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.

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

Agenda Introduction of Standards Metadata Management Version Control Governance Final Thoughts © 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 © 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 DM USUBJID Unique Subject Identifier © 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) © 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 © 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 © 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 © 2015 Accenture All Rights Reserved.

How to control versions/ How to manage standards? © 2015 Accenture All Rights Reserved.

Standards Metadata Management vs Governance Making decisions Governance Setting the environment where others can manage effectively © 2015 Accenture All Rights Reserved.

What is governance? Process Specified roles/responsibility 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 © 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 © 2015 Accenture All Rights Reserved.

Three key components of Standards Governance People Process Technology © 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 Develop the metadata for the standard Approvers Approve the new or revised standard © 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 © 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. © 2015 Accenture All Rights Reserved.

Examples of Governance Workflow SDTM DM (Developer) QC (Validator) CDISC compliance checks (OpenCDISC) © 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 © 2015 Accenture All Rights Reserved.

Examples of “Modification” workflow of Standards Governance © 2015 Accenture All Rights Reserved.

Technology of Standards Governance Definition: The system/technology which people and workflow of standards governance operates on Evolution: Spreadsheet-based Team Site or Share point Metadata Repository © 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) © 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 © 2015 Accenture All Rights Reserved.

Governance Final Thought Standards Management © 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 © 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 © 2015 Accenture All Rights Reserved.