Evaluation Of Alternative Transport Formats

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Project Title

Evaluate and Prototype Alternative Transport Formats for Submission to support both Structure and Content Requirements

Project Team Members

List team leads and team members. Identification of a project manager is recommended.

Affected Stakeholder

Industry users preparing data for submission to regulatory agencies, and users within regulatory agencies receiving and reviewing data.

Project Meeting Frequency

  • Kick off Meeting 10-Dec-2015

Definition(s) of Problem/Issue/Challenge

For decades, the submission format for clinical data has been the SAS v5 transport format and just recently those formats have contained CDISC SDTM and ADaM datasets. In 2012, the FDA held a public meeting to discuss the challenges and gaps in the SAS v5 transport format that limited their ability to review the data. The challenges identified included a combination of technical issues (e.g. limitations in variables and label lengths) and content issues (e.g. inability to define relationships without external metadata). The FDA initiated a Pilot project in 2013 to evaluate CDISC Dataset-XML as an alternative transport format. They conducted this pilot over a year and summarized their findings. The FDA concluded that the DS-XML format helped to address basic technical challenges; however, the size of the data was still an issue. While content issues were not addressed in the scope of the pilot, follow up discussions have indicated that content gaps are also part of the challenge.

Potential Technological Solution(s)

Other Initiatives that can be leveraged/merged

Recommended Solution(s)

This prototype would show that clinical data can be modelled to build missing relationships and provided to regulatory in a format that supports analyses.

Specific Actions

Phase I: Evaluate Alternative Transport Formats to support structure and content

Phase I will explore alternative transport formats/models to address structural and content gaps within the existing transport format and associated content. The following steps are proposed:

  • Collaborate with industry and regulatory agencies to identify use cases that are not being fully addressed by the current transport format.
  • Extend BRIDG for a targeted set of core clinical data domains to support the use cases defined in the first step (e.g. Demographics, Adverse Events, Exposure, and Vital Signs).
  • Identify a technology set and create an exectuable model that supports the required multi-dimensionality of the clinical data and other use cases.

Phase 2: Prototype Model Mapping SDTM to transport format

If Phase I identifies a clear path forward, Phase 2 will leverage existing SDTM pilot data and the protoype model developed in phase I to map pilot SDTM data to the model thus providing an alternative transfer format. The following steps are proposed:

  • Represent pilot SDTM data using the prototype model.
  • Test whether new transport format can support use cases
  • Evaluate the performance of the new model against the existing models along a pre-determined set of quality metrics (such as ease of use, data quality)

Deliverables and Dates:

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Last revision by Glow,12/7/2015

Deliverable Date (ddMONyyyy)
Something Great 14MAR2013