The document outlines key interview preparation questions related to Clinical Data Management (CDM), including definitions, importance, phases, and common tools used. CDM ensures data quality and integrity through structured processes, consisting of setup, conduct, and close-out phases which include essential activities such as data entry and protocol adherence. Additionally, it emphasizes the critical role of a protocol in guiding the research process and maintaining the integrity of data collection and analysis.

1. Interview Preparation Questions
Clinical Data Management
PART-1

2. INDEX
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2
3
4
5
1.Define CDM.
2.What is the importance of CDM?
3.What are the different databases used for
CDM?
5.What is the protocol? Explain its importance
in CDM.
4.What are the different phases of CDM?

3. CDM is a process in which the clinical
data is collected,validated, reconciled
and archived as per GCP and applicable
regulatory requirements.
Define Clinical Data Management.

4. Clinical research studies provide crucial
information. Clinical data
management provides:
•Assurance of data quality
•Accelerated development
•Protection from data loss
•Complete and accurate collection of data
•Assurance of data integrity and quality
during database transfer
•True representation of the trial in the study
database
What is the importance of CDM?

5. Commonly used CDM tools are
1.ORACLE CLINICAL,
2. CLINTRIAL,
3. MACRO,
4. RAVE,
5. eClinical Suite.
• In terms of functionality, these software tools
are more or less similar and there is no
significant advantage of one system over the
other.
What are the different databases used
for CDM?

6. Three phases in CDM –
• Setupphase
• Conductphase
• Closeoutphase
1. Set-up phase–Set up phase will contain protocol review,CRF
design and edit check,auto query,and creation testing of edit
check.
2. Conduct phase–The conduct phase will contain data entryand
discrepancy management, lab recollection, SAE reconciliation,
and medicalcoding.
3. Close-out phase – Theclose-outphasewillcontainfreezing,
locking,andunlocking.
What are the different phases of CDM?

7. •A Protocol is a document that describes the
objective(s),design,
methodology,statistical considerations,and organization of a
trial.
• Protocol serves as a comprehensive document that provides
guidance for all parties involved in the research process,
including investigators, study coordinators, data managers,
and regulatory authorities.
Here's why protocols are important in CDM:
•The protocol defines the study design,including the research
questions, hypothesis, and objectives. It outlines the study’s
specific aims and provides a clear road map for data collection
and analysis.
What is the protocol?Explain its importance in
CDM.

9. Acheivements-
2023