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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :Phase Forward Provides Free Download for CDISC Adopters.. 2009-10-30 19:44:02 
M.Anusha
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Joined: 2009-07-29 10:23:16
Posts: 9
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Hello,

Phase Forward, a provider of data management solutions for clinical trials and drug safety, released its DefineValidator tool, Release 1.0, as a free download for Clinical Data Interchange Standards Consortium (CDISC) adopters.

The tool was adapted from a current feature of Phase Forward’s WebSDM product, which was developed under a Cooperative Research and Development Agreement (CRADA) for the U.S. Food and Drug Administration (FDA) to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format. 

The define.xml file is used by the FDA to understand the contents of CDISC SDTM submissions, and is necessary to load clinical study data into the FDA’s Janus data warehouse. Problems with the file can delay loading of submission data into Janus and make it difficult for reviewers to understand SDTM data submissions.

Unfortunately, many of these files received to date by FDA have been problematic, partly due to the lack of a widely available validation tool that can be used by most sponsors. Phase Forward’s DefineValidator tool is designed to help sponsors identify and correct define.xml errors prior to submitting to FDA, which should streamline the submission process for both parties.

“We’re very pleased that Phase Forward has contributed this important tool to the standards community,” said David Iberson-Hurst, vice president of technical services for CDISC. “Tools like this will help increase the adoption of CDISC standards among sponsors and help FDA to continue to realize the many benefits of working with CDISC data standards.”

The DefineValidator tool is currently available for download at www.phaseforward.com/products/ cdisc/. “The free release of this tool underscores Phase Forward’s longstanding commitment to industry standards,” said Steve Rosenberg, senior vice president of products and services for Phase Forward. “As a founding sponsor of CDISC, we want to help ensure the widespread adoption of standards, making the submission process work more smoothly for everyone.”

regards

anusha
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