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Beyond regulatory submission - standards metadata management
The document discusses standards metadata management and regulatory requirements for clinical data submission, specifically focusing on CDISC standards. It highlights the evolution of standards metadata management, including the introduction of a centralized metadata repository (MDR) and the need for automated clinical artifacts development processes. Additionally, it emphasizes the importance of managing and evolving standards metadata to enhance operational efficiency and improve regulatory compliance in clinical trials.
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Beyond regulatory submission - standards metadata management
- 1. Beyond regulatory submission - Standards Metadata Management KevinLee 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. 2© 2015 AccentureAll Rights Reserved. Agenda Regulatory Requirement on Clinical Data Standards(i.e., CDISC) Standards driven process Standards Metadata Management Final Thoughts
- 3. 3© 2015 AccentureAll Rights Reserved. Standards? What do we think first about Standards?
- 4. 4© 2015 AccentureAll Rights Reserved. Standards driven electronic submission of clinical trial data
- 5. Current Status ineSubmission in CDER FDA 5© 2014 Accenture All Rights Reserved.
- 6. Current Status inCDISC Submission in CDER FDA 6© 2014 Accenture All Rights Reserved. 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
- 7. Section 745A(a) ofthe Federal Food, Drug, and Cosmetic Act (FD&C Act) 7© 2014 Accenture All Rights Reserved. • Enhanced by Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. • Requires that submissions be submitted in electronic format.
- 8. New FDA Guidanceon CDISC eSubmission 8© 2014 Accenture All Rights Reserved. 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
- 9. 9© 2015 AccentureAll Rights Reserved. What else for Standards? • Anything else beside submission? • What else can we do with standards?
- 10. Accenture Survey onStandards usage in the future 10© 2014 Accenture All Rights Reserved. 87 66 64 30 0 50 100 Regulatory Compliance Operational Efficiency Standards-based, Automated metadata driven clinical data development Data interoperability with other Standards How does your organization want to use CDISC Standards in the future
- 11. 11© 2015 AccentureAll Rights Reserved. What is beyond standards? Standards Standards driven process
- 12. 12© 2015 AccentureAll Rights Reserved. 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)
- 13. 13© 2015 AccentureAll Rights Reserved. Model T production and price over year $0 $100 $200 $300 $400 $500 $600 $700 $800 $900 $1,000 0 500,000 1,000,000 1,500,000 2,000,000 2,500,000 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1920 1921 1922 1923 1924 1925 1926 Production Price for 1910: $900 and 20,000 vs 1925: $260 and 2,000,000
- 14. 14© 2015 AccentureAll Rights Reserved. Thoughts: Can we build an automated process with Standards just like Henry Ford did?
- 15. 15© 2015 AccentureAll Rights Reserved. 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
- 16. 16© 2015 AccentureAll Rights Reserved. Standards driven automated clinical artefacts development ETL system Standards CDASH(EDC) SDTM Clinical Artefacts CDASH(EDC) datasets SDTM datasets
- 17. 17© 2015 AccentureAll Rights Reserved. Questions What are needed for automated clinical artefacts development?
- 18. 18© 2015 AccentureAll Rights Reserved. Things needed for automated clinical artefacts development Standards metadata – source and target datasets ETL system System readable transformation metadata Standards Metadata Management
- 19. 19© 2015 AccentureAll Rights Reserved. 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 metadata Dataset Variable Name Variable Label Type CT Role DM USUBJID Unique Subject Identifier Char Identifier DM Age Age Num Identifier • Structural source metadata Dataset Variable Name Variable Label Type CT DEMO USUBJID Unique Subject Identifier Char
- 20. 20© 2015 AccentureAll Rights Reserved. Questions What if Standards change or evolve?
- 21. 21© 2015 AccentureAll Rights Reserved. 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
- 22. 22© 2015 AccentureAll Rights Reserved. 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)
- 23. 23© 2014 AccentureAll Rights Reserved. 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
- 24. 24© 2015 AccentureAll Rights Reserved. Evolution of metadata system Spreadsheet or document Database Metadata Repository
- 25. 25© 2015 AccentureAll Rights Reserved. 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)
- 26. 26© 2015 AccentureAll Rights Reserved. MDR Protocol Global Library CDASH TFL ADaM SDTM Protocol Study 001 CDASH TFL ADaM SDTM Study level metadata definition development in MDR
- 27. 27© 2015 AccentureAll Rights Reserved. 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
- 28. © 2015 AccentureAll Rights Reserved. Final Thought Management Standards Metadata Standards Regulatory Clinical Data Submission Standards Metadata-driven Automated Clinical Artefacts Development
- 29. 29© 2015 AccentureAll Rights Reserved. Contacts and Questions Kevin Lee Email: kevin.s.lee@accenture.com LinkedIn: www.linkedin.com/in/HelloKev inLee Slides: www.slideshare.net/KevinLee 56 Tweet: @HelloKevinLee Blogs: HiKevinLee.tumblr.com
Editor's Notes
- #6 First, let’s us take a look at current status in electronic submission.
- #7 And, if we look at CDISC submission, FDA is also getting more of CDISC data.
- #9 The FDA Guidance document, once finalized, will be binding rather than recommendation.
- #24 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.