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Clinical Data Management Overview

The document outlines key concepts and questions related to Clinical Data Management (CDM), including its importance, the lifecycle of clinical trials, and data management processes. It covers various terms such as Case Report Forms (CRF), Adverse Events (AE), and database lock, as well as the roles of Clinical Data Managers and tools used in CDM. Additionally, it addresses data quality assurance, discrepancy management, and medical coding in the context of clinical trials.

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shalini rudresh
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64 views3 pages

Clinical Data Management Overview

The document outlines key concepts and questions related to Clinical Data Management (CDM), including its importance, the lifecycle of clinical trials, and data management processes. It covers various terms such as Case Report Forms (CRF), Adverse Events (AE), and database lock, as well as the roles of Clinical Data Managers and tools used in CDM. Additionally, it addresses data quality assurance, discrepancy management, and medical coding in the context of clinical trials.

Uploaded by

shalini rudresh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Test :- Clinical Data Management

1. What is Clinical Data Management, and why is it


important?
Ans:

2. Can you describe the lifecycle of a clinical trial?


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3. What is CRF?
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4. explain the basic steps involved in the data


management process for a clinical trial?
Ans:

5. How do you ensure data quality and integrity


throughout the clinical trial?
Ans:

6. What are the roles of Clinical Data Manager?


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7. What is AE and SAE?


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8. What are the 3 steps of CDM? And explain them.


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9. How to manage data discrepancies in clinical


trials?
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10. What is MedDRA?


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11. What is database lock in clinical data


management?
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12. Explain objectives of CDM.


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13. Give some examples for cdm tools used in
Clinical Data Management Systems (CDMS).
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14. Explain edit checks.


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15. What is Medical Coding?


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16. What is DCF?


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17. What is the role of Medical Coding in CDM?


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18. What is Data Capture and explain the tools.


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