Structured and user-friendly.

CustomerAdminTool

• Management of separate customer areas
• Release of administrators and project schemas
• Release of basic application functions
• Documentation of database schema
• Software update history

FormBuilder

• Independent creation of form setup including database (automatic generation of database structure and data model)
• Creation of the eCRF (visit plan, form families, forms, items and help texts)
• Specification of online checks and plausibility tests (format errors, interdependencies, value thresholds, completion, adopted values and simple scores)
• Specification of additional study parameters (electronic signature, AuditTrail, documents, randomization, qualification test)
• Visit plan configuration
• Flexible configuration settings (e.g. eSignature, source data verification, data entry workflow and monitoring)
• Configuration of reports and statistics for displaying typical overviews
• Quality assurance and setup with separate test area
• Change management with versioning of the form setup and all configuration settings
• Comprehensive automatic documentation of the database and all versions of the study setup

AdminTool

• Central management of participants (assignment of passwords), centres, roles and patients
• Parameterisable role and rights system (defined generally and on a form-related basis)
• Patient management
• Patient limiting option (recruitment per participant)
• Participant management (projects, centres, locations)
• Editing of the study-specific layout
• Independent layout management for each project/customer
• Incremental AuditTrail
• Activity log for participants and patients
• Automatic password assignment facility
• Individual language setting can be defined for the user interface
• Option to define a preferred patient overview

DataCapture

• Complete web-based entry of patient data
• Study inclusion and pseudonymisation of patients
• Option to use own pseudonyms
• Medical data recorded in accordance with the study protocol via eCRF
• Scalable eSignature
• AuditTrail for recording all changes to medical data
• Role-dependent query management
• Online monitoring with query dialogue
• Up-to-the-minute reports for a quick overview of study progress and data capture statu
• Statistics for displaying typical overviews
• (Serious) adverse events workflow (optional: automatic fax and/or e-mail notifications)
• Automatic messaging system for adverse events and exceeded value thresholds (optionally also via e-mail)
• Patient status (e.g. if patient consent is withdrawn)
• Patient and data import
• Importing of image data (e.g. DICOM, jpg, gif, png, avi, mpg)
• Source data verification for reliable data entry
• All forms for a patient summarised in a printable patient file, also as a PDF
• Double data entry
• Patient Reported Outcome
• Flagging of missing values

Pseudonymisation

• Pseudonymisation of personal data in compliance with data privacy regulations
• Identifying data on paper or via external database
• Linking with the Mainzelliste

ExportSearchTool

• Export patient data from the database
• Supported export formats: CSV, SAS, SPSS, CDISC-ODM and TXT
• Asynchronous generation with e-mail notification upon completion of the export
• Search/filter function with dynamic search forms
• Role-based access rights
• Export protection via TAN
• Search/export history
• Option for automated export triggering
• Creation of individual export templates