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FDA/PhUSE WG 5

FDA/PhUSE WG 5. Development of Standard Scripts for Analysis & Programming Goals and Objectives. Goals and Objectives. Developed by WG leadership team Posted on WG 5 Wiki: http://www.phusewiki.org/wiki/index.php?title=WG5_Charter Provide a starting point and focus for March F2F sessions.

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FDA/PhUSE WG 5

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  1. FDA/PhUSE WG 5 Development of Standard Scripts for Analysis & Programming Goals and Objectives

  2. Goals and Objectives • Developed by WG leadership team • Posted on WG 5 Wiki: http://www.phusewiki.org/wiki/index.php?title=WG5_Charter • Provide a starting point and focus for March F2F sessions.

  3. Goals • Support development of validated scripts • Enable use of cutting edge analysis techniques within the review environment • Develop technical requirements for a non-fee based platform that houses the scripts • Share approaches for analysis of clinical trials safety data to develop a core set of analyses for characterization of compound safety profiles.

  4. Objectives • Develop a platform for sharing scripts that will • Support development of script library that leverages industry data standards. • Encourage script contributions from the pharmaceutical community, regulators and academics. • Encourage ongoing improvement of contributed scripts. • Provide documentation with sufficient detail that consumers know how and when to use the script. • Support a library search capability. • Develop metadata for contributed programs. • Develop standards for specifying analysis. Network with subject matter experts to develop a list of core tables figures and listings applicable across compounds.

  5. Objectives • Develop standards for specification of data transforms. • Develop a process for registering, managing, testing and publishing scripts. • Leverage existing CDISC SDTM and ADaM standards. • Identify validation rules for ADaM datasets that would support successful execution of scripts. • Develop a glossary of analysis terminology. • Develop recommendations for a process that validates scripts. • Provide test data to support validation of scripts. • Contribute to the review and approval process by filling gaps while avoiding duplication of effort.

  6. WG5 – Subgroups… • What scripts do we want/need? • Creation and validation of scripts • Platform for script management

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