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Accenture
Accelerated R&D
Standards Metadata
Management – version
control and its governance
Kevin Lee
CDISC NJ Meeting at...
2© 2015 Accenture All Rights Reserved.
Happy New Year
Year of Sheep
• 2015
• 2003
• 1991
• 1979
• 1967
• 1955
• 1943
3© 2015 Accenture All Rights Reserved.
Agenda
Introduction of Standards Metadata
Management
Version Control
Governance
Fin...
4© 2015 Accenture All Rights Reserved.
Introduction of Standards
• Industry Standards
• Clinical Data Interchange Standard...
5© 2015 Accenture All Rights Reserved.
Introduction of Metadata Management
• Definition
• Managing data about other data
•...
6© 2015 Accenture All Rights Reserved.
Examples of Metadata Management
• Creating new standards (e.g., variables and domai...
7© 2015 Accenture All Rights Reserved.
Industry CDISC Standards versions
• CDASH – 1.1
• SDTM (IG) – 1.2 (3.1.2), 1.3 (3.1...
8© 2015 Accenture All Rights Reserved.
Company Standards versions
• Industry + company-specific standards
• Global standar...
9© 2015 Accenture All Rights Reserved.
Why version control is important?
• FDA Requirements
• CDISC Standards compliant da...
10© 2015 Accenture All Rights Reserved.
How to control versions/ How to
manage standards?
11© 2015 Accenture All Rights Reserved.
Standards Metadata Management vs
Governance
Management
• Making decisions
Governan...
12© 2015 Accenture All Rights Reserved.
What is governance?
According to a report by
Boeing, from 2001 through
2010, the n...
13© 2015 Accenture All Rights Reserved.
What is standards governance?
Standards governance is:
• Oversight for the develop...
14© 2015 Accenture All Rights Reserved.
Three key components of Standards
Governance
People
Process
Technology
15© 2015 Accenture All Rights Reserved.
People of Standards Governance
Below is a general example of
some roles and respon...
16© 2015 Accenture All Rights Reserved.
Standards Group/SME in Governance
• Types
• Functional SME
• Centralized
Standards...
17© 2015 Accenture All Rights Reserved.
Governance Process
• Workflow
• Definition
• An orchestrated and repeatable patter...
18© 2015 Accenture All Rights Reserved.
Examples of Governance Workflow
SDTM DM
(Developer)
QC (Validator)
CDISC
complianc...
19© 2015 Accenture All Rights Reserved.
Governance Process in Standards
• Systematic business activities by standards reso...
20© 2015 Accenture All Rights Reserved.
Examples of “Modification” workflow of
Standards Governance
Human task
System task...
21© 2015 Accenture All Rights Reserved.
Technology of Standards Governance
Spreadsheet-
based
Team Site
or Share
point
Met...
22© 2015 Accenture All Rights Reserved.
Metadata Repository (MDR)
• General definition: a database created to store
metada...
23© 2015 Accenture All Rights Reserved.
Metadata Repository (MDR) -
continued
• Benefits
• Data-based management, not docu...
24© 2015 Accenture All Rights Reserved.
Final Thought
Governance
ManagementStandards
25© 2015 Accenture All Rights Reserved.
Sneak preview on 2015
• Metadata Repository
• Data Modeling on Standards metadata
...
26© 2015 Accenture All Rights Reserved.
Contacts and Questions
Kevin Lee
Email:
kevin.s.lee@accenture.com
Linkedin:
www.li...
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Standards metadata management - version control and its governance

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Over the past decade, CDISC Standards have been widely accepted and implemented in clinical research. The FDA’s final “Guidance for Industry on electronic submission” mandates that submission data conform to CDISC standards, including SDTM, ADaM and SEND. Life sciences organizations, therefore, need to ensure that submission data be compliant to regulatory requirement standards (e.g., CDISC and eCTD). One of the biggest challenges, however, that organizations face is the evolution of standards, which lead the different versions of standards. The presentation will discuss how organization manage the different versions of industry standards and company standards. The presentation will introduce governance on metadata management.

