User manual of the application HD4DP v2

User manual of the application HD4DP v2 Bart.Servaes Wed, 05/03/2023 - 17:34

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. In this article we describe how to use it. To navigate to the EAM application, enter the URL https://eam.healthdata.be in your internet browser.

Note: As the documentation of the EAM portal is being updated on a regular basis, please be advised to check the Release notes first.

Select one of the following capacities that suits your position in order to request access to an HD application:

End-users
Single IT points-of-contact, also 'IT SPOC'
International users

Standard End-users

To request access to healthdata.be applications (such as HD4DP v2 and healthstat.be) as a standard end-user, you need to click on REQUEST ACCESS in the blue text box in the middle of the screen.

You will be directed to the next screen, where you select the button Log in with eID.

Clicking on this button leads you to the government's Federal Authentication Service (FAS), where you can log in with multiple digital keys with eID or digital identity.

If you choose to connect with ItsMe, you can enter your cell phone number.

Follow the instructions on your mobile device via the ItsMe application.

Once you have run through the ItsMe login procedure, you want to select the green confirmation button (available in FR and NL) in the screen below to access the Sciensano environment.

After selection of the confirmation button, you are logged in to the EAM portal page as indicated by the available My profile and Log out options to the top-left of your screen.

When selecting the REQUEST ACCESS link in the blue highlighted text box, in order to fill out the Request access form, the following message appears:

Click on the My profile link in the message, which redirects you to your profile page. Your user profile needs validation before being able to enter and complete the Request access form.

Select the Edit tab to complete your profile information.

Next to the profile information that is automatically prefilled based on your eID data, you need to complete the following fields:

NIHDI Number: Your NIHDI number if available.

Organization: Add the organization(s) you are affiliated with. This field includes the name and NIHDI number of the organization.

Email address: Mandatory field for which the content can't be retrieved from the eID. Your email address will be used for communication on the profile validation and access request.

State: Select one of the options (see image underneath):

Draft: This status indicates that you have not finished completing the profile fields yet. Only you can see the filled in data at this stage. Modification of the profile information is restricted to the status "Draft". You can however Save profile information as Draft to finalize and send it for validation lateron.
Validation Requested: The provided user profile information is complete and you want to send it for validation to the SPOC.

Click on the Save button to send your profile information to the SPOC. An Access Denied message appears on the screen, indicating you can't modify your filled in and sent profile information anymore.

Return to the My profile page to see your profile has the pending status. Also, the Edit tab has disappeared, preventing from modifications afterwards:

Your profile will soon be validated by the SPOC, which will be visible on your profile page as follows:

After validation of your profile by the SPOC, you select Home to return to the EAM portal page. Attention: Do not select the button "Request access" (soon: "Request SPOC rights"), since this leads to the process of requesting access as a SPOC.

In the EAM portal page you want to select the REQUEST ACCESS link in the blue highlighted text box again.

Select the hospital you are affiliated with for the application(s) and project(s) you want to request access to.

You can now start completing the Request Access form.

Please fill in all required fields (indicated with a red asterisk *), make a selection in the mandatory drop-down lists and, optionally, tick the check boxes for additional help and/or information.

Type of login field:

If you select "Belgium resident" for the field “Type of Login”, entering the mobile phone number is optional.

If you are a "Non-Belgium resident", the Mobile phone number field becomes mandatory to allow for the two factor authentication:

Role of requestor in project field

You must indicate your role in the project (Local Study Lead, Local Study Associate or Local Study Support). Your role determines your access options in HD4DP2 for this project. Read more about the scope of the roles in User roles in HD4DP v2.

When selecting Local Study Support you will be asked to select the name of your Local Study Associate in a drop-down list. This list is automatically populated and specific to the organization you have selected earlier.

HD4DP2.0 field

Click in the field under HD4DP2.0 if you want to access the application to make registrations for the selected project:

Healthstat.be field

Click in the field under healthstat.be if you want to access the reporting of the selected project:

It can happen that a user inadvertently submits requests for access to the same applications and/or projects. The requests are screened for duplicates by checking on organization number, role, author group and project code. In case duplicates are detected, the end-user will receive the following message:

Once you have completed the Request Access form, click on the Submit button. When the submission was successful, you will receive a confirmation message.

