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.
If you are new to wikis you might want to check out the help section. To get started click on your working group below.
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The Working Groups are governed by the Computational Science Steering Committee which provides oversight to the Working Groups.
Useful Information for Projects
Have a Project idea?
Complete the New Project Request template for submission to the Steering Committee through your Working Group Lead
Giving a PhUSE Presentation?
Here is the link for PhUSE CS Power Point Template
Writing a White Paper / PhUSE Deliverable?
Use this PhUSE Deliverable Template to get you going
Need to create a Wiki project area?
Use this link to start promoting the work your project is doing
Call for Volunteers
Need additional support? People to join the project? Contact wendy(at)phuse.eu who can advertise through the PhUSE media outlets
Overview Of PhUSE Structure And Projects
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
Clinical Legacy Data Conversion Plan & Report
SDTM ADaM Implementation FAQ
(Relaunched) Standardizing Data within the Inspection Site Selection Process
Study Data Standardization Plan (SDSP)
Pooling WHO Drug B3 Format
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
Visualisation of Group Related Differences in Histopathology Data
Industry SEND Progress Survey
Nonclinical Script Assessment Project
Data Consistency: SEND Datasets and the Study Report
Demystifying Define-XML Codelist Handling for Nonclinical Studies
Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies
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 CONCLUDED
Investigating the use of FHIR in Clinical Research (new)
Clinical Trials Data as RDF
Introduction to Clinical Development Design (CDD) Framework
Educating For The Future
Methodologies and technologies utilized in the clinical development process have been largely unchanged since 2005. Externally, there have been immense advancements in technology and mindsets related to working with data that have had little impact in our industry. This Working Group sees this as a risk. The risks breakdown into 3 categories:
1) There is a risk of advancement happening outside of our domain that may expose us to threats that we are unable to protect ourselves against.
2) There is a risk that our skill sets and capabilities become outdated and external forces strongly influence the Industry without us having a say
3) There is a risk that we are missing opportunities to become more efficient and to use these advancements to deliver better value for patients
The goal of this Working Group is to develop frameworks by which to educate the PhUSE community at large. The frameworks will be designed to educate the community on the importance of topics where we feel we have gaps, the details of the topics themselves, and how they can be used to drive innovation in the industry.
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 Archived Working Groups & Projects
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.