Welcome to the PhUSE Wiki
The PhUSE Wiki is an PhUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.
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Currently 6,567 users are helping to Share, Contribute and Advance clinical informatics.
All content on this wiki is non-binding. All content expresses opinions of users and not necessarily that of their employer nor PhUSE. See our Disclaimers page
What is this place?
The PhUSE Wiki is an PhUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics. The wiki has three main goals:
- To support the Computational Science Symposium (CSS) Working Groups by creating an online collaboration environment.
- To support the sharing of statistical and informatics software code (SAS,R etc).
- To serve as a medium to share information related to software programming and processes for pharmaceutical, biotech, CRO, medical device and health care programmers.
What can I do here?
Well that depends who you are. If you are a CSS Working Group member you can click here to access your specific working group. If you are authoring a wiki for the PhUSE Annual Conference you can click here.Otherwise, if you have something to share, enter the title of your page into the box at the right. If you are looking for something, use the search at the top right of this page.
Start by creating a User account. In order to keep this Wiki transparent for all users it would be great if you could use your real name as your user name. Note that you also need to create a User account if you are a PhUSE member. Your PhUSE login details do not work here. It might also be good to familiarize yourself with the wiki language. After that, you are welcome to add, edit, read, and discuss anything in this wiki. If you have questions, please contact us . Interested, but don't know which topic to tackle? Check out the Wanted pages. Make someone's day by answering their question.
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Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA October 2017
Refuse to File: NDA & BLA Submissions to CDER. Guidance for Industry.
Last revision by JaneSeery, 01/5/2018