Validator for CDISC

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

Community 2.0 Released!

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Max and Sergiy will speak at the NJ CDISC User Group on Jan 28, 2015

Registration is now open for the next NJ CDISC User Group meeting, scheduled for Wednesday, January 28, 2015 from 1-5pm. The meeting will be held at TAKE Solutions in Princeton, NJ. Please register by January 20, via the link below:

Register for the NJ CDISC User Group

Meeting Agenda:

  • Kevin Lee (Accenture):  Standards Metadata Management: Version Control and its Governance
  • Fred Hofstetter and Ian Fleming (d-Wise):  Leveraging R and Shiny for point and click ADaM Analysis
  • Archana Bhaskaran and Kannan Subramanian (Novartis):  Metadata Management – Our Journey Thus Far
  • Sangeeta Bhattacharya:  Trial Design Domains
  • Max Kanevsky and Sergiy Sirichenko (Pinnacle 21):  FDA Finalizes Requirements for Standardized Data
  • Andrew Ndikom (Novartis Vaccines):  ADaM Compliant Table Creation Macros

FDA Finalizes Requirements for Standardized Study Data

On December 17th, the FDA made its long-awaited announcement: future submissions will be required in standardized format.

“ The Agency may Refuse To File (RTF) for NDAs and BLAs, or Refuse To Receive (RTR) for ANDAs an electronic submission that does not have study data in conformance to the required standards… ”  – FDA Guidance for Industry

This represents a seismic shift for the industry. However, adapting to this new paradigm can be relatively painless — if you have the right guidance.

Through this webinar, we’ll cover the details of the new mandate, what it all means, and the steps you’ll need to take. Our speakers are Dhananjay (DJ) Chhatre (former FDA operations research analyst) and Sergiy Sirichenko (co-founder of OpenCDISC): two industry experts who currently support the FDA’s eDATA team.

For your convenience, we’ll be providing this webinar at two different times.

WEBINAR SESSION 1 WEBINAR SESSION 2
Date: Wed, Jan 7, 2015
Time: 9:00 am EST
(15:00 CET)
Length: 1 hour
Date: Thu, Jan 8, 2015
Time: 2:00 pm EST
(11:00 am PST)
Length: 1 hour
Register Register

In this webinar, we will cover:

  • Descriptions of the final guidance documents and their contents
  • How these new regulations will impact you
  • FDA’s timeline for implementation
  • How to communicate with the FDA during the process
  • Technical implementation of CDISC standards
  • Questions & Answers

Best regards.
OpenCDISC Team

Introducing OpenCDISC Community 2.0

We are proud to announce the release of our next generation open source toolkit. Community 2.0 was created just for the CDISC professional and provides a wealth of game-changing new tools, including an upgraded version of Validator, a Define.xml Generator, and more. Download OpenCDISC Community 2.0 here

OpenCDISC Community 2.0 includes the following new features:

  • Validator – upgraded with FDA validation rules and ability to validate against study specific value level metadata
  • Define.xml Generator – creates fully compliant Define.xml 2.0 for SDTM, SEND, and ADaM datasets
  • Data Converter – quickly converts data between SAS XPORT, Dataset-XML, Excel, and CSV formats
  • ClinicalTrials.gov​ Miner – aggregates clinical outcome measures/endpoints across trials and therapeutic areas

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.

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!

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