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).

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© 2015 Accenture All Rights Reserved.
Happy New Year
Year of Sheep
• 2015
• 2003
• 1991
• 1979
• 1967
• 1955
• 1943

3. 3© 2015 Accenture All Rights Reserved.
Agenda
Introduction of Standards Metadata
Management
Version Control
Governance
Final Thoughts

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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© 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© 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)

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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

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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

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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

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How to control versions/ How to
manage standards?

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Standards Metadata Management vs
Governance
Management
• Making decisions
Governance
• Setting the
environment where
others can manage
effectively

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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© 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

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Three key components of Standards
Governance
People
Process
Technology

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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

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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

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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.

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Examples of Governance Workflow
SDTM DM
(Developer)
QC (Validator)
CDISC
compliance
checks
(OpenCDISC)

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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

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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

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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:

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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)

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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

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Final Thought
Governance
ManagementStandards

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Sneak preview on 2015
• Metadata Repository
• Data Modeling on Standards metadata
• Process metadata
• Study definition Metadata
• Automated E2E clinical data development

26. 26© 2015 Accenture All Rights Reserved.
Contacts and Questions
Kevin Lee
Email:
kevin.s.lee@accenture.com
Linkedin:
www.linkedin.com/in/kevinlee
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Tweet: @HelloKevinLee
Blogs: HiKevinLee.tumbrl.com