User manual of the application HD4DP v1

User manual of the application HD4DP v1 manager Thu, 05/23/2024 - 14:50

Access the application HD4DP v1

To access the HD4DP v1 application, you need an account, a username and a password. If you do not have an account, you can request one by following the steps below. If you have an account, follow the instructions under “Sign In” at the end of this page.

Open the link for the HD4DP v1 application. You will see the screen below.

Please contact your IT department to obtain the link of the HD4DP v1 application on the server of your organization. In case you could not be further helped, you can contact healthdata.be at support.healthdata@sciensano.be to get the link. The link is specific in every organization based on the server on which the HD4DP application is running.

Click on the Request account link on the login page.
Fill out the request form:
- Enter a username, first name, last name and e-mail address
- Select the organization and data collection(s)
- Fill in the Requester e-mail field if a person requests an account for a third person
- Submit the request using the Request button

Confirmation e-mails are sent to the person for whom the account was requested as well as the requester, if the field "Requester e-mail" was filled.
The approval or rejection for the user account is confirmed by mail. Depending on your organization, this could take a few hours.
- This action will be done by an HD4DP v1 administrator in your organization
- The confirmation mail will include all the necessary information to log in

Sign in

Logging in to the HD4DP v1 application is done in 3 steps:

Enter your username and password in the appropriate fields
Select the correct organization
Click on "Log in"

manager Fri, 03/07/2025 - 09:59

Request access to a data collection

On this page we describe how a user, who is logged into the HD4DP v1 application, can request access to a desired data collection.

Go to the Settings tab in the right upper corner of the screen.
Look for the User profile section and click on the Edit Profile button.

In the section Request data collection access you click on the drop-down list.

Select the desired data collection.
Click on the Send request button to submit.
A mail is sent to the responsible HD4DP administrator to handle your request.

manager Wed, 12/04/2024 - 15:51

Navigate to a register

Click on the Registrations tab.
Select the register to create or modify registrations. Click on the top left corner and a drop down menu will be shown. The list of available registers is provided: Data Collections (in this article, we randomly selected the project BNMDR).
Select the correct version of the registry. In case of different versions/periods select the one with the green bullet.

manager Wed, 12/04/2024 - 16:20

Create and submit registrations

The Registrations tab shows the user the available registries. A user can start collecting data from this view.

Creating and submitting a registration consists of 4 steps:

Select the registry for which you want to create a registration.

(The documentation below includes generic sample screens designed solely to illustrate what the process entails, irrespective of the registry involved.)

Click on "New registration" button.

Fill in the registration form and save or submit the registration with the buttons below.

Save the registration temporarily if needed. The status of the record will be "Open" for saved registrations.

Submit the registration if no validation errors present. The status of the registration will change to "Sending".

When the record has been processed, the status will change to "Submitted".

As soon as a registration is sent, the "status confirmation" column will show "Pending".

It shows "OK" once the registration has arrived, and "NOK" if the registration did not arrive within 48 hours. If the status is "NOK", the software will automatically try to resend the registration up to 10 days after the initial submission.
For the statuses "Sending","Corrections needed" and "Approved" the status confirmation will be empty because the registration has not yet been submitted.
A registration can be "Reopened" if needed as long as the status of the registration is "Submitted".

manager Wed, 12/11/2024 - 15:26

Change or complete registrations

A user can modify and complete a registration in four steps:

Select the register from which you wish to modify one or more registration(s).

(The documentation below includes generic sample screens designed solely to illustrate what the process entails, irrespective of the registry involved.)

Click on the registration to be changed, and complete the form. The status of the record is then:
- Open for registrations saved manually or by uploading a csv file
- Corrections needed for registrations with errors

Save registration temporarily if necessary. Record status becomes Open for stored registrations.

Send the registration if there are no more validation errors.
- Registration status changes to Sending

When the record is processed, the status changes to Submitted.

Once a registration is sent, the message Pending appears in the status confirmation column.

When the registration is received, the message OK appears; if the registration is not received within 48 hours, the message NOK appears. With the status "NOK", the software will automatically try to send the registration up to 10 days after the initial submission.
For the statuses Sending, Corrections needed and Approved, the status confirmation is empty because the registration has not yet been sent.
A registration can be Reopened if necessary, as long as the status of the registration is "Submitted".

manager Wed, 12/11/2024 - 15:32

Delete registrations

Only registrations with status Open or Corrections needed can be deleted.

The following steps are required to delete the registration:

Select the record and version for which you wish to delete a registration

(The documentation below includes generic sample screens designed solely to illustrate what the process entails, irrespective of the registry involved.)

Select the registration(s) you wish to delete
Select the Actions button and select the Delete registrations option

Select Yes to confirm

manager Wed, 12/11/2024 - 12:43

The progress bar

The progress bar shows the progress of the registration and can be found in:

the view list of a register;
the detailed view of a record.

View list example

Detailed view example

The progress bar can be divided into three sections, listing the number of errors, remarks and correct fields in a registration.

