Summary
Highlights
Simple Forms is a user-friendly tool for collecting patient data, designed to be intuitive for users with varying experience levels. It emulates HTML forms and integrates directly with Oracle Clinical, either as a real-time data display or as a standalone system. Simple Forms displays data in real-time, leveraging existing Oracle Clinical data structures, and can be extensively customized. It evolved from an HTML forms submission interface in 2004 to a full EDC solution by 2005, and has been used in production for about six years for Phase IV trials, patient diaries, and survey data collection.
Simple Forms consists of an administration tool for configuration and an EDC tool for data entry. It supports various data collection modes: standard mode for typical EDC, survey mode for anonymous data, patient diary mode for single-patient, single-user access, and timed mode for scheduled data entry with notifications. The system also supports email notifications to facilitate data entry and keep submissions on track.
The user experience is designed to be simple: log in, filter patients, and enter data. Login can integrate with Active Directory or local users, and the system is 21 CFR Part 11 compliant with encrypted passwords and session timeouts. Simple Forms supports five languages (English, French, German, Spanish, and one more) and allows the same study to be collected in multiple languages. All prompts are configurable, allowing organizations to change terminology like 'patient' to 'subject'. International date formats are also supported.
The administration tool simplifies study setup. Book templates (analogous to DCI books) can be generated from Oracle Clinical DCI books in three clicks. Security settings are highly customizable, allowing access control by site, patient, or even specific books. Simple Forms offers additional functionalities like unscheduled events and configurable look and feel. The platform is easy to install, validated, and integrates seamlessly with existing Oracle Clinical structures without compromising validation.
The live demo showcases the end-user experience for a CRA. It covers logging in, filtering patients using custom fields (e.g., name, DOB, allergic reactions), navigating through patient visits, and entering data into forms. The forms feature automatic population of dates, drop-down lists from DPVs or custom tables, support for international date formats, and multivariate checks that prevent submission errors. Forms process asynchronously, and errors are highlighted. Dynamic patient numbers and custom prompts can be configured. Forms can be printed for records.
The admin tool demo illustrates the ease of setting up a new study, creating book templates from Oracle Clinical DCI books, activating them, and setting user security. The demo also highlights the timed mode where patient diaries are structured based on timelines and email notifications. Finally, the survey mode is demonstrated, showing how it streamlines data entry for surveys by directly presenting the form and providing a submission confirmation.
In the Q&A, the presenter discusses Simple Forms' performance, noting that it is fast and responsive, comparable to what's seen in the demo even on home internet. Simple Forms will be certified for iPad use, building on its existing compatibility with Mac and PC. It works with various Oracle Clinical versions, from 4.0 up to 4.6. The discussion clarifies that intervals are defined within Oracle Clinical's planned events and that Simple Forms integrates with these. The 'reset form' button restores the last saved state. Password controls leverage Oracle profile constraints, and there's no limit to simultaneous users. Audit trails are comprehensive and 21 CFR Part 11 compliant, tracking submissions and changes similar to RDC or Oracle Clinical.
Fonts and styles are highly customizable using cascading style sheets. Reports from Oracle Clinical and other organizational tools can be utilized, and an upcoming enhancement will allow users to download visible data to Excel. External data forms are handled through Oracle Clinical's data loading facilities. Data extraction is possible through the Oracle Clinical ACI, and soon via Excel reports. Generating patient data reports with graphic layouts is a minor enhancement being considered. Medical coding would typically be done with TMS, though Simple Forms can support dynamic lists for hierarchy auto-population. Dynamic DVGs (Discrete Value Groups) are flexible, supporting standard Oracle Clinical lists or constantly changing values by fetching them real-time. Custom Oracle select statements can link external tables to drop-down lists, and field responses can be integrated with database functions for real-time calculated values.