Creating a Review Plan


With Targeted SDV (Source Data Verification) and DMR (Data Management Review), you can define SDV or DMR requirements for a subject in a Review Plan. Targeted SDV and DMR are extremely flexible and support varying review requirements across Items at the Form level. You can also configure Targeted SDV or DMR for some Forms to be very granular, drilling down to a specific Item Group and Item combination.

For example, in a Review Plan with a broader scope, you would only need to set the requirement mode at the Form level to apply the SDV or DMR requirement to all Items inside that Form. In a more granular Review Plan, you could select individual Item Groups and Items so that your SDV or DMR requirement only applies to certain components within a Form.

You can also configure an Item for a certain requirement mode, regardless of the Item Group or Form to which the Item belongs.

With a Review Plan, you can configure your Study to only require SDV or DMR on the Items that need it, saving your monitoring and data management users time.

Item Requirement Modes

For each Item in a Review Plan, there are two (2) Requirement Modes available: Required, meaning that users must complete SDV or DMR for the item, and No Review. When SDV or DMR for an Item is No Review, Vault EDC does not display a checkbox for that Item.

By default, when you create a Review Plan, Vault marks all Items as Required. You can then edit your plan to mark certain Forms, Item Groups, or Items as No Review.

Legacy Review Plans: Optional Mode

Before the 19R1.3 release, there was another requirement mode, Optional. This mode was deprecated with the 19R1.3 release (May 2019). Review Plans created prior to this release are considered “legacy” review plans. Vault continues to allow the Optional requirement mode on these plans, but if you make any changes to those Optional items, Vault will no longer allow you to select Optional.

Vault EDC Studio includes a Review Plan Editor in Studio > Review Plans. With the Review Plan Editor, you can quickly and easily assign Requirement Modes to all of your data collection Items. Note that users with the appropriate permissions can also create Review Plans from Admin > Business Admin. Learn more.

To access the Review Plan Editor, navigate to Studio and click to open Review Plans.

The Review Plan Editor has a header, where you can configure the Review Plan, and two main content areas for adding to the Review Plan, the Driving panel and the Form panel.

Header in the Review Plan Editor

Driving Panel

The Driving panel is where you can navigate to various Forms in your study design to assign requirement modes to form Items. In the current release, the Driving panel only displays forms from the latest casebook version that are used in the study schedule (Vault does not display orphaned Forms).

You can search for Forms in the **Driving **panel. To search for a Form:

  1. Begin typing the form’s Name _or _External ID in the Search box. Vault searches your study’s forms as you type.
  2. Locate your Form in the search results.
  3. Optional: Click Clear (X) to clear your search query.
  4. Click the Form to open it in the Form panel.

Driving panel

Form Panel

In the Form panel, you’ll identify required Items for review. The Form panel displays all Items in a form, grouped by Item Group. By default, all Items on the Form are marked as Required in the Required column. In the Required column, you can click to change that item or item group’s Requirement Mode to No Review.

Form panel

Creating a Review Plan

Your Review Plan record represents your Targeted SDV or DMR plan for a Study Site. Review Plan Object Definition records represent individual SDV or DMR requirements. The Review Plan Object Definition record is a child of the Review Plan object. Note that you must have separate Review Plans for your SDV requirements and your DMR requirements.

To create a new Review Plan:

  1. Navigate to Studio > Review Plans.
  2. Click + New Review Plan.

    New Review Plan button

  3. Enter a Name for your review plan.
  4. Select a Review Task:
    • SDV: Select to create a targeted SDV plan
    • DMR: Select to create a targeted DMR plan
  5. Optional: Choose Not Required for Event Date Review to exclude Event Dates from your plan. Vault sets this to Required by default, indicating that your plan should enforce SDV or DMR as Required for Event Dates in your study.
  6. Optional: Enter a Description with details about your review plan.
  7. Set the requirement mode for Items on all Forms requiring review. See details below.
  8. Click Save.

How to Add & Remove Items

To update an item’s Requirement Mode:

  1. In the Review Plan Editor, locate the Form in the Driving panel.
  2. Click the Form to open it in the Form panel.
  3. To set the requirement mode for the entire Form, you can click Required or No Review in the Driving panel.

    Driving panel with one Form selected

  4. In the Form panel, click Required for each Item you want to require review for. To mark Required items as No Review, click again. You can click Required on an Item Group header to indicate that all Items in that group should be Required or No Review.

    Required Item in the Form panel

  5. Repeat steps 1-4 until you have finished adding and removing Items from your Review Plan.
  6. Click Save.

How to Bulk Add & Remove Forms

You can set Forms as Required or No Review in bulk from the Driving panel:

  1. In the Driving panel, select the checkbox for each Form you want to set requirements for. Vault indicates the number of Forms selected in the Driving panel header.
  2. Click Required or No Review to set the requirement mode for the selected Forms. Bulk Selection of Forms in the Driving panel

  3. Click Remove (x) to deselect all Forms.

    Click Remove to deselect forms

How to Edit a Review Plan

You can edit your existing Review Plans using the Review Plan Editor.

To edit an existing Review Plan:

  1. Navigate to Studio > Review Plans.
  2. Click your Review Plan Name to open it in the Review Plan Editor.
  3. Make your changes.
  4. Click Save.

