SEND – A Year in Review

Title: SEND – A Year in Review
Date: Thursday, December 1, 2016
Time: 1:00 PM EST

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Companies are now familiar with the need for making SEND compliant datasets in their nonclinical submissions.  However, there are still challenges across industry which need to be addressed and the continual development of the SEND standards only make this more difficult.  For example, the requirement of having a Define.xml file is new this year; and with the recent release of the Define.xml 2.0 rules by CDISC the processes for creating a compliant Define file will also have to be adjusted.  PointCross has had the opportunity to review a number of datasets from all different types of source files in 2016, which allowed us to identify the issues and challenges still facing the industry.

During this webinar we look back at 2016 and discuss common quality problems and errors that occur during conversion of data to SEND and merging of different source files.  We will focus primarily on the lessons learned from the review of validation reports, both for SEND and the Define file. Topic areas will include:

  • What are the common issues you may encounter?
  • How can you prepare now to avoid these issues in the future?
  • What can you do to eliminate errors that do not apply to your submission?

The PointCross Validator, being released in December, is the last area of focus.  We talk about the purpose of the PointCross Validator – to have a single tool to validate the SEND dataset and Defile file, and which only considers CDISC and FDA nonclinical rules for SEND and the updated Define.xml schema specified by CDISC.  This nonclinical only focus will also help reduce confusion of which errors are relevant to your submission.  Future updates to the validator will increase the scope of available validation checks to include the abilities to: check individual domains prior to merging data to a final SEND package, and a feature for checking the SEND content against the Define file declarations.  Updates will also be applied as new versions of the CDISC Controlled Terminology are released.

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