulatory Activities)
• ICD-10 (International Classification of Diseases)
• SNOMED CT

Correct Answer: MedDRA (Medical Dictionary for Regulatory Activities)

Q10. Which practice is recommended for subject identifiers recorded in CRFs to protect patient privacy?

• Recording full names and national ID numbers in the CRF
• Using pseudonymized subject IDs and keeping linkage logs at the site
• Storing identifiable data on the sponsor server with public access
• Removing all identifiers including dates of birth before collection

Correct Answer: Using pseudonymized subject IDs and keeping linkage logs at the site

Q11. What is the typical sponsor expectation for reporting a Serious Adverse Event (SAE) discovered at a site?

• Report to sponsor immediately, typically within 24 hours of awareness
• Report only at the end of the study
• Send the SAE with the next site visit monitoring report
• No reporting needed if the investigator documents it in source notes

Correct Answer: Report to sponsor immediately, typically within 24 hours of awareness

Q12. Which activity is performed prior to database lock to ensure integrity of analysis datasets?

• Finalization of statistical analysis plan and resolution of all data queries
• Publishing interim results in a journal
• Erasing audit trails to expedite analysis
• Re-randomizing treatment allocation

Correct Answer: Finalization of statistical analysis plan and resolution of all data queries

Q13. In CSR preparation, which appendix commonly documents protocol deviations and violations?

• Appendix with informed consent forms only
• Appendix summarizing protocol deviations and subject-level listings
• Appendix for investigational product manufacturing
• Appendix containing raw laboratory instrument logs

Correct Answer: Appendix summarizing protocol deviations and subject-level listings

Q14. Which edit check type helps detect inconsistent dates such as a visit date occurring before enrollment?

• Range check
• Format check
• Cross-field consistency check (logic check)
• Duplicate check

Correct Answer: Cross-field consistency check (logic check)

Q15. Who usually issues data clarification forms or electronic queries for CRF discrepancies?

• The regulatory authority inspector
• The study data manager or clinical data management team
• The site pharmacist without sponsor oversight
• The journal editor preparing publication

Correct Answer: The study data manager or clinical data management team

Q16. Which procedure is important when implementing a new CRF version during an ongoing trial?

• Apply the new version retroactively to all previously collected data without documentation
• Use version control, document changes, and train sites on the update
• Allow sites to choose between versions randomly
• Stop data collection at all sites until the next regulatory inspection

Correct Answer: Use version control, document changes, and train sites on the update

Q17. For concomitant medication coding in the database, which dictionary is commonly used by sponsors?

• MedDRA for medications
• WHO Drug Dictionary or WHO-DD
• ICD-10
• DSM-5

Correct Answer: WHO Drug Dictionary or WHO-DD

Q18. Which element is a key requirement of ICH E6 (GCP) regarding documentation for CRFs and trial records?

• All trial documentation must be publicly editable
• Records must be accurate, attributable, legible, contemporaneous, original, and retained
• Only electronic records are acceptable; paper records are prohibited
• Investigators may discard records after publication

Correct Answer: Records must be accurate, attributable, legible, contemporaneous, original, and retained

Q19. What is the role of “line listings” in CSR appendices?

• They summarize aggregated study-level efficacy endpoints only
• They provide subject-level detailed records (e.g., AEs, labs) for review
• They are marketing materials for the investigational product
• They replace the need for TFLs

Correct Answer: They provide subject-level detailed records (e.g., AEs, labs) for review

Q20. When preparing the CSR safety section, which activity is essential to ensure consistency between datasets and report text?

• Ignoring dataset derivation rules and writing narrative summaries only
• Reconciling coded adverse event frequencies in datasets with the tabular summaries and narratives
• Removing all patient identifiers from datasets and not reconciling counts
• Delaying safety summaries until after regulatory submission

Correct Answer: Reconciling coded adverse event frequencies in datasets with the tabular summaries and narratives

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