Post on 12-Mar-2020
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
Oracle Health Sciences Streamlining SDTM with CDASH input
Mike Collinson Life Sciences Architect Oracle Health Sciences Consulting (HSC) March 2016
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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.
2
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
• 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
3
Streamlining SDTM with CDASH input Agenda
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
• 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
4
Clinical Regulatory Background FDA Binding Guidance on SDTM Submissions
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
Conversion to SDTM
5
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)
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
• 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)
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. | 7
Conversion to SDTM Oracle Data Management Workbench (DMW) data processing
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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
8
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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
9
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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
10
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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
11
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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
12
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
DMW QuickStart Data Flow
13
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
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
DMW QuickStart Study Template
14
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
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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
15
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
DMW QuickStart Data Visualization Data Visualization in Business Intelligence tools
•Direct Integration with OBIEE
•Data is updated automatically using DMW triggered execution
16
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
DMW QuickStart Data Visualization Data Visualization in Business Intelligence tools
•Direct Integration with OBIEE
•Data is updated automatically using DMW triggered execution
17
Copyright © 2015, Oracle and/or its affiliates. All rights reserved. |
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
18
1 2
6
3
5 4