Medical University of Graz:
\nERASe Trial \u2013 Clinical Drug Study<\/h1><\/h1><\/div>- <\/i><\/span>\n
Multicenter study in 8 hospitals with 400 patients<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
End-to-end digital process from data acquisition to evaluation<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Audit trail \/ quality assurance for the complete traceability of changes<\/p>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
The clinical trial project team captures all patient data digitally using the HybridForms App.<\/strong> The protocols of the ward rounds as part of clinical drug study are documented in the participating eight hospitals digitally and across sites in a multi-stage process with HybridForms.<\/span><\/p>\n<\/div>HybridForms: Digital forms in medical research<\/h2><\/div>In the Case Report Forms, users are guided through the application in a structured manner.<\/strong> Mandatory fields are clearly marked, entries are automatically validated, and the system displays warning messages in the event of errors. This ensures that recorded data such as vital signs, previous illnesses, therapy, medication and laboratory parameters are complete and accurate \u2013 an important criterion for the success of a study.<\/p>\nDigitally captured data is more secure than paper and available faster.<\/strong> All data on the end devices is encrypted and automatically synchronized with the core server, making the information immediately available centrally. This means that studies across different locations can be documented reliably and without delays, even in distributed teams \u2013 efficiently, securely and transparently.<\/p>\nThe changes made with each form update are logged with Audit Trail<\/a><\/strong> \u2013 an important quality assurance feature. By tracing back, details such as version, date, time, user and type of change can be tracked at any time.<\/p>\n<\/div><\/div><\/div>About the Medical University of Graz<\/h3><\/div>The Medical University of Graz<\/strong> is a center of innovative cutting-edge medicine in Austria. Its central tasks include teaching and training of the highest standard, research at an international level:
\n2,400 employees, 3,450 students, 1,500 scientific staff, 19 university hospitals, 36 clinical departments, 1 clinical institute, 1,500 beds, 7 day hospital areas, 87,400 inpatients \/ year, 414,900 patients \/ year.<\/p>\nThe project Clinical \u00bbDrug Study \u2013 ERASe-Trial\u00ab\u2002was managed by the HybridForms integration partner
\nKapsch BusinessCom<\/strong>.
\nKapsch BusinessCom supports international companies and organizations in the Smart Hospital, Health & Social Care sector in the digital transformation and optimization of their processes.<\/p>\n<\/div><\/div><\/div><\/div><\/div>Electronic Case Report Forms (eCRF) with detailed documentation of ward rounds in a multi-step process using HybridForms<\/h2><\/div><\/div><\/div>![\"Medical](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2024\/08\/HybridForms-Checkliste-MedUniGraz-62.png\" "\\"Med")
<\/span><\/div><\/div><\/div><\/div>![\"Medical](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2024\/08\/HybridForms-Checkliste-MedUniGraz-61.png\" "\\"Med")
<\/span><\/div><\/div><\/div><\/div>More about digital documentation in healthcare & research<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>![\"Norbert](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2022\/01\/Norbert-Tripolt-MedUni-Graz-01.jpg\")
<\/div>\n\u00bbFor our multi-center study project, we were looking for an electronic CRF system that allows intuitive work, follows a logical structure and is easy to use for the study staff. In addition, the system had to comply with the specified regulations (monitoring, audit trail, role functions, data export). HybridForms and Kapsch BusinessCom were able to meet these requirements to our complete satisfaction.\u00ab<\/p>\n<\/div><\/div><\/blockquote>
Dr Norbert Tripolt | Clinical Department of Endocrinology and Diabetology<\/strong>, Medical University of Graz<\/span><\/a><\/span><\/div><\/div><\/div><\/div><\/div><\/div>![\"Bernd](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2022\/01\/Bernd-Lueckl-Kapsch-01.jpg\")
<\/div>\n\u00bbWith the HybridForms platform, it was possible for us as a digitization partner to optimally cover the requirements of our customers and provide a simple, intuitive solution for digital data capture on mobile devices. Especially the use of the HybridForms functionalities \u203aStages\u2039 und \u203aAudit Trail\u2039 enabled the full coverage of the multi-stage review process as well as the seamless traceable handling of the clinical double-blind drug study.\u00ab<\/p>\n<\/div><\/div><\/blockquote>
Dipl.-Ing. Bernd L\u00fcckl | Team Lead ICT Delivery Microsoft Productivity & Web Applications<\/strong>, K-Businesscom<\/span><\/a><\/span><\/div><\/div><\/div><\/div><\/div><\/div>![\"Logo](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2021\/11\/Logo-MedUni-Graz-02.png\")
<\/a><\/span><\/div><\/div><\/div><\/div>![\"Logo](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2022\/09\/Logo-Kapsch-Businesscom-02.png\")
<\/a><\/span><\/div><\/div><\/div><\/div><\/div><\/div>![\"Medical](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2024\/08\/Form-Paper-MedUni-ERASe-Trial-61.png\" "\\"Digital")