Single IT points-of-contact (IT SPOC)

A single-point of contact or SPOC is a role that extends beyond the function of a VTE/RAE. More specific, it can be any employee within an organization whom this role has been assigned to.

To request access to healthdata.be applications such as like HD4DP v2 and healthstat.be as a single-point of contact (SPOC), you want to select GIVE ACCESS in the white text box to the right of the screen.

If you have not yet requested access to these forms, and therefore are not recognized as a user with the SPOC role, you will receive the following message:

In this case you want to select My Profile (top left in the menu) and click on the button Request access (soon: "Request SPOC rights").

The Request access [RAE] screen pops up.

Fill in all requested fields and click on the Submit button.

After submission of the RAE form healthdata.be support carries out a background check considering your SPOC authority within the organization mentioned, and will send you a confirmation e-mail with a special token. Once you have received this token, return to the My Profile page and select the button Enter access token.

The Access token screen appears:

Fill in the NIHDI code for your organization and the access token you received per e-mail. After clicking on Submit, you will be redirected to the EAM portal page, where you again select GIVE ACCESS.

The ACCESS REQUEST form appears. By filling out the requested fields, a SPOC is able to give access to users within their organization who want to access a healthdata.be application (HD4DP2.0 or Healthstat).

Once you have completed the Access Request form, click on the Submit button. When the submission was successful, you will receive a confirmation message.

If you now return to My profile, you will see that it has been extended with the information "Responsible Access Entry" under User role(s). Also the tabs Profiles, Requests, Batch create requests and Edit have been added.

The Profiles tab of the validated SPOC profile offers the possibility to Search, Select and Sort profiles. Selected user profiles in the list can be Validated or Rejected via the Action drop-down menu.

In the Requests tab the SPOC can manage the overview of requests. More information is to be found on SPOC actions upon a request.

See documentation under Give access to multiple users in batch for more information on the Batch create requests tab.

Saved user profile information can't be modified, unless upon action of the SPOC. The Edit tab offers the option to enter the NIHDI number, add organizations, modify the email address and toggle the state between Validated or Rejected. Select the Save button to install the new profile information.

International users

For international users a link to a special form will be provided:

https://eam.healthdata.be/forms/hd_eam_access_request_user_int

Selecting this link redirects you to a more extensive Request Access form. Fill in all required fields (indicated with a red asterisk *), make a selection in the mandatory drop-down lists and, optionally, tick the check boxes for additional help and/or information:

After submitting the form, an e-mail is sent to the Service Desk staff for an identification and authorization process. If the request is approved, the international user receives an e-mail with account information. International users, however, are not able to log in, nor can they consult overviews of requests at this moment.

Bart.Servaes Wed, 05/03/2023 - 17:34

User roles in HD4DP v2

Several user roles are possible in the HD4DP v2 application:

Local Study Lead: This role takes responsibility for the study or project within the participating healthcare organization. Often this is the head of the clinical department involved in the study or project. The Local Study Lead can:

make registrations in HD4DP v2
view all registrations made by colleagues (regardless of role) for the study or project

Local Study Associate (author): The Local Study Associate is a healthcare professional that participates in the study or project. He/she reports/records medical information towards the researcher using HD4DP v2 and thereby assumes responsibility on the correctness of the reported information. He/she is considered to be the author of the registration. For each author an author group will be created. This will be represented in the registration form. The Local Study Associate can:

make registrations in HD4DP v2
only see all registrations assigned to his/her author group, not those of other colleagues (other author groups) in the same healthcare organization participating in the same study or project

Local Study Support (co-author): A Local Study Associate can delegate registration to a Local Study Support. Often this is an administrative collaborator or staff of a department medical coding. The Local Study Associate is still considered the author of the registration; the Local Study Support is considered co-author. The Local Study Associate can view and change registrations made by Local Study Support. The Local Study Support can:

make registrations in HD4DP v2
only see all registrations assigned to his/her author group, not those of other colleagues (other author groups) in the same healthcare organization participating in the same study or project

By default, only 1 Local Study Lead is created by healthdata.be (Sciensano) for each project within each organization. This means that only 1 person can see all registrations made for that project within that organization. This policy prevents HD4DP v2 users to see personal and sensitive information from persons they do not have a therapeutic relationship with.

