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SDTM-ETL^TM

The user-friendly ODM to SDTM Mapping software

New: Version 1.1 now available

The problem
Overview
Features
Extract, Transform and Load
Advantages over other ETL software tools
Product information
New in version 1.1
Coming soon on version 1.2
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, 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.

Overview

SDTM-ETL: Overview SDTM-ETL^TM acts on CDISC ODM files (v.1.2) 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.

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 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
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
No propriety formats used, only CDISC standards formats

New in version 1.1: export of SDTM datasets in SAS Transport (XPORT - .xpt) files

Extract, Transform and Load

SDTM-ETL^TM is a real ETL tool. 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 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
Condiderable lower cost than other ETL tools

Product information

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

New in version 1.1

Upon request of some of our customers, following features have been added to version 1.1:

Output of SDTM records in SAS Transport V (oldfashioned, but still required by the FDA)
Creation of additional, non-standard SDTM variables as described by the rules in the SDTM IG v.3.1
Full CDISC Controlled Terminology implemented as define.xml CodeLists: Package 1 / Lab Test Codes and SDTM Package 2A

Coming soon in version 1.2

Version 1.2 will have the following additional features:

Creation of sponsor-defined SDTM Domains
Even more export options

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.

Licensing

For more information about licensing options and pricing, please contact us.

SDTM-ETLTM