Top 25 Interview Questions and Answers for Clinical Data Management

Introduction

• Welcome message and request for likes and subscriptions.
• Aim: Discuss top 25 interview Q&A for Clinical Data Management (CDM).

1. What is Clinical Research?

• Branch of healthcare science determining the safety and efficacy of medications, devices, diagnostic products, and treatments for human use.
• Difference between clinical research and clinical practice.

2. What is Clinical Data Management?

• Process of handling data from clinical trials.
• Goal: Produce and maintain quality data.

3. What do CDM Professionals Do?

• Maintain accurate, clean, and consistent patient data for regulatory reporting.

4. Phases of Clinical Trials

• Phase 1: Human Pharmacology trial.
• Phase 2: Therapeutic Exploratory trial.
• Phase 3: Therapeutic Confirmatory trial.
• Phase 4: Post-marketing Surveillance trial.

5. What is IND (Investigational New Drug)?

• Agent tested in a clinical trial.

6. What is ICH GCP?

• ICH: International Council on Harmonization.
• GCP: Good Clinical Practice, an international ethical and scientific quality standard.

7. What is Informed Consent (ICF)?

• Process of learning key facts about a clinical trial before deciding to participate.
• Ongoing process to provide information to participants.

8. Who Sponsors Clinical Trials?

• Sponsored/funded by organizations like physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies, federal agencies (NIH, DoD, VA).

9. What is a Protocol?

• Study plan for all clinical trials safeguarding participants' health and addressing research questions.
• Describes eligible participants, schedule of tests/procedures, medications, dosages, and study length.
• Separate video available on protocol understanding.

10. What is CRF (Case Report Form)?

• Specialized document in clinical research for collecting study-specific data.
• Can be electronic or paper copy.

11. Examples of Case Report Forms

• Medical history, ECG, labs (hematology, chemistry, thyroid, serology), demographics, physical examination, adverse events, vital signs (BP, heart rate).

12. What is Adverse Event and Adverse Drug Reaction?

• Adverse Event: Unexpected medical problem during treatment, can be mild, moderate, or severe.
• Adverse Drug Reaction: Noxious and unintended response to a medicinal product.

13. What is Placebo?

• Inactive substance used for comparisons in clinical studies to isolate the study treatment effect.

14. Stages of CDM

• Divided into three stages: Study startup, study conduct, study closeout.
• Separate detailed video available.

15. Daily Routine as a CDM Professional

• Process clinical data, verify entries, develop data questions, monitor staff work, resolve entry issues.

16. What is PK/PD?

• PK (Pharmacokinetics): Movement of drugs through the body (ADME: Absorption, Distribution, Metabolism, Excretion).
• PD (Pharmacodynamics): Body's biological response to drugs.

17. What is Discrepancy Management?

• Systematically addresses discrepancies within a clinical study/trial.
• Identify cause, assess error, take appropriate action, resolve or route discrepancy.

18. How to Identify Discrepancy?

• Clarify with prescriber; send a query to site personnel or email.

19. What is Subject Status Report?

• Identifies if subject has completed, withdrawn, experienced death, or is ongoing in the study.

20. What is SAE Reconciliation?

• Process ensuring adverse events in clinical and safety databases match.
• Performed periodically during clinical trial.

21. What is a Source Document?

• Document where data collected for a clinical trial is first recorded.
• Entered later into CRF (Case Report Form).

22. Databases for CDM Activities

• Medidata Rave, Inform, Oracle Clinical, ClinTrial.

23. What is Freezing of Data?

• Revoking rights to modify database; no changes added, deleted, or modified.

24. What is Database Lock?

• After all data cleaning and verifying accuracy, revoke user access to prevent changes.
• Difference from freeze: freeze allows some access, lock prevents all access.

25. Coding Dictionaries Used in CDM

• MedDRA: For coding adverse events and medical history.
• WHO Drug Dictionary: For coding medications.

Conclusion

• Summary of the main topics discussed.
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