Rule implementation tools

When you set up a study, your implementation team designs and codes the rules that are attached to data items on study forms. The following methods are available for implementing rules in a study database.

• The Central Designer application—The Central Designer application enables study designers and developers to create rule and rule context definitions, along with definitions of the CRFs used in a study.
• Oracle provides tools that enable you or the Oracle team that sets up your study to administer rules in batch mode:
  • MedML—The Oracle XML for representing and exchanging clinical data definitions created in the InForm application. The Forms Definition Language is a set of Extensible Markup Language (XML) tags that conform to a data definition schema created for defining study elements, including rules. By using these tags, you can define the administrative elements and rules for a study in a format that the MedML Installer utility can process and load into the study database.
  • MedML Installer utility—A utility that parses the XML files you generate with MedML tags, validates them against the MedML schema and the constraints enforced by the database schema, and loads the study components they define into the database.
• The system administration module of the InForm application includes pages that enable you to perform some rule administration tasks and to review the definitions of rules and the contexts in which they run.

For most rule definition activities, Oracle recommends using the Central Designer application. After using the Central Designer application to define rules, execute a Central Designer deployment package to load the definitions into the study database. After a study is in progress, you can use the InForm application rule administration pages to review or update the definitions of specific rules.

Note: For information about the Central Designer application, the MedML language, and the MedML Installer utility, see the Central Designer documentation and the MedML online Help.