Predefined rules versus custom rules

Predefined rules are included as part of Oracle Clinical One Platform, Study designers can apply these rules to questions during the study design process. Custom rules are more advanced rules, typically created by a rules designer, that apply more complex validation, or determine actions in response to certain criteria.

Predefined rules can be selected during study design and are often (but not always) used for validating data. Study designers apply these rules to a specific question in a specific form to help facilitate appropriate data entry in a study. These rules allow study designers to better control the quality of the data that is collected by generating a validation error message every time the condition set by the rule isn't met. However, these rules are only available for a limited number of commonly encountered conditions.

Custom rules allow queries to be displayed for questions that have been answered and when specific conditions are met for the data that is entered. Custom rules can also be used to calculate the values of read-only questions or determine other actions such as sending an email notification. These rules are written using Javascript and require some knowledge of basic coding principles. Oracle Clinical One Platform provides an efficient interface where you can create, validate, and publish rules using JavaScript.

Note:

When using predefined rules in your study design, you should be aware that queries raised by predefined validation rules must be resolved before subjects can be screened or randomized. They can also prevent dispensation actions. However, when using custom rules, the system allows subjects to be screened or randomized even when the query is not resolved. Apply predefined validation rules carefully. Always validate your custom rules in Testing mode to ensure you are getting the expected results before approving the rule for use in a Production study.