HD4DP v2

In the following sections, we will provide you with information on how to proceed with the application HD4DP v2.

manager Tue, 01/04/2022 - 13:30

Request access to an HD application for a specific project

Healthdata.be applications such as HD4DP v2 and healthstat.be process sensitive personal information. Therefore, strictly controlled processes are used to grant access to these applications. The Entity Access Management (EAM) portal of healthdata.be facilitates these processes.

Due to the migration from EAM version 2.7 to EAM version 3.0 both systems will exist parallel during the transition period. Make sure that you always use the version currently available for your organization.

Below you will find the links to the user manuals to the different EAM systems. When selecting the desired version, the manual will appear in a separate tab.

When requesting access via the EAM portal version 2.7, go here.

When requesting access via the EAM portal version 3.0, go here.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

manager Fri, 11/10/2023 - 10:27

User roles in HD4DP v2

Each healthcare organisation has at least one Access Manager who is watching over the access rights to the applications of the own organisation and is managing them in the HD Entity Access Management (EAM) system. In this process, access requests by healthcare organisation employees are analysed and validated if legitimised. The scope of the accesses granted to HD4DP2 may differ, which is reflected in various user roles. Based on access rights, following three user roles can be distinguished:

Local Study Lead (author):

The Local Study Lead can:

edit and review all peer registrations (regardless of role) for the study or project;
make registrations in HD4DP v2

This role might be but should not be limited to the responsible for the study or project within the participating healthcare institution.

Local Study Associate (author):

The Local Study Associate can:

edit and review the own registrations, not those of other colleagues from the same healthcare organisation participating in the same study or project. The indicated registrations are limited to the patients treated by the Local Study Associate;
make registrations in HD4DP v2.

The Local Study Associate is a healthcare provider participating in the study or project. This is reflected in the registration form.

Local Study Support (co-author):

The Local Study Support can:

edit and review registrations belonging to the author group they are linked to;
make registrations in HD4DP v2.

A Local Study Associate and Local Study Lead can delegate registration tasks to a Local Study Support. This might be but should not be limited to an administrative assistant or staff from a medical coding department. The Local Study Associate and Local Study Lead are still considered the author of the registration; the Local Study Support is considered the co-author. The Local Study Associate and Local Study Lead can view and modify Local Study Support entries.

By default, only 1 Local Study Lead is intended by healthdata.be (Sciensano) for each project within each organisation. The idea is that only one person is meant to see all submissions for that project within that organisation. This policy prevents users of HD4DP v2 from seeing personal and sensitive information from individuals with whom they do not have a therapeutic relationship. For policy deviations on this, healthcare organisation staff should contact their Data Protection Officer (DPO).

Remarks:

The scope of the access rights does not necessarily reflect the hierarchy within your healthcare organisation.
It is up to the Access manager to change roles from/to Local Study Lead, Local Study Associate and Local Study Support. These requests are carried out in the EAM system.

Bart.Servaes Thu, 11/09/2023 - 14:40

Access the HD4DP v2 application

Access the HD4DP v2 application manager Fri, 12/09/2022 - 16:37

Navigate to the RAXONE project

When logged in, you will see the Welcome page. In the left dark blue menu you can see all the study programs and projects you have access to.

When you select the study program Chiesi Managed Entry Agreement, you can see the study project MEA Raxone.

Select the study project MEA Raxone.

You will see that the study project MEA Raxone consists of only one part: MEA Raxone.

manager Tue, 04/12/2022 - 16:20

Create a RAXONE registration

To create a registration for the study project Raxone MEA, select "Raxone MEA" in the dark blue left menu.

You will see the number of versions of this study section. In this case, there is only one version.

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...

In the top right corner of the screen you can find a green button "+ New registration". Press this button.

After pressing the button "+ New registration", the main screen will now be replaced with 2 sections: a study form (in the middle of the screen) and a Table of contents (on the right side of the screen).

By completing the study form, you will create a "Primo-implantation" registration for the study project Endobronchial valve.

The Table of contents indicates which sections you must complete. You can also use the table of contents to navigate through the study form: pressing a section in the table of contents will take you to this section in the study form.