Standards governance simply means “Do the right things” in standards implementation and management. The presentation will discuss how life sciences organizations can better fulfill their goals for standards implementation and management using governance. The presentation will also discuss the main aspects of data governance from the CDISC standards perspective, addressing the role of people(e.g., requestor, developer and approval), processes(e.g., work flow of requesting, developing and approving), and technology (e.g., spreadsheet, share point and MDR).

Published in: Healthcare
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Standards metadata management - version control and its governance

  1. 1. Accenture Accelerated R&D Standards Metadata Management – version control and its governance Kevin Lee CDISC NJ Meeting at 01/28/2015 We help our Clients deliver better outcomes, so they can improve the quality of people’s lives.
  2. 2. 2© 2015 Accenture All Rights Reserved. Happy New Year Year of Sheep • 2015 • 2003 • 1991 • 1979 • 1967 • 1955 • 1943
  3. 3. 3© 2015 Accenture All Rights Reserved. Agenda Introduction of Standards Metadata Management Version Control Governance Final Thoughts
  4. 4. 4© 2015 Accenture All Rights Reserved. Introduction of Standards • Industry Standards • Clinical Data Interchange Standards Consortium (CDISC) – CDASH, SDTM, ADaM and LAB • NCI CT • HL7 • eCTD (electronic Common Technical Document) • Company Standards • Global Standards • Therapeutic Standards • Business Unit Standards
  5. 5. 5© 2015 Accenture All Rights Reserved. Introduction of Metadata Management • Definition • Managing data about other 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
  6. 6. 6© 2015 Accenture All 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)
  7. 7. 7© 2015 Accenture All Rights Reserved. Industry CDISC Standards versions • CDASH – 1.1 • SDTM (IG) – 1.2 (3.1.2), 1.3 (3.1.3), 1.4 (3.2) • PRM – 1.0 • LAB – 1.01 • SENDIG – 3 • ADaM (IG) – 2.1 (1.0) • SMD-XML – 1.0 • ODM-XML – 1.3.1, 1.3.2 • Define-XML – 1.0, 2.0 • DataSet-XML – 1.0
  8. 8. 8© 2015 Accenture All Rights Reserved. Company Standards versions • Industry + company-specific standards • Global standards version • GS v1 – CDASH 1.1, SDTM (IG) 1.3(3.1.2), ADaM(IG) 2.1(1.0) • GS v2 – CDASH 1.1, SDTM (IG) 1.4(3.2), ADaM(IG) 2.1(1.0) • Annual global standards version • GS v2013 • GS v2014 • GS v2015
  9. 9. 9© 2015 Accenture All Rights Reserved. Why version control is important? • FDA Requirements • CDISC Standards compliant data submission • Data Standards Catalog • Versions that FDA supports and requires. • Submission document • SDRG(Study Data Reviewer’s Guide) • ADRG(Analysis Data Reviewer’s Guide) • Multiple studies employed different versions across the duration of a submission • Phase I used SDTMIG 3.1.2, but Phase II and III used SDTMIG 3.1.3. • ISS/ISE
  10. 10. 10© 2015 Accenture All Rights Reserved. How to control versions/ How to manage standards?
  11. 11. 11© 2015 Accenture All Rights Reserved. Standards Metadata Management vs Governance Management • Making decisions Governance • Setting the environment where others can manage effectively
  12. 12. 12© 2015 Accenture All Rights Reserved. What is governance? According to a report by Boeing, from 2001 through 2010, the number of fatalities per one million flight hours is less than one. It attributed the success rate of air traffic control to:  Process  Specified roles/responsibility  Technology/system
  13. 13. 13© 2015 Accenture All Rights Reserved. What is standards governance? Standards governance is: • Oversight for the development and maintenance of clinical data standards • An instrument that ensures that a standard is developed efficiently, consistently, and properly used across the clinical trials organization • Assurance that maximum process efficiency from a standards- based clinical data lifecycle is achievable  Process – change requests and governance workflow  Specified roles/responsibility – SMEs who ensure standards are applied appropriately  Technology/system – technology and systems that support change requests and governance workflow
