Import Sponsor CRFs | Galaxy Eclinical

Features

Import Sponsor-Defined CRFs

Under 'CDASHIG CRF' in the menu, click Import Sponsor Worksheet to display the list of worksheet files containing sponsor-defined CRF metadata available for import. You can search the worksheets and then select the worksheet to be imported.

The worksheets are in the user folder specified on the import page. The folder is established at installation, along with a sample worksheet template.

Click here for information about importing CDASHIG Example CRFs.

Create Sponsor-Defined CRFs

The Clinical Standards MDR App lets you define your annotated CRFs for reference by users and other applications.

The process is simple. You create your own Excel worksheet in a format similar to the CDASH worksheets for Example CRFs. A sample template for the worksheet is provided. There are edit rules that the worksheet must conform to. See the Edit Rules for Sponsor-Defined CRFs below.

The steps to import a CRF are:

Create the Excel Worksheet for the CRFs. Move your worksheet to the file folder specified. The file folder is established at installation
Go to the Clinical Standards MDR App, click Import Sponsor Worksheet, a list of all the worksheets available for import are listed. You can search for those not yet imported, or by any column on display, for example worksheet name.
You can replace worksheets in the database that have the same worksheet version.
Click the worksheet you want to import to the database. You will be notified of any error found. See the Edit Rules for the Sponsor CRFs below.
Upon completion you can import another worksheet, browse or view the sponsor-defined annotated CRFs.

What does the Sponsor CRF Worksheet Contain?

The Excel worksheet has the same layout as the CDASH Installation Guide Example CRFs with the following columns extensions.

Title - Title for the eCRF example.
Example number - a numeric integer. Default is 1. It is used when there is more than one example for the domain.
Domain - The short name for the domain, e.g. 'DA'.
Version - The version of the CRF taken from the worksheet name.

The Clinical Standards MDR App also contains:

Origin - The system automatically ensures this is 'Sponsor'.
Create Date - The date that the version was imported.
Unique Identifier - A unique numeric identifier for each row in the table.

For further information see the Edit Rules for the Sponsor CRFs below.

The worksheet for the Example CRF ('DA') Example 1 is:

Edit Rules

The Clinical Standards MDR App allows you to either view the annotated CRF, or display the metadata details for the CRF. For 'DA", example 1 it is:

What are the Edit Rules for Sponsor-Defined CRFs?

To ensure the integrity of the data the following is checked. If an error is found against these edit rules, a message is displayed.

The following must be present and must be unique for the CRFs:

Worksheet name which must start with the following format 'SPONSOR_V'. The words that follow are separated by '_'.
Version - The version name is automatically derived from the worksheet name, less the word 'Sponsor_'. To make changing a CRF easy, simply import the CRF worksheet to overwrite the prior one. You will be asked to confirm if you want to overwrite all matching CRFs.
Domain - Must be a valid CDSIC domain.
Example number - Must be numeric. Should be unique for the version and Domain,
CDASH Variable - Should not repeat within an CRF.

The following must be present:

Order number - Must be numeric and should not repeat within an example CRF.
Title Name