In case organizations create more then 1 Local Study Leads for a project within that organization, so that they all can see each others registrations, and thus personal and sensitive information from persons they do not have a therapeutic relationship with, the organizations are fully responsible and accountable for this policy deviation. Healthdata.be (Sciensano) cannot be held responsible or accountable for this policy deviation. Professionals wanting to participate in projects are kindly suggested to contact the Data Protection Officer (DPO) of their organization to consult them about this intended policy deviation.

Bart.Servaes Wed, 05/03/2023 - 17:35

Give access to an HD application for someone from your organization

To give access to the applications of healthdata.be (like HD4DP v2 and healthstat.be), you need to click on GIVE ACCESS in the white text box on the EAM portal page.

You can give access to

a single user
multiple users in batch

Give access to a single user

After selection of GIVE ACCESS on the EAM portal page, an ACCESS REQUEST form is shown.

Completing this form is similar to the process on the Request Access page for standard end-users. In the capacity of a SPOC, however, you will now fill in an Access Request form for a user within your organization.

Please fill in all required fields (indicated with a red asterisk *), make a selection in the mandatory drop-down lists and, optionally, tick the check boxes for additional help and/or information.

Organization NIHDI number

The NIHDI number of the organization is already provided, since your account is connected to this organization.

Role in project

When selecting Local Study Support, you will be asked to make a selection in the drop-down list of Author groups. These author groups are specified for the organization in question.

HD4DP2.0 field

Click in the field under HD4DP2.0 if you want to access the application to make registrations for the selected project:

Healthstat.be field

Click in the field under healthstat.be if you want to access the reporting of the selected project:

Once you have completed the access request form, click on the Submit button. When the submisson was successful, you will receive a confirmation message.

If you now return to My profile, the User profile is extended with the Organization name and code. And an extra tab Batch create requests has been added.

Continue to Give access to multiple users in batch in order to give access to multiple users in one operation.

Give access to multiple users in batch

The person whom has been assigned the SPOC role for the healthcare organization (HCO) is able to give access to multiple users in batch. The SPOC therefore needs to return to the User profile page and select the tab Batch create requests.

In the tab Batch create requests a CSV file can be selected via the file selection button.

Upload the CSV file and click on the Run the batch creation button. An example of a CSV file structure is available here:

hd_eam_bulk_access_request_example-correct.csv Download

By doing so, a master request per line will be automatically generated, and then the information will be split into sub-requests (one per application or project) and saved in the healthdata.be DB2 for further processing.

A table schema (https://specs.frictionlessdata.io//table-schema/) to validate CSV looks as follows. An example file is available here: eam_csv_batch_requests_schema.json

User roles and corresponding values

To complete the “role”, 3 different choices are possible:

1= Local Study Lead: Only 1 Local Study Lead can be created by healthdata.be (Sciensano) for each registry within each organization.
2= Local Study Associate (= author). This will be the default role a user will receive, the reason why it was prefilled with “2”.
3= Local Study Support (= co-author). This role can be given if it is more suitable for the user. A Support will always need an Associate to which he/she will be assigned.

When selecting role 3 (= Local Study Support), the name of the ‘Local Study Associate’ is expected in the field “author_group”. To be filled in in the format <first_name last_name> of the Associate, with just 1 space (tab) between the two names).

When selecting role 2 (= Local Study Associate), the field author_group must be left empty.

Bart.Servaes Wed, 05/03/2023 - 17:35

Overview of the requests

After submission of the requests for access and receipt of the confirmation message, you are able to consult the validation process and other features of the requests via the tab Requests overview on the My Profile page.

Based on the scope of the requests overview, we can distinguish between

end-user, and
IT SPOC (single point-of-contact).

Overview of the requests for end-users

In order to view their own requests, end-users can open the My Profile page and click on the tab Requests overview.

