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Beyond regulatory submission - Standards Metadata Management
Kevin LeeCDISC NJ Meeting at 06/17/2015
We help our Clients deliver better outcomes, so they can improve the quality of people’s lives.
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Agenda
Regulatory Requirement on Clinical Data Standards(i.e., CDISC)
Standards driven process
Standards Metadata Management
Final Thoughts
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Standards?
What do we think first about Standards?
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Standards driven electronic submission of clinical trial data
Current Status in eSubmission in CDER FDA
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Current Status in CDISC Submission in CDER FDA
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In 2010, 23% of SDTM in NDA
In 2011, 39% of SDTM and 32% in ADaM in NDA
In 2013, 55% of SDTM in NDA
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
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• Enhanced by Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012.
• Requires that submissions be submitted in electronic format.
New FDA Guidance on CDISC eSubmission
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Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Standardized Study Data
Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A (a) of the Federal Food Drug, and Cosmetic Act
Binding rather than recommendation
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What else for Standards?
• Anything else beside submission?• What else can we do with standards?
Accenture Survey on Standards usage in the future
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Regulatory Compliance
Operational Efficiency
Standards-based, Automated metadata driven clinical data development
Data interoperability with other Standards
0 10 20 30 40 50 60 70 80 90 100
87
66
64
30
How does your organization want to use CDISC Standards in the future
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What is beyond standards?
StandardsStandards
driven process
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Henry Ford Assembly Line
The Model T was Ford's first automobile mass produced on moving assembly lines with completely interchangeable STANDARDized parts. (Dec 1st, 1913)
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Model T production and price over year
1909
1911
1913
1915
1917
1919
1920
1922
1924
1926
0
500,000
1,000,000
1,500,000
2,000,000
2,500,000
$0
$100
$200
$300
$400
$500
$600
$700
$800
$900
$1,000
ProductionPrice for
1910: $900 and 20,000 vs 1925: $260 and 2,000,000
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Thoughts: Can we build an automated process with Standards just like Henry Ford did?
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How to apply Standards to clinical artefacts development
Henry Ford Car
production
Model T
Interchangeable Standardized
parts
Automated Assembly line
Clinical artefacts
development
SDTM datasets
SDTM & CDASH(EDC), CT standards
Automated ETL system
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Standards driven automated clinical artefacts development
ETL system
Standards CDASH(EDC) SDTM
Clinical Artefacts
CDASH(EDC) datasets
SDTM datasets
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Questions
What are needed for automated clinical artefacts development?
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Things needed for automated clinical artefacts development
Standards metadata – source and target datasets
ETL system
System readable transformation
metadata
Standards Metadata
Management
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Types of Standards Metadata
Target dataset
Target variable
Machine readable derivation
Source dataset
Source variable
DM USUBJID = DEMO USUBJID
DM AGE %AGE(DM.RFSTDTC – BRTHDTC)
• System readable transformation metadata
• Structural target metadataDataset Variable Name Variable Label Type CT Role
DM USUBJID Unique Subject Identifier Char Identifier
DM Age Age Num Identifier
• Structural source metadataDataset Variable Name Variable Label Type CT
DEMO USUBJID Unique Subject Identifier Char
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Questions
What if Standards change or evolve?
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Standards Metadata Management• Definition
• Managing data about standards data• Examples of metadata
Variable Name
Variable Label Type CT Role Core
STUDYID Study Identifier Char Identifier Req
DOMAIN Domain Abbreviation Char DM Identifier Req
USUBJID Unique Subject Identifier
Char Identifier Req
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Examples of Metadata Management• Creating new standards (e.g., variables and domains)• Modifying the attributes (e.g., label, type) of current
standards• Adding the new attributes to current standards• Archiving the standards• Managing the information that transforms data into a
new structure (e.g.: CDASH to SDTM)• Leveraging the Schedule of Events table to determine
the data domains required for a study• Assigning versions (e.g., major or minor) to standards
after changes• Maintaining multiple versions of standards (e.g.,
SDTMIG 3.1.2, 3.1.3)
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Evolution of Standards Metadata Management
InitialNo Standards Metadata Management
BasicSiloed, manual management of spreadsheet-based Standards metadata
AdvancedIntroduction of Centralized MDR and Development of Standard Metadata using MDR
OptimizingStudy Definitions Standards Metadata within the MDR for automating metadata-driven
processing
InnovativeProtocol-driven Study Definitions automatically generated from Trial-Level Standards Metadata enabled by semantic metadata
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Evolution of metadata system
Spreadsheet or document
Database
Metadata Repository
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Metadata Repository (MDR)• Definition
• Database created to store metadata• Function
• Storages of Standards metadata in global library• Manage Standards metadata• Govern Standards metadata• Develop study-level metadata from global library• Feed metadata to other system(e.g., EDC and
ETL system)
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MDR
Protocol
Global Library
CDASH
TFL
ADaM
SDTM
Protocol
Study 001
CDASH
TFL
ADaM
SDTM
Study level metadata definition development in MDR
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Why is Study Level metadata definition in MDR important?
MDR
Protocol
Study 001
CDASH
TFL
ADaM
SDTM
Protocol
EDC database
eCRF
SDTM datasets
ADaM datasets
TFL
It can dictate study level artefacts development.
Study 001
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Final Thought
Management
Standards Metadata
Standards
Regulatory Clinical
Data Submission
Standards Metadata-driven
Automated Clinical Artefacts
Development
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Contacts and Questions
Kevin LeeEmail: [email protected]
LinkedIn: www.linkedin.com/in/HelloKevinLee
Slides: www.slideshare.net/KevinLee56
Tweet: @HelloKevinLee
Blogs: HiKevinLee.tumblr.com
