Configure predefined validation rules to raise queries

About this new feature

Study designers typically add predefined rules to the form design to validate an answer, to ensure a given criterion is met, or to trigger a specific action, such as to display a dynamic question or form or to send a notification. Other scenarios can be covered by using custom JavaScript rules, which are programmed and tested by rule designers.

This enhancement enables query functionality specifically for predefined validation rules that are added to the form design. With this, your team no longer needs to create custom rules to raise queries when validation criteria have not been met. This reduces the potential programming errors and time needed to apply this kind of rule. Additionally, the validation functionality is now optional, as well as the added query functionality. This means you can now create rules on forms that can act as:

Validation, which throws errors and prevents site users from performing Randomization and Trial Supply Management (RTSM) actions until the errors are resolved.
Validation raised as a query, which also prevents RTSM actions. However, in this case you can close the related queries to allow the impacted RTSM actions to proceed, without first being required to address the validation error.
Simple query, which identifies the answers that do not meet the given criteria for data reviewers but without impacting RTSM actions. These raised queries will follow the normal query workflow.

The RTSM actions that can be impacted by validation rules are screening, randomization and dispensation. Whether a specific RTSM action is impacted or not depends on the question settings and whether it is required for those events. The ability to identify specific questions as required for specific RTSM actions is a new feature also introduced in this release. See Improved data entry workflows for Data Collection and Randomization and Trial Supply Management (RTSM).

Details for study designers

If you are a study designer working with predefined validation rules, here is what's new for you:

When you add or update a validation rule in the form design, you now have two configuration toggles available: Validation and Create a Query.

You must activate at least one toggle for a validation rule, or you can activate them both. Depending on the rule configuration the result can be different:

Configuration	Result
Validation	An answer that does not meet the rule criteria becomes invalid and may impact RTSM actions. Invalid answers include a red outline and an error message, which is defined by the study designer in the rule configuration.
Create a Query	Queries are raised for answers that fail to meet the rule criteria, but they are not invalid and do not impact RTSM actions. Queries only appear after data is saved and submitted. However, upon data entry, a red outline surrounds the answer, and an error message appears (as in validation) to inform the site user of the failed criteria and give them a chance to correct the answer before saving it, if applicable. If data is submitted and the query is raised, the failed validation indicators disappear.
Validation and Create a Query	An answer that fails to meet the rule criteria becomes invalid and a query is raised on it. RTSM actions may be impacted as well. If entered data fails to meet the validation criteria, a red outline and an error message appear upon data entry. A query is then raised, but only once data is submitted. Since the answer becomes invalid, the failed validation indicators remain.

Configuration

Result

Validation

An answer that does not meet the rule criteria becomes invalid and may impact RTSM actions.

Invalid answers include a red outline and an error message, which is defined by the study designer in the rule configuration.

Create a Query

Queries are raised for answers that fail to meet the rule criteria, but they are not invalid and do not impact RTSM actions.

Queries only appear after data is saved and submitted. However, upon data entry, a red outline surrounds the answer, and an error message appears (as in validation) to inform the site user of the failed criteria and give them a chance to correct the answer before saving it, if applicable. If data is submitted and the query is raised, the failed validation indicators disappear.

Validation and Create a Query

An answer that fails to meet the rule criteria becomes invalid and a query is raised on it. RTSM actions may be impacted as well.

If entered data fails to meet the validation criteria, a red outline and an error message appear upon data entry. A query is then raised, but only once data is submitted. Since the answer becomes invalid, the failed validation indicators remain.

You can still add multiple validation rules to the same question, which get evaluated using a logical operator AND or OR. It is possible to combine rules configured differently (validation-only, query-only, or both) in a single question, but you cannot combine logical operators.

You can find more information about this functionality in the Study Designer User Guide, after the Release Assessment Environment (RAE) upgrade.

Details for site and other sponsor users

Whether you're a site user dealing with validation errors on collected data or a sponsor user reviewing data and managing queries, here's how your workflow might be impacted by this new feature:

If any of these rules are triggered during data collection, the site user has the option to correct the entered data and resolve it. In the case of a raised query, the site user can also provide an answer to it, for example when it is not applicable to update the entered data. After that, if a sponsor user closes the query, the validation is resolved.
Any user with permissions to close programmed and manual queries will also be able to close these types of queries.

Note:
If there is more than one query on a question, it is possible that some are validations and some are not.
When multiple validation rules are added to a question, there is a difference in how these conditions are processed and how the error messages display:
- For multiple rules following an OR condition, the validation rules are all evaluated until one validation is met or all have been evaluated and failed. Since an OR condition only fails when all validations fail, all associated error messages or queries will be displayed in that case. Then, if at least one error or query is resolved, the OR condition is met and all errors disappear and triggered queries are closed.
- For multiple validations following an AND condition, the system evaluates all rules. If any condition is failed, the entire condition fails and an error message or query will appear for each and all failed validations. The question remains in a failed state until all errors or queries are resolved.
If a query is closed manually, it will not be re-evaluated unless data is updated even if the rule is updated and changes are applied with Advanced Study Versioning (ASV). Predefined validation rules will always be re-evaluated when data is updated.
As with any other query, these queries resulting from predefined validation rules are visible and can be managed from the queries side pane, within the visit, and from the Query List page for query management at the study level. These queries are also included in the Queries report, and they display everywhere with Auto Calculation as the issuing user.
Future date validations for Date/Time questions are not exactly designer validation rules. However, these are now also triggered as queries. For more information see Future dates now raise queries when not allowed.

Impact on reports

The predefined validation rules are now included in the Rules report, but separate from custom rules. To support this, the Rules report is now available in an XLSX format, instead of a CSV format, which includes all the validation rules in a separate tab called Designer Validation rules. In the PDF and HTML formatted outputs, there is a new section with the same name for all these predefined validation rules added in form design. For more information see Rules report is now available in XLSX format.

Additional changes to other reports are also applied to support this enhancement. The following reporting changes are introduced:

Report	Type of change	Description
Study Design report	Modified column data	In the Validation Rules column for forms, for validation rules added in form design, the type (Validation, Validation and Query or Query) is appended to the front of the existing information. For example: Validation and Query: Exactly 1.
Annotated CRF report	Modified column data	In the Validations column, for validation rules added in form design, the type (Validation, Validation and Query or Query) is appended to the front of the existing information. For example: Rule 1: Validation and Query: Exactly 1.
Rules report	New section and columns	The predefined validation rules are included in this report, in a new Designer Validation rules section or tab (depending on the format). See the Rules report documentation for details about the columns added to this section.
Queries report	New column	A new Type column is added to indicate whether it has validation functionality (Validation and Query), is generated by custom rules (Auto Query), or is a manual query (Manual).

Already working in a live study?

When this new feature is released, existing validation rules will get configured with only the Validation toggle active, to preserve existing functionality. As soon as this release is available, you can create new validation rules that create queries or update any at any time to add query functionality to existing rules.

You can apply these or any updates to predefined validation rules using Advanced Study Versioning (ASV). Find more information about the impacts of using this new feature with ASV in About Advanced Study Versioning, after the RAE upgrade.