CDM Interview Question Part I is a comprehensive guide designed to help candidates prepare for interviews in the field of Clinical Data Management (CDM). This resource covers a wide range of commonly asked interview questions and provides detailed explanations and tips on how to approach each question effectively. Whether you are a fresh graduate or an experienced professional looking to advance your career in CDM, this guide offers valuable insights into the interview process and equips you with the knowledge and confidence to excel in your interviews. It covers various aspects of CDM, including data collection, data cleaning, data validation, data standards, regulatory compliance, and more.

1. Interview Preparation Questions
Clinical Data Management
16-06-2023 www.clinosol.com | info@clinosol.com 1
Part I
Prepared By:-
Ankita Kumari
M. Pharm
Clinosol Student ID-026/022023

2. 16-06-2023 www.clinosol.com | info@clinosol.com 2
Define CDM.
1
What is the importance of CDM?
2
What are the different databases used for CDM?
3
What are the different phases of CDM?
4
What is the protocol? Explain its importance in CDM.
5
What is the time and event schedule?
6
What is the difference between paper CRF and eCRF?
7
Explain any 5 forms.
8
What are standard forms? Give some examples of a standard form.
9
What are repeating forms?
10

3. 1. Define Clinical Data Management.
16-06-2023 www.clinosol.com | info@clinosol.com 3
CDM is a process in which the clinical data is collected, validated,
reconciled and archived as per GCP and applicable regulatory
requirements.

4. 2. What is the importance of CDM?
16-06-2023 www.clinosol.com | info@clinosol.com 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

5. 3. What are the different databases used for CDM?
16-06-2023 www.clinosol.com | info@clinosol.com 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.

6. 4. What are the different phases of CDM?
16-06-2023 www.clinosol.com | info@clinosol.com 6
Three phases in CDM –
Set up phase
Conduct phase
Closeout phase
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 entry and
discrepancy management, lab recollection, SAE reconciliation,
and medical coding.
3. Close-out phase – The close-out phase will contain freezing,
locking, and unlocking.

7. 5. What is the protocol? Explain its importance in
CDM.
.
16-06-2023 www.clinosol.com | info@clinosol.com 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 roadmap for data collection and
analysis.

8. 6. What is the time and event schedule?
16-06-2023 www.clinosol.com | info@clinosol.com 8
In a clinical trial, a tabular representation of sequentially
planned protocol events and activities is called a Schedule of
Assessments.
The protocol should clearly outline the activities that are to be
performed for the research study. This includes a plan for the
administration of study treatment and a list of assessments and
procedures that are to be performed for the duration of the
study.

9. 7. What is the difference between paper CRF and
eCRF?
16-06-2023 www.clinosol.com | info@clinosol.com 9

10. 8. Explain any 5 forms.
16-06-2023 www.clinosol.com | info@clinosol.com 10
Different forms are:-
1. Demographic form-This form includes demographic details of a
subject like age, gender, date of birth, race, height etc.
2. Medical history forms- This includes the previous medical
history of subjects like MH start date, MH ongoing, Is MH being
treated, ICF signed or not etc.
3. Inclusion/exclusion criteria form- This form includes has subject
met all inclusion and exclusion criteria, Inclusion criteria,
exclusion criteria.
4. Lab form- This form includes test sample details like sample
type, specimen ID etc.
5. Vital signs form- This form includes blood pressure, heart rate,
temperature, pulse, weight etc.

11. 9. What are standard forms? Give some examples of
a standard form.
16-06-2023 www.clinosol.com | info@clinosol.com 11
Standard forms – standard forms are those which will be used for
all studies.
Example of the standard form includes the
Demographic form, Medical history form, Vital signs form, Lab,
ECG, Pregnancy, Inclusion/exclusion form, AE form, and Disposition
form.

12. 10. What are repeating forms?
16-06-2023 www.clinosol.com | info@clinosol.com 12
Repeating forms are those forms that allow site users to
collect multiple instances of the same data.
E.g. Adverse event form.
Concomitant medication form etc.

13. Thank You!!
To get regular updated
content, events and
learning opportunities
from us,
connect/follow/subscribe
to us at
@clinosolresearch
16-06-2023 www.clinosol.com | info@clinosol.com 13