Validator for CDISC

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

Community 2.0 Released!

OpenCDISC Enterprise

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FDA Publishes Official Validation Rules for Submission Data

This morning, November 18th, the Food and Drug Administration (FDA) published its first official list of validation rules for CDISC SDTM. These long awaited rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.

The FDA is asking sponsors to validate their study data before submission using these published validation rules and either correct any validation issues or explain, why they could not be corrected, in the Study Data Reviewer's Guide. This recommended pre-submission validation step is intended to minimize the presence of validation issues at the time of submission.

Rest assured: we have implemented the new FDA validation rules in the upcoming OpenCDISC Community 2.0 — keeping you ahead of the curve. Please join Sergiy Sirichenko — co-founder of OpenCDISC and an FDA Data Fitness Analyst — to learn about the new FDA validation rules and how you can get compliant in time for your next submission.

Note: We offer two sessions to accomodate different time zones. The content is identical.

WEBINAR SESSION 1 WEBINAR SESSION 2
Date: Tue, Dec 2, 2014
Time: 9:00 am EST
(15:00 CET)
Length: 1 hour
Date: Wed, Dec 3, 2014
Time: 2:00 pm EST
(11:00 am PST)
Length: 1 hour
Register Register

In this webinar, we will cover:

  • FDA Study Data Technical Conformance and related guidances
  • Conformance vs. Quality validation rules
  • Purpose, structure, and content of the new FDA validation rules
  • Comparison of FDA validation rules to rules defined by OpenCDISC Validator 1.5
  • Using OpenCDISC Community 2.0 to comply with FDA submission requirements

Best regards.
OpenCDISC Team

OpenCDISC Live comes to San Francisco

OpenCDISC Live is making its way to the San Francisco Bay Area for the West Coast swing of our 2014 tour!
Enjoy this opportunity to meet the creators of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first West Coast Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes.
We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist
the process.

Eventbrite - OpenCDISC Live San Francisco

OpenCDISC Live comes to New Jersey

OpenCDISC Live

OpenCDISC Live is making its way to North Jersey for the second stop on our 2014 tour! Enjoy this opportunity
to meet the developers of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our second Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes. We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist the process.

Eventbrite - OpenCDISC Live New Jersey

NJ CDISC USER GROUP - SEPTEMBER 17 AT BRISTOL-MYERS SQUIBB IN HOPEWELL

Registration is open for the next meeting, scheduled for September 17, 2014 from 1-5pm. The meeting will be hosted by by Bristol-Myers Squibb at their Hopewell Campus. Web conferencing will also be available. Please register by Friday, September 5. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=6009005008101025352

Meeting agenda:

  • Alex Loboda, Eisai:  How to ensure good quality data in your submission
  • Vineet Jain, independent consultant:  Robust approach to create Define.xml 2.0
  • Marcelina Hungria, DIcore Group:  SDTM / Overview and Status of the new Ophthalmic Examinations (OE) Domain Mode
  • Vincent Guo, Novartis:  Model X-Ray Image Data into ADaM BDS Structure – Specialty Data for a Complex and Important Efficacy Endpoint that Assesses Joint/Bone Structural Damage and Progression
  • New feature:  Panel discussion

See you there!

OpenCDISC Live Boston

Welcome to the first ever OpenCDISC Live Forum - a series of events where you can meet the developers of
OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes.
We'll also give you an in-depth look at OpenCDISC Validator 1.5 and show you how it's new advancements
can assist the process.

Eventbrite - OpenCDISC Live Boston

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!

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