Clinical Data Management - Class 4

DH308: NIRMAL PUNJABI
DH 308 – Class 4
13th January 2023
Clinical Data
Management
- Nirmal Punjabi, Ph.D.
Welcome to the course. We will start at 11:05 am.

Today’s Agenda (Class 4)

• Revisit Class 3 Class 4:
• Clinical Trials • Background
• Phases
• Clinical Data
• Terminology
• Source
• Why?
• Types
• Data v/s Outcome
• Clinical Data
• Clinical Trials Database
• Vital Parameters
• Study Startup
• Clinical Data Planning
13-01-2023 2
Clinical Data
Types, Information, Source
13-01-2023 3
Clinical Data Types/Sources

Basic
Parameters
Other
Clinical
Pathology
medical
instruments
Data Tests
Source
Medical
Imaging
13-01-2023 4

• Basic Parameters
• Individual Specific
• Age / Height / Weight / Sex / Gender / Color
• Current Physical / Mental status
• Medical History
• Doctor’s notes
• Prescriptions
• Ethnicity
• Occupation / Lifestyle
• Address/Region
13-01-2023
Image Reference: 5

• Pathology Lab Data
13-01-2023
6
Image Reference:
• Medical Imaging
• Modalities
• X-Ray
• Computed Tomography (CT)
• Positron Emission Tomography (PET)
• Magnetic Resonance Imaging (MRI)
• Ultrasound
7
13-01-2023
Image Reference:www.mdbonedocs.com;

• Medical Imaging
• Tumors / Lesions / Implant
• Size / Shape / Count
• Time dependent Images

• PET scan monitoring movement and
uptake of dyes.
8
13-01-2023 Image Reference:www.mdbonedocs.com;

• Medical Imaging
• Example
• CT Severity score (0-25)
• Video
• Cardiac Ultrasound
9
13-01-2023 Image Reference:www.mdbonedocs.com;

• Electro cardiogram (ECG)
13-01-2023
Image Reference: www.brainkart.com; www.liftl.com 10
ECG basics: Cardiac Electrophysiology
13-01-2023 11 Image Reference:

ECG basics: Cardiac Electrophysiology

• ECG
• ECG signal
• Limb Leads
• Einthoven’s Triangle
• Chest Leads
13-01-2023 Image reference: https://link.springer.com/article/10.1007/s10462-021-09999-7; https://geekymedics.com/understanding-an-ecg/;

12
https://ecgwaves.com/topic/ekg-ecg-leads-electrodes-systems-limb-chest-precordial/
Health basics: Cardiovascular

Cardiac disorders
• Important parameters
• Blockage
• Heart muscle damage
• Movements
• Sound
• ECG signal
• Shape
13-01-2023 Image Reference: https://ib.bioninja.com.au/options/option-d-human-physiology/d4-the-

13
heart/electrocardiography.html

Cardiac disorders
• Important parameters
• ECG signal
• Shape
• Blood pressure
• Heart rate
• Oxygen saturation
• Respiratory rate
• Temperature
• …
Image Reference: https://www.mdpi.com/2077-0383/10/22/5450; https://www.sinokmed.com/blogs/news/what-is-the-spo2-sensor;
13-01-2023 https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/diagnosis-treatment/drc-20373417;
14
https://www.health.harvard.edu/heart-health/tips-to-measure-your-blood-pressure-correctly;

•Health basics: Cardiovascular
• ECG signal in wearable
device
• Limb Leads
• Single Lead
• Apple Watch
• LifeSignals Chest Patch
• Multi Lead
• SmartCardia Patch
13-01-2023 Image reference: https://www.smartcardia.com/; https://www.vivalink.com/; https://support.apple.com/en-

15
us/HT208955

•Health basics: Cardiovascular
• ECG signal
13-01-2023 16
Image reference: https://ecgwaves.com/topic/ecg-normal-p-wave-qrs-complex-st-segment-t-wave-j-point/
Clinical Data: Data Types …

• Data Types: • Data Types:
• Quantitative • Tabular Data
• Time Series
• Qualitative • Free Text
• Images & Videos
13-01-2023 17
Clinical Data
Data Types
Qualitative Quantitative
Nominal Ordinal Binary Discrete Continuous
Patient History Number of Hemoglobin

Skin color Pain/Discomfort
(Yes/No) visits level
13-01-2023 18
Clinical Data Types: Practice
13-01-2023 19
Reference: https://www.who.int/tdr/diseases/tuberculosis/case-report-form.pdf
Clinical Data Types: Practice
13-01-2023 20

• Tabular Data
• Rows / Columns
• Dependent and independent
parameters
• Multiple variables
• Example:
• Pathology lab reports
• Time Series
• Same variable over different
time
• Example:
• ECG, EEG, Heart Rate, PPG
13-01-2023 21

• Free Text
• Example:
• Physician Notes, Radiology
reports
• Images and Videos

• Gray Scale / Color
• Example:
• X-ray / CT /
• Thermal Image / fMRI
13-01-2023 22
Clinical Trials Database

• https://clinicaltrials.gov/
• https://ctri.nic.in/Clinicaltria
ls/login.php
• WHO
13-01-2023 23

Clinical Data Management - Class 4

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DH308: NIRMAL PUNJABI

Welcome to the course. We will start at 11:05 am.

Today’s Agenda (Class 4)

Clinical Data Types/Sources

Clinical Data Types/Sources

Clinical Data Types/Sources

Clinical Data Types/Sources

Clinical Data Types/Sources

• Time dependent Images

Clinical Data Types/Sources

Clinical Data Types/Sources

ECG basics: Cardiac Electrophysiology

13-01-2023 11 Image Reference:

ECG basics: Cardiac Electrophysiology

13-01-2023 Image reference: https://link.springer.com/article/10.1007/s10462-021-09999-7; https://geekymedics.com/understanding-an-ecg/;

Health basics: Cardiovascular

13-01-2023 Image Reference: https://ib.bioninja.com.au/options/option-d-human-physiology/d4-the-

Health basics: Cardiovascular

Health basics: Cardiovascular

13-01-2023 Image reference: https://www.smartcardia.com/; https://www.vivalink.com/; https://support.apple.com/en-

Health basics: Cardiovascular

Clinical Data: Data Types …

Nominal Ordinal Binary Discrete Continuous

Patient History Number of Hemoglobin

Clinical Data Types: Practice

Clinical Data Types: Practice

Clinical Data: Data Types …

Clinical Data: Data Types …

• Images and Videos

Clinical Trials Database

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