50
INTERVIEW Q&A FOR
CLINICAL DATA MANAGER
(CDM)
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been taken in the preparation of this work, neither the author nor the publisher shall have any liability to any person or entity
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book.
Brindha Chandrasekaran
01
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS CLINICAL DATA MANAGEMENT
(CDM)?
Clinical Data Management is the process of
collecting, cleaning, and managing clinical
trial data to ensure accuracy, completeness,
and compliance with regulatory
requirements.
Brindha Chandrasekaran
02
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHY IS CLINICAL DATA MANAGEMENT
IMPORTANT IN CLINICAL TRIALS?
It ensures data integrity, regulatory
compliance, and reliable results, which are
essential for drug approval and patient
safety.
Brindha Chandrasekaran
03
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE THE KEY PHASES OF CLINICAL
DATA MANAGEMENT?
Study setup
Data collection
Data validation
Data cleaning
Database lock
Brindha Chandrasekaran
04
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE THE REGULATORY
GUIDELINES FOLLOWED IN CDM?
ICH-GCP (International Council for
Harmonisation – Good Clinical Practice)
FDA 21 CFR Part 11
EMA guidelines
CDISC standards
Brindha Chandrasekaran
05
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS THE ROLE OF A CLINICAL DATA
MANAGER?
A Clinical Data Manager oversees data
collection, validation, and cleaning,
ensuring data quality and compliance with
regulations.
Brindha Chandrasekaran
06
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS AN ELECTRONIC DATA CAPTURE
(EDC) SYSTEM?
An EDC system is software used to collect,
manage, and store clinical trial data
electronically.
Brindha Chandrasekaran
07
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
NAME SOME COMMONLY USED EDC
TOOLS.
Medidata Rave
Oracle Clinical
Veeva Vault EDC
REDCap
OpenClinica
Brindha Chandrasekaran
08
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE THE ADVANTAGES OF USING
AN EDC SYSTEM OVER PAPER-BASED
DATA COLLECTION?
Faster data entry
Reduced errors
Real-time data access
Improved compliance
Brindha Chandrasekaran
09
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A CASE REPORT FORM (CRF)?
A CRF is a document used in clinical trials to
collect patient data as per study protocol.
Brindha Chandrasekaran
10
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS THE DIFFERENCE BETWEEN
ECRF AND PAPER CRF?
eCRF: Electronic Case Report Form used
in EDC systems
Paper CRF: Physical document used for
manual data collection
Brindha Chandrasekaran
11
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DATA VALIDATION IN CDM?
It is the process of ensuring collected data
is accurate, complete, and consistent with
protocol requirements.
Brindha Chandrasekaran
12
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE EDIT CHECKS IN CDM?
Edit checks are automated validations that
identify errors, inconsistencies, or missing
values in the dataset.
Brindha Chandrasekaran
13
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A DATA QUERY?
A Data Query is a request sent to the site to
clarify or correct incorrect or missing data.
Brindha Chandrasekaran
14
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DATA DISCREPANCY
MANAGEMENT?
It involves identifying, tracking, and
resolving discrepancies in clinical trial data.
Brindha Chandrasekaran
15
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS THE PURPOSE OF A DATA
CLEANING PLAN?
It outlines procedures for identifying and
correcting data errors before database lock.
Brindha Chandrasekaran
16
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS 21 CFR PART 11?
A US FDA regulation that ensures electronic
records and signatures are trustworthy,
reliable, and equivalent to paper records.
Brindha Chandrasekaran
17
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS CDISC IN CLINICAL DATA
MANAGEMENT?
The Clinical Data Interchange Standards
Consortium (CDISC) provides standardized
formats for clinical trial data submission.
Brindha Chandrasekaran
18
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS SDTM IN CDM?
Study Data Tabulation Model (SDTM) is a
CDISC standard for structuring clinical trial
data for regulatory submission.
Brindha Chandrasekaran
19
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS ADAM IN CDM?
Analysis Data Model (ADaM) is a CDISC
standard used for preparing datasets for
statistical analysis.
Brindha Chandrasekaran
20
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS ICH-GCP?
A set of international guidelines ensuring
the ethical and scientific quality of clinical
trials.
Brindha Chandrasekaran
21
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A CLINICAL DATABASE?
A secure system used to store and manage
clinical trial data.
Brindha Chandrasekaran
22
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DATABASE LOCK IN CLINICAL
TRIALS?
The process of finalizing the database by
preventing further changes to the data
before statistical analysis.
Brindha Chandrasekaran
23
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS SOFT LOCK VS. HARD LOCK?
Soft Lock: A temporary lock allowing
minor changes before final submission
Hard Lock: A permanent lock
preventing any further modifications
Brindha Chandrasekaran
24
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DATA FREEZE?