  14. 14. 14© 2015 Accenture All Rights Reserved. Three key components of Standards Governance People Process Technology
  15. 15. 15© 2015 Accenture All Rights Reserved. People of Standards Governance Below is a general example of some roles and responsibilities that sponsors implement to effectively carry out their standards governance. Role Skillset Responsibility Requestors • Programmers • Data Management Request a new or revised standard Developers • Standards SME • Programmers • Data Management Develop the metadata for the standard Approvers • Standards SME Approve the new or revised standard
  16. 16. 16© 2015 Accenture All Rights Reserved. Standards Group/SME in Governance • Types • Functional SME • Centralized Standards Group • Advisory Group • Responsibility • SME for each business unit (e.g. DM) – develop the standards • Advisory/Centralized Standards Group – approve the new/change standards
  17. 17. 17© 2015 Accenture All Rights Reserved. Governance Process • Workflow • Definition • An orchestrated and repeatable pattern of business activity enabled by the systematic organization of resources • A sequence of operations, declared as work of a person or group.
  18. 18. 18© 2015 Accenture All Rights Reserved. Examples of Governance Workflow SDTM DM (Developer) QC (Validator) CDISC compliance checks (OpenCDISC)
  19. 19. 19© 2015 Accenture All Rights Reserved. Governance Process in Standards • Systematic business activities by standards resources that manage the standards. • Examples of Types: New Request, Modify and Retire • Workflow: Request, Development and Approval Change Request • Assessment • Impact Development • Technical • Subject Matter Implementation • Review • Approval
  20. 20. 20© 2015 Accenture All Rights Reserved. Examples of “Modification” workflow of Standards Governance Human task System task Email Notification Requestor System Reviewer Final Reviewer email notification to Developer Developer Assign the appropriate SME Notify Developer email notification to Developer Standards Change Request Review the request Request is appropriate? Notify Requestor No Yes email notification to assigned SME Change Standards Notify the assigned SME Notify Reviewer Review Standards Change Pass or Fail for Standards Change No Update on Standards and its version Yes Notify Requestors and Developers Start
  21. 21. 21© 2015 Accenture All Rights Reserved. Technology of Standards Governance Spreadsheet- based Team Site or Share point Metadata Repository • Definition: The system/technology which people and workflow of standards governance operates on • Evolution:
  22. 22. 22© 2015 Accenture All Rights Reserved. Metadata Repository (MDR) • General definition: a database created to store metadata. • Its function in Standards Governance: • Stores Standards metadata – Global, TA, Compound and Study level • Defines the roles and responsibility of people • Defines the business process • Drives roles-based, system-driven business process • Develop and maintain standards(e.g., version controls) • Stores the history of all the activities(e.g., requestor, approvals, dates and time, duration)
  23. 23. 23© 2015 Accenture All Rights Reserved. Metadata Repository (MDR) - continued • Benefits • Data-based management, not document-based • More systemic/organized metadata management • System-based governance workflow • Control data flow, then control business process • Improve business process • Time-efficient, process-efficient • History of all the activities • Transparency
  24. 24. 24© 2015 Accenture All Rights Reserved. Final Thought Governance ManagementStandards
  25. 25. 25© 2015 Accenture All Rights Reserved. Sneak preview on 2015 • Metadata Repository • Data Modeling on Standards metadata • Process metadata • Study definition Metadata • Automated E2E clinical data development
  26. 26. 26© 2015 Accenture All Rights Reserved. Contacts and Questions Kevin Lee Email: kevin.s.lee@accenture.com Linkedin: www.linkedin.com/in/kevinlee 1995 Tweet: @HelloKevinLee Blogs: HiKevinLee.tumbrl.com

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