Database design in the context of Clinical Data Management (CDM) is a crucial aspect of organizing and managing clinical trial data effectively and efficiently. A well-designed database ensures that data collected during a clinical trial is accurate, consistent, and accessible, facilitating data analysis, reporting, and regulatory submissions. Clinical Data Management involves various steps, including data collection, validation, cleaning, and reporting

1. Welcome
Database Designing in Clinical Data Management
Rimpa Pandit
M. Pharmacy
158/082023
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
1

2. Index
• Introduction
• Stages of Clinical Data Management
• Key aspects of CDM
• What is CRF
• eCRF
• Database Design
• Database Development
• Clinical Data Management Process
• Future trends
• Conclusion
• Reference
10/18/2022 www.clinosol.com | follow us on social media
@clinosolresearch
2

3. Introduction
• Clinical Data Management is the collection, integration and
validation of clinical trial data. During the clinical trial, the
investigator collect the data on the patients health for a defined
time period.
• Clinical Data Management (CDM), or Clinical Data Management
System (CDMS), is used in clinical research to manage the data of
a clinical trial.
• CDM plays a crucial role in evaluating the safety and
effectiveness of drugs, diets, medical devices, digital
therapeutics tools, and other types of treatment, diagnosis, or
methods to prevent health problems. If properly handled, it
significantly reduces time required for a new medical product
launch.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
3

4. Stages of Clinical Data Management
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
4

5. Key aspects of CDM
 Data Collection and Entry
 Data Validation and Quality Control
 Database Design and Maintenance
 Data Cleaning
 Data Security and Compliance
 Data Audits and Inspections
 Reporting and Analysis
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
5

6. What is CRF?
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
6
A case report form (CRF) is a printed, optical, or
electronic document designed to record all
protocol-required information on each subject in a
clinical research study.
The CRF facilitates complete and standardized
data collection that promotes efficient processing,
analysis, and reporting of information, as well as
exchange of data across sites and to the
Sponsor/Principal Investigator/Data Coordinating
Center. Investigators are encouraged to modify
the CRFs to meet the needs of each particular
research study.

7. eCRF
 An eCRF (electronic case report form) is a digital questionnaire
that is used to collect data about a clinical study and research
participants.
 The data collected in eCRFs is what biostatisticians analyze to
draw a conclusion from a study.
 eCRFs allow detailed data collection at distinct times. It follow
standards for data exchange and compliance.
 It standardize data storage for research and clinical care. It
support transparency by providing real time access to data.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
7

8. Database Design
Data from clinical trial will be collected and stored in CDMS. A database is
simply a structured set of data. A clinical trial database is a set of data
collected during the study and organized in rows and columns.
The database incorporates a questionnaire schema of the case report forms.
SOME DATABASE MANAGEMENT SYSTEM (DBMS):
1. QAData CDMS
2. MS Access
3. Oracle
4. Clintrial
5. Medidata Rave
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
8

9. Database Development
• A database should be designed to facilitate data entry and the extraction of data for analysis.
Database development includes databases design and database edit check specifications.
• In practice, for a given clinical trial, to facilitate data entry and the extraction of data for analysis, a
protocol-specific database is set up using standard templates (e.g., modules and format libraries or
data dictionaries) where available.
• The use of standard templates enhances the efficiency of the database development process and
facilitates subsequent aggregation of the data.
• Once the applicable standard templates are identified, the protocol-specific database can be built by
creating the following associated structures of
 Data entry screens, which are identical to CRFs
 Test data
 Derived variables
 Data validation routines; and
 Audit trial
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
9

10. Clinical Data Management Process
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
10

11. Future trends
 Integration of AI and machine learning for
data analysis.
 Handling big data in clinical research.
 Evolving regulations and their impact on
database design.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
11

12. Conclusion
Clinical data management systems have benefitted from technological advancements,
which have produced encouraging results in terms of data generation speed and quality.
There is a gradual transition from paper-based to electronic systems for CDM processes to
match the expectations of pharmaceutical companies and regulatory agencies for
generating high-quality data for reliable evaluation of drugs, biologics, and medical
devices.
A properly designed database provides with access to up-to-date, accurate information. It
helps to share data quickly, effectively, and securely across an organization.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
12

13. Reference
https://research.uic.edu/compliance/human-subjects-irbs/qip/case-report-forms-crf/
https://www.linkedin.com/pulse/clinical-data-management-fundamental-steps-involved-trials-
worksure
https://www.egnyte.com/guides/life-sciences/ecrf
https://www.altexsoft.com/blog/clinical-data-management/
https://www.pharma-iq.com/
https://en.m.wikipedia.org/wiki/Clinical_data_management#
https://images.app.goo.gl/HJND4BMvJedu8akN7
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
13

14. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
14