The overview shown can be searched and sorted in the top row as needed (see figure below). End-users will only see a list of requests they have created for themselves.

Request UUID field

This field contains the unique ID’s of the requests. The occurence of the same unique ID in several rows indicates that this master request consists of several subrequests, each one per project and per application that has been selected in the request form. These subrequests are than saved in the healthdata.be DB2 for further processing.

Status field

The Status field indicates whether the request has been created (value “created”; meaning to be approved by the SPOC) or approved (value “approved_rae”; meaning the request was approved by the SPOC and will be ready for sharing credentials).

Role in project field

The values in this field are Local Study Lead, Local Study Associate, Local Study Support. More detailed information about these roles can be found in User roles in HD4DP v2.

Application field

This field contains the application you have selected in the Request Access (End-User) or Access Request form to access the public health projects: HD4DP2.0 or Healthstat.be.

Project code field

The value in this field is the Healthdata.be business project code. Entering this code in the publically accessible FAIR portal (fair.healthdata.be) results in the dataset for this project.

Or you can enter this code in the Advanced search field on the Healthdata.be docs pages to find the respective project’s documentation.

Overview of the requests for IT single points-of-contact (IT SPOC)

SPOCs have the capacity to view all requests for their organization.

To view the Status of the request of the users of their affiliation, the SPOC needs to select the My Profile page and to click on the tab Requests overview (see screenshot below). Requests in this overview can be searched and sorted as needed.

New: Actions field

This field describes the extra actions a SPOC can take, i.e. approve or reject requests. This functionality is explained in SPOC actions upon a request in more detail.

Request UUID field

Status field

The Status field can only receive the status “approved_rae” since the request was made by the SPOC.

Role in project field

The values in this field are Local Study Lead, Local Study Associate, Local Study Support. More detailed information about these roles can be found in User roles in HD4DP v2.

Application field

This field contains the application you have selected in the Request Access (End-User) or Access Request form to access the public health projects: HD4DP2.0 or Healthstat.be.

Project code field

The value in this field is the Healthdata.be business project code. Entering this code in the publically accessible FAIR portal (fair.healthdata.be) results in the dataset for this project.

Or you can enter this code in the Advanced search field on the Healthdata.be docs pages to find the respective project’s documentation.

Bart.Servaes Wed, 05/03/2023 - 17:36

SPOC actions

In this article, we cover the different actions of a SPOC in more detail.

SPOC actions upon a request

SPOCs will be notified in case a request for access was made by a colleague, allowing them to review the overview table to manage all requests for their organization.

To open the overview table, the SPOC needs to navigate to "My Profile" followed by selection of the "Requests" tab. The overview of the requests appears (see below).

In the Actions field an Approve/Reject selection button is displayed next to each request with the status created or approval_requested (framed in blue). Two actions are possible now: the SPOC can either approve or reject the user's request.

When selecting Approve, and after confirmation of this action, the status of the request changes to "approved_rae" and the dates in both fields Updated and Completed are updated accordingly as demonstrated in the screenshots below. Once the registry goes in production the account will be created automatically and the credentials will be shared to the user by e-mail.

Approve action:

Pop-up confirmation query:

Approved:

When returning to the overview, you will notice that the status of the request has changed to "approved_rae". The Approve/Reject button in the Actions field has disappeared.

When selecting Reject, and after confirmation of this action, the request receives the status "rejected", the dates in the fields Updated and Completed are updated accordingly. A rejected request remains in the overview for information purposes. Compare following screens:

Reject action:

Pop-up confirmation query:

Rejected:

The requester will also be notified of the rejected request by e-mail:

Dear,

Your request for access to EAM was rejected.

Please contact your HD4DP SPOC for more information.

Best regards
Healthdata Support

Bart.Servaes Wed, 05/03/2023 - 17:37

Access the application HD4DP v2

To access the application HD4DP v2, you must first request an account. If you do not have an account yet, please read the article "Request access to an HD application for a specific project" first.

