Written in

Central Designer rule expression language, using the Rule Wizard.

PL/SQL.

Can make calls to

Predefined functions that are included in the Central Designer rule model, or user-defined functions. Central Designer rules can access numerous rule model properties and methods and can include predefined or user-defined constants.

Functions and procedures in PL/SQL packages that are provided with the software or created by the user. These functions include:

• Basic functions—To investigate the structure of the database.
• String functions—To manipulate string data.
• User-defined functions—To use either in a specific protocol or for an entire instance. Instance-wide functions are available to all protocols.

Associated with

Study designs, study elements, study events, forms, and items. A data-entry rule can reference:

• A study object and its children.
• Properties and values of the study object and its children.

If the data-entry rule is designed to generate a query or calculate a value, when a study is deployed to the InForm software, the deployment process creates the InForm structures that determine the item or items to be updated.

A panel within a protocol. Rules and derivations become part of the validation procedure of the panel. If a Clintrial rule fires and fails on EDC data, a query synchronizes back to the InForm software and attaches to an item in the InForm study.

The CIS software determines the InForm item on which to place the query by using Clintrial Resolve error items. These items are ordered, and the CIS software evaluates each one in turn, placing the query on the first item that is mapped to a non-calculated InForm item.

Can be used to validate

EDC data only.

EDC or paper-based data, or both.

Note: To use Clintrial rules and derivations in an integrated study, you must install the Clintrial Resolve module.