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Features

Defining Sponsor Domain Metadata

The eClinical MDR App lets you define your sponsor-defined domain metadata for reference by users and other applications. 

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The process is simple.  You create your own Excel worksheet in the same format as CDASH. A sample template for the worksheet is provided.  Each worksheet represents a version of the metadata.  There are edits that the worksheet must conform to.  See the Edit Rules for Domain Worksheets below.

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The steps are:

  1. Create the Excel Worksheet for the version you want.  A worksheet template can be downloaded at installation, or found in the directory in MS Visual Studio, Sample Domain Worksheet.  Each worksheet represents a version of the metadata.  When importing the worksheet, the worksheet metadata replaces the corresponding metadata version in the MDR database.    

  2. Move your worksheet to the directory in MS Visual Studio, Sponsor Defined Domain Worksheets

  3. Go to the eClinical MDR app, click Import Domains, then click your sponsor-defined domain to import the worksheet to the database. You will be notified of any errors found.

  4. When complete, you can browse and reference the data.

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Image_CDASH_DOMAIN_Import.png

What does the Domain Worksheet Contain?

The Excel worksheet has the same layout as the CDASH Installation Guide Domains with the following extensions.

  • Domain - The short name for the domain, e.g. 'AE'

  • Version  - The version for the example CRF. Must be unique in the worksheet.

  • ​Origin -  The source of the data. Must be 'Sponsor'.

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The eClinical MDR App automatically adds to the database:

  • Create Date

  • Unique identifier

The worksheet looks like this.

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Image_CDASH_DOMAIN_Worksheet.png

When the worksheet is imported, the list of domains appears for you to browse.  See Browsing a Domain. You can search by filter. 

When you select a Domain (e.g. domain 'AE'), the details display from the eClinical MDR. 

Image_CDASH_Domain_detail.png
Edit Rules

Edit Rules for the Domain Worksheets

To ensure the integrity of the data when importing, the following is checked. A message is displayed if an error is found against these edit rules.

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Each worksheet pertains to one version. You cannot have more than one version in a worksheet. Upon import, the version in the worksheet replaces the corresponding version in the eClinical MDR database.  

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The following must be unique in the worksheet. 

  • Version - must appear once in the worksheet. Sponsor-defined domains must have a unique version name with a leading prefix of "Sponsor" + "_xxxxx", e.g. "Sponsor_V01_CDASHIG_V.2.2"

  • Domain

  • Data Collection Scenario

  • CDASH Variable - Should not repeat within a domain and Data Collection Scenario.

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The following must be present.

  • Version - For Sponsor-defined domains, the origin must start with "Sponsor".

  • Domain

  • CDASH Variable

  • Variable Order - The sequence of the variables within the domain must be numeric.

  • Origin Name - Identifies the source of the data. For Sponsor-defined domains, the origin must be "Sponsor". For CDASH domains, the origin is "CDASH Library".

                        

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