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.
»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.«

Workflow stages with step-by-step processing of forms by different users with different visibilities

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.