SDTM-ETLTM
The user-friendly ODM to SDTM Mapping software - Information about previous versions
The software with the lowest cost benefit ratio for generating SDTM/SEND datasets!
Information about the most recent version can be found here
The SDTM-ETLTM software is considered to be the lowest cost - highest benefit software for creating SDTM and SEND datasets in the industry.
All that is required is that your EDC system can export clinical data in CDISC ODM format (most EDC systems do so).
SDTM-ETL is completely "SAS®-free", i.e. unlike other solutions, you do not need an (expensive) SAS® license, nor do you need any statistical software.
SDTM-ETL comes with an extremely user-friendly graphical user interface, allowing to create most of the mappings by drag-and-drop or per mouseclick.
Many CROs and service providers have already discovered SDTM-ETL and are using it for preparing their submissions to the regulatory authorities.
Instruction movies
New in version 3.2
New in version 3.1
New in version 3.0
New in version 2.2
New in version 2.0
New in version 1.6
New in version 1.5
New in version 1.4
New in version 1.3
New in version 1.2
Training
Licensing
Instruction movies
A set of instruction movies is available on our demo application server.
This set of instruction movies is regularly extended and improved. So we invite you to visit the 'instruction movies' website regularly.
New in version 3.2
Version 3.2 has the following additional features:
- Wizards for easier generation and editing of ValueLists
- Retrieving page numbers from an annotated CRF in PDF format
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The "New Features" document can be downloaded here.
New in version 3.1
Version 3.1 has the following additional features:
- Creating and Editing Trial Design Datasets
- Integrated OpenCDISC 1.5 Validator
- "Find Domain" wizard
- Display of define.html in favorite browser
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The "New Features" document can be downloaded here.
New in version 3.0
Version 3.0 has the following additional features:
- Support for the newest CDISC standards: Define-xml 2.0, SDTMIG-3.2, Dataset-XML
- Graphical User Interface: Hide domains, embedded Smart Submission Dataset Viewer
- Vendor Extension support
- Autosave of the working define.xml
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The "New Features" document can be downloaded here.
New in version 2.2
Version 2.2 has the following additional features:
- Full support for SDTM 1.3 and SDTM-IG 3.1.3
- Additional domain templates: medical devices, oncology, non-subject-data, draft SDTM 1.4 domains
- New functionality: suggestion for the SDTM/SEND Variable Length (on request of the FDA)
- Further improved dialogs and wizards
- Considerably improved performance
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The "New Features" document can be downloaded here.
New in version 2.0
Version 2.0 has the following additional features:
- Full support for and implementation of SDM-XML (Study Design Model in XML)
- New color schema for required / expected / permissible variables
- Improved possibilities for tailoring the logs
- Viewing of log files
- Newest CDISC Controlled Terminology implemented in the templates
- Latest version of OpenCDISC
- Full support for SDTM 1.2 Amendment 1
- New functionality: create CodeList from existing MeasurementUnits
- Extended functionality for "View - SDTM CDISC Notes" - direct access to PDF documents
- Additional option: turning "graying out ODM tree nodes" off and on
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New in version 1.6
Version 1.6 has the following additional features:
- Implementation of SEND v.3.0 final
- Automated creation of the RELREC dataset and records - movie
- Subject Global Variables
- Searching function in scripting editor
- Sticky notes for SDTM variables
- "Required" / "Expected" / "Permissible" shown in "CDISC Notes"
- Batch / command line execution of existing mappings
- SDTM-ETL Light version available
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The "New Features" document can be downloaded here.
New in version 1.5
Version 1.5 has the following additional features:
- Full support for the (draft) SEND v.3.0 standard
- Automated splitting of COVAL fields in CO domain
- Multiple COVAL fields when creating SQL to generate database tables (user selectable)
- Multiple COVAL fields when cleaning up the define.xml file (user selectable)
- Special versions for ODM sources with vendor-extensions now available (e.g. OpenClinica®/ClinCapture®)
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The "New Features" document can be downloaded here.
New in version 1.4
Version 1.4 has the following additional features:
- Partial support for non-SDTM (such as ADaM) datasets (on request)
- Support for ODM "Alias" containing SDTM and CDASH annotations
- Fast mapping for CDASH forms
- Automated generation and population of SDTM "Comments" (CO) domain from ODM Annotation/Comment elements
- Faster access to user-defined functions
- Extended HTML view of the underlying define.xml
- Mapping completeness report
- Logging with timestamps
- Integration of the OpenCDISC-Validator
- Even more support for sponsor-defined domains and for non-standard variables
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A 22-page "New Features" document can be downloaded here.
New in version 1.3
Version 1.3 has the following additional features:
- Non-standard variables (going into SUPP-- at execution time)
- Full implementation of SDTM 1.2 / SDTM-IG 3.1.2
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New in version 1.2
Version 1.2 has the following additional features:
- Creation of sponsor-defined SDTM Domains
- Full support for ODM 1.3
- More scripting functions
- User-defined scripting functions
- Superior browser view of define.xml
- Even more export options
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Training
Although the use of the SDTM-ETL software is very intuitive, many of our customers desire to get some training to start working with the software.
In our experience, one day of training usually suffices to make a jumpstart with the software. Such trainings are of course offered by us, usually at the location
of the customer.
A copy of the tutorial, explaining many of the features of the software, and used during trainings, is available on request.
We are currently also developing online training materials
Licensing
The SDTM-ETL software is available at highly competitive prices. Considerably volume discounts can be obtained. Academic licenses are available at a reduced price.
For more information about licensing options and pricing, please contact us.
XML4Pharma, Katzelbachweg 18, 8052 Thal, Austria
