Skip Ribbon Commands
Skip to main content

English Language

:

Announcements :All itemsUse SHIFT+ENTER to open the menu (new window).Open MenuOpen Menu

Use the Announcements list to post messages on the home page of your site.
TitleUse SHIFT+ENTER to open the menu (new window).
  
Body
Use SHIFT+ENTER to open the menu (new window).
  
  

​The SDS team has released SDTM 1.3 for a two week public review. You can access it by clicking on this link.

  

​

We are looking for speakers to contribute to our day on the topic of:
“Submissions: The Holy Grail”
 
Presentations should be approximately 30 minutes long and demonstrate practical examples of how standards have been used in submissions including legacy data conversion experiences, end to end solutions, automated SDTM generation, application of the ADaM model, along with challenges and solutions of using the CDISC standards.
 
If you would like to take part, please send a summary of your presentation (no more than 200 words) to committee@esug.org.uk by Tuesday 1st May 2012.

  

​

ESUG TC EVENT on Define.XML
 22nd March 2012
PRESENTATIONS NOW AVAILABLE
 
 
Over 100 people registered for our first teleconference of 2012! A recording of the event and the two presentations are now available in our Face to Face & Teleconferences document folder.
 
 
  

The next face to face meeting has been rescheduled for 2012. The date and venue to be announced in January.​

  
The CDISC Teleconference recording on SHARE is now available here.
  

Full details can be found on the CDISC website: http://www.cdisc.org/education-and-events

Overview of the forthcoming training and webinars: 

·        Public Training Courses, Tucson, Arizona, USA
19 – 21 January 2011

  

Our most recent TC was kindly presented by Peter van Reusel and Florence Somers from Business and Decision Life Sciences, Belgium.   The presentations were well received, and there were at least 60 people who had dialed in simultaneously – some of these had hired rooms to show the WebEx presentations to more than one person.

The presentations can be still viewed on the CDISC ESUG website, where for the first time you can also hear the (unedited!) podcast of the audio from the TC.

There is still time to rate the TC by completing a quick survey.

 Links:

Traceability between SDTM and AdAM converted analysis datasets

CDISC Data Standards Validation – How can it be done?

Audio podcast from the 30SEP2010 TC

Rate the 30SEP2010 TC in our survey

 

The next CDISC ESUG event is the one day event on Thu 9th December 2010

  
ESUG TC EVENT on the 30th of September 2010
OPEN FOR REGISTRATION           

The English Speaking User Group (ESUG) Committee would like to invite you to our TC event on the 30th of September 2010.

To enable us to plan for numbers (and to ensure we have enough phone lines) for this event you will need to register, please email Veronica.A.Martin@gsk.com (with your e-mail address) to sign up for this event by the 27th of September 2010.

 Date of event :                 Thursday 30th of September 2010

Time of event :                 10:00 AM - 11:30 AM London Daylight Time
Event details :                    30 min for topic 1 (followed by 10 min of Q&A)

30 min for topic 2 (followed by 10 min of Q&A)

 

Topic 1: Title: “CDISC SDTM Validation: How can we do it right? (general)”

Main Content:

·         This is a talk about the importance of SDTM validation (or compliance), especially for FDA submission

·         Briefly discusses the approach in the Business & Decision Life Sciences environment

 

Topic 2:  “Traceability between SDTM and ADaM converted datasets”

Main Content:

·         Currently, SDTM is mapped from the original collected datasets for FDA submissions

·         When FDA request the analysis datasets from ADaM, the traceability issue arises because the converted analysis datasets were not based on the SDTM datasets

·         Discusses a practical approach to ensure traceability so the statistical analysis will produce the same results

 


  

The CDISC Analysis Data Model Team has released a draft version of the ADaM Validation Checks for review.  Included with the document is a comment template to provide comments on either the text within the document or specific checks.  After the comment period the ADaM team will review comments, incorporate, and publish the ADaM Validation Checks.

