Business & Decision Life Sciences Managing Data …Allow traceability of data, more data...

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Business & Decision Life Sciences Managing Data Standards Libraries Compliance Deborah Paletta, 12 OCT 2015


Agenda

Crea%on of a Data Standards Library

CDISC Compliance: Challenges & Considera%ons

Conclusion


Updates over time (SEP 2015)

BRIDG v3.0

BRIDG v2.2

ADaM v2.1

ADaM IG v1.0

BRIDG v1.1.1

BRIDG v2.0

BRIDG v2.1

SDTM v1.2

SDTM IG v3.1.2

CDASH v1.0

ODM v1.1

SDTM v1.0

SDTM IG v3.1

ODM v1.2

BRIDG v3.0.1

BRIDG v3.0.2

BRIDG v3.0.3

Protocol Model v1.0

ADaM Val.

Checks v1.0

ODM v1.3.1

SDTM v1.1

SDTM IG v3.1.1

ODM v1.2.1

Define.xml v1.0

ADaM v2.0

ODM v1.3

2012 2009 2011 2013 2002 2010 2008 2005 2003 2004

/

…

Alzheimer v1.0

SEND v3.0

SDTM v3.1.2 Am.1

ADaM Val.

Checks v1.1

CDASH v1.1

SDM.XML v1.0

Pain

Tuberculosis

Devices

BRIDG v3.1

BRIDG v3.2

PRM Toolset v1.0

CDASH UG v1.0

SDTM v1.3

SDTM IG v3.1.3

ADaM Val. Checks

v1.2

Parkinson’s Disease

Virology

Content Standards

Technical Standards

Semantics

Therapeutic Areas

2014

…

SDTM v1.4

SDTM IG v3.2

Alzheimer v1.1

Asthma

Protocol Concept

Guide

BRIDG UG v2

ADaM IG v1.1

PKD

Define.xml v2.0

CDASH v1.2

BRIDG v4.0

ADaM MD Guide

CDASH E2B SAE IG

SDTM Associated Persons IG

v1.0

SDTM Pharmacogenomics

IG v1

SEND IG v3.1

ADaM Integration IG v1.0

ADaM General Occurrence Model

v1.0

SDTM Device Submission Pilot

Extended ODM PRM XML Schema

Define.xml IG Validation

Multiple Sclerosis

Diabetes

Virology-Hepatitis C

QT Studies

Cardiovascular

ADaM Metadata Guide

SEND IG for REPROTOX V1

2006 2007

BRIDG v1.0

BRIDG v1.1

2015

ADaM IG v2

SDTM Devices IG v1.1

(Components)

SDTM DEVICE IG v1.1

SDTM Vaccine Data IG v1

SDTM v1.5

SDTM IG v3.3

Infuenza

CDASH/UG v2 and Model

Breast cancer

Dyslepidemia

Schizophrenia

Traumatic Brain Injury

COPD

CT registery XML schema

v1

…


Data Standards Governance

DATA STANDARDS LIBRARY CRF

CDASH

SDTM

ADaM

TA Standards Industry Standards Company Standards

External

Internal

New TA

New Studies

New Data Type

CFDA

EMA


Library Creation Process

Non-‐standard CRF

Protocol SAP Template

ADaM Standard CRF

CDASH SDTM Analysis Results

CDISC Industry Standards Define Data Standards

Clinical Team

Sponsor

Sponsor Specific CDISC Standards


Data Standards Solution Overview

  An integrated solution with six components:

