Metadata Management – Our Journey Thus Far Archana Bhaskaran Oncology Database Development Operations 28-Jan-2015

Metadata Management – Our Journey Thus FarArchana Bhaskaran

Oncology Database Development Operations

28-Jan-2015

2 |CDISC NJ UG : Metadata Management – Our Journey Thus Far| Jan-2015| A. Bhaskaran| Business Use Only

Disclaimer

The opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily those of Novartis. Novartis does not guarantee the accuracy or reliability of the information provided herein.


Agenda


Introduction

Present a high level overview of Novartis roadmap on metadata management and associated processes from inception to present.

What is Metadata?

Metadata is information about the data.

Metadata describes the domains and data elements used in clinical trials

• Example of metadata: variable names, type, derivation algorithm, codelists, etc.


MDR Roadmap

Novartis has defined an end to end process that governs the framework to define, maintain and use of metadata within a single repository to support all upstream and downstream processes and tools.

• Beginning:- iMDR - Interim MetaData Repository (Excel spreadsheets)

• Current:- MDR - off-the-shelf Oracle based global metadata management tool customized for

Novartis

• Future:- MDR – off-the-shelf Oracle based ‘Single Repository’ that enables the management

of Global standards and study level Metadata


Metadata Hub

Standards Development / Modeling

MDR

Data Collection(CDMS)

Data Warehouse

Submission(SDTM, ADaM)

Like a center screw in a wheelthe Metadata (Standards) in the MDR drives all Implementation programs and data flow (hence process)


Type of metadata maintained

Clinical Data Elements (CDE)

Controlled Terminology (CT)

Derivations and Imputations (DI)

Reference Tables (Lab/Non-Lab/Questionnaires)

Master Data Domains (MDD)

External Partners


Metadata Management – Our Beginning(2009)..

iMDR – Interim MetaData Repository

Contained only global level metadata with no version control.

Metadata was defined and managed in excel spreadsheets for each type of metadata. E.g. CDE, CT, etc.

All files were stored and maintained in a central sharepoint location


Metadata Management – Our Beginning (contd) Domain Sheet - Clinical Data Elements Tab

Data Elements were defined at Domain level. One spreadsheet for every domain referred as the domain sheet. E.g. AE, CM, etc.

The domain sheets contained metadata from collection through submission (SDTM)• ADaM metadata was maintained separately in Excel spreadsheets.

Each domain sheet contained two main tabs: Clinical Data Elements and Derivations/Imputations.

• Clinical Data Elements – Contained data elements from collection and submission (SDTM). Each element had 53 attributes that were defined

• Derivation/imputations – Contained details on the derivations for elements that were derived or imputed. Each derivation had 19 attributes that were defined.


Metadata Management – Our Beginning (contd)Domain Sheet - Clinical Data Elements Tab

The Clinical Data Elements Tab


Metadata Management – Our Beginning (contd.)Domain Sheet – Derivations/Imputations Tab

This sheet provides information regarding the derivations and imputations used within the data domain.

Derivation: a sequence of steps, logical or computational, from one result to another. The result is a new variable. Example of this method is AGE_DRV - If Date of Birth is present and non-missing then the derived variable will be calculated as Visit Date of Visit 1 minus the Date of Birth.


Metadata Management – Our Beginning (contd.)Domain Sheet – Derivations/Imputations Tab

Imputation: Creating a value when all or part of the original variable is missing.

Example of this method is commonly found within dates• Data collected Mar1960• Data imputed 15Mar1960


Metadata Management – Our Beginning (contd.)Controlled Terminology

Defines the codelist choices that are allowed in a domain for a given CDE.

Master controlled terminology was maintained in Excel sheet. Subsets (groups) of codelist values were maintained within CDMS system.

This sheet contained 24 attributes for each value defined in a codelist.


Metadata Management – Our Beginning (contd.)QC measures

QC checks – SAS based programs to check for the completeness of the domain sheets based on pre-established rules.

Manual Review


Metadata Management – Current (2013)

Metadata defined and maintained in an off-the-shelf Oracle based tool customized for Novartis.

A Central global metadata repository that holds all metadata that is easily accessible to all end users

The same concept from iMDR was adapted into the MDR tool.

The views were customized to match the iMDR sheets for ease of review and use by end users

Following key enhancements were made to the tool:

• Enabled workflow process for adding and approving new objects

• User friendly screens for codelist and lab reference tables were added

• Introduced online validation checks and QC reports

• Updated interface views for use by downstream systems


Metadata Management – CurrentClinical Data Element View

Derivations/Imputation View


Key Benefits Achieved Controlled and Audit trailed environment

Better quality gained by having on-line checks and built in QC reports

Efficiency gained in defining and maintenance of metadata. E.g. Codelist, lab reference tables, etc.

User friendly data entry screens for codelists and reference tables

Efficiency gained by providing improved interface views to the downstream systems

Reduced manual review steps

Instant access to all end users to browse metadata


Current Challenges

18


Metadata Management - Future

Support both Global Data Standards and Study level metadata needs

Support global & study level governance workflows

Enable integration with CDMS and CDISC - SHARE

Enable integration with upstream and downstream systems

Create views to support Define.xml requirements

Integrate ADaM Metadata and Structures


Metadata Management - Future Proposed process flow


Governance workflow model

Data Standards

GovernanceRequestor(CTH/CTL)

Requestor(CTH/CTL)

Requestor(CTH/CTL) CSUCSUCSU

Standards Extended

Team

Request

Decision

Feedback * CSU encompasses:Clinical Science UnitBusiness Unit (i.e. Oncology)Translational Sciences (TS)

• Requester - Identifies new needs for data element /codelist for safety / indication standards

• Onc. Standards - approves (from a scientific & franchise specific standpoint) requests

• DSG - final approval

DSG - Standards Experts who approve requests from CSUs, with input from Extended Team, as required (senior representatives with a background in Clinical Science, Biostatistics, Statistical Reporting, Data Management

• Ext. Team - Provides adhoc expertise in specific functional area (e.g. Imaging, lab data, biomarker development)

• Oncology - Integrated Disease Area strategy team (IDS)


Questions?

Documents

Metadata Management – Our Journey Thus Far Archana Bhaskaran Oncology Database Development Operations 28-Jan-2015