Difference between revisions of "PhUSE Wiki"

From PhUSE Wiki
Jump to: navigation, search
m
m
 
(42 intermediate revisions by 3 users not shown)
Line 14: Line 14:
 
       <tr align="center">
 
       <tr align="center">
 
         <th><big>'''[http://www.phuse.eu PhUSE Website]'''</big></th>
 
         <th><big>'''[http://www.phuse.eu PhUSE Website]'''</big></th>
         <th><big>'''[[Computational_Science_Working_Group_Steering_Committee|CS Steering Committee]]'''</big></th>
+
         <th><big>'''[[Computational_Science_Working_Group_Steering_Committee|Steering Committee]]'''</big></th>
         <th><big>'''[[CSS Working Groups|CSS Working Groups]]'''</big></th>
+
         <th><big>'''[[CSS Working Groups|Useful Information]]'''</big></th>
 
         <th><big>'''[[Good_Programming_Practice_Guidance|GPP]]'''</big></th>
 
         <th><big>'''[[Good_Programming_Practice_Guidance|GPP]]'''</big></th>
 
       </tr>
 
       </tr>
Line 49: Line 49:
 
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Need help with the Wiki? Ideas to Improve?</div>
 
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Need help with the Wiki? Ideas to Improve?</div>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
<big>The Wiki Team are always looking at ways to improve this site. We want to make this user friendly, current and of benefit to PhUSE Members. If you have a question, query or need help, please use this '[http://www.phusewiki.org/wiki/index.php?title=Have_a_Wiki_Question%3F_Need_help%3F_Use_this_forum_to_ask_you_question '''Discussion Forum''']'. A member of the team will do their best to assist and all feedback is welcome. Equally should you wish to be part of the team, contact wendy@phuse.eu </big>
+
<big>The Wiki Team are always looking at ways to improve this site. We want to make this user friendly, current and of benefit to PhUSE Members. If you have a question, query or need help, please use this '[http://www.phusewiki.org/wiki/index.php?title=Have_a_Wiki_Question%3F_Need_help%3F_Use_this_forum_to_ask_you_question '''Discussion Forum''']'. A member of the team will do their best to assist and all feedback is welcome. Equally should you wish to be part of the team, contact wendy@phuse.eu </big><br>
 +
<br>
 +
<br>
 
</div>
 
</div>
 
</div>
 
</div>
 
<br/>
 
<br/>
<!-----------------------------What is this place------------------------------>
+
<!-----------------------------Industry News------------------------------>
 
<div style="border:1px solid #8898BF;">
 
<div style="border:1px solid #8898BF;">
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">What is this place?</div>
+
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Industry News</div>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
The PhUSE Wiki is an [http://www.phuse.eu PhUSE]/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics. The wiki has three main goals:<br />
+
GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PhUSE Privacy Policy]]''' and contact the PhUSE Office at office@phuse.eu if you have any queries.<br>
#To support the [[FDA Working Groups|Computational Science Symposium (CSS) Working Groups]] by creating an online collaboration environment.
+
<br>
#To support the [[Standard Scripts|sharing]] of statistical and informatics software code (SAS,R etc).
+
PhUSE & [https://www.phusewiki.org/wiki/images/6/6a/PhUSE_HL7_SOU_2018_FINAL.pdf HL7 MOU] October 2018 <br>
#To serve as a medium to share information related to software programming and processes for pharmaceutical, biotech, CRO, medical device and health care programmers.
+
<br>
 +
FDAs Website now has a page referencing PhUSE and their deliverables which can be found [https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm482470.htm here] <br>
 +
<br>
 +
Here's the [https://www.fda.gov/downloads/forindustry/datastandards/studydatastandards/ucm384744.pdf link] to the latest version of the Technical Conformance Guide ('''TCG''') which has been updated by the FDA March 2018<br>
 +
<br>
 +
*Refuse to File: [https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588242.pdf?utm_campaign=CDER%20New%2012%2F13 NDA & BLA Submissions to CDER]. Guidance for Industry.<br>
 +
*Formal meetings between [https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf FDA and Sponsors or Applicants] of PDUFA Products<br>
 +
*Best Practices for communication between [https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm475586.pdf IND Sponsors and FDA] during Drug Development<br>
 +
<br>
 +
PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current [http://www.phusewiki.org/wiki/images/6/67/PhUSE_CDISC_MOU_2018_to_2019.pdf version].
 
</div>
 
</div>
 
</div>
 
</div>
Line 68: Line 79:
 
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">PhUSE Events</div>
 
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">PhUSE Events</div>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;"><br>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;"><br>
<br>
+
[[Image:SDE_2018_Standard_Banner.jpg|500x500px|link=http://www.phuse.eu/single-day-events-2018]]<br>
[[Image:Single Day Events 100.jpg|500x500px|link=http://www.phuse.eu/single-day-events-2018]]<br>
 
<br>
 
 
<br>
 
<br>
 
[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]<br>
 
[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]<br>
 
<br>
 
<br>
<br>
+
[[Image:2019_US_Connect_Website_Banner.jpg|500x500px|link=http://www.phuse.eu/us-connect19]]<br>
[[Image:PhUSE_Raleigh_2018_Web_Banner.jpg||500x500px|link=http://www.phuse.eu/us-connect18]]<br>
 
<br>
 
<br>
 
 
</div>
 
</div>
 
</div>
 
</div>
Line 105: Line 111:
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
<br>
 