Data Standards Library

Management

Study Specifica%on

Study Metadata

Study Valida%on

Issue Management

Administra%on


Data Standards Solution Overview

RAW DATA & METADATA

SPECIFICATION

STUDY METADATA

SPECIFICATION

DATA MANAGEMENT AREA

DEFINE.XML

ISSUE Reports

STUDY SDTM DATA &

METADATA

STUDY METADATA REPOSITORY

STUDY SPECIFICATION

DATA STANDARDS

LIBRARY

ISSUE Reports

COMPARISON

VALIDATION

DM

DATA COLLECTION

AREA

DBA EDC

CRO


DBA

RAW DATA & METADATA

SPECIFICATION

STUDY METADATA

SPECIFICATION

DATA COLLECTION AREA

STUDY SPECIFICATION


DATA STANDARDS

LIBRARY

COMPARISON

STUDY SDTM DATA &

METADATA

VALIDATION

ISSUE REPORTS

DM

ISSUE REPORTS

STUDY METADATA

SPECIFICATION

DBA

EDC

CRO

STUDY METADATA

REPOSITORY

DEFINE.XML

DATA MANAGEMENT AREA DATA

COLLECTION AREA

DEFINE.XML

ISSUE Reports

STUDY SDTM DATA &

METADATA

STUDY METADATA

REPOSITORY

STUDY SPECIFICATION

DATA STANDARDS

LIBRARY

ISSUE Reports

COMPARISON

VALIDATION

DM

EDC

CRO

Library Management


Management


DBA

RAW DATA & METADATA

SPECIFICATION

STUDY METADATA

SPECIFICATION


STUDY SPECIFICATION


DATA STANDARDS

LIBRARY

COMPARISON

STUDY SDTM DATA &

METADATA

VALIDATION

ISSUE REPORTS

DM

ISSUE REPORTS

STUDY METADATA

SPECIFICATION

DBA

EDC

CRO

STUDY METADATA

REPOSITORY

DEFINE.XML


COLLECTION AREA

DEFINE.XML

ISSUE Reports

STUDY SDTM DATA &

METADATA

STUDY METADATA

REPOSITORY

STUDY SPECIFICATION

DATA STANDARDS

LIBRARY

ISSUE Reports

COMPARISON

VALIDATION

DM

EDC

CRO

Study Specification – Study Metadata

Study Specifica%on

Study Metadata


DBA

RAW DATA & METADATA

SPECIFICATION

STUDY METADATA

SPECIFICATION


STUDY SPECIFICATION


DATA STANDARDS

LIBRARY

COMPARISON

STUDY SDTM DATA &

METADATA

VALIDATION

ISSUE REPORTS

DM

ISSUE REPORTS

STUDY METADATA

SPECIFICATION

DBA

EDC

CRO

STUDY METADATA

REPOSITORY

DEFINE.XML


COLLECTION AREA

DEFINE.XML

ISSUE Reports

STUDY SDTM DATA &

METADATA

STUDY METADATA

REPOSITORY

STUDY SPECIFICATION

DATA STANDARDS

LIBRARY

ISSUE Reports

COMPARISON

VALIDATION

DM

EDC

CRO

Study Validation – Issue Management

Study Valida%on

Issue Management


Agenda



Conclusion


Three main areas

Challenges related to CDISC-Compliance

1. Metadata Creation

2. Metadata Loading 3. Updates in Library Management Module



  Challenges

•  Alignment of vision of different team players

•  Divergent viewpoints on the requirements, priorities and understanding of standards

•  Development of EDC System independent standard CRFs

1. Creation of Metadata


1. Creation of Metadata

Considerations •  Streamlined vision

•  Define objectives and processes

•  Agree/Enforce DS Library design principles


2. Loading of Metadata

  Challenges

•  Although BDLS-defined validation rules are available in the Library

Management (LM) module, CDISC validation rules are not available at this

level

•  Risk of loading non-CDISC compliant metadata into Data Standards (DS)

Library


  Considerations

•  Set of external QC tools to check for compliance between the metadata created and:

- CDISC CDASH UG

- CDISC SDTM IG

- Controlled Terminology

2. Loading of Metadata

External QC Tool

Metadata File

Compliance Report



3. Updates in Data Standards Library

  Challenges

–  No CDISC validation rules available at the LM module level

–  Non-CDISC-compliant library objects could be created when working in

the Data Standards Library in the LM Module


DATA STANDARDS

REPORT TOOLS

Managed within Library Module •  Library Compliance Report comparing

Company standards to CDISC standards •  Auto-‐generate change requests with

impact report

DATA STANDARDS GOVERNANCE

Automa%cally connect to SHARE

Synchronize CDISC metadata

  Considerations

•  eSHare API Integration •  CDISC eSHARE DS Library in LM

•  Reporting Tool in LM

3. Updates in Data Standards Library


Agenda



Conclusion


When creating a Data Standards Library…

  Alignment team vision:

- Define objectives and processes

- Agree/Enforce DS Library design principles

  Implement a CDISC eSHARE DS Library that allows

- Promoting CDISC compliant metadata to repository

- Generating CDISC compliant study specifications

- Compare study data to sponsor-specific DS Library

- Compare study data to a specific standard version in the CDISC

eSHARE DS Library

  Implementation of CDISC validation rules and sponsor-specific business rules


DBA

RAW DATA & METADATA

SPECIFICATION

STUDY METADATA

SPECIFICATION


COLLECTION AREA

DEFINE.XML

ISSUE REPORTS

STUDY SDTM DATA &

METADATA

STUDY METADATA REPOSITORY

STUDY SPECIFICATION

SPONSOR DS LIBRARY

ISSUE REPORTS

COMPARISON

VALIDATION

DM

EDC

CRO

COMPARISON REPORTS

CDISC eSHARE LIBRARY

DATA STANDARDS GOVERNANCE

REPORT TOOLS

Data Standards Extended Solution


Benefits of a CDISC compliant Data Standards Library

  Eliminate data inconsistencies, improves quality and ensures full CDISC (CDASH/SDTM/ADaM) compliance resulting in a reference for internal stakeholders.

  Drive the streamlining of internal processes and ensures Regulatory compliance.   Allow traceability of data, more data trustworthiness and tighter data

governance.

  Can be automated by integrating in a fully automated platform, the CDISC Data Standards Library solution of Business and Decision Life Sciences (CDmation).

  Reduce timelines, allows fewer resources and produces ‘ready for submission’ data.

  Enable control and cooperation with partners and vendors.


Thank you for your attention. Vienna, Austria, 12 OCT 2015


Business & Decision Life Sciences Sint-Lambertusstraat 141 rue Saint-Lambert

B-1200 Brussels T: +32 2 774 11 00 F: +32 2 774 11 99

[email protected] http://www.businessdecision-lifesciences.com/

Deborah Paletta | Project Manager Data Standards | [email protected]

Business & Decision Life Sciences Managing Data …Allow traceability of data, more data...

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