Adding data elements

There are several ways to add data elements to your namespace:

Reusing existing data elements from other registries

To copy a data element from another registry into your namespace select the respective namespace, open the data element and select your namespace under Import into my namespace in the options menu. A copy of this data element will now be available in your own namespace.

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Creating new data elements

If you are unable to find a suitable data element you can create a new one. To do so, open the New menu at the top of the screen and select New Dataelement. Then follow the wizard on your screen to name and define the data element and specify the value domain. You can navigate through the different steps using the Previous and Next buttons.

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2. Definitions

Select a designation, or name, for the data element. In the data entry form, the designation will be displayed next to the input field and can consist of key words or a written phrase or question (e.g. ‘Details’; ‘Age at diagnosis’; ‘Weight’; …).

Include a definition to add a short explanation or additional information about the data element. This is useful especially if the designation is not self-explanatory or may be ambiguous. The definition will appear as a tooltip in the form when the user hovers the mouse cursor over the label or input field. Both the designation and definition fields have to be completed in order to proceed.

You also need to select a language for the data element from the searchable dropdown menu.

Figure 11

It is also possible to define data elements in different languages. To add a defintion in an additional language, click on Add another definition and complete the details as above, selecting the appropriate language from the dropdown menu.

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3. Validation

In this step you have to specify which data type the data element belongs to, e.g. whether it is a number, string or list, and provide further information about the data element, e.g. a range or unit of measure. These properties cannot be modified at a later stage, so it is important to have a clear idea about the data element to be created.

OSSE supports a range of validation types which can be selected from the dropdown menu: * “List of permitted values”: to select one or more answer options from a pre-defined list of values. * “Integer”: to enter natural numbers without decimal points. * “Float”: to enter numbers with one or more decimal points. * “Boolean”: to make decisions between true and false, i.e., yes-/no-decisions or applicable vs. not applicable * “String”: to enter any number of arbitrary characters (numbers and letters), e.g. to provide additional details as a free text. * “Date”: to indicate a date (e.g., ‘date of last examination’) which can be displayed in different formats. * “Time”: to indicate a time of day in either 12- or 24-hour time format. * “Datetime”: similar to “Date” but including the precise time in either 12- or 24-hour time format as described in “Time”. * “Catalogs”: to select data from a structured list of standard values such as the ICD-10 catalogue of medical diagnoses or a list of countries.

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List of permitted values

For each answer option, you have to enter a permitted value (the unique value or code that is stored in the registry), a designation (the name of the item which is displayed in the form) and a definition (a short explanation which is available in the form when hovering the mouse cursor over the item). In addition, you can specify the language, which is set to the data element’s language(s) by default. To add another answer option, click ‘Add another permitted value’ and complete the details as before. To remove an answer option, click the corresponding ‘Remove’ button. Please keep in mind that you will not be able to modify the permitted value or add / remove options later.

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String

For strings you can specify a maximum length or a regular expression that the string has to match. Check the respective box and enter a number or regular expression, if required.

Figure 15

Integer / Float

For numbers (either with or without decimal points) you can specify whether the value needs to be in a certain range by ticking the Within range box and entering an upper and/or lower limit below with the respective boxes checked. In addition, you can include a unit of measure such as “cm” or “mmol”.

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Date

For dates you have the choice between different formats to display and store the date and can specify whether the day should be included by checking or unchecking the With days box. It is recommended not to use the The local time format option as this may different between different PCs or browsers.

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Time

For times you can choose between 12-hour and 24-hour time format and specify whether seconds should be included.

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4. Slots

In this step you can provide additional details about data elements in the form of key-value pairs. These are not interpreted by the MDR but used by the OSSE.EDC, for instance, to modify the way that fields are displayed. Currently, this is mainly relevant for data elements of the type List of permitted values and can otherwise be skipped. For List of permitted values you now have the choice between different ways to display the answer options. By default, permitted values are presented as a dropdown list from which users can select a specific value. However, values can also be displayed as radio buttons, allowing users to select one option only, or checkboxes, allowing selection of multiple answer options.

Figure 19

Enter inputType into the Name field and either SELECT_ONE_RADIO for display as radio buttons or SELECT_MANY_CHECKBOX for display as checkboxes into the Value field.

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6. Verification

In this step you can review and check all details before releasing the data element. Click Finish as draft to save the data element but provide the opportunity to edit the data element later via the My Drafts menu at the top. Click Finish and release to release the data element and make it available for use in the OSSE FormEditor. Please note that details specified in the validation step, including data type, unit of measure and range, can no longer be modified once the data element is released.

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Deriving new data elements from existing ones

Existing data elements can be used as templates if the new element differs from the existing one only in a few details. Open an existing data element and select Use this element as template from the options menu in the upper right corner. Proceed through the wizard as described above; all parameters of the new element can now be edited at will.

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