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Release 2.0.0

At a Glance Details
  • Version Number: 2.0.0
  • Release Date: May 29, 2020
  • Primary Audience: Medidata Rave users

Tool Overview

The caDSR CDE Validator is a web-based tool that accepts an Architect Loader Spreadsheet (ALS) in .xslx format from your desktop and produces a report that you can view in (or download from) the Validator. Medidata Rave creates the ALS file. The Validator extracts a list of forms from the ALS and validates the details of the questions against associated caDSR CDEs.

The Validator requires that the ALS file contain the following worksheets and that they be non-empty and properly formatted: 

  • CRFDraft
  • Forms
  • Fields
  • DataDictionaryEntries
  • UnitDictionaryEntries

The Validator reads the ALS sheets, allows the user to select one or more forms from the Protocol for processing, and produces: 

  • Summary counts reporting what was processed
  • Detailed reports for each form where one or more of the ALS questions did not fully match the associated CDE details

    If none of the questions on a form produced Warnings or Errors, the Validator does not produce a report for that form.

The system generates several additional reports, including summary and detailed information in several categories of CDEs:

  • Network Rave Data Standards (NRDS)
  • CDISC (CDASH and SDTM)
  • Optionally: NCI Standard Template Forms CDEs contained in the template modules marked "mandatory"

You can view the reports in a supported browser (Mozilla Firefox or Google Chrome) and then you have the option to download the reports in Microsoft Excel format and save that file to your desktop. The Excel format provides features for filtering results in each column, such as displaying only the Errors. Neither the contents of the report nor the ALS file itself are saved in caDSR. If you do not download the report, you can upload the file into the Validator and process the file each time you want to see the report. 

A CDE (Common Data Element) is the unique pairing of a Data Element Concept (DEC) and a Value Domain (VD). A Data Element Concept provides the conceptual definition of the data element, the primary semantics or meaning of the Common Data Element. A Value Domain describes specific acceptable values or rules for values (such as datatype and maximum length) for that Common Data Element.

Access

The CDE Validator is publicly accessible through an internet browser at the following location:

https://cdevalidator.nci.nih.gov/

FAQs, Forum, and Support

Getting Support

If you need assistance, contact the CBIIT Application Support Team:

Documentation 

The following documentation is available for the current release.

Related Tools

Medidata Rave® is a cloud–based clinical data management system used to electronically capture, manage, and report clinical research data. 

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