Please send comments to CDISC Review by 20 August 2010 with a Subject Line of "ADaM Validation Checks Review". Here is a link to the posting on the CDISC website:  http://www.cdisc.org/adam. The validation checks, comments sheet and instructions for review are contained in the zip file, which can be downloaded by clicking here.

  

New posting to the CDISC website that covers the latest information available on FDA Documents that affect CDISC. Two new documents relevant to CDISC have now been posted to the FDA website and one announced in the Federal Register. 

·         FDA CDER Data Standards Plan V1.0 (Draft of the FDA CDER Data Standards Plan)

·         PDFUA IV IT Plan Update (Prescription Drug User Fee Act (PDUFA) IV IT Plan) 

Please refer to the link provided for highlights pulled from each of the documents. At the end of the posting, you find a list (not exhaustive) of the activities FDA CDER and CBER have initiated recently to demonstrate that they are serious in executing the new Data Standards Plan.

 

  

As members of the CDISC User Group, we share a common interest in the development, maintenance and adoption of CDISC standards. A vital component of our success is the  recruitment of the best people to key positions in our organisation and E3C are no exception.  The E3C feels that its process for identifying potential new committee members needs to become more transparent and trawl the available talent pool more effectively. Including the User Groups in identifying candidates will achieve this and make our process more democratic.

Consequently the E3C wishes to extend the call for nominations to the European User Groups (EUG). It has requested that each EUG considers candidates from amongst its membership and evaluates potential members before submitting a maximum of 2 candidates. The E3C retains the privilege to reject a candidacy but will provide an explanation to the User Group proposing that individual. It will be the E3C’s intent to accept at least one candidate from any User Group that submits nominations.  These candidates will join the pool of nominees proposed by E3C members and will be included in the voting process to be performed this year in August.

There are currently 3 vacant positions on the E3C for successful candidates to occupy as from 1st January 2011. The E3C has requested that any nominations from a User Group are submitted to E3C  by the User Group Leader by the 31st July 2010.  Any interests for nomination must be submitted to Veronica Martin (Veronica.A.Martin@gsk.com) by the 26th of July 2010.

The nomination should include the CV of the nominee and a motivation letter in which the candidate explains what he/she has done so far for CDISC, the reasons for joining the E3C and what he/she would bring to the CDISC organization. The outcome of the E3C vote should be known by mid September 2010.

If you have any questions about the process please let me know.

Thanks

Veronica Martin

  

English Speaking User Group Face to Face Meeting
The Practical Use of the CDISC Standards
Define to ADaM

13th July 2010, University of Brunel, Uxbridge
Sponsored by Medidata Solutions Worldwide

AGENDA

WAIT LIST ME

CANCEL REGISTRATION

Please note that this event is currently full. We are wait listing all new applications. 

  

If you are interested in the latest information from CDISC and FDA with respect to improving clinical research processes and regulatory reviews through standards, please attend this webinar (and invite your colleagues of all disciplines).  Topics will include (but are not limited to) the following: 

  • CDISC now has a full suite of standards available, from protocol through analysis and reporting.  Learn the value of the protocol standard in preparing for trial registration, eSubmissions, publications and using EHRs for research.
     
  • FDA CDER and CBER are developing Standards Implementation Plans.  These promise to provide useful input for those planning eSubmissions to these FDA centers. Learn more details on what is new and what is coming from FDA.
     
  • Learn how to avoid costly legacy data conversions and save time and money on your next clinical research project.

The opportunities of SHARE and use of CDISC standards end-to-end to support protocol-driven research will also be discussed. And, preliminary results are available from the most recent CDISC industry survey.  A glimpse of what is coming will be shared in this webinar, with plenty of time for Q&A.

  

The ESUG TC event on DEFINE.XML was held on the 27th of May 2010. There was a huge amount of interest from the user group on the topic . The event was well attended with over 60 people dialling in to learn more about DEFINE.XML.

This was an opportunity for attendees to learn more about DEFINE.XML. The following was covered at the TC :

·         A high level overview of the standard

·         The way that define.xml can be used to trace analysis results back to the source

·         An overview of how to implement define.xml and integrate it into the datasets/results generation process

·         A description of the metadata requirements according to the ADaM V2.1 standard in more detail.

