IWRS

Dacima's IWRS (Interactive Web Response System) is a web-based patient randomization module designed for clinical trials. It is fully integrated into Dacima's eClinical Suite and supports the configuration of patient randomization processes and enrollment/eligibility forms without requiring programming expertise.

The module is intended for a range of clinical trial roles, including trial coordinators, investigators, nurses, monitors, and biostatisticians. It supports both single-centre and multi-centre trial designs, with the option to delegate randomization management to participating centres.

Setup and Configuration

• Graphical User Interface (GUI) for configuring the randomization process without programming knowledge
• Design of enrollment and eligibility forms, including validation checks and eligibility rules
• Configuration of patient ID format
• Support for single-stage enrollment forms or multi-stage enrollment forms for studies requiring multiple steps or stages
• Configuration of inclusion and exclusion criteria

Randomization Methods and Options

• Simple randomization, block randomization, and permuted block randomization
• Minimization functionality
• Stratification options
• Blinded and unblinded randomization options
• Single-stage enrollment: randomization triggered after completion of an enrollment or inclusion form
• Multi-stage enrollment: randomization triggered after the last enrollment form or step across multiple forms is completed
• Simulation capability during the development phase

Patient and Trial Management

• Role-based user access to manage different permission levels across trial roles
• Coordinating centre can manage randomization centrally or delegate to participating centres in multi-centre trials
• Automatic email notifications when a patient is randomized
• Subject management screen for tracking randomization status and patient enrollment status
• Patient management and status tracking features
• Built-in reports and data querying capabilities
• Data export features
• Drug and device allocation and management via the Supply Management module

Compliance and Audit

• FDA 21 CFR Part 11 compliant
• Complete audit trail

Dacima's IWRS module is part of the broader eClinical Suite offered by Dacima Software, which is a member of the EvidentIQ Group. The platform is available in English and French, and a fully functional trial version is available upon request.