<\/span><\/div><\/div><\/div><\/div><\/div><\/div>Digital data capture for medical facilities: Interactive mobile forms for process-compliant documentation & collaboration in distributed teams<\/h2><\/div><\/div><\/div>Requirements of the Medical University of Graz<\/h3><\/div>In a randomized, double-blind (patients and physicians), placebo-controlled multi-center study, the effects of Ertugliflozin on ventricular arrhythmias will be investigated and evaluated. 8 hospitals throughout Austria are participating (under the coordination of the Medical University of Graz) with approximately 400 patients and a duration of 30 months.<\/strong><\/p>\nDue to the cross-site orientation, the project was planned as an electronic clinical trial (eTrial) for data collection and information sharing. Because of the positive experiences in other studies (CBmed \u2013 Center for Biomarker Research<\/a> and \u00d6DG \u2013 Austrian Diabetes Society<\/a>) the decision was made again to use HybridForms for the implementation of the digital forms with workflow.<\/p>\n<\/div><\/div><\/div>Launch & implementation of the project as an end-to-end digital solution<\/h3><\/div>- <\/i><\/span>Digitization workshop<\/strong> with process analysis, design and implementation of the digital form with workflow stages by Kapsch BusinessCom.<\/div><\/li>
- <\/i><\/span>HybridForms App & Software for mobile forms processes<\/strong> for data capture, review and correction of data \u2013 with workflow stages, rights and roles.<\/div><\/li>
- <\/i><\/span>Operation of the core server on-premises<\/strong> by the IT of the Medical University of Graz in the in-house data center.<\/div><\/li>
- <\/i><\/span>User Management & Administration<\/strong> by the Medical University of Graz.<\/div><\/li><\/ul><\/div><\/div>
Learning and benefits in clinical practice<\/h3><\/div>- <\/i><\/span>Optimal data quality<\/strong> through structured capture with automatic checking.<\/div><\/li>
- <\/i><\/span>Display only of relevant content<\/strong> depending on user rights & roles.<\/div><\/li>
- <\/i><\/span>Pseudonymization<\/strong> of patient data in accordance with data protection guidelines.<\/div><\/li>
- <\/i><\/span>Fully digital data<\/strong> for research and scientific analysis.<\/div><\/li><\/ul><\/div><\/div>More on the Pilot Project (PoC)<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>
Workflow stages with step-by-step processing of forms by different users with different visibilities<\/h2><\/div><\/div><\/div>![\"Medical](\"https:\/\/www.hybridforms.net\/en\/wp-content\/uploads\/sites\/3\/2022\/01\/HybridForms-MedUniGraz-Flowchart-ERASe-Trial-EN.png\" "\\"ERASe-Trial")
<\/span><\/div><\/div><\/div><\/div><\/div><\/div>HybridForms with secure enterprise features and multi-step forms workflow for adherence to compliance guidelines for clinical studies<\/h2><\/div><\/div><\/div>Workflow & Stages<\/h3><\/div><\/a><\/div>- <\/i><\/span>Process with multiple stages and users (study nurse, physician, …)<\/div><\/li>
- <\/i><\/span>Visibility, read and write permissions depending on user role<\/div><\/li>
- <\/i><\/span>Acquisition, review, rework of data in multiple visits<\/div><\/li><\/ul><\/div>
Smart Collaboration: Step-by-step processing of a form<\/strong><\/p>\n<\/div>
\nERASe Trial \u2013 Clinical Drug Study<\/h1><\/h1><\/div>
- <\/i><\/span>\n
Multicenter study in 8 hospitals with 400 patients<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nEnd-to-end digital process from data acquisition to evaluation<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nAudit trail \/ quality assurance for the complete traceability of changes<\/p>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
The clinical trial project team captures all patient data digitally using the HybridForms App.<\/strong> The protocols of the ward rounds as part of clinical drug study are documented in the participating eight hospitals digitally and across sites in a multi-stage process with HybridForms.<\/span><\/p>\n<\/div>
HybridForms: Digital forms in medical research<\/h2><\/div>
In the Case Report Forms, users are guided through the application in a structured manner.<\/strong> Mandatory fields are clearly marked, entries are automatically validated, and the system displays warning messages in the event of errors. This ensures that recorded data such as vital signs, previous illnesses, therapy, medication and laboratory parameters are complete and accurate \u2013 an important criterion for the success of a study.<\/p>\n
Digitally captured data is more secure than paper and available faster.<\/strong> All data on the end devices is encrypted and automatically synchronized with the core server, making the information immediately available centrally. This means that studies across different locations can be documented reliably and without delays, even in distributed teams \u2013 efficiently, securely and transparently.<\/p>\n
The changes made with each form update are logged with Audit Trail<\/a><\/strong> \u2013 an important quality assurance feature. By tracing back, details such as version, date, time, user and type of change can be tracked at any time.<\/p>\n<\/div><\/div><\/div>
About the Medical University of Graz<\/h3><\/div>
The Medical University of Graz<\/strong> is a center of innovative cutting-edge medicine in Austria. Its central tasks include teaching and training of the highest standard, research at an international level:
\n2,400 employees, 3,450 students, 1,500 scientific staff, 19 university hospitals, 36 clinical departments, 1 clinical institute, 1,500 beds, 7 day hospital areas, 87,400 inpatients \/ year, 414,900 patients \/ year.<\/p>\nThe project Clinical \u00bbDrug Study \u2013 ERASe-Trial\u00ab\u2002was managed by the HybridForms integration partner
\nKapsch BusinessCom<\/strong>.
