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Once you have created an Item Group in a Form, you can add Items to it.

You can create or import Items from within an Item Group view, in the Item References section.

Click the New Item in the Add menu. You will be taken to the Item-specific page, which allows you to define the following:

  • Item Basics

  • Sample-related settings

  • Data Validation Rules for the Item

  • Reporting fields

Item Basics

  • Prompt - this is an optional text that can be displayed to the users during data collection. If you leave this blank, the “Name” field from the Item Reporting section will be used.

  • Data Type - is arguably the most important field to configure for an Item. It determines how the user will be able to interact with the Item during data collection.

  • Code List - you can associate a predefined list of selectable answers to the users during data collection. The Code Lists can be defined in CRF Design > Study Library > Library menu > Code Lists. The datatype of the Item needs to match the datatype of the Code List.

  • Radio Buttons? - this is a control to display the possible answers as radio buttons (when ticked) or as a dropdown (when unticked).

  • Help Text - you can provide some optional help text that would help/guide the users during data collection.

  • Capture Time? - this setting allows to record the time entered in the datetime type of Item, as the time the Item was collected. Read more here. This will need to be enabled, if you are associating a Sample Processing Path with the Item.

  • Barcode Verify? - If you check this tickbox, users will need to scan an Item barcode in order to collect this Item. This will need to be enabled, if you are associating a Sample Processing Path with the Item.

  • Require External Barcode? - you can mark that the Item requires an external barcode when data is collected.

  • Measurement Units - you can add measurement units to the Item, if needed. Measurement units can be configured in the CRF Design > Study Library > Library menu > Measurement Units.

  • Label Field 1 / 2 - add some optional text which you can later use on Labels for the Item.

  • Base Type - If you are working on an Item that could be used in particular workflows, facilitated by Base Types, you can select the relevant Base Type for the Item here.

Sample-related Settings

This section allows you to define the Sample Processing and Lab Processing settings for Items that are Samples.

  • Sample Processing > Sample Path - defines which Sample Path should be used to process the Sample after collection. Sample Processing Paths can be configured in the Samples > Configure module. The Sample Path needs to be locked in Samples > Configure in order to appear in this dropdown.

Selecting a Sample Path in this dropdown, also requires you to check the “Barcode Verify?” and “Capture Time?” tickboxes.

  • Sample Transfer - this setting can be used to configure Sample Transfers (Aliquots) to trigger Safety Lab Orders after processing.

  • Lab Processing > Lab Panel - defines which Lab Panel should be performed on a Sample that is send to an external Safety Lab.

Data Validation section

Here you may setup the data validation rules for the Item:

Length - this can be used with data types “text”, “integer” and “float”. In case of Text and Integer, this defines the maximum allowed number of characters for the users to enter during data collection. In case of Float, this defines how many numbers should be entered before a decimal space; this needs to be used together with the “Significant Digits” field.

Significant Digits - this can be used with the data type “float”. This will define how many digits should be displayed after the decimal space.

Hard Lower / Hard Upper Ranges - these are the hard limits to the data entries in the item. The Item needs to be numeric. During data collection, if a user enters a value lower than the Hard Lower or higher than the Hard Upper, the user will not be able to save the entry. They will be forced to correct the value before saving.

Soft Lower / Soft Upper Ranges - these are soft limits for the data entry, these can be Study-specific. If a user enters a value that is lower than Soft Lower or higher than soft higher, they will be forced to enter a comment prior to saving the value.

Disallow Future Date - prevents the user from entering a date in the future.

Reporting Section

In the Reporting section, you can define various details that will be used later on to generate reports for collected data.

Name - the name of the Item, as you wish it to be reported.

Origin - CRF / Protocol / eDT

SAS Field Name -

SDS Var Name -

LOINC Code -

Description -

Comment -

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