50

INTERVIEW Q&A FOR

CLINICAL DATA MANAGER
(CDM)

Disclaimer: The information in this book is for informational purpose only, without warranty. Although every precaution has
been taken in the preparation of this work, neither the author nor the publisher shall have any liability to any person or entity
with respect to any loss or damage caused or alleged to be caused directly or indirectly by the information contained in this
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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