DH308: NIRMAL PUNJABI

DH 308 – Class 9
1st February 2023

Clinical Data
Management
- Nirmal Punjabi, Ph.D.

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

 DH308: NIRMAL PUNJABI

Today’s Agenda (Class 9)

• Revisit Class 8 Class 9:
• Clinical Data Planning • Clinical Data Management
• Regulations
• Clinical Data Planning
• India Specific
• Regulatory Requirement in India
• Protocol / Standard
Operating Procedure (SOP)
• Standards
• Data Interoperability
• Common standards / dictionary
• WHO ICD
• SNOMED-CT
• LOINC
• Protocol / Standard Operating
Procedure (SOP)

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Clinical Data
Planning

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Clinical Data Planning

SOP/ Protocol

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Standard Operation Procedure

• “Standard Operating Procedures (SOPs) are detailed, written instructions
which must be followed when performing certain tasks. They are an
essential source for communicating to researchers the agreed, defined
methodology which must be followed to ensure consistency between
researchers and, in multi-centre studies, the consistency between
individual research sites.”
• Helps in compliance with GCP & regulatory requirements
• Good quality trials:
• Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
• Compliance with the study protocol:
• A trial should be conducted in compliance with the protocol that has received prior
institutional review board (IRB)/independent ethics committee (IEC) approval/favorable
opinion.

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Standard Operation Procedure

• Sections: • Good Practices:
• Purpose • Self Explanatory
• Definitions • Understand real world
• Abbreviations challenges
• Procedure • Should not be open-ended
• References • Should be able to
• Document History document changes
(Created, Modified,
Accepted,..) Clear and Unambiguous

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Standard Operation Procedure: For?

Domains for Clinical Data Management:
• Study Start • Data Management & Statistics
• Research Ethics, Equipment, • Database editing/modification
Randomization & Blinding for Trials • Documentation
• Study Conduct • Statistical Analysis Plan
• Informed Consent, • Monitoring & Audit of Trials
• Case Report Forms • Audit guidelines
• Study Close Out • Administration
• Archiving, Publications • Management of SOPs
• Pharmacovigilance & Regulatory • Editing/Updating/New SOPs
• Retention of Health records
• Adverse Events,
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SOP Examples

8
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Clinical Data Planning

Parameters Selection: Challenges

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Clinical Data Planning

• Parameter/Events Selection
• In-line with the hypothesis and clinical research theme
• Should facilitate the statistical analysis plan
• Data points measurement should be feasible

• Baseline data
• Data just before starting the Intervention.
• Reference for comparative study (before v/s after)
• Supporting Conclusion

• Historical data
• Inclusion / Exclusion criteria
• Low Screen Failure Rate

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Image Reference:www.eppo.int
 DH308: NIRMAL PUNJABI

Clinical Data Planning

• Parameter/Events Selection Visit
Target day of visit
Baseline Month 1
30
Month 3
90
Month 6
180
Month 12
360
• Will depend on Outcomes protocol assessment
time windows (days)
+3 +7 + 14 + 14

• Primary History and examination x x x x x

• Secondary Weight x x x x x
• Safety / Adverse Events Vital signs x x x
Hematology x x x x x
Biochemistry x x x x x
• Time sensitive parameters Urinary pregnancy test x

Tumor response x x x x x
Blood samples for x
x x
predictive markers

Concomitant medication x x x x

Administer treatment x
QOL questionnaire x x x x (12 weeks only)
Adverse event
x x x x x
monitoring

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Image Reference:www.eppo.int
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Clinical Data Planning

• Best practice
• Take data in basic form
• CT value in RT-PCR test
• Temperature value
• Blood pressure value
• Blood Glucose level

• Avoid collapsing data

• Avoid converting from quantitative to qualitative

• Define clear parameters to be extracted from high density images for analysis
• Number of tumors
• Size/Area of stones/calcification

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Image Reference:www.eppo.int
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Clinical Data Planning

• Manage code book
• Coding for storage in database
• 1= Yes, 0 = No
• Same codes throughout for similar questions

• 000 = not known

• -555 = not disclosing
• Should NOT match with the range of the fields. For example: Negative number as code in
Age field ( for unknown age)/

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Clinical Data Planning

Case Report Forms

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Case Report Form

• International Council for Harmonisation of technical requirements for
pharmaceuticals for human use (ICH)
• ICH guidelines for Good Clinical Practice (GCP)
• Case Report Form: “A printed, optical, or electronic document designed to
record all of the protocol required information to be reported to the sponsor
on each trial subject”

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Case Report Form design

• To collect data
• According to the ‘protocol’
• Easily Analyzable
• Fit the requirements of statistical analysis plan
• Minimize queries

• Types
• Paper based
• Electronic

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Clinical Data Planning

• Collection strategy
• Paper based forms
• Retrieval
• Manual Entry
• Double entry
(validation)
• Scanning
• With OCR
• Shape
• Text
• Color

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Image Reference: Wikipedia; https://restoringtrials.org/glossary/case-report-form-crf/; www.istock.com
 DH308: NIRMAL PUNJABI

Clinical Data Planning

• Collection strategy (ctd..)
• Electronic record
• Survey forms
• Tools
• Validation

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Image Reference: https://workspace.google.com/products/forms/; www.popularmechanics.com