Data management systems and electronic data capture MCQs With Answer

Introduction: Data management systems and electronic data capture (EDC) are central to modern clinical research, enabling accurate, compliant, and timely collection of trial data. This blog offers M.Pharm students a focused set of multiple-choice questions with answers to reinforce core concepts such as EDC architecture, data standards (CDISC: CDASH, SDTM, ADaM), validation and user acceptance testing, audit trails, 21 CFR Part 11 compliance, query handling, and database lock procedures. Questions emphasize practical and regulatory considerations—design of eCRFs, discrepancy management, encryption, role-based access, and common EDC platforms—preparing students for both exams and real-world clinical data management tasks.

Q1. What is the primary function of an Electronic Data Capture (EDC) system in clinical trials?

• To generate clinical trial protocols automatically
• To collect, store and manage clinical trial data electronically
• To design investigational medicinal products
• To perform randomized controlled trials without investigators

Correct Answer: To collect, store and manage clinical trial data electronically

Q2. Which statement best describes a key advantage of EDC over paper CRFs?

• EDC eliminates the need for monitoring visits entirely
• EDC allows real-time data access and reduces transcription errors
• EDC prevents all protocol deviations
• EDC always reduces total study cost regardless of study size

Correct Answer: EDC allows real-time data access and reduces transcription errors

Q3. What does CDMS stand for in clinical research data management?

• Clinical Data Monitoring System
• Central Drug Management System
• Clinical Data Management System
• Critical Data Management Solution

Correct Answer: Clinical Data Management System

Q4. Which of the following acronyms summarizes core data integrity attributes commonly required in regulated clinical trials?

• GCP
• ALCOA+
• HIPAA
• CSV

Correct Answer: ALCOA+

Q5. 21 CFR Part 11 regulates which aspect of computerized systems used in clinical trials?

• Pharmacokinetic modeling methods
• Electronic records and electronic signatures
• Clinical trial insurance requirements
• Drug manufacturing site inspections

Correct Answer: Electronic records and electronic signatures

Q6. What is an audit trail within an EDC system?

• A summary report used for safety analyses
• A secure, time-stamped record of all data changes and actions
• A template for CRF design
• A backup copy of the database stored offsite

Correct Answer: A secure, time-stamped record of all data changes and actions

Q7. SDTM in the context of clinical data standards stands for:

• Standard Data Transfer Model
• Study Data Tabulation Model
• Statistical Data Treatment Manual
• Secure Data Transmission Method

Correct Answer: Study Data Tabulation Model

Q8. What is the purpose of CDASH in clinical data collection?

• To specify standard analysis datasets for regulatory submission
• To provide standards for case report form fields and data collection
• To manage clinical trial supply logistics
• To encrypt data at rest and in transit

Correct Answer: To provide standards for case report form fields and data collection

Q9. What does “database lock” mean in the context of clinical trial data management?

• The database is archived and permanently deleted
• The database is encrypted for the first time
• The database is frozen and no further changes are allowed without documented justification
• The database is transferred to the sponsor without any checks

Correct Answer: The database is frozen and no further changes are allowed without documented justification

Q10. In data management, what triggers a query to be raised to a site?

• A protocol amendment has been approved
• Data inconsistency, missing values, or out-of-range entries are detected
• An investigator completes source documents
• A patient withdraws consent

Correct Answer: Data inconsistency, missing values, or out-of-range entries are detected

Q11. DCF in clinical data management refers to:

• Data Collection Form
• Data Clarification Form
• Drug Certification File
• Database Configuration File

Correct Answer: Data Clarification Form

Q12. Who typically performs User Acceptance Testing (UAT) for an EDC system before study start?

• External auditors only
• Sponsor and end-users such as data managers and clinical staff
• Only the EDC vendor developers
• Regulatory agency inspectors

Correct Answer: Sponsor and end-users such as data managers and clinical staff

Q13. Role-based access control in an EDC system is used to:

• Allow all users equal full access to the database
• Restrict user access and actions based on assigned job roles
• Automatically resolve data queries
• Replace the need for passwords

Correct Answer: Restrict user access and actions based on assigned job roles

Q14. Which statement about audit trails is correct?

• Audit trails can be edited by site staff to correct mistakes
• Audit trails are optional for regulatory-submitted studies
• Audit trails must be tamper-evident and preserved for inspection
• Audit trails are only required for safety data entries

Correct Answer: Audit trails must be tamper-evident and preserved for inspection

Q15. What is the primary purpose of encrypting clinical trial data?

• To increase database processing speed
• To ensure confidentiality and protect data during storage and transmission
• To automatically validate CRF entries
• To convert data into SDTM format

Correct Answer: To ensure confidentiality and protect data during storage and transmission

Q16. Which of the following is a commonly cited operational benefit of using EDC?

• Guaranteed reduction of adverse events
• Faster query resolution and shorter time to database lock
• Automatic regulatory approval
• No need for data managers

Correct Answer: Faster query resolution and shorter time to database lock

Q17. Which of these are examples of widely used EDC platforms?

• Medidata Rave, Oracle Clinical, OpenClinica, REDCap
• SPSS, SAS, Stata, R
• Salesforce, SAP, Oracle ERP, Microsoft Dynamics
• Photoshop, Illustrator, InDesign, CorelDRAW

Correct Answer: Medidata Rave, Oracle Clinical, OpenClinica, REDCap

Q18. What is the primary role of CRF annotation during database build?

• To schedule monitoring visits
• To map CRF fields to SDTM variables for submission-ready datasets
• To encrypt eCRF pages
• To replace the need for data validation plans

Correct Answer: To map CRF fields to SDTM variables for submission-ready datasets

Q19. In clinical data warehousing, ETL stands for:

• Evaluate, Test, Launch
• Extract, Transform, Load
• Encrypt, Transfer, Log
• Entry, Tracking, Lock

Correct Answer: Extract, Transform, Load

Q20. ADaM datasets are primarily designed to support:

• Source data capture at investigator sites
• Analysis and generation of statistical outputs for submissions
• Randomization and drug supply management
• Construction of CRF page layouts

Correct Answer: Analysis and generation of statistical outputs for submissions

Download