Clinical Data Management (CDM) Interview
Questions & Answers
Prepared for: Arangi Manasa
Q: What is Clinical Data Management (CDM)?
CDM is the set of processes and systems used to collect, validate, clean, store and prepare
clinical trial data so it is accurate, complete and ready for statistical analysis and regulatory
submission. It ensures trustworthy data that supports reliable study conclusions.
Q: Why is CDM important in clinical trials?
It ensures patient safety, regulatory compliance, and credible study outcomes. High-quality
data supports drug approvals and minimizes trial delays due to errors or missing information.
Q: What are the key steps in CDM?
1. Protocol review & CRF design 2. Database design & validation 3. Data collection & entry 4.
Data validation & cleaning 5. Medical coding 6. Database lock & transfer.
Q: What is the difference between CRF and eCRF?
CRF is a paper form, while eCRF is an electronic version used in EDC systems like Medidata
Rave. eCRFs improve data accuracy, reduce transcription errors, and support real-time
validation.
Q: What are the main challenges in CDM?
Handling large datasets, integrating multiple data sources, ensuring data privacy, resolving
queries on time, and maintaining data consistency and integrity.
Q: Explain the database lock process.
Database lock means freezing the data after all queries are resolved and validations are
complete. No further changes are allowed, and the clean data is sent to the biostatistics team
for analysis.
Q: What do you mean by data validation and query resolution?
Data validation checks for inconsistencies, missing data, and protocol deviations. Query
resolution involves communicating with sites to correct or confirm unclear data entries.
Q: What is medical coding and why is it necessary?
Medical coding standardizes medical terms using dictionaries like MedDRA and WHO-DD. It
ensures consistency in recording adverse events, medical history, and medications.
Q: How do you ensure data accuracy and integrity?
By using edit checks, following SOPs, performing reconciliation, maintaining audit trails, and
ensuring only authorized personnel handle the data in validated systems.
Q: What happens after database lock?
The clean dataset is sent to the biostatistics team for analysis, which supports clinical study
reports and regulatory submissions. Post-lock changes are rare and documented.
Q: What CDM tools or EDC systems do you know?
Medidata Rave, Oracle Clinical, OpenClinica, and REDCap are commonly used. They support
eCRF design, edit checks, and database validation.
Q: What is MedDRA and what is it used for?
MedDRA (Medical Dictionary for Regulatory Activities) is used to code and classify adverse
events in a standardized way for analysis and reporting.
Q: What is WHO-DD?
WHO Drug Dictionary is used for coding medications in clinical trials. It ensures consistent
naming and grouping of drugs across studies.
Q: What are ICH-GCP guidelines and why are they important?
ICH-GCP guidelines ensure clinical trials are ethical, scientifically sound, and protect
participant safety. Compliance ensures credible and acceptable data for regulatory review.
Q: What is 21 CFR Part 11?
An FDA regulation that defines the standards for electronic records and signatures, ensuring
they are secure, traceable, and equivalent to paper records.
Q: If you find inconsistent data from two sources, how will you handle it?
I would verify both sources, raise a query to the site for clarification, and document the
resolution before updating the database.
Q: How do you prioritize multiple queries during data cleaning?
Prioritize queries based on patient safety impact, timelines, and importance for analysis.
Address critical data first, then secondary queries.
Q: What steps will you take to ensure data privacy?
I follow HIPAA and GDPR guidelines, restrict access, anonymize patient data, and use secure
systems with audit trails to protect confidentiality.
Q: A site is not responding to your queries — what would you do?
I would send reminders, escalate to the project manager or CRA, and document all
communication to maintain transparency.
Q: How do you handle missing or incorrect data entries?
I raise a query to the site, verify corrections, and ensure updates follow audit trail and
documentation requirements.
Q: Why do you want to work in Clinical Data Management?
I am interested in combining my pharmacy knowledge with data quality and analysis. CDM
ensures accurate data that protects patient safety and supports research outcomes.
Q: How does your pharmacy background help in this role?
It gives me understanding of medical terminology, drug mechanisms, and adverse events,
which helps in accurate data review and medical coding.
Q: What do you know about clinical trial phases?
Phase I tests safety, Phase II tests efficacy, Phase III confirms results in large populations, and
Phase IV monitors post-marketing safety.
Q: What do you understand by SAE (Serious Adverse Event)?
An SAE is an event that causes death, hospitalization, disability, or is life-threatening. Such
events must be reported immediately for patient safety.
Q: What skills are you developing for this role?
I am improving my knowledge of CDM tools, Excel, medical coding, and GCP principles while
developing strong communication and documentation skills.
