CSS Working Groups
This wiki is available to document the progress of the PhUSE Computational Science (CS) working groups and projects. The wiki enables quick,easy and transparent online collaboration. Working groups each have a main page which is the starting page for all Working Group activity.
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The Working Groups are governed by the Computational Science Steering Committee which provides oversight to the Working Groups.
PhUSE CS Working Groups
Optimizing the Use of Data Standards
The development and adoption of data standards over the last decade has shown significant promise in improving efficiencies in the product submission and review process. However, there have also been gaps, issues and challenges in the interpretation and use of the standards. This group will identify specific gaps preventing FDA and industry from optimizing the use of standards and collaborate to close those gaps.
NEW: The ADRG team within the Optimizing the Use of Data Standards announces the release of the FINAL ADaM Data Reviewer's Guide. Visit the Wiki page for more information and to download the draft documents.
NEW: A new Project within the Optimizing the Use of Data Standards is getting started to develop a templates for a Study Data Standardization Plan.. Visit the Wiki page for more information on how you can participate on this new project.
Development of Standard Scripts for Analysis and Programming
With the development and implementation of industry data standards, there is a great opportunity to develop standard reporting across industry and to support the needs of FDA medical and statistical reviewers. This working group will identify potential standard scripts for data transformations and analyses across an within therapeutic areas. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set.
NEW: Version 1 Demographics, Disposition, Medications white paper is final: Analyses and Displays Associated with Demographics, Disposition, and Medications
NEW: Public draft Adverse Events white paper available for review (deadline: 16Jan2015): Analyses and Displays Associated with Adverse Events
NEW: Public draft Outliers or Shifts from Normal to Abnormal white paper available for review (deadline: 16Jan2015): Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal – Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements
NEW: Standard Scripts Index page is available: Standard Script Index
Non-Clinical Road-map and Impacts on Implementation There is a need to improve nonclinical assessment and regulatory science by identifying key needs and challenges in the field and then establish an innovative framework for addressing them in a collaborative manner. The group created a framework for moving certain projects forward to support nonclinical informatics efforts and to develop specific implementation solutions and SEND.
This emerging technologies working group will be an open, transparent forum for sharing pre-competitive means of applying new technologies and is being challenged with creation of well-defined collaborative projects that will describe, prioritize, assess, and assist advancement of these opportunities. Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “The Cloud”.
NEW: Data Transparency: Data De-idendentification Standard Rules - This project will focus in the first place to define de-identification standards in terms of rules to apply, rational and impact on data utility for quasi and direct identifiers in SDTM 3.2.
Semantic Technology This workgroup will investigate how W3C semantic standards can support the clinical and non-clinical trial data life cycle from protocol to submission including the representation of CDISC Foundational Standards in RDF, modeling analysis results, and representing a protocol in RDF.
Project Resources: Tools and Processes to Support Your Work
Below is a list of Working Group and Project oversight information.
CSS New Project Wiki Template Page
PhUSE 2012 Archived Working Groups
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