The presentations are posted to the CDISC portal. Click here to access slides.  

If you are interested in finding out more about DEFINE.XML then come to our next event which is scheduled for the 13th of July 2010 at Brunel University.

  

Join us for the next ESUG Event

ESUG TC EVENT on the 27th of May
An opportunity to learn more about DEFINE.XML

The English Speaking User Group (ESUG) Committee would like to invite you to our FIRST event for 2010.

To enable us to plan for numbers (and to ensure we have enough phone lines) for this event you will need to register, please email Veronica.A.Martin@gsk.com to sign up for this event by the 25th of May 2010.

Topic: DEFINE.XML

This is an opportunity to learn more about DEFINE.XML. At this event the attendees will get a high level overview of the standard. The presenters will talk about how a reviewer can trace analysis results back to the source via define.xml and show one possible solution how to implement define.xml and integrate it into the datasets/results generation process. The presenter will describe the metadata requirements according to the ADaM V2.1 standard in more detail.

Date: Thursday 27th of May 2010

Time: 10:00 AM - 11:30 AM London Daylight Time

Event details : 70 minute presentation, 15 minute Q&A.

Presented By: David Iberson-Hurst and Monika Kawhol

 Agenda:

  • Intro to define.xml [20 mins; Dave Iberson-Hurst]
  • Tools [5 mins; Dave Iberson-Hurst]
  • CDISC activities/plans around define.xml [5 mins; Dave Iberson-Hurst]
  • Applications [20 mins; Monika Kawohl]
  • Define.xml in the context of ADaM [20 mins; Monika Kawohl]
  
 
Has your company prepared to get the most from these?
 
At our face to face meetings the user discussion has always returned the greatest reward for participants and so this year the annual conference is scheduling structured user discussion forums.
 
However, to get the best from these they need you to come prepared with questions and answers on a number of topics gathered from your company.
 
See the attached document for full details!
Attachment
  
We need your feedback to make sure we deliver what you want. Have your say on the content of the next and future teleconferences and face to face events.
 
 
  

Face to Face Meeting

Implementing CDISC standards from protocol to p-value

 10th December 2009, Medidata Uxbridge


 

Click HERE to register.

 

The ESUG committee are pleased to announce their next Face to Face meeting scheduled for December 10th. This meeting will focus on the implementation of the CDISC standards from protocol through to p-value with a number of presentations from users at sponsor companies, CROs and software vendors describing their real life experiences of understanding, interpreting and implementing the CDISC standards, the obstacles that they had to overcome and their thoughts and ambitions for the future, the emphasis as always on the practice rather than the theory.

 

This meeting will follow the same successful format of previous USER forums with a mixture of presentations and breakout sessions intended to facilitate networking and stimulate open discussion and lively debate.

 

The day will include:

  • Updates and news from the CDISC ESUG committee
  • CDISC Experience Exchange: Confirmed presentations cover topics such as:-
    • Experiences generating a CDISC Submission
    • The challenges faced by a CRO
    • Experiences implementing SDTM
    • Using CDISC standards from protocol to p-value
  • Breakout sessions, including ‘Birds of a feather’ sessions giving you the chance to exchange ideas and network on topics of common interest.
The meeting will take place at Medidata in Uxbridge on the 10th December from 10AM to 4 PM UK time. We would like to thank PhUSE for their continued support to these meetings and registration using this link is free for existing PhUSE Society members.

Attachment
  

ESUG Upcoming Events

The ESUG Committee has finalised the dates for the final events in 2009, which are:

  • The next ESUG TC will be on the 17th of September 2009 at 14:00PM UK time/9:00AM (US time)
  • The next ESUG F2F meeting will be on the 10th of December 2009

Please record the ESUG upcoming events in your calendar. More details about the events will be sent out over the next few weeks. If you have any questions about the upcoming events don't hesitate to contact Veronica.A.Martin@gsk.com

If anyone has suggestions for topics then please contact the ESUG Committee by e-mailing Veronica at the above e-mail address.