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.
For instructions on how to subscribe to the working group/project email list or contact a working goup leadership team click here
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
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
Demystifying Define-XML Codelist Handling for 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 for at least the last 15 years. Since 2005, there have been immense advancements in technology and mindsets related to working with data that have not made their way into our industry. The ET&T working group sees this as a risk. Our opinion is that the general gap in knowledge and skills is so large now that it has the potential to leave us exposed to broad external forces that we are ill prepared to take advantage of. We view this as a large risk for the current workforce of people who perform this work. There are a number of projects that the ET&T group should be working on, to address some of these topics, such as modern programming languages for data science (for example Python, R, or Scala), machine learning, artificial intelligence, design thinking, and agile software development, just to name a few. The goal of this project would be to develop and carry out a framework to educate the PhUSE community at large, on both the importance of these topics, the details of the topics themselves, and how they can be used to drive innovation in the industry. Our initial goal is to identify areas that we see as being the most pressing.
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.