accenture accelerated r&d standards metadata management – version control and its governance...

Accenture Accelerated R&D

Standards Metadata Management – version control and its governance

Kevin LeeCDISC NJ Meeting at 01/28/2015

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Year of Sheep• 2015• 2003• 1991• 1979• 1967• 1955• 1943


Agenda

Introduction of Standards Metadata Management

Version Control

Governance

Final Thoughts


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


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


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)


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


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


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


How to control versions/ How to manage standards?


Standards Metadata Management vs Governance

Management• Making decisions

Governance• Setting the

environment where others can manage effectively


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


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


Three key components of Standards Governance

People

Process

Technology


People of Standards GovernanceBelow 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


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


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.


Examples of Governance Workflow

SDTM DM (Developer) QC (Validator)

CDISC compliance

checks (OpenCDISC)


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


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


Developer

Standards Change Request

Review the request

Request is appropriate?

Notify Requestor No

Yes


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


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:


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)


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


Final Thought

Governance

ManagementStandards


Sneak preview on 2015

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


Contacts and Questions

Kevin LeeEmail: [email protected]

Linkedin: www.linkedin.com/in/kevinlee1995

Tweet: @HelloKevinLee

Blogs: HiKevinLee.tumbrl.com

accenture accelerated r&d standards metadata management – version control and its governance...

Documents

new standards

multiple versions of

type of current standards

issise slide

data domains

sdtm ig

different versions

gs v2 cdash