Electronic Data Capture
Real-time data management.
Electronic Data Capture includes real-time alert, query, and audit management. Each electronic form is configured to ensure that data entry is dynamically validated by format, range, and other dependencies based on input data relationships. Electronic forms include functions for electronic signatures and the ability to generate sub-forms that require collecting open-ended data.
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Features
- Data stored in a central database accessible any time, any place
- Project summary reports indicating performance across all participants and study groups
- Configurable electronic forms for unique workflows
- Alerts to prompt corrective action or reasons for override
- Email notifications
- Automated calculations and form creation for additional visits or repeatable events
- User access controlled by predefined roles and permissions
All the tools necessary.
DATATRAK Electronic Data Capture allows for easy management of patient data, electronic form completion, visit scheduling, query turn-around, top recurring queries and alerts, site compliance, and custom reports. A variety of powerful and configurable data cleaning tools are available, all from a single login. Clients can specify company-specific and study-specific checklists, reports, and workflows in order to configure the software to their needs.
Features
- Single login for all tools
- Granular permissions to enable only the tools a user needs
- Custom workviews and checklists
- Real-time trial statistics
- Advanced trial summary reports
- Dynamically-generated manager screens to manage study progress
- Answer Status
- Source Document Verification
- Locking
- Electronic Signatures
- Forms
- Queries
- Alerts
- Comments
- Codes
- Synonyms
- Visit Schedules
Customizable reports and exports.
Electronic Data Capture features include performance reporting, dynamic report generation, exports in a variety of formats, and trial-specific electronic forms and PDFs. DATATRAK’s efficient custom reporting tool transforms real-time data across sites, forms, and records. Reports can be created, configured, and executed at any time by your users, and study data can be exported for statistical analysis and eSubmission. A variety of formats are supported, including text, CSV, Excel, SAS, and eSubmission. Exports can be configured in a CDISC SDTM compliant format.
Features
- 24/7 access to data for reporting and exporting
- On-demand, ad hoc reporting of study performance metrics
- Reporting output in a variety of formats, including Excel, SAS, text, and more
- Report results directly to the browser window, or in a downloadable file
- View data represented in visual charts and graphs
- Role-based access to viewing, editing, and/or creating reports
- Standard submission format accelerates completion of agency reviews lending to quicker market release
- Ease of navigation – PDF export files include hyperlinks to audit and query trails
- PDF Bookmark indexing by visit and domain
Superior medical coding.
Fully integrated within the EDC system is a complete Medical Coding package. Choosing to use DATATRAK Medical Coding brings standardization and accessibility to any clinical trial. Each code can be reviewed and marked as approved using system flags.
Features
- Automatic population for questions with codes consistent with coding dictionaries
- Use of client proprietary medical dictionaries or industry standard MedDRA, WHODrug, etc
- Searchable codes based on various configurable fields
- Coding linkable to specific electronic forms
- Auto-code exact matches to dictionaries and synonym tables
- Maintain relationships between particular medical events and concomitant medications
- Apply smart synonym technology to auto code term-plus-indication combinations