Standards metadata management - version control and its governance

Accenture Accelerated R&D

Standards Metadata

Management – version

control and its governance

Kevin Lee

CDISC NJ Meeting at

01/28/2015

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Happy New Year

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 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


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

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


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 Lee

Email:

[email protected]

Linkedin:

www.linkedin.com/in/kevinlee

1995

Tweet: @HelloKevinLee

Blogs: HiKevinLee.tumbrl.com

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Standards metadata management - version control and its governance