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.
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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. Here is a list of our current projects.
Best Practices for Data Collection Instructions
Best Practices for Metadata Documentation (define.xml versus reviewer's guide)
Data Reviewer's Guide in XML
Define-XML V2.0 Completion Guidelines and Stylesheet Recommendations
Legacy Data Conversion Plan & Report
SDTM ADaM Implementation FAQ
(Relaunched) Standardizing Data within the Inspection Site Selection Process
Study Data Standardization Plan (SDSP)
Standard Analyses and Code Sharing Leverage crowd-sourcing to improve the content and implementation of analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes. Here is a list of our current projects.
Script discovery and acquisition
Repository content and delivery
Repository governance and infrastructure
Communication, Promotion and Education
Analysis and Display White papers
Test Dataset Factory
- Published Whitepapers:
- JumpStart Screen Shots (Version 1.0 word version)**
- Jumpstart Screen Shots (Version 1.0 pdf version)**
- Adverse Events White Paper Version 1.0: 03FEB2017 (PDF version)
- Adverse Events White Paper Version 1.0: 03FEB2017 (word version)
- 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
Nonclinical Topics 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. Here is a list of our current projects.
Nonclinical Study Data Reviewers Guide
SEND Implementation User Group
Application of SEND Data for Analysis
Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping
Visualisation of Group Related Differences in Histopathology Data
Industry SEND Progress Survey
Test Submission Forum Group
Nonclinical Script Assessment Project
Data Consistency: SEND Datasets and the Study Report
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”. Here is a list of our current projects.
Cloud Adoption in the Life Sciences Industry
Statistical Computing Environment
Data Visualizations for Clinical Data
Evaluation of Alternative Transport Formats
Investigating the use of FHIR in Clinical Research (new)
Educating for the Future (new)
Linked Data & Graph Database
Prototyping Next Generation Transport Formats
The Linked Data and Graph Databases Working Group (formerly the Semantic Technology Working Group) will be running a breakout session at the 2017 CSS will differ from previous symposiums. In addition to the project breakout sessions, the Working Group will host a separate breakout session that will build upon the Alternative Transport Format project in the Emerging Trends and Technologies Working Group and prototype next generation transport formats. This hands-on sessions will represent data in different formats including CDISC Dataset XML, the Resource Description Framework (RDF) and Neo4j property graphs. The wrap-up session will include a debrief and attempt to draw conclusions from the prototyping activity.
The Working Group welcomes anyone with CDISC business knowledge or data modeling knowledge to join the prototyping activities (i.e. you don’t need to be a technology expert). Registration for these sessions will be limited. Please indicate your interest by selecting Linked Data and Graph Databases Working Group during the registration. If you have any questions in advance, please contact Tim.Williams@phuse.eu or Scott.Bahlavooni@phuse.eu.
Representing Clinical Program Design in RDF
Development of a Clinical Development Design (CDD) Ontology
Clinical Trials Data as 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
Standardizing data within the Inspection Site Selection Process (Re-launched in the
Optimizing the Use of Data Standards Working Group)
FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.