Note that you can edit the Name, Review Task, Event Dates Review, and Description from the Properties panel.

Review Plan properties in the Properties panel

Review Plan Editable Properties

The following are editable properties in the Properties panel for Review Plans. You can also edit these properties from within the Review Plan Editor. See About the Properties Panel for more details.

Property Description
Name The Name of the Review Plan object record
Review Task The review task, either SDV or DMR, associated with the Review Plan
Event Dates Review Indicates whether or not the Review Plan has review required for Event Dates, either Required or No Review
Description A description of the Review Plan

How to Delete a Review Plan

You can delete Review Plans from the Properties panel. Note that you can only delete a Review Plan that is not assigned to a Site.

To delete a Review Plan:

  1. Navigate to Studio > Review Plans.
  2. Click in the row for your Review Plan.
  3. In the Properties panel, click Delete.

    Delete action in the Review Plan's Properties panel

  4. In the Delete Review Plan confirmation dialog, click Continue.

How to Copy a Review Plan

You can delete Review Plans from the Properties panel. Note that you can only delete a Review Plan that is not assigned to a Site.

To delete a Review Plan:

  1. Navigate to Studio > Review Plans.
  2. Click in the row for your Review Plan.
  3. In the Properties panel, click Copy.

    Copy action in the Review Plan's Properties panel

  4. Make any required changes.
  5. Click Save.

Site-Specific Review Plans

Instead of having a single Review Plan for DMR or SDV in your entire Study, you can choose to assign Review Plans on a site-by-site basis. If EDC Tools Site Review Plan Assignment is enabled in your vault, lead data managers can assign Review Plans at the site and subject level from EDC Tools > Review Plan Assignments.

If that feature is not enabled in your vault, you can still assign Review Plans to Sites by using the Review Plan Site object.

Example: Site Experience Level

For example, a Study may use one experienced site and then another site that is conducting its first ever clinical trial. For the experienced site, you can configure an SDV-type Review Plan with fewer Required items. Then you can configure a second Review Plan that requires SDV for all Items in the Study for the inexperienced site.

How to Assign Review Plans to Sites

Create multiple Review Plans for your Study.

To assign a Review Plan to a Site:

  1. Navigate to the Review Plan Site object from Admin > Business Admin or a custom tab.
  2. Click Create.
  3. Enter a Name for your record.
  4. Select a Review Plan to use for the site.
  5. Set the Review Plan Site Status to Active.
  6. Select your Study, Study Country, and Study Site.
  7. Click Save.

Create a Review Plan Site record for each of your Sites.

How Vault Assesses SDV & DMR Modes

Vault applies your Review Plan at object record creation. Once you’ve created a Review Plan, Vault handles it automatically. When a data entry user creates a new Casebook, Vault applies your Review Plan and sets requirement modes for each Item as it is created. As your Study progresses, and Vault adds and removes Forms and Items (based on Rules), Vault continues to evaluate SDV and DMR requirements for each new data collection object. 

Vault only includes Items where SDV is Required in the SDV percentage complete on a Form. When Vault displays 100%, it means that 100% of Required SDV is complete, rather than 100% of any available SDV on a Form.

Re-assigning Requirement Modes

In some situations, you may need to update your Review Plan mid-study. You can use Vault EDC to bulk update the SDV or DMR requirements for existing Casebooks in your Study.

You can also use the Re-assign Targeted SDV or Re-assign Targeted DMR jobs to evaluate requirements if you create a Review Plan after your Study begins.

To re-evaluate:

  1. Navigate to the affected Study’s Site listing page.
  2. Open the Tools > EDC Tools area.
  3. From the Jobs tab, create a job to re-assign the DMR or SDV mode.
  4. If you chose Run Now, Vault begins the job after you click Save. When finished, Vault sends you an email notification with a link to download the job log and any relevant output files. For scheduled jobs, Vault runs the job at the configured time, and you will receive an email notification with a link to download the job log and relevant output files each time the job runs.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard Vault Owner or Design security profiles can perform the actions described above by default. If your vault uses custom security profiles, you must have the permissions described in the Profile Permissions table.

Profile Permissions

Users with the Vault Owner security profile are automatically able to perform the actions described above. If your vault uses custom security profiles, you must have the following permissions:

Type Label Controls
Security Profile Object: Review Plan: Create, Edit Ability to create and edit Review Plan records.
Security Profile Object: Review Plan Object Definition: Create, Edit Ability to create and edit  Review Plan Object Definition records.
Security Profile Object: Review Plan Site: Create, Edit Ability to create and edit Review Plan Site records.
Security Profile Object: Event Definition: View Ability to view Event Definition records in Admin > Business Admin and get their Private Key.
Security Profile Object: Form Definition: View Ability to view Form Definition records in Admin > Business Admin and get their Private Key.
Security Profile Object: Item Group Definition: View Ability to view Item Group Definition records in Admin > Business Admin and get their Private Key.
Security Profile Object: Item Definition: View Ability to view Item Definition records in Admin > Business Admin and get their Private Key.
Security Profile EDC: EDC Tools: Access Ability to access the EDC Tools area and initiate the Re-evaluate Targeted SDV Mode or Re-evaluate Targeted DMR jobs.

Learn more about permission sets.


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