Each section has its own color and meaning.

Red: mandatory fields and fields containing an error. These need to be solved before the registration can be submitted.
Blue: Empty optional fields. The registration can be submitted with empty optional fields.
Green: correctly filled fields.

Hover over the progress bar to display the number of fields per section.

manager Wed, 12/11/2024 - 17:21

Validation errors and validation warnings

Data that are filled in manually or that are present in the uploaded file are subject to errors.

These errors will be shown as validation errors, (absence of) required fields, validation warnings under the validation part which in the right panel of the screen. An explanation of the error is given.

Clicking on the validation error or warning will navigate to the field concerned.

These records need to be corrected first and then submitted for registration.

manager Thu, 12/12/2024 - 09:11

Registration statuses overview

This article explains the different registration statuses in HD4DP v1 as of v1.8.

Where to find the status of a registration?

Statuses are shown in 'Status' column which is per default the first column in the overview:

What is a Status Confirmation?

The status confirmation gives information about the arriving of the data in HD4DP. The status confirmation, which is in fact a substatus of a registration is shown in the column 'Status confirmation'.

To view the 'Status Confirmation', modify the list view add the column 'Status confirmation':

As soon as a registration is sent and has status 'Submitted', the confirmation column will show the following substatus:

Pending
OK: the registration has arrived
NOK: the registration did not arrive within 48 hours

The different registration statuses

Open*: a registration is created and stored. It has not been submitted
Sending: the registration is being sent to HD4RES
Submitted: the registration has been sent to HD4RES. This does not necessarily mean that the registration has arrived in HD4RES
Registrations in status 'Corrections needed'*: the researcher verified the registration and added some comments. Review the comments and correct where necessary
Approved: the researcher verified and approved the registration
Registrations with status 'Follow-up needed'*: a follow-up registration is needed for this registration. Fill in the newly available fields
Error: your account is not authorized to create and submit registration for this register. Please contact support.

* action is required from the user

The below scheme summarizes the different registration statuses in HD4DP and Processing Data and their relation to each other:

manager Wed, 12/11/2024 - 17:39

Registrations in status 'Corrections needed'

Registrations with status 'Corrections needed' need to be revised. The researcher has comments that require an update or revision.

In order to look for registrations which need corrections, select in the registration tab the tab ‘Status’ and ‘correction needed’.

Select the record with status 'Corrections needed'

Verify and react to the comments made by the researcher by selecting the ‘comments’ tab

Reply to the comments and modify the registration and save the comment

Click 'Re-submit' to send the corrections to the researcher. Alle validation errors need to be solved before the 'Re-submit' button becomes available

manager Tue, 12/10/2024 - 12:56

Registrations with status 'Follow-up needed'

Some registrations need follow-up e.g. to monitor multiple consultations of a patient. Therefore additional information will be asked at predefined milestones, which are defined in the set-up phase of the registry.
Follow-up registrations can be triggered by:

Timing e.g. x time after the initial registration
Answers in the initial registration e.g. only if the patient has taken medication X
A combination of both e.g. if the patient has taken medication X, ask follow-up information 3 months later

In order to look for registrations which need follow-up, select in the registration tab the tab ‘Status’ and ‘follow-up needed’.

If the Status column shows 'Follow-up needed' and the 'Follow up' column is active, the user can add the extra information needed in the details of the registration.

Note: the process of validation and resending the registration(s) back for the follow-up data takes minimum 4 hours.

Select 'Follow up' in the settings of the view:

The Follow-up column is now shown in the view:

When follow-up is needed, the column 'Follow up' in the list view indicates if follow-up is needed by indicating:

Planned: follow-up will be needed in the future, indicated by the date indication
- 'Status Column' shows 'Submitted', no action is needed at this moment
Active: the questions for this follow up are now visible and can be filled
- 'Status Column' shows 'Follow-up needed', action is needed
Submitted: the follow-up column will change to submitted after the additional information is given
- 'Status Column' shows 'Submitted', no more action is needed

Depending on how many times follow-up is needed, a row is added to the column. The milestones are indicated by t1, t2 etc.

manager Tue, 12/10/2024 - 12:56

Submit registrations in bulk

The registrations that need to be submitted, have to be checked to proceed the registration in bulk
Click on the button 'Actions' and select 'Submit registrations'. The number of selected records is displayed between brackets

Confirm the submission on the window that appears

A summary of the registrations that are submitted and failed is shown. The records that contain errors will not be submitted

manager Wed, 12/04/2024 - 16:38

Finalize the data collection

The researcher needs to be notified if the registration is ready.

There are 2 ways to finalize the registration:

1. By using the link in the Registration tab:

2. By using the button in the Participation tab:

Confirm finalization of the data collection:

Sometimes additional data is requested by the researcher. This must be completed first before using the finalize button or link.

After you select the Finalize data collection button, the researcher will be notified.

manager Wed, 12/04/2024 - 19:10