Once your account has been created, you will receive an e-mail with following information (Note that the text between the [ ] will be adapted.):

Organization: [RIZIV number - Name]
Login: [email]
Password: [password]
Application URL: [url]

With these credentials you can access the application HD4DP v2 of your organization:

Go to the url mentioned in the email
Select "your organization" from the list
Your organization: [RIZIV number – Name]
Click on "Next"
Fill in your "username" and "password"
Click on "Log in"

Bart.Servaes Wed, 05/03/2023 - 17:37

Navigate to the IQECAD 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 [ ], you can see the study project [ ].

(screenshot)

Select the study project [ ].

You will see that the study project [ ] consists of 1 part: [ ].

(screenshot)

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!

Bart.Servaes Wed, 05/03/2023 - 17:40

Create an IQECAD registration

Create an IQECAD registration Bart.Servaes Wed, 05/03/2023 - 17:41

Find an IQECAD registration

Find an IQECAD registration Bart.Servaes Wed, 05/03/2023 - 17:41

Update an IQECAD registration

Update an IQECAD registration Bart.Servaes Wed, 05/03/2023 - 17:41

Delete an IQECAD registration

Delete an IQECAD registration Bart.Servaes Wed, 05/03/2023 - 17:42

Submit an IQECAD registration

Submit an IQECAD registration Bart.Servaes Wed, 05/03/2023 - 17:42

Send a correction registration

Suppose you want to send a correction to a submitted registration. In that case you need to navigate in the dark blue left menu to the study program and next to the study project concerned. Then, select the respective part.

Important: A correction registration can only be added, if the status of the registration is submitted.

A correction registration can be added in two ways:

via the overview table;
via the preview page of a registration.

Send a correction via the Overview table

When the registration was submitted, the correction registration can be added via the overview table. This table will appear in the main part of your screen, when selecting a version of a study section. It contains, among others, the following items: Registration ID, Progress, Author, Co-author, Unique ID, Business Key, Registration Code, National Registry ID of the patient…

Use the filters in the table header to find the registrations that need a correction. For example, you can use the "Status" (set to "Sent") filter to get only submitted registrations.

Then, you must select the "Action" button at the top right of the overview table.

Three options are displayed: "Submit", "Delete" and "Add correction", but only the option "Add correction" is available for submitted registrations. Now select "Add selection".

After you have selected "Add correction", a pop-up window will appear asking you to confirm the action of adding a correction registration for the selected registration. If you are sure of this action, click on "Confirm". If not, click on "Cancel".

If you confirm, you will be redirected to the correction registration form.

The correction DCD only contains:

Business key of original registration,
The name of Data Collection,
The field or variable which is wrong,
The correction value,
Comment field.

Some fields are automatically filled with values of the original registration, e.g "Data collection " and "Business_KEY" .

The number of fields to correct in the same correction registration is limited to three. You can add another field to correct by clicking on "Add another".

When you finish filling the correction registration, you can add a comment and send the correction by clicking on the "Submit" button.

Send a correction via the Preview page

We can also add a correction form in the preview page of a registration. Therefore, open the overview table and click on the registration you want to correct. Now, you will be redirected to the preview page.

Click on the "Add correction" button to add a correction for current registration.

Follow same steps described in previous section (See "Send a correction via the Overview table")

Preview a correction registration

The correction form is a generic form available in the left dark blue menu for all projects and DCDs.

If you want to preview "correction registrations" already submitted, you navigate to the study program Correction form and then to the study project Correction form. Finally, you select the last version of "Correction form" in the dark blue left menu.

All correction registrations (of different projects) will be displayed. You can use the filters in the table header to find a specific registration.

If you want to preview a correction registration, you need to click on the desired registration in the overview table. You will now be redirected to the preview page.

Bart.Servaes Thu, 05/04/2023 - 17:27

Registration statuses in HD4DP v2

This article explains the different registration statuses in HD4DP v2.

Statuses are shown in Status column

You can select the columns you want to display via the menu Select visible columns located in the top-right corner:

Select the columns you want to display and click on Apply.

Description of the statuses:

Open: Registration is created and stored. It has not been submitted

Deleted: Registration has been deleted.

Submitted: Registration has been submitted and sent.

Bart.Servaes Thu, 05/04/2023 - 17:26