Oracle Health Sciences Streamlining SDTM with CDASH input User Networks/Europe/English...

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Oracle Health Sciences Streamlining SDTM with CDASH input

Mike Collinson Life Sciences Architect Oracle Health Sciences Consulting (HSC) March 2016


Safe Harbor Statement

The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

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• Clinical Regulatory Background

• Conversion to SDTM

• Central Designer / InForm CDASH Study

• DMW QuickStart

– CDASH Support

– SDTM Libraries

– Review Model and Traceability

– Libraries and Templates

– Data Extract

– Data Visualization

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Streamlining SDTM with CDASH input Agenda


• Submission Guidance

– FDA SDTM Submissions: 2017 • Paper and non-eCTD submissions will

no longer be accepted

– PMDA SDTM Submissions: 2016

• FDA Submission Gateway – 80% of trials in SDTM in 2015

• FDA Data Standards Catalog

– Catalogues evolving support for CDISC Standards

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Clinical Regulatory Background FDA Binding Guidance on SDTM Submissions


Conversion to SDTM

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Source: Tufts research on “Industry Adoption of eClinical Solutions and CDISC Standards”

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

2004 2007 2011 2014

SDTM

ADaM

CDASH

ODM

LAB

SEND

Adoption Trends for CDISC standards (2004-2014)


• Oracle has created a platform for reducing the time from EDC and External data to SDTM/ADaM/Analysis Datasets.

• Transformations and validation checks are automated as fresh data arrives

• Traceability from source to deliverable is maintained at the level of the single data point

• Study components (transformations, edit checks) are reused as linked objects, making them easy to track and maintain

• HSC can accelerate study set up based on CDASH forms using eShare derived transformations included in a Study Template

Conversion to SDTM Oracle’s strategic approach using Data Management Workbench (DMW)

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Conversion to SDTM Oracle Data Management Workbench (DMW) data processing


Central Designer / InForm QuickStart CDASH Study Simplify EDC set up using CDASH forms

• Simplify study set up with Central Designer CDASH Library

•CDASH v1.1 support

•English and Japanese forms

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Central Designer / InForm QuickStart CDASH Study DMW connects directly to the EDC data

•DMW inherits –Clinical data

–Metadata

–Operational data

from the CDASH study automatically

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DMW QuickStart SDTM Libraries Change controlled Libraries for all versions

•Control SDTM versions with Libraries easily loaded from zip files

•Transformations created from eShare cdash-2-sdtm-map.xls

• Facilitate submissions in CDISC SDTM

•Deliver data to downstream systems

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DMW QuickStart Review Model and Traceability Complete Data Model designed for Data Management

•Designed for specifically for Data Management

•Pre-built mapping from CDASH –Supports DM Review with InForm

–Default Listings show queries

–TMS Medical Dictionary coding

• Single point of change

•Traceability is maintained from CDASH > Review > SDTM

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DMW QuickStart Libraries and Templates

• Study and Template objects based on pre-existing Therapeutic Area Libraries

• Template Study provided to simplify study set up

• Includes Review and SDTM

• Can reduce study set up time to around 30 minutes

Simplify and speed Study Set Up

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DMW QuickStart Data Flow

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EDC, Coding Integration, DMW Data Models, Transformations, GVA Schema and Data Extract

TMS

MedDRA

InForm

Study InF2DMW

CDASH Data

Meta data

Operational

DMW Study InF2DMW

SFTP

Data Mart / SAS v5

Xpt file generator

InF2DMW_SDTM

SDTM

InF2DMW_Review

Review

1 – InForm

2 – Review

Clinical

Meta data

Operational

Clinical

10 - SDTM

Clinical

Trial Design

99 - Visit

SV

Visualization Adapter: - Data Extract

- Visualization Tools

Data Load: -Clinical

- Metadata - Operational

- Queries


DMW QuickStart Study Template

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InForm

Study InF2DMW

CDASH Data

Meta data

Operational

DMW Study InF2DMW

SFTP

Data Mart / SAS v5

Xpt file generator

InF2DMW_SDTM

SDTM

InF2DMW_Review

Review

1 – InForm

2 – Review

Clinical

Meta data

Operational

Clinical

10 - SDTM

Clinical

Trial Design

99 - Visit

SV

GVA Schema created when Template data models are installed

InForm objects created and installed in a single step

Accelerated EDC Integration, Study Set up and Data Delivery

Data Models, TMS coding and Transformations created almost instantly from Study Template


DMW QuickStart Data Extract Instant data delivery to downstream systems

•GVA Business Areas for direct connection to Review and SDTM data –JReview

–Spotfire

–SAS

• SAS xpt file generation for SDTM –Scheduled / On Demand

–Files placed on sFTP for secure download

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DMW QuickStart Data Visualization Data Visualization in Business Intelligence tools

•Direct Integration with OBIEE

•Data is updated automatically using DMW triggered execution

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DMW QuickStart Data Visualization Data Visualization in Business Intelligence tools

•Direct Integration with OBIEE

•Data is updated automatically using DMW triggered execution

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DMW QuickStart

1. CDASH Input

2. Review Model

3. SDTM Models

4. Libraries & Template

5. Data Extract / Visualization

6. Security

Oracle Health Sciences Services have completed a set of standards based accelerators to aid CDASH and SDTM Adoption

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Oracle Health Sciences Streamlining SDTM with CDASH input User Networks/Europe/English...

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