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SDTM-ETL^TM

The user-friendly ODM to SDTM Mapping software

New: February 2012: Version 2.0 is now available

New: SDTM-ETL for OpenClinica^® Users

The problem
History
Overview
Features
Extract, Transform and Load
Advantages over other ETL software tools
Product information
Instruction movies
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
Currently in development
Training
Licensing

The problem

Setting up and executing a mapping between your clinical data and the CDISC SDTM Standard is not an easy task. For some SDTM Variables, a 1:1 mapping is possible, but usually, clinical data items need to be combined to come to an SDTM Variable (n:1 mapping). Furthermore, codelists need to be mapped, and clinical data categorized to SDTM codelists.
At the same time, the define.xml file needs to be constructed and kept in sync with the designed mapping.
Furthermore, the mapping needs to be executed on the available clinical data and an SDTM database created and populated.

Unfortunately, until now there was no software package on the market which could do this all at the same time in a user-friendly way. Therefore, XML4Pharma developed SDTM-ETL^TM, a visual, easy to use software package for setting up mappings between clinical data in your operational database and the SDTM standard.

History

The SDTM-ETL^TM software is the further development of the "SDTMWandler" ("SDTM Transformer") a software package developed for, and in close cooperation with TMV e.V. ("Telematikplattform für Medizinische Forschungsnetze e.V."), the German Informatics/Telecommunication Platform for Medical Research Networks. TMV e.V. wanted a software package to transform ODM metadata and clinical data into SDTM format, this in order to build databases and data warehouses, needed to be able to compare clinical studies of the different partners in the academic network.

Overview

SDTM-ETL: Overview SDTM-ETL^TM acts on CDISC ODM files (v.1.2, 1.3 or 1.3.1) which can easily be exported from any modern EDC, CDM system or database (the CDISC ODM standard is THE exchange format for clinical data between sponsors, CROs and the FDA).

In SDTM-ETL^TM, the clinical data metadata are represented as a tree on the left side of the screen, whereas the SDTM standard is represented as a table on the right side of the screen.

Mappings can be created simply by drag-and-drop, wizards showing up automatically, making the mapping process very intuitive and easy. The mappings are then stored in an easy-to-learn scripting language within the underlying define.xml itself.

Features

Create mappings using drag-and-drop
Candidates for mapping are color-marked according to data type
Hot candidate (according to ODM "SDSVarName") highlighting
CodeList mapping wizards pop up when appropriate
n:1 mapping generation through easy-to-learn scripting language
Many wizards for generating scripts automatically
Wizards for codelist mapping
Full support for as well SDTM 1.1 (SDTM-IG 3.1.1), SDTM 1.2 (SDTM-IG 3.1.2) and SEND 3.0-draft
Full CDISC SDTM and Lab Controlled Terminology implemented
Many build-in functions for combining data (n:1 mappings)
Edit domain and variable properties
Testing of mappings on test clinical data
Generate transformation code on-the-fly (XSLT code)
Execute transformation code on clinical data
Automated generation of SUPP-- datasets and records
Automated generation of CO-domain and records
Create SQL statements to create an SDTM database
Populate SDTM database with generated SDTM records
Define.xml export
Validation of ODM metadata, ODM clinical data, define.xml and SDTM records against the CDISC standards and for internal consistency
Build-in OpenCDISC validator
No propriety formats used, only CDISC standards formats

Export of SDTM datasets in SAS Transport (XPORT - .xpt) files

Extract, Transform and Load

SDTM-ETL^TM is a real ETL tool - but specializing in SDTM. Once a mapping generated, clinical data can be extracted from ODM files, transformed into SDTM records, and loaded into the created SDTM database.

As such, SDTM-ETL^TM, together with our Study Designer and our other product offerings, is one of the first real realizations of CDISC end-to-end.

Advantages over other ETL software tools

Designed and developed for use with CDISC standards
Only uses CDISC open standards - no propriety formats
No SAS software nor macros required - but export in SAS XPT anyway
No SAS skills required at all
Condiderable lower cost than other ETL tools or statistical software

Product information

More product information is available in the product flyer, and in the product brochure.

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 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

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

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^®)

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

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

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

Currently in development (for release 2.1)

We are currently planning and working on the following additional features

Implementation of new CDISC Oncology Domains (TU, TR, RS)
Implementation of new Devices Domains (DI, DU, DX, DE, DT, DR, DO)

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.

OpenClinica^® is a trademark of Akaza Research LLC in the United States and other countries.
XML4Pharma is not a certified partner, reseller, or affiliate of Akaza Research LLC, and is not certified, approved, or sponsored by Akaza Research LLC in connection with the installation, operation, maintenance or support of the OpenClinica^® software platform, the OpenClinica^® Enterprise software platform or any other Akaza products.

SDTM-ETLTM