A process where data is temporarily locked
to conduct interim analyses.
Brindha Chandrasekaran
25
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE THE KEY STEPS BEFORE
DATABASE LOCK?
Data cleaning
Query resolution
Reconciliation of discrepancies
Quality checks
Brindha Chandrasekaran
26
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS MEDICAL CODING IN CDM?
The process of standardizing adverse
events, medications, and diseases using
dictionaries like MedDRA and WHODrug.
Brindha Chandrasekaran
27
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS ADVERSE EVENT (AE)
RECONCILIATION?
Ensuring reported adverse events in clinical
data match those in safety databases.
Brindha Chandrasekaran
28
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A DATA MANAGEMENT PLAN
(DMP)?
A document outlining procedures for data
collection, validation, and cleaning.
Brindha Chandrasekaran
29
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A CLINICAL STUDY REPORT
(CSR)?
A detailed report summarizing clinical trial
results submitted to regulatory agencies.
Brindha Chandrasekaran
30
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A DATA REVIEW MEETING?
A meeting where data issues, discrepancies,
and queries are discussed before database
lock.
Brindha Chandrasekaran
31
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE COMMON DATA QUALITY
ISSUES IN CDM?
Missing data
Inconsistent values
Duplicate entries
Protocol deviations
Brindha Chandrasekaran
32
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
HOW DO YOU HANDLE MISSING DATA IN
CLINICAL TRIALS?
Querying the site
Imputation methods
Sensitivity analysis
Brindha Chandrasekaran
33
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DUPLICATE DATA, AND HOW IS
IT PREVENTED?
Duplicate data occurs when the same
information is entered multiple times; it is
prevented by automated checks and
manual review.
Brindha Chandrasekaran
34
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS SOURCE DATA VERIFICATION
(SDV)?
The process of checking CRF data against
source documents for accuracy.
Brindha Chandrasekaran
35
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS RISK-BASED MONITORING
(RBM)?
A monitoring approach focusing on high-
risk areas to improve efficiency and data
quality.
Brindha Chandrasekaran
36
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DATA ANONYMIZATION IN
CDM?
The process of removing personally
identifiable information to protect patient
confidentiality.
Brindha Chandrasekaran
37
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS METADATA IN CDM?
Data that provides other information about
the data, such as field names and variable
descriptions.
Brindha Chandrasekaran
38
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS REAL-WORLD DATA (RWD) IN
CDM?
Data collected outside clinical trials, such
as electronic health records (EHRs) and
patient registries.
Brindha Chandrasekaran
39
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A PROTOCOL DEVIATION?
Any instance where trial procedures differ
from the approved protocol.
Brindha Chandrasekaran
40
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DATA STANDARDIZATION IN
CDM?
The process of structuring data according to
regulatory and industry standards like
CDISC.
Brindha Chandrasekaran
41
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE THE KEY SKILLS REQUIRED
FOR A CLINICAL DATA MANAGER?
Knowledge of clinical trial regulations
Data analysis skills
Proficiency in EDC tools
Attention to detail
Brindha Chandrasekaran
42
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS THE FUTURE OF CLINICAL DATA
MANAGEMENT?
Increased use of AI & automation
Integration of real-world data
Cloud-based data management systems
Brindha Chandrasekaran
43
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS THE ROLE OF ARTIFICIAL
INTELLIGENCE IN CDM?
AI helps automate data validation, anomaly
detection, and query resolution.
Brindha Chandrasekaran
44
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DATA INTEGRITY IN CDM?
The accuracy, consistency, and reliability of
data throughout its lifecycle.
Brindha Chandrasekaran
45
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT ARE THE CAREER OPPORTUNITIES
IN CLINICAL DATA MANAGEMENT?
Clinical Data Coordinator
Clinical Data Analyst
Data Manager
CDM Lead
Brindha Chandrasekaran
46
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS AUDIT TRAIL IN CDM?
A record of all data changes in an EDC
system for compliance tracking.
Brindha Chandrasekaran
47
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS DOUBLE DATA ENTRY?
A method where two people enter the same
data independently to check for
discrepancies.
Brindha Chandrasekaran
48
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS PATIENT-REPORTED OUTCOME
(PRO)?
Data directly reported by the patient about
their health condition.
Brindha Chandrasekaran
49
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS A DATA CUT?
Extracting a dataset for analysis at a
specific time point.
Brindha Chandrasekaran
50
50 INTERVIEW QUESTIONS FOR CDM
(CLINICAL DATA MANAGER)
WHAT IS THE PURPOSE OF A CLINICAL
TRIAL MASTER FILE (TMF)?
It contains essential documents that allow
trial conduct evaluation and compliance
verification.
Brindha Chandrasekaran
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