DH308: NIRMAL PUNJABI

DH 308 – Class 1
04th January 2023

Clinical Data
Management
- Nirmal Punjabi, Ph.D.

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

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Today’s Agenda
• Class Introductions • Course Administrative:
• Pre-requisites
• Grading system
• Introduction to ‘Clinical Data • Reference Materials
Management’
• Groups
• Teams platform
• Objective of the course
• Topics to be covered

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Class Meet and Greet

• Name
• Year & Program (UG/Masters/Ph.D.)
• Department
• What sparks your interest in the course topic?
• Optional: Any example of Clinical Data?

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Introduction to
Clinical Data Management
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Etymology of Course Name

CLINICAL DATA MANAGEMENT

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Introduction to Clinical Data Management

Clinical Clinical
• From Merriam-Webster Dictionary:
• “of, relating to, or conducted in or as if in a clinic: such as
• involving direct observation of the patient
• based on or characterized by observable and diagnosable
symptoms”
• Other meanings:
• Objective; Precise; Analytical

• Source: Clinic (Eng.) – Clinique (French) – Klinike (Greek)

• “Medical practice at the sickbed”

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Image Reference: https://ocrc.net/;
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Introduction to Clinical Data Management

Data Data
• From Merriam-Webster Dictionary:
• “factual information (such as measurements or statistics) used
as a basis for reasoning, discussion, or calculation”

• Source: datum (Eng.) – Datus (Latin)

• “given; offered; yielded”

• Classification
• Signal / Information
• Noise / Background
• Type: Depends on the situation

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Image Reference: Wikipedia ‘Data’;
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Introduction to Clinical Data Management

Management Management
• From Merriam-Webster Dictionary:
• “the act or art of managing : the conducting or supervising of
something (such as a business)”
• “judicious use of means to accomplish an end”

• Source: manage (Eng.) - manege (English) – Maneggio (Italian) –

maneggiare (Italian) - manus (Latin)
• “horsemanship” - “to handle, touch” - hand

• Start / Creation – Maintenance – End / Transform

• Processes / Regulations / Protocols

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Introduction to Clinical Data Management

Clinical Data Management

“Management of Clinical Data”

Clinical Data Management= Clinical Data + Data Management
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10-01-2023 Image Ref: https://ocrc.net/; Wikipedia ‘Data’; https://trendythingy.in/
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Clinical Data
Sources, Types, Significance
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Clinical Data
• Data generated from Clinical Research/Studies/Trials

• Clinical Research
• Patient-oriented research
• Epidemiological studies

10-01-2023 Source: US FDA 11

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Clinical Research
• To understand the effect of drug
/ medicine / vaccine
• New
• Repurposing

• Example:
• Testing for anti-malarial drug for
covid19 patients.

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Image Reference: Volkmann et al, 2020. https://doi.org/10.1371/journal.pone.0241497
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Clinical Research
• To check the effectiveness of
medical device.
• Diagnosis
• Treatment
• Functional

• Example:
• Use of UV-light endoscope as
covid19 treatment
• Brain-Computer Interface chip to
improve control for Alzheimer
patients.

10-01-2023 Image Reference: https://neuralink.com/approach/ 13

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Clinical Research
• Validation of diagnostic tests

• Example:
• Breath Analyzer as replacement
to conventional blood tests

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Image Reference: https://breathonix.com/
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Clinical Research
• To understand the mechanism
of disease progression.

• Example:
• New variants infection
pathways.

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Image Reference: Hosseini et al, DOI: https://doi.org/10.1016/j.virol.2020.08.011 Virology, 2020
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Clinical Research
• Preclinical (in vitro)

• Preclinical (in vivo)

• Clinical Trials

• Exclusions:
• Only on tissues/organ in vitro and
without mapping it to patient.

