To create a Primo-implantation registration for the study project Heart defibrillators, select "Primo-implantation" in the dark blue left menu.
You will see the number of versions of this study section. In this case, there is one version: v1.
When you select the highest version of this study section for the first time, you will see an empty overview table in the main part of your screen. The table contains, among others, the following items: Registration ID, Progress, Author, Co-author, Unique ID, Business key, Registration code, National registry ID of the patient...
The study section is not always available in the selected language. In that case the text frame pictured below covers the language selection buttons. It automatically disappears after a few seconds.
You will have to select the desired language through the respective language buttons:
NL for Dutch, FR for French or EN for English.
In the top right corner of the screen you can find a green button "+ New registration". Select this button.
After selection of the "+ New registration" button the main screen will be replaced by 2 sections: a study form in the middle of the screen and a table of contents on the right-hand side of the screen.
By completing the study form you will create a registration for the respective study project.
Table of contents
The Table of contents offers an overview of the sections that are to be completed. It can also be used to navigate through the study form instead of scrolling up and down in the study form: clicking on a section in the table of contents will take you directly to this section in the study form.
Take into account that the study form may contain conditional fields. This means that some fields with selection options ONLY will be displayd IF related fields in previous sections have been completed.
E.g. the field ‘Type implantaat / Type d’implant’ under section ‘Implantaatgegevens / Données d’implant’ ONLY opens up, IF the field ‘Type resectie / Type de résection’ in the section ‘Interventiegegevens / Données de l’intervention’ has been completed.
Detailled information on conditional fields is to be found in the respective DCD specifications.
If you want to search and add the data of the implant used, you first have to select the Implant data item in the Table of contents from the right-hand side section of the screen. The relevant item will now appear in the middle section of the screen.
In case an implant with notification code has been used, it is possible to retrieve the corresponding data from the SADMI database. In order to do so, you select yes under Implant(s) used? and implant with notification code under Type of implant.
In some interfaces this option is also referred to as genotificeerd serieproduct implantaat. Select this option.
Now, click on the Search button. The SADMI Notification code search window will pop up. Enter the notification code you have available in the relevant field and click on the Search button.
The screen refreshes and shows all implant data underneath the search button.
It is now NECESSARY to select the Choose button to the right in order to effectively ADD the data to the registration form.
Hereafter, you will automatically return to the registration form, where the SADMI notification code of the implant has been registered. You can now repeat the procedure above to add further implants via the "Add another" button.
In case an implant without notification code has been used, you have to select the Category and enter the necessary data you have at hand.
Note: SADMI stands for Source Authentique des dispositifs médicaux implantables. General and technical information can be found in the SADMI cookbook which is provided through the eHealth platform.
By selecting the tab "Progress" on the right-hand side of the screen, the table of contents will be replaced by a progress bar and a list of open validation errors).
You can use the list of open validation errors to navigate through the study form: selection of a validation error in the list will take you to this section in the study form.
When the study form is completed and there are no validation errors, you can save or submit this registration: Save or Submit. Notice that the Submit button is in clear green.
When the study form is completed but there are validation errors, you can save but not submit this registration: Save but not submit. Notice that the Submit button is in dim green.
When the study form is saved or submitted, the screen switches to the overview table. Now, this table is not empty anymore but shows the saved or submitted registration.
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