By pressing the tab "Progress" on the right 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: pressing 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. 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. 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.

manager Tue, 04/12/2022 - 16:20

Find a RAXONE registration

To find a registration for the study project Raxone MEA, select "Raxone MEA" in the dark blue left menu.

When you select a version of this study section, you will see the summary table in the main part of your screen. This table contains, among other things: Registration ID, Progress, Author, Co-author, Unique ID, Business Key, Registration Code, National Patient Registry Number…

In the header of the summary table, you can use the filter below each column label. In the example below, the last name "Khan" has been entered in the filter (text field), so only the record with "Khan" is displayed.

manager Tue, 04/12/2022 - 16:21

Update a RAXONE registration

A "Raxone MEA" registration can be updated as long as the registration has not yet been submitted. If the status of a registration is "Saved" , the registration can still be updated.

To update a registration for the study project Raxone MEA, select "Raxone MEA" in the dark blue left menu.

When you select a version of this study, you will see the summary table in the main body of your screen. The table includes the following items: Registration ID, Progress, Author, Co-author, Unique ID, Business Key, Registration Code, National registry number of the patient.…

Use the filters in the header of the table to find the registration you want to update.

Once you have found the registration, you can open the registration's study form by clicking on the corresponding row in the summary table.

You can complete missing fields and/or change previously completed fields in the survey form.

At the end of the survey form, you can Save or Submit the registration.

A registration can be updated as long as it has the status "Saved" and as long as the registration not has been submitted. A submitted registration cannot be updated or deleted again.

manager Tue, 04/12/2022 - 16:21

Delete a RAXONE registration

A "Raxone MEA" registration can be deleted as long as the registration has not yet been submitted. If the status of a registration is "Open" , the registration can still be deleted.

To delete a registration for the study project Raxone MEA, select "Raxone MEA" in the dark blue left menu.

When you select a version of this course of study, you will see the summary table in the main body of your screen. The table includes the following items: Registration ID, Progress, Author, Co-author, Unique ID, Business Key, Registration Code, National registry number of the patient...

Use the filters in the header of the table to find the registration you want to delete.

Once you have found the registration you want to delete, you must select the registration by checking the checkbox at the beginning of the row in the summary table.

Then you need to press the "Actions" button at the top right of the summary table.

There are now two options, "Submit" and "Delete". Now press "Delete".

After you press "Delete," a pop-up message will appear asking you to confirm the deletion of the selected registration(s). If you are sure about this action, press "Confirm." If not, press "Cancel."

If you delete the registration, you cannot change its status or content.

The deleted registration will not be removed from the summary table. It remains present, but the status has changed from "Open" to "Deleted".

If you want to see only Open and Sent registrations, you can adjust the filter on the "Status" item in the summary table.

A registration can be deleted as long as the registration has not yet been submitted. If the status of a registration is "Open", the registration can still be deleted.

manager Tue, 04/12/2022 - 16:21

Submit a RAXONE registration

A "Raxone MEA" registration can be submitted at the end of the creation process using the study form (see: Create a Raxone MEA registration).

When the registration was completed using the study form, saved and there are no more validation errors, the registration can also be submitted via the overview table. This method can be useful to submit multiple registrations in the same action.

To submit a registration for the study project Raxone MEA using the overview table, select "Raxone MEA in the dark blue left menu.

Use the filters in the header of the table to find the registration(s) you want to submit. For example, you can use the filters "Status" (set to "Open") and "Validation Errors" (set to "0") to find the registrations that are eligible for submission.

Once you have found the registration(s) you want to submit, you must select the registration(s) by checking the checkbox at the beginning of the row in the summary table.

Then you need to press the "Actions" button at the top right of the summary table.

There are now two options, "Submit" and "Delete". Now press "Submit".

After you press "Submit," a pop-up message will appear asking you to confirm the submission of the selected registration(s). If you are sure about this action, press "Confirm." If not, press "Cancel."

Once you confirm the submission, you cannot change the content of the registration(s). Sent registrations can also no longer be deleted.

The sent registration remains present in the summary table, but the status has changed from "Open" to "Submitted".

If you want to see only "Open" registrations, you can adjust the filter on the "Status" item in the summary table.

A registration can be submitted at the end of the creation process using the study form (see: Create a [project] registration).

manager Tue, 04/12/2022 - 16:21