User Manual Biologika Registry v1 - Med Uni Graz

Psoriasis Registry – Graz – Austria User Manual

Version 1.0 Page 1 of 19

User Manual



Table of content Table of content.......................................................................................................................... 2 1. Introduction ........................................................................................................................ 3

1.1. Contact person............................................................................................................ 3 2. Login .................................................................................................................................. 4

2.1. Edit user details and change password....................................................................... 4 2.1.1. Edit User Details: ............................................................................................... 5 2.1.2. Change password................................................................................................ 6

3. Add new patient ................................................................................................................. 7 3.1. Baseline data of new Patient ...................................................................................... 7

3.1.1. Previous biologic TX ......................................................................................... 7 3.1.2. Previous non-biologic TX .................................................................................. 7 3.1.3. Concomitant disease at baseline......................................................................... 8

3.2. Example:..................................................................................................................... 8 4. Edit data............................................................................................................................ 10 5. Add a new cycle ............................................................................................................... 11

5.1. Add baseline visit for new cycle .............................................................................. 11 5.2. Add another visit ...................................................................................................... 13 5.3. Add last visit of the cycle......................................................................................... 13 5.4. Overview .................................................................................................................. 14 5.5. Visit Schedule .......................................................................................................... 15

6. Reports ............................................................................................................................. 16 6.1. Doctor Site Report.................................................................................................... 16 6.2. Medication Report.................................................................................................... 17

7. Exports ............................................................................................................................. 18 8. Reporting a Suspected Unexpected Serious Adverse Reaction (SUSAR)....................... 19



1. Introduction The aim of this user manual is to describe the process of how to use the Psoriasis Registry Database. This system is a web application; this means that the application can be reached when connected to the internet.

1.1. Contact person If you have any questions which go beyond this user manual or need username and password to login please contact: Univ.Prof. Dr. Wolf Email: [email protected] Telephone: +43 316 385 2371 Dr. Inzinger Email: [email protected] Telephone: +43 316 385 2371



2. Login To see the login screen please enter www.psoriasis-therapieregister.at into your Internet browser. The following screen will appear:

Please enter your username and password and click “Login”. After your successful login the following screen will appear.

This is the Patient Overview screen, which shows all patients you already added. Please note that as long no patients have been added the message “No patient data found” will appear.

2.1. Edit user details and change password When logging in for the first time please verify your user data and change your password.

Therefore please click home in the left top corner:



Your current details will be displayed:

2.1.1. Edit user details: To change your user details click “Edit Data” and complete your details on the next screen.

After you completed your details please click “Save” to save your details.



2.1.2. Change password To change your password click “Set New Password”

On this screen please enter your old password which you used to log in and enter your new password, which you will user from now onwards, into the fields “New Password” and “Retype New Password”. Click “Set New PW” to save your new password.



3. Add new patient

To add a new patient click “New Patient” on the screen above.

3.1. Baseline data of new patient In order to add a new patient to the database the following fields need to be filled: Data Entry: whether the data is entered prospective or retrospective. Participant in Clinical Trial: if the patient is participating in a clinical trial or not (yes / no) Birth date: Date of birth Gender: male / female. Height: in cm. Please choose n/a if the height is unknown. Family History: If the patient has a family history with psoriasis. Duration of Diseases: number of years with diseases.

3.1.1. Patient number The patient number is a system created number. The first number indicates the ID of your country. The second number indicates the site (your hospital). The third number is a incremental number. This means if, like in the case above, the ID of the country is 02; the ID of the hospital is 02 then the first patient number used will be 02-02-0001. The second patient will be 02-02-0002…

3.1.2. Previous biologic TX Please specify previous treatments with biologics, contraindications and TX failure. If your required option is not available tick “Others” and specify.

3.1.3. Previous non-biologic TX Please specify previous treatments with non-biologics, contraindications and TX failure. If your required option is not available tick “Others” and specify.



3.1.4. Concomitant disease at baseline Please specify current concomitant diseases at baseline. If your required option is not available tick “Others” and specify.

3.2. Example:



The data saved above will then be displayed as Cycle 0.



4. Edit data Please check the data you entered. You have the possibility to edit your data within 24 hours, in case of any mistake. Click “Edit Baseline” to edit the data. For change-history purposes please indicate the reason for your change.

Please note that after 24 hours you are not able to change data anymore. This is to make sure that no data is modified by accident. In case you need to correct data on a later stage you can contact the administrator at specified in section 1.1. Contact person



5. Add a new cycle

5.1. Add baseline visit for new cycle

To add a new cycle click “(+) Cycle” in the upper right corner. Please add the data of the baseline visit.

After clicking the “Save” button the saved data will be displayed:



Click on “Cylce 01” to see the overview of the cycle you just created:

To add a new visit click “New” button.



5.2. Add another visit To add a new visit click “New” button. (see above)

Please fill the data of the new visit and click “Save” Click on “Cylce 01” again to see the overview of the cycle.

5.3. Add last visit of the cycle To add the last visit of the cycle add a new visit (like above) but set “End of TX” to “Yes”.

The system will ask you to indicate the main reason for the end of the cycle.

This visit will end the cycle.



When you end a cycle:

• it will be possible to add a new cycle. • you will see the cycle overview in the patient overview.

5.4. Overview The patient overview shows you all current information of the patient and summarizes visits and cycles. For more detailed cycle information you can click “Toggle Visibility” at “Detailed Cycle History” and a more detailed overview per cycle will be displayed.



5.5. Visit Schedule In order to get an overview on when to schedule future visits you can click “Schedule” on the cycle overview screen. The system will inform you on when to schedule upcoming visits.

To print this information in a printer friendly format click “print”



6. Reports For reports click the “Reports” button in the top navigation bar. There two different types of reports available:

• Doctor Site Reports • Medication Reports

When you enter the reports screen the Doctor Site Report will be shown. To change to the Medication Report, select “Medication Report” in the drop down box and then click “submit”.

6.1. Doctor Site Report The Doctor Site Report will show and overview of all patients and cycles you entered to the system. Statistical PASI score calculations will be displayed.



6.2. Medication Report The medication report will give you information on cycle quantity, patient demographics (gender and age) and PASI scores for each medication.



7. Exports The export function allows you to export all data you add to the database in a .csv format. As soon as you click on “Export” in the top line navigation, the export screen will be shown and a pop up will open to save the .csv export on your computer. The export file is compressed in a .zip file.

Save the file on your computer. All newer versions of Microsoft Windows support .zip file, however if you are not able to open the file, you might need the program “WinZip” which can be downloaded from http://www.winzip.com/ If for any reason the pop up does not open. You can click the green link “Export temporary/export-<DATE and TIME>.zip“ to download the export. You can open the export in Microsoft Excel of any text editor.



8. Reporting a Suspected Unexpected Serious Adverse Reaction (SUSAR)

For SUSAR reporting please use the AGES SUSAR Report attached to this document.

Date post:	23-Nov-2021
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User Manual Biologika Registry v1 - Med Uni Graz

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