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.
- Study Data Standardization Plan (SDSP) - Development of a recommended study data standardization plan early in the development cycle to optimize implementation of CDISC SEND, SDTM, ADaM data standards is the focus of this new project.
- (Re-Launched) Standardizing Data within the Inspection Site Selection Process - The FDA's Office of Special Investigations has developed a standard tool to select sites for inspection. This Working Group will complete a gap analysis of data elements needed by this tool and data elements currently represented by CDISC standards. Upon completion, the gap analysis will be submitted to the CDISC organization for consideration of development of site-level domains and other new standards.
- ADRG and SDRG Work Packages Referenced in Final FDA Study Data Technical Conformance Guide, Dec 2014
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.
- Published Whitepapers:
- Analyses and Displays Associated with Measures of Central Tendency - Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Submission Documents (PDF Version) 10Oct2013
- Analyses & Displays Associated with Measures of Central Tendency - Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Submission Documents (Word Version) 10Oct2013
- Analyses and Displays of PK 25Mar2014
- Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinnical Trials and Integrated Summary Documents (PDF Version) 07Oct2014
- Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Intergrated Summary Documents (Word Version) 07Oct2014
- Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal: Focus on Vital Signs, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Summary Documents (PDF Version) 10Sep2015
- Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal: Focus on Vital Signs, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Summary Documents (Word Version) 10Sept2015
- Analyses and Displays Associated with Thorough QT/QTc Studies (PDF Version) 11Mar2016
- Analyses and Displays Associated with Thorough QT/QTC Studies (Word Version) 11Mar2016
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.
Emerging Trends and Technologies 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”.
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.
- Representing a Clinical Program Design in RDF - This project will develop an RDF information model to capture, retain, reuse and share the design of clinical program.
- Analysis Results and Metadata - Development of standard models and technical standards for the storage and usage of analysis results data and metadata to support clinical and non-clinical applications.
- Representing Regulations and Guidance in RDF - This project will valuate the feasibility of representing regulations and guidance documents in RDF. If you are interested in participating in this project, please email us at: CSS-SemanticTechnologies (at) phusewiki.org
- NEW: Use Cases for Linked Data - The pharmaceutical, biotechnology, and device development industry has long been constrained by two dimensional, row and column, data structures. These two dimensional data structures support multi-dimensional business processes and multi-dimensional data. The additional dimensions are often defined by non-executable, human business knowledge. Knowledge differences or gaps contribute to inefficient and/or laborous business processes. This project will document use cases for linked data in the clinical trial life-cycle. If you are interested in participating in this project, please email us at: CSS-SemanticTechnologies (at) phusewiki.org
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
Standardizing data within the Inspection Site Selection Process (Re-launched in the
Optimizing the Use of Data Standards Working Group)
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