Validator for CDISC

  • Open-source
  • Fully Configurable
  • Validates SDTM and more

OpenCDISC Enterprise

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OpenCDISC Validator 1.5 - Available Now

We're pleased to announce the availability of OpenCDISC Validator 1.5.
Download OpenCDISC Validator 1.5 here

What’s New in Version 1.5

  • Validation against SDTM 1.4 model and SDTMIG v3.2
  • Validation of Define-XML v2.0
  • Support for Dataset-XML format
  • Updated SEND config for FDA compliance
  • Various bug fixes and minor engine enhancements. Please refer to the changelog for details.
  • Various updates to SDTM 3.1.3, 3.1.2, 3.1.1, and SEND 3.0 configs. For a complete list of validation rule changes please refer to the release notes.

NJ CDISC User Group - April 17 at Celgene in Summit

Registration is open for the next meeting, scheduled for April 17, 2014 from 1-5pm. The meeting will be hosted by Celgene at their Summit site. Web conferencing will also be available. Please register by Wednesday, April 9. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=8000008002105027347

Meeting agenda:

  • Lex Jansen and Marcelina Hungria:  Dataset-XML - A New Exchange Format for Clinical Research Data
  • Greg Steffens:  SUPPQUALs
  • Kevin Lee: CDISC Journey on Lymphoma Studies using Cheson 2007
  • Joyce Hernandez:  CDISC Pharmacogenomics/Genetics Standard 
  • Karin LaPann:  Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions using SAS®

See you there!

CALL FOR PRESENTATIONS FOR NJ CDISC USER GROUP MEETING

The next meeting of the NJ CDISC Users Group will be held the afternoon of April 17, 2014 at Celgene in Summit. If you are interested in presenting at the meeting, please contact Patricia Majcher at patricia.majcher@novartis.com by March 7. 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!

NJ CDISC User Group - January 14 at Sanofi in Bridgewater

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!

Call for presentations for NJ CDISC User Group meeting

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!

OpenCDISC Validator 1.4.1 and Rule Updates

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.

NJ CDISC User Group - September 19 at Merck in Summit

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!

New Jersey CDISC User’s Group is resuming its activities

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!

OpenCDISC Validator 1.4 and SDTM 3.1.3 Validation

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

OpenCDISC Validator 1.3 Released

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.

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