Managing Rules in EDC Tools

You can execute rules from EDC Tools > Rules. In the Rules tab, you can review each rule’s expression criteria and rule action, as well as execute one or more rules with the Run Rules job. This is especially useful after you’ve completed an amendment. Note that Vault doesn’t list rules with the Send Email or Set Item Value actions in the Rules tab.

Prerequisites

Users with the standard CDMS Lead Data Manager study role can perform the actions described above by default. If your vault uses custom Study Roles, your role must have the following permissions:

Type Permission Label Controls
Standard Tab EDC Tools Tab

Ability to access the EDC Tools tab

Functional Permission

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.


Rules Listing

You can view all rules associated with your Study, except for Send Email and Set Item Value rule actions, from EDC Tools > Rules.

To filter the rule listing:

  1. Click to expand the Advanced Filters panel.
  2. Select Rule Actions to include in the list. Advanced Filters panel

  3. Select Date Range with a Start Date and an End Date to only show Rules that were modified within that date range.
  4. Click Find Rules.

If Protocol Deviations is enabled in Study Settings, Lead Data Managers can view Protocol Deviations rules from EDC Tools > Rules.

View Rule Details

To view the rule’s properties, expression, and actions:

  1. Navigate to EDC Tools > Rules for your Study.
  2. Click the Name of the rule you want to view.
  3. Vault opens the Rule Details dialog. Review the rule information.
  4. When finished, click Close.

Running Rules

You can run one or multiple rules to evaluate user-entered data in your Study. You can also preview the results of this job before running it.

For query-type rules, system queries that have been manually closed will not be recreated if the form is resubmitted, the item values that are being evaluated in the rule have not changed, or when you run the Run Rules job.

To run rules:

  1. Navigate to EDC Tools > Rules.
  2. Select the Rules that you want to run.
  3. Optional: Select the Select All checkbox to run all rules in the study.
  4. Click Run Rules.
  5. In the Run Rules dialog, select Selected subjects if you want to run rules on a selection of subjects. Otherwise, leave Run rules on set to All subjects.
  6. If you chose Selected subjects, select the Subjects you want to include.
  7. Optional: Click Preview to see the outcome of this job without actually executing the rules.
  8. Click Run. Vault begins the job. When finished, Vault sends you an email notification with a link to download the job log and any relevant output files.

About the Output Files

The job output for the Rules job is a ZIP folder containing four (4) CSV files:

  • “rule_details.csv”: Lists the Rules executed as part of the job, with details about the actions performed. Note that the “Skipped” action indicates that the action performed by the rule has already occurred, for example, the Query was already created.
  • “create_delete_dynamics_details.csv”: Lists with detail each component added to the schedule as part of a dynamic rule.
  • “dynamics_summary.csv”: Summarizes the dynamic Event Groups, Events, Forms, Item Groups and Items added or removed from the schedule during rule execution.
  • “errors.csv”: Lists any errors that occurred during rule execution