Case report forms, contracts and diary cards MCQs With Answer

Introduction

This quiz set focuses on Case Report Forms (CRFs), clinical trial contracts, and diary cards—three pillars of clinical research data quality and regulatory compliance. Tailored for M.Pharm students, the questions probe design principles, source data relationships, electronic CRF functionalities, audit trails, validation and data-cleaning processes, and typical pitfalls. The contracts section emphasizes sponsor–site agreements, confidentiality, indemnity, payment terms and intellectual property considerations. Diary card items cover patient-reported outcomes, compliance monitoring, eDiary benefits and bias reduction. These MCQs aim to deepen your practical understanding of documentation, contractual responsibilities and patient data capture required by ICH-GCP and regulatory inspections.

Q1. What is the primary purpose of a case report form (CRF) in a clinical trial?

• To record laboratory equipment maintenance schedules
• To collect advertising material for the study
• To capture protocol-required data for each trial subject to ensure complete and accurate data collection
• To replace source documents at the investigator site

Correct Answer: To capture protocol-required data for each trial subject to ensure complete and accurate data collection

Q2. Which of the following best describes an essential difference between paper CRFs and electronic CRFs (eCRFs)?

• eCRFs cannot be used for multicenter trials
• eCRFs provide real-time edit checks and audit trails while paper CRFs usually require manual query management
• Paper CRFs always ensure better data quality than eCRFs
• eCRFs eliminate the need for monitoring visits

Correct Answer: eCRFs provide real-time edit checks and audit trails while paper CRFs usually require manual query management

Q3. Which principle of data integrity emphasizes that data should be attributable, legible, contemporaneous, original and accurate?

• ALCOA+
• GXP
• HIPAA
• CAPA

Correct Answer: ALCOA+

Q4. In CRF design, which element is MOST important to minimize variability in data collection across sites?

• Allowing free-text for all adverse event descriptions
• Detailed data definitions and a comprehensive CRF completion guideline
• Using different units for the same laboratory test at each site
• Leaving laboratory fields optional

Correct Answer: Detailed data definitions and a comprehensive CRF completion guideline

Q5. What is a Data Clarification Form (DCF), also commonly called a query, used for?

• To request site invoices for payment processing
• To obtain clarification or correction from the site about discrepancies observed in CRF data
• To transfer patient files between sites
• To request regulatory approval from authorities

Correct Answer: To obtain clarification or correction from the site about discrepancies observed in CRF data

Q6. Which of the following is the primary purpose of the audit trail in an eCRF system?

• To store patient signatures as images
• To record who made changes, when and why, ensuring traceability of data edits
• To automatically approve all protocol deviations
• To prevent any data entry errors by blocking edits

Correct Answer: To record who made changes, when and why, ensuring traceability of data edits

Q7. What is the main legal document that governs responsibilities, payment, and liability between the sponsor and the investigator site?

• Material Transfer Agreement (MTA)
• Clinical Trial Agreement (CTA) or Site Agreement
• Informed consent form
• Case report form

Correct Answer: Clinical Trial Agreement (CTA) or Site Agreement

Q8. Which clause in a clinical trial contract typically addresses coverage for investigator negligence or subject injury?

• Confidentiality clause
• Intellectual property clause
• Indemnity and insurance clause
• Publication rights clause

Correct Answer: Indemnity and insurance clause

Q9. Which document is essential to demonstrate delegated responsibilities at a trial site and often referenced to complete CRF entries?

• Delegation of Authority Log (DL)
• Curriculum vitae of sponsor staff
• Site advertising materials
• Investigator’s bank details

Correct Answer: Delegation of Authority Log (DL)

Q10. For diary cards used to capture patient-reported outcomes, which approach most reduces recall bias?

• Collecting responses at the final study visit only
• Using daily eDiary entries with time stamps and reminders
• Allowing patients to fill weekly retrospective summaries
• Asking site staff to fill patient diaries

Correct Answer: Using daily eDiary entries with time stamps and reminders

Q11. Which coding dictionary is commonly used for coding adverse events recorded in CRFs?

• ATC (Anatomical Therapeutic Chemical)
• MedDRA (Medical Dictionary for Regulatory Activities)
• ICD-10 only
• WHO Drug Dictionary exclusively

Correct Answer: MedDRA (Medical Dictionary for Regulatory Activities)

Q12. Which item is NOT typically captured in a subject diary card for an outpatient pharmacology trial?

• Dosing time and dates
• Occurrence and severity of symptoms or adverse events
• Laboratory analyzer calibration logs
• Concomitant medication use

Correct Answer: Laboratory analyzer calibration logs

Q13. When a protocol amendment changes a CRF field, what is the correct process to maintain compliance?

• Allow sites to choose whether to implement the change
• Update the CRF version, document the change history, retrain staff and obtain any required approvals
• Discard old CRFs without retention
• Inform only the sponsor and not the investigator

Correct Answer: Update the CRF version, document the change history, retrain staff and obtain any required approvals

Q14. Which confidentiality document protects proprietary trial information when shared between sponsor and external collaborators prior to a formal contract?

• Data Safety Monitoring Board Charter
• Confidentiality or Non-Disclosure Agreement (CDA/NDA)
• Clinical Trial Agreement (CTA)
• Delegation of Authority Log

Correct Answer: Confidentiality or Non-Disclosure Agreement (CDA/NDA)

Q15. In dispute resolution of site payments under a CTA, which contractual element typically defines milestones and payment triggers?

• Data management plan
• Payment schedule and milestones clause
• Investigator brochure
• Ethics committee approval letter

Correct Answer: Payment schedule and milestones clause

Q16. Which of the following is a major regulatory concern if paper diary cards are used and are undated or filled retrospectively?

• Improved subject compliance
• Data integrity issues due to potential backfilling and recall bias
• Better blinding of treatment allocation
• Faster eCRF integration

Correct Answer: Data integrity issues due to potential backfilling and recall bias

Q17. Which activity is the monitor (CRA) least likely to verify against the CRF during source data verification (SDV)?

• That adverse events recorded on the CRF match source medical records
• That informed consent is dated prior to study procedures
• That site financial contracts are favorable to the sponsor
• That concomitant medications listed on CRF are documented in source notes

Correct Answer: That site financial contracts are favorable to the sponsor

Q18. What is the most appropriate way to handle personally identifiable subject information within CRFs and diary cards to comply with data protection laws?

• Include full national ID numbers on all pages
• Use subject initials and a unique subject ID code; store identifiers separately with restricted access
• Share identifiers freely between sponsor and any subcontractor without agreements
• Publish subject names in study reports for transparency

Correct Answer: Use subject initials and a unique subject ID code; store identifiers separately with restricted access

Q19. Which clause in a CTA typically governs publication rights of investigators and the sponsor?

• Data retention clause
• Publication and confidentiality clause, often including review period and sponsor input
• Adverse event reporting clause
• Delegation log clause

Correct Answer: Publication and confidentiality clause, often including review period and sponsor input

Q20. For adverse event reporting timelines, which statement reflects a common regulatory requirement for SUSARs (Suspected Unexpected Serious Adverse Reactions)?

• SUSARs do not need to be reported to regulators
• SUSARs must be reported expeditiously—often within 7 to 15 calendar days depending on seriousness and agency guidance
• SUSARs are only reported annually
• SUSARs should be documented in diary cards only and not submitted anywhere

Correct Answer: SUSARs must be reported expeditiously—often within 7 to 15 calendar days depending on seriousness and agency guidance

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