Consistency & Acceleration in CRF Design
The STUDY COMPOSER offers an intuitive graphical point-and-click interface for defining a trial and creating relevant metadata.
Data managers get a feature-rich, powerful environment in which to configure dynamic eCRFs, including more complex validation checks. The XML structure based on the CDISC ODM standard is automatically generated in the background. The use of XClinical’s STUDY COMPOSER in combination with a CDISC-certified EDC system allows the eCRF design and configuration of the EDC system to be performed in a single step, thus saving even more time and money.
Highlights
- Replaces MS Word and Excel and accelerates the CRF and data validation plan (DVP) setup process
- Automatically generates the annotated CRF, data validation plan, visit matrix, database specs and other key documents from the eCRF design on the basis of a single, central XML-based set of metadata, keeping everything in sync
- Builds an item and CRF library in the standard CDISC ODM format for the consistent reutilization of existing items and CRF definitions in different trials
- Enables unambiguous communication and efficient collaboration between CROs, sponsors, vendors and all other parties involved
Features
- Screenshot Study Composer (click for the large version ⊕)
- Intuitive graphical interface for quick and easy CRF design
- Smart search & copy functions for creating and using a library
- Easy and unambiguous definition of a data validation plan
- Automatic output of the annotated CRF, visit matrix and data validation plan in table form
- Easy setup and management of amendments
- Validated, CDISC ODM-compliant storage of the CRF design
- Can be used in combination with any EDC system
- Imports third-party vendor extensions without any modifications
