CSS Working Groups
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
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.
NEW: The ADRG team within the Optimizing the Use of Data Standards announces the release of the DRAFT ADaM Data Reviewer's Guide template and instructions. The team will be meeting in Silver Spring MD on 2014-03-17 to work on the final drafts. Comments and suggestions are welcome and encouraged. Visit the Wiki page for more information and to download the draft documents.
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
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.Current user rating: 97/100 (2 votes)