Many clinical trial data entry software packages deal with error correction. Entrypoint i4 takes a proactive approach by dealing with error prevention, or "intelligent data capture." Intelligent data capture is an integral part of the application design: the application functions so that data entered in one field or form determines what other fields and forms are presented. For example, checking the box next to an adverse reaction displays a form for entering adverse reaction details.
Elements of the trial protocol can be embedded in electronic case report forms. When the protocol is implemented in the CRFs themselves, users don't have to search through manuals to find out how to respond to a question. Instead, the electronic data forms guide them through data entry, determining what, where and how to enter the correct information.
Many protocol rules can be embedded using Entrypoint i4's built-in validation features. These features can be defined for individual fields (edit checks), and forms (on-screen validation). Special features include:
- Immediate error detection and flagging.
- Data retrieval: data from one field can be automatically retrieved for a field on another format, eliminating the need for double entry.
- Data selection from lookup tables: users can select from a set of valid values stored in a table or key the value manually; if the user keys the entry, it is accepted only if it is in the table.
- Ranges of acceptable/unacceptable values: pre-set ranges define the scope of values that are acceptable or unacceptable in the field.
- Date checks: the application can check against today's date, flag invalid dates such as 02/31/, or compare with a date range.
- Re-key verification: the user retypes the data in the fields flagged for re-keying before closing the batch to ensure accuracy. You can assign this type of verification to all or selected fields.
Occasionally, built-in validation features may not do the job; if so, you can use one of Entrypoint i4 custom validation features: add a custom error message or custom help to inform the user of what is required. Or create custom data validation routines with EntrypointScript for the special protocol rules that require them.
Embedding the trial protocol in electronic case report forms eliminates a large number of discrepancies while the data is keyed. As an example, one company generated 6,000 paper queries at approximately $100 apiece, amounting to over $600,000. Reasons for the queries ranged from not knowing what form to fill out, how to fill it out, what data to enter or box to check, and skipping fields that required input. Switching to Entrypoint electronic case report forms prevented discrepancies during the data entry phase, substantially reducing the number of queries.