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Image Reference: Dobrovolskaia, 2013; https://doi.org/10.1016/j.jconrel.2013.05.025
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Clinical Trials (Phases)

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Examples of Clinical Trials

• WHO's Solidarity Plus trial

• 52 countries involved (as
of 2nd January 2023)
• 14200 hospitalized
patients
• 600 hospitals
• 2000 researchers
• Total : 7 drugs (4
repurposed & 3 now)

10-01-2023 Image Reference: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial- 18

for-covid-19-treatments
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Examples of Clinical Trials

• Recovery Trial
• 48348 Participants (as of 3rd January 2023)
• 200 sites in UK & some international sites
• Testing treatments for COVID-19 and Influenza

• The RECOVERY Trial is registered at ISRCTN50189673

• EU Clinical Trials Register: EudraCT 2020-001113-21
• Clinical Trials.gov: NCT04381936

• Randomised, Embedded, Multifactorial Adaptive Platform Trial for

Community-Acquired Pneumonia (REMAP-CAP; NCT02735707)
• 10000 participants (estimated as on 3rd January 2023)

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Clinical Data Types/Sources

Basic
Parameters

Other
Clinical
Pathology
medical
instruments
Data Tests

Source

Medical
Imaging

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Conventional: Case Report Forms (Paper

forms)

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Challenges with Clinical Data

• Large data sets

• Interdependent parameters

• Confounding factors

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Challenges with Clinical Data

• Large data sets

• Interdependent parameters

• Confounding factors

• Long life cycle

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Data Management
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Generation / Collection
Representation
Formatting
Documentation
Data Quality Control
Life-Cycle Transformation
Access and sharing
Security & Back-up
Archiving

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Clinical Data Management

Clinical Data + Data Management

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Clinical Data Management

• Data Planning
• Case report form (CRF) design,
• Clinical trials database design and programming
• Data standards,
• Data acquisition,
• Data integration into the clinical trials database,
• Data review for quality control
• Database creation and maintenance
• Regulations
• Audit trails

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Clinical Data Management

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Standard Tools for Clinical Research Data

Capture

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Objective of the course

• Overview of the domain of Clinical Data Management
• Why is it needed?
• Where is it applicable?

• Provide understanding of the process of Clinical Data Management

• Study Startup
• Study Conduct
• Study Close Out

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Course Contents
• Background: Clinical Trials, Technical Terms, Medical Data Types
• Different Domains
Section 1 • Clinical Trials
• Medical Terms
• Study Start up - Data Planning: Hypothesis, Validated Instruments, CRF • Planning
design, eCRF design, Defining codes/rules, SOPs; Building / selecting
Section 2 databases, Testing Databases • Research Planning
• Human Factors Design
• Study Conduct: Data retrieving, Data cleaning, Documentation of Adverse • Protocols
events,
Section 3 • Error mitigation
• Database selection
• Study Close Out: Data validation & lock, Send for Analysis
• Data-types
Section 4 • Regulations in Practice
• HIPAA
• Future application: Role of AI/ML in clinical trials
• CFR 21, 11
Section 5 • Bio-statistics
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Pre-requisites
• None
• Ready to catch up with new jargons across domains
• Data collection tools/forms

• Good to know:
• Basic understanding of common health parameters (Blood pressure, Heart
rate, etc.)
• Basic understanding of medical data from X-Ray, CT scan, ECG,

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Grading system *
• Assignments (Individual): 15 %
• Quiz: 10 %
• Course Project/Group Assignment: 20 %
• Mid-Sem: 25%
• End-Sem: 30 %

• Attendance/Class interaction (expected): ≥ 70%

* Tentative
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Microsoft Teams for communication

• For Assignments / Online class / Discussions / Updates

• Teams code to join ‘DH308 Clinical Data Management 2023’

•tee4jwj

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Class Schedule for January

• Wednesday and Friday: 11:05am to 12:30 pm

• Exception:
• 20th January (Friday) : No class
• 21st January (Saturday): 11:05 am to 12:30 pm.

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Discussion / Doubts / Ideas / Feedback session

• Every Alternate Saturday from 11 am to 12 noon
• Optional & Online on Teams

• Schedule for January

• 7th January 2023
• 28th January 2023

• In-person meeting:
• E-mail me ([email protected]) to schedule.
• Schedule for January:
• 7th January
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References
• Susanne Prokscha - Practical Guide to Clinical Data Management, CRC
Press
• Jay Herson - Data and Safety Monitoring Committees in Clinical Trials-
Chapman and Hall, CRC Press.
• Richard K. Rondel, Sheila A. Varley, Colin F. Webb - Clinical Data
Management, Wiley
• Clinical Data Interchange Standards Consortium (CDISC) website
• WHO Good Clinical Research Practice
• US FDA resources
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Clinical data : Primarily data generated

during Clinical Trials or Clinical Research
Studies

Data Management Cycle: From Collection

to Archiving

Summary
Clinical Data Management Scope

Plan for the course

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Thank you

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