Medical University of Graz:
ERASe Trial – Clinical Drug Study
ERASe Trial – Clinical Drug Study
The clinical trial project team captures all patient data digitally using the HybridForms App. 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.
HybridForms: Digital forms in medical research
In the Case Report Forms, users are guided through the application in a structured manner. 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 – an important criterion for the success of a study.
Digitally captured data is more secure than paper and available faster. 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 – efficiently, securely and transparently.
The changes made with each form update are logged with Audit Trail – 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.
About the Medical University of Graz
The Medical University of Graz 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:
2,400 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.
The project Clinical »Drug Study – ERASe-Trial« was managed by the HybridForms integration partner
Kapsch BusinessCom.
Kapsch BusinessCom supports international companies and organizations in the Smart Hospital, Health & Social Care sector in the digital transformation and optimization of their processes.
»For 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.«
»With 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 ›Stages‹ und ›Audit Trail‹ enabled the full coverage of the multi-stage review process as well as the seamless traceable handling of the clinical double-blind drug study.«
Digital data capture for medical facilities: Interactive mobile forms for process-compliant documentation & collaboration in distributed teams
Requirements of the Medical University of Graz
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.
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 – Center for Biomarker Research and ÖDG – Austrian Diabetes Society) the decision was made again to use HybridForms for the implementation of the digital forms with workflow.
Launch & implementation of the project as an end-to-end digital solution
Learning and benefits in clinical practice
Workflow stages with step-by-step processing of forms by different users with different visibilities
HybridForms with secure enterprise features and multi-step forms workflow for adherence to compliance guidelines for clinical studies
Secure data & systems
Sensitive data: GDPR compliant documentation and storage
GCP – Good Clinical Practice
Good Clinical Practice is an international ethical and scientific standard for the planning, conduct, documentation, and reporting of clinical trials involving human subjects.
For quality assurance of the processes and as a standard operating procedure (SOP), detailed textual documentation including change management and data verification must be ensured. The traceability of changes at any time is a central issue here.