Registration is now open for the January 14, 2014 meeting. The meeting will be held from 1-5pm at Sanofi, 55 Corporate Drive (Room B-1121), Bridgewater, NJ. Web conferencing will also be available. Please register by Monday, January 6. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=1009002005108017393

Meeting agenda:

• Jeff Xia (Galderma): Demo of how to check hyperlinks in define.xml and corresponding CRF Page number in blankcrf
• Jian Chen; Peter Smilansky (Edetek): End-to-End Study Management using BRIDG
• Nate Freimark (Theorem Clinical): Approaches to Creating ADaM Subject-Level Analysis Datasets (ADSL) for Integrated Analyses
• Kevin Lee (Cytel): CDISC Journey to solid tumor using RECIST 1.1
• Greg Steffens (Novartis): Data and metadata related to SUPP data sets

See you there!

The next meeting of the NJ CDISC Users Group will be held the afternoon of January 14, 2014 at Sanofi in Bridgewater, NJ. If you are interested in presenting at the meeting, please contact Pei Lee Tien by November 8. Her email address is pei.tien@novartis.com. Presentations should be no more than 20 minutes long (excluding time for Q&A). Any CDISC-related topic is welcome. We look forward to hearing from you!

We're pleased to announce the availability of OpenCDISC Validator 1.4.1.
Download OpenCDISC Validator 1.4.1 here

What’s New in Version 1.4.1

• Support for latest ADaM v1.2 Validation Checks
• Validation of QS Controlled Terminology
• Enhanced Excel report with the versions of Validator, MedDRA, and CDISC CT
• Refined SDTM, SEND, and ADaM rule messages and descriptions
• Various bug fixes and minor enhancements. Please refer to the changelog for details.

For a complete list of validation rule changes please refer to the release notes or review the latest rules posted on OpenCDISC Validation Rules Repository.

The next meeting of the New Jersey CDISC User Group will be held the afternoon of Thursday, September 19, at Merck in Summit. Web conferencing will be available. The agenda for the meeting is as follows:

• Karin LaPann and Terek Peterson – Automation of ADaM dataset creation with a retrospective, prospective, and pragmatic process
• Jeff Xia – Demonstration of how to check hyperlinks in Define.xml and corresponding CRF page numers in blankcrf
• Richard Senecal and Ganesh Sankaran – Working with value-level metadata in Define.xml v2.0
• Mark Wheeldon – CDASH

Please register by Friday, September 13, using the link below:

NJ CDISC User Group Registration >

See you there!

The New Jersey CDISC User’s Group is resuming its activities. As a starting point, the group plans to focus on CDISC implementation challenges and experience, for both legacy data and new studies, as well as knowledge sharing across companies.

The group's next meeting will be held the afternoon of Monday, June 17, at Novartis Pharmaceuticals Corporation in East Hanover, NJ. Tele/web-conferencing will also be available.

Please contact Susan Lenczyk (susan.lenczyk@novartis.com) by Wednesday, June 12, to register for this meeting.

If you would also like to present a paper at the meeting, please contact Gina Wood (georgina.wood@novartis.com) by Friday, May 17. Topics of interest include (but are not limited to):

• CDISC submission experiences: FDA feedback, lessons learned, validation approach
• Conversion of legacy data

Hope to see you at the meeting!

The OpenCDISC team is pleased to announce the availability of OpenCDISC Validator 1.4.
Download OpenCDISC Validator 1.4 here

What’s New in Version 1.4

• Support for SDTM 1.3 model and SDTMIG v3.1.3
• Compliance with CDER Common Data Standards Issues Document
• Performance and scalability enhancements for large studies
• Simplified management of multiple CDISC Contolled Terminology versions
• Over 100 new validation rules
• Updates to SDTM, SEND, and ADaM rules

The OpenCDISC team is pleased to announce the availability of OpenCDISC Validator 1.3.
Download OpenCDISC Validator 1.3 here

What's New in Version 1.3

The latest release introduces a number of major enhancements and usability improvements. The validation engine has been upgraded to support split datasets. The Excel report has been revised to improve readability. For example the issues summary tab is now grouped by domain, while terminology issues are collapsed into instances of distinct terms thus significantly reducing the size of the details tab. Also, the process of enabling MedDRA validation has been simplified. Please refer to Configuring OpenCDISC Validator for MedDRA guide for more information.

For a complete listing of enhancements and bug fixes please refer to the changelog.

SEND, SDTM Amendment 1, and other Validation Rule Updates

We are also happy to announce support for SEND 3.0 and SDTM 3.1.2 Amendment 1 standards. Now is your chance to test drive your data against these checks. Please post your questions/comments on the forum. We are looking forward to your feedback.

The FDA will host its annual Computational Science Symposium at the scenic Silver Spring Civic Center on March 19-20. The meeting will provide an update on standards, tools, and process initiatives across regulatory review. However, this year the conference is being organized by PhUSE instead of DIA, which promises a number of changes. The format of the meeting has been updated to establish collaborative working groups to address a number of current challenges. These workgroups will focus on the following:

• Working Group 1: Data Validation and Quality Assessment
• Working Group 2: Standardizing data within the Inspection Site Selection Process
• Working Group 3: Challenges of Integrating and Converting Data across Studies
• Working Group 4: Standards Implementation Issues with the CDISC Data Models
• Working Group 5: Development of Standard Scripts for Analysis and Programming
• Working Group 6. Non-Clinical Road-map and Impacts on Implementation

For more information or to sign up, visit PhUSE at http://www.phuse.eu/css.

We look forward to seeing you there!

The OpenCDISC team is happy to announce the upcoming PhUSE Single Day Event, which will be held in Philadelphia on August 11th at Drexel University‘s downtown campus. If you are not familiar with PhUSE, it’s a non-profit organization dedicated to providing a forum for pharmaceutical programmers to share ideas, knowledge, and new technologies relevant to the future direction of our industry.

The Philadelphia event will focus on "Metadata” and its use throughout the clinical data flow process from protocol design to regulatory submission. Attendees will get a chance to learn and share experiences on a range of topics including the collection of metadata, implementation of metadata repositories, and the use of metadata for legacy data conversion, analysis, and submission. The event will feature a group of excellent speakers and panelists from local sponsors and CROs including Merck, AstraZeneca, GlaxoSmithKline, and ICON, as well as presentations from the leads of CDISC SHARE, CDISC Protocol Representation, and CDISC XML Technologies teams.

The event is free to PhUSE members and only $40 for non-members. We think this is a great opportunity to mingle and share ideas with your colleagues and we highly recommend it to all OpenCDISC community members.

Check out this link for more information http://www.phuse.eu/One-Day-Events2011USAPhil.aspx

We're pleased to announce the availability of OpenCDISC Validator 1.2.1. This is a maintenance release and includes the following bug fixes:

• Resolved an issue where data with define.xml that had a reference to undefined or external code list would fail to validate
• Fixed issue where year-only dates were not being compared correctly
• Updated the incorrectly labeled xpath column in the Excel report
• Fixed issue where define.xml generator would only print out first code list item

To download this new version, please visit:

http://www.opencdisc.org/download

Best Regards,
The OpenCDISC Team