\nKapsch BusinessCom supports international companies and organizations in the Smart Hospital, Health & Social Care sector in the digital transformation and optimization of their processes.<\/p>\n<\/div><\/div><\/div><\/div><\/div>Electronic Case Report Forms (eCRF) with detailed documentation of ward rounds in a multi-step process using HybridForms<\/h2><\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/div>More about digital documentation in healthcare & research<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>\n\u00bbFor our multi-center study project, we were looking for an electronic CRF system that allows intuitive work, follows a logical structure and is easy to use for the study staff. In addition, the system had to comply with the specified regulations (monitoring, audit trail, role functions, data export). HybridForms and Kapsch BusinessCom were able to meet these requirements to our complete satisfaction.\u00ab<\/p>\n<\/div><\/div><\/blockquote>
Dr Norbert Tripolt | Clinical Department of Endocrinology and Diabetology<\/strong>, Medical University of Graz<\/span><\/a><\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n\u00bbWith the HybridForms platform, it was possible for us as a digitization partner to optimally cover the requirements of our customers and provide a simple, intuitive solution for digital data capture on mobile devices. Especially the use of the HybridForms functionalities \u203aStages\u2039 und \u203aAudit Trail\u2039 enabled the full coverage of the multi-stage review process as well as the seamless traceable handling of the clinical double-blind drug study.\u00ab<\/p>\n<\/div><\/div><\/blockquote>
Dipl.-Ing. Bernd L\u00fcckl | Team Lead ICT Delivery Microsoft Productivity & Web Applications<\/strong>, K-Businesscom<\/span><\/a><\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/a><\/span><\/div><\/div><\/div><\/div><\/a><\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/div><\/div><\/div>Digital data capture for medical facilities: Interactive mobile forms for process-compliant documentation & collaboration in distributed teams<\/h2><\/div><\/div><\/div>
Requirements of the Medical University of Graz<\/h3><\/div>
In a randomized, double-blind (patients and physicians), placebo-controlled multi-center study, the effects of Ertugliflozin on ventricular arrhythmias will be investigated and evaluated. 8 hospitals throughout Austria are participating (under the coordination of the Medical University of Graz) with approximately 400 patients and a duration of 30 months.<\/strong><\/p>\n
Due to the cross-site orientation, the project was planned as an electronic clinical trial (eTrial) for data collection and information sharing. Because of the positive experiences in other studies (CBmed \u2013 Center for Biomarker Research<\/a> and \u00d6DG \u2013 Austrian Diabetes Society<\/a>) the decision was made again to use HybridForms for the implementation of the digital forms with workflow.<\/p>\n<\/div><\/div><\/div>
Launch & implementation of the project as an end-to-end digital solution<\/h3><\/div>
- <\/i><\/span>Digitization workshop<\/strong> with process analysis, design and implementation of the digital form with workflow stages by Kapsch BusinessCom.<\/div><\/li>
- <\/i><\/span>
HybridForms App & Software for mobile forms processes<\/strong> for data capture, review and correction of data \u2013 with workflow stages, rights and roles.<\/div><\/li>- <\/i><\/span>
Operation of the core server on-premises<\/strong> by the IT of the Medical University of Graz in the in-house data center.<\/div><\/li>- <\/i><\/span>
User Management & Administration<\/strong> by the Medical University of Graz.<\/div><\/li><\/ul><\/div><\/div>Learning and benefits in clinical practice<\/h3><\/div>
- <\/i><\/span>Optimal data quality<\/strong> through structured capture with automatic checking.<\/div><\/li>
- <\/i><\/span>
Display only of relevant content<\/strong> depending on user rights & roles.<\/div><\/li>- <\/i><\/span>
Pseudonymization<\/strong> of patient data in accordance with data protection guidelines.<\/div><\/li>- <\/i><\/span>
Fully digital data<\/strong> for research and scientific analysis.<\/div><\/li><\/ul><\/div><\/div>More on the Pilot Project (PoC)<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>Workflow stages with step-by-step processing of forms by different users with different visibilities<\/h2><\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/div><\/div><\/div>HybridForms with secure enterprise features and multi-step forms workflow for adherence to compliance guidelines for clinical studies<\/h2><\/div><\/div><\/div>
Workflow & Stages<\/h3><\/div><\/a>
<\/div>- <\/i><\/span>Process with multiple stages and users (study nurse, physician, …)<\/div><\/li>
- <\/i><\/span>
Visibility, read and write permissions depending on user role<\/div><\/li>- <\/i><\/span>
Acquisition, review, rework of data in multiple visits<\/div><\/li><\/ul><\/div>Smart Collaboration: Step-by-step processing of a form<\/strong><\/p>\n<\/div>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>