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Frequently Asked CDM Interview Questions

This document provides a list of crucial interview questions for preparing for a Clinical Data Management (CDM) position. Key topics include the lifecycle of clinical trials, data collection systems, data integrity, compliance regulations, and challenges in CDM. It also emphasizes the importance of coding medical terms and offers hints for answering each question effectively.

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Tanishka Kulkarni
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6 views

Frequently Asked CDM Interview Questions

This document provides a list of crucial interview questions for preparing for a Clinical Data Management (CDM) position. Key topics include the lifecycle of clinical trials, data collection systems, data integrity, compliance regulations, and challenges in CDM. It also emphasizes the importance of coding medical terms and offers hints for answering each question effectively.

Uploaded by

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

TOP CDM
INTERVIEW
QUESTIONS
ARE YOU PREPARING FOR A CLINICAL DATA MANAGEMENT INTERVIEW? HERE ARE
SOME CRUCIAL QUESTIONS YOU SHOULD KNOW!

@PHARMAGEEK
01
QUESTION 1
What is the lifecycle of Clinical Trials, and
how does CDM fit into it?

Hint: Think about the phases of clinical trials


(Phase I-IV) and how data is managed,
cleaned, and locked during each stage.

@PHARMAGEEK
02
QUESTION 2
What are some Data Collection Systems
apart from EDC, and how are they used?

Hint: Consider systems like paper CRFs,


IVRS, or ePRO used to collect data in
specific scenarios.

@PHARMAGEEK
03
QUESTION 3
What is a Soft Lock, and how does it differ
from a Hard Lock?

Hint: Think of data integrity and locking


milestones. Soft Lock is also known as
Freezing.

@PHARMAGEEK
04
QUESTION 4
What is 21 CFR Part 11, and why is it crucial in
clinical data management?

Hint: It’s related to electronic records and


signatures. Think compliance, security, and
validation.

@PHARMAGEEK
05
QUESTION 5
How is UAT (User Acceptance Testing)
performed in CDM systems?

Hint: UAT varies by organization, but the


goal is to ensure every data validation rule
works correctly under all test scenarios
before going live.

@PHARMAGEEK
06
QUESTION 6
How would you handle a situation where a
trial's data has been compromised?

Hint: Think about root cause analysis, risk


mitigation, and communication with
stakeholders

@PHARMAGEEK
07
QUESTION 7
What is the difference between Protocol
Deviation and Protocol Violation?

Hint: Deviation is usually unplanned but


minor; violation impacts study integrity or
safety.

@PHARMAGEEK
08
QUESTION 8
What are the different types of Edit Checks
used in CDM? Provide examples.

Hint: Edit checks validate data


automatically. Refer GCDMP for further
details.

@PHARMAGEEK
09
QUESTION 9
What are the key challenges faced in
clinical data management, and how can
they be resolved?

Hint: Consider data inconsistencies, query


resolution, and system downtimes. Share
examples of how you’ve solved them!

@PHARMAGEEK
10
QUESTION 10
Why is coding medical terms (Medical
Coding) essential in clinical data
management, and what tools are used for
it?

Hint: Focus on standardizing terms like


adverse events (e.g., MedDRA, WHO-DD). It
ensures consistency across trials

@PHARMAGEEK
11
SAURADEEP MITRA

STAY TUNED FOR REGULAR


JOB POSTINGS AND UPDATES.

SHARE YOUR INSIGHTS


AND EXPERIENCES BELOW!

@PHARMAGEEK
SAVE FOR LATER!

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