1. Beyond regulatory submission - Standards Metadata Management Kevin Lee CDISC NJ Meeting at 06/17/2015
We help our Clients deliver better outcomes, so they can improve the quality of people’s lives.

2. Agenda Regulatory Requirement on Clinical Data Standards(i.e., CDISC)
Standards driven process
Standards Metadata Management
Final Thoughts
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3. Standards? What do we think first about Standards?
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4. Standards driven electronic submission of clinical trial data
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5. Current Status in eSubmission in CDER FDA
First, let’s us take a look at current status in electronic submission.
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6. Current Status in CDISC Submission in CDER FDA
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
And, if we look at CDISC submission, FDA is also getting more of CDISC data.
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7. Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Enhanced by Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012.
Requires that submissions be submitted in electronic format.
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8. New FDA Guidance on CDISC eSubmission
Guidance for Industry:
Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A (a) of the Federal Food Drug, and Cosmetic Act
Guidance for Industry:
Providing Regulatory Submissions in Electronic Format – Standardized Study Data
Binding rather than recommendation
The FDA Guidance document, once finalized, will be binding rather than recommendation.
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9. What else for Standards?
Anything else beside submission?
What else can we do with standards?
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10. Accenture Survey on Standards usage in the future
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11. What is beyond standards?
Standards driven process
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12. 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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13. Model T production and price over year
1910: $900 and 20,000 vs
1925: $260 and 2,000,000
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14. Thoughts: Can we build an automated process with Standards just like Henry Ford did?
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15. 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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16. Standards driven automated clinical artefacts development
CDASH(EDC)
SDTM
ETL system
Clinical
Artefacts
CDASH(EDC) datasets
SDTM datasets
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17. Questions
What are needed for automated clinical artefacts development?
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18. 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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19. Types of Standards Metadata
Structural source metadata
Dataset
Variable Name
Variable Label
Type CT
DEMO
USUBJID
Unique Subject Identifier
Char
Structural target metadata
Dataset
Variable Name
Variable Label
Type CT
Role DM
USUBJID
Unique Subject Identifier
Char
Identifier
Age
Num
System readable transformation metadata
Target dataset
Target variable
Machine readable derivation
Source dataset
Source variable DM
USUBJID =
DEMO
AGE
%AGE(DM.RFSTDTC – BRTHDTC)
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20. Questions What if Standards change or evolve?
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21. 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 DM
USUBJID
Unique Subject Identifier
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22. 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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23. Evolution of Standards Metadata Management
Initial
No Standards Metadata Management
Basic
Siloed, manual management of spreadsheet-based Standards metadata
Advanced
Introduction of Centralized MDR and Development of Standard Metadata using MDR
Optimizing
Study Definitions Standards Metadata within the MDR for automating metadata-driven processing
Innovative
Protocol-driven Study Definitions automatically generated from Trial-Level Standards Metadata enabled by semantic metadata
So, let’s look at partnerships in Pharmaceutical industry. In 2012 Avoca Report, 50% of Drug companies are using partnerships and about 70% of CRO are using partnerships.
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24. Evolution of metadata system
Spreadsheet or document
Database
Metadata Repository
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25. 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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26. Study level metadata definition development in MDR
Global Library
Study 001
Protocol
Protocol
CDASH
CDASH
SDTM
SDTM
ADaM
ADaM
TFL
TFL
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27. Why is Study Level metadata definition in MDR important?
It can dictate study level artefacts development.
Study 001
Study 001
Protocol
Protocol
EDC database
CDASH
eCRF
SDTM
SDTM datasets
ADaM
ADaM datasets
TFL
TFL
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28. Management Final Thought Standards Metadata Standards
Regulatory Clinical Data Submission
Standards Metadata-driven Automated Clinical Artefacts Development
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29. Contacts and Questions
Kevin Lee
LinkedIn: inLee
Slides:
Blogs: HiKevinLee.tumblr.com
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