Summary

This article describes the functionality of the Partial Metadata Status feature. 

Table of Contents

• Applied Plans
  • Form Summary
  • Question Level
  • Subjects Manager
• Change and Override Metadata Plans
  • Reconcile Metadata Plans
  • Change Metadata Status Plans
  • Require SDV

Design | System

With the Partial Metadata Status feature you can set which questions are required for the Data Review, Signature and SDV metadata statuses through the configuration of metadata status plans. For the SDV metadata status, you can also configure dynamic plans that randomly select the questions required for Source Document Verification based on the percent chance that the form should be SDVed.

Applied Plans

Form Summary

Once the trial has been configured to include partial metadata status plans, the Form Summary will designate which forms are required and not required.

1. In the Subject Manager select a subject.
2. On the Form Summary, note the use of ‘NOT APPLICABLE’ for forms that aren’t required.

As you complete forms, note that for Dynamic SDV plans, some of the optional forms change to being required. This is due to the dynamic percentage applied to the SDV plan to limit the number of questions that need Source Document Verification.

Question Level

Once the trial has been configured to include partial metadata status plans, the listed actions that can be applied to each question will differ based on the plan.

1. In the Subject Casebook select a form.
2. Note that for specific questions included in plans, some metadata statuses can only be applied to those specific questions.

Subjects Manager

The Subject Manager lists the plans applied to each subject. If given the proper permissions, you can change the plan for each subject.

Note: The Subject Manager will only display plans that have been configured for the trial. For example, if no Data Review plans have been configured, the Date Review Plan column will not appear.

Change and Override Metadata Plans

Reconcile Metadata Plans

When changes are made to the Data Architect file, those with permission to use the reconcile utility can use the utility to update existing records based on the new version of the plan.

1. On the Study Homepage, hover the mouse over the ‘Actions’ tab and select ‘Reconcile.’
2. In the list of Reconcile options, select ‘Reconcile Metadata Plans.’

A Warning screening will report the number of records about to be reconciled.

3. To perform the reconciliation, click the ‘Yes’ button. Otherwise, click the ‘No’ button.
   • A completion screen will display the results of the reconciliation.
4. Click the ‘Done’ button to return to the Study Homepage.

Change Metadata Status Plans

Those with permission to change metadata status plans can move a record from one plan to another.

1. In the Subject Manager, check the checkbox beside all subjects that need to switch to another plan.
2. In the Actions dropdown menu, select ‘Change Metadata Plans.’
   
3. Click the ‘Go’ button.
4. On the resulting screen, select a new plan from the dropdown list for each plan that should change.
   
5. Click the ‘Yes’ button to change the plan or the ‘No’ button to return to the Subject Manger without changing the plan.

Require SDV

Those with the correct permissions can set a form to require Source Document Verification regardless of the plan.

1. In the Subject Casebook or Subject Manager, check the checkbox beside all forms that should require SDV.
2. In the Actions dropdown menu, select ‘Require SDV.’
   
   
3. Click the ‘Go’ button.
4. On the Warning screen that appears, confirm the requireSDV action, which cannot be undone.

The Casebook will update and no longer show a ‘NOT APPLICABLE’ message in the SDV column for the previously selected form(s).

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