<br>
'''NEW''' Standard Analyses and Code Sharing Working Group has now published Version 2:0 White Paper on Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Document. Click [https://www.phuse.eu/css-deliverables here] for the revised version under White Papers<br>
+
Our '''Data Standards for Non-Interventional Studies''' project are seeking your input on the challenges you face during creation of the analysis datasets and handling of the data for the observational studies. We would be grateful if you could take the time to answer this two question survey.  
 +
<br><br>
 +
Link to [https://www.surveymonkey.co.uk/r/9YZGYX9 Survey]<br>
 
<br>
 
<br>
'''NEW''' - PhUSE [http://www.phuse.eu/css-deliverables Standard Operating Procedure] on version control for PhUSE deliverables<br>
+
A '''NEW''' Nonclinical project has just been approved and the leads are looking for volunteers to join the project. [[to bring together deep knowledge of SEND and RDF/linked data and broaden the base of people in the SEND community with understanding the concept of RDF/linked data to facilitate a qualified discussion.|Understanding RDF Linked Data for Potential Nonclinical Use]] are looking to to bring together deep knowledge of SEND and RDF/linked data and broaden the base of people in the SEND community with understanding the concept of RDF/linked data to facilitate a qualified discussion.  
 
<br>
 
<br>
'''NEW''' Optimising the Use of Data Standards Working Group are pleased to announce the publication of the Study Data Standardised Plan, Sponsor Implementationn and relevant Template. Click [https://www.phuse.eu/css-deliverables here] for the deliverables.<br>
+
<br>
 +
PhUSE [http://www.phuse.eu/css-deliverables Standard Operating Procedure] on version control for PhUSE deliverables<br>
 
<br>
 
<br>
'''Calling all volunteers'''. Are you interested in joining one of the new projects recently approved by the CS Steering Committee?. This [http://www.phuse.eu/cs-new-project-ideas link] will take you to an overview of the latest projects looking for members.<br>
+
Calling all volunteers. Are you interested in joining one of the new projects recently approved by the CS Steering Committee?. This [http://www.phuse.eu/cs-new-project-ideas link] will take you to an overview of the latest projects looking for members.<br>
 
<br>
 
<br>
'''[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables]''' <br>
+
[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables] <br>
 
<br>
 
<br>
'''[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
+
[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
 
<br>
 
<br>
'''[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings''''''<br>
+
[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
 
<br>
 
<br>
'''Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]'''<br>
+
Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]<br>
 
<br>
 
<br>
 
</div>
 
</div>
 
</div>
 
</div>
 
<br>
 
<br>
<!----------------------------------------Industry News------------------------------------------->
 
<div style="border:1px solid #8898BF">
 
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Industry News</div>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;"><br>
 
FDAs Website now has a page referencing PhUSE and their deliverables which can be found [https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm482470.htm here] <br>
 
<br>
 
Here's the [https://www.fda.gov/downloads/forindustry/datastandards/studydatastandards/ucm384744.pdf link] to the latest version of the Technical Conformance Guide ('''TCG''') which has been updated by the FDA March 2018<br>
 
<br>
 
*Refuse to File: [https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588242.pdf?utm_campaign=CDER%20New%2012%2F13 NDA & BLA Submissions to CDER]. Guidance for Industry.<br>
 
*Formal meetings between [https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf FDA and Sponsors or Applicants] of PDUFA Products<br>
 
*Best Practices for communication between [https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm475586.pdf IND Sponsors and FDA] during Drug Development<br>
 
<br>
 
PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current [http://www.phusewiki.org/wiki/images/6/67/PhUSE_CDISC_MOU_2018_to_2019.pdf version].
 
 
|}
 
|}
  

Latest revision as of 08:42, 15 October 2018

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.


PhUSE Website Steering Committee Useful Information GPP
PhUSE Web Page Wiki.jpg
CS Steering Committee (Wiki).jpg
CSS Working Groups Wiki.jpg
Good Programming Practice Guidance Wiki.jpg

Join a Working Group now!


Currently 6,766 users are helping to Connect, Share, 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

Need help with the Wiki? Ideas to Improve?

The Wiki Team are always looking at ways to improve this site. We want to make this user friendly, current and of benefit to PhUSE Members. If you have a question, query or need help, please use this 'Discussion Forum'. A member of the team will do their best to assist and all feedback is welcome. Equally should you wish to be part of the team, contact wendy@phuse.eu



Industry News

GDPR has gone live. Please review PhUSE Privacy Policy and contact the PhUSE Office at office@phuse.eu if you have any queries.

PhUSE & HL7 MOU October 2018

FDAs Website now has a page referencing PhUSE and their deliverables which can be found here

Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA March 2018


PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current version.


PhUSE Events

SDE 2018 Standard Banner.jpg

Frankfurt Connect Web Banner.jpg

2019 US Connect Website Banner.jpg


Create a new Wiki page

Enter the page title:




Working Group News


Our Data Standards for Non-Interventional Studies project are seeking your input on the challenges you face during creation of the analysis datasets and handling of the data for the observational studies. We would be grateful if you could take the time to answer this two question survey.

Link to Survey

A NEW Nonclinical project has just been approved and the leads are looking for volunteers to join the project. Understanding RDF Linked Data for Potential Nonclinical Use are looking to to bring together deep knowledge of SEND and RDF/linked data and broaden the base of people in the SEND community with understanding the concept of RDF/linked data to facilitate a qualified discussion.

PhUSE Standard Operating Procedure on version control for PhUSE deliverables

Calling all volunteers. Are you interested in joining one of the new projects recently approved by the CS Steering Committee?. This link will take you to an overview of the latest projects looking for members.

CS Collaboration Catalog of Deliverables

Working Group Quarterly Newsletters

PhUSE Webinars - Upcoming events and past presentations & recordings

Want to become a member of PhUSE? Here's how




Last revision by WendyDobson, 10/15/2018