Difference between revisions of "CSS Working Groups"

From PHUSE Wiki
Jump to: navigation, search
m (SaschaAhrweiler moved page FDA Working Groups to CSS Working Groups)
(No difference)

Revision as of 16:16, 17 January 2014


This wiki is available to document the progress of the PhUSE Computational Science Symposium (CSS) 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

PhUSE CSS Working Groups

Currently active projects for all Working Groups can be found here

Improving Data Quality This working group will focus on collaborating to develop a robust process to rapidly validate and assess data quality as data moves through product lift cycle across both industry and regulatory review. The group will discuss current pains and potential solutions regarding topics such as current data validation rules, therapeutic specific data issues and improving the quality of the data to support specific analytical needs.

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.

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.

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 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”.

PhUSE 2012 Archived Working Groups


Data Validation and Quality Assessment

Standardizing data within the Inspection Site Selection Process

Challenges of Integrating and Converting Data across Studies

Standards Implementation Issues with the CDISC Data Models

Development of Standard Scripts for Analysis and Programming

Non-Clinical Road-map and Impacts on Implementation

Working Group Oversight

Below is a list of Working Group and Project oversight information.
CSS New Project Wiki Template Page


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.