Creating a Review Plan in Business Admin


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.

Creating a Review Plan in Business Admin

Users with access to Admin > Business Admin and create permissions on the appropriate objects can also configure their Review Plans from Admin > Business Admin.

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 more easily create and relate object records for your plan, add a Review Plan Object Definition related object section to the Review Plan page layout.

To create a Review Plan:

  1. Navigate to the Review Plan object, either from Admin > Business Admin or a custom tab.
  2. Click Create.
  3. Select a Study.
  4. Select a Review Plan Type.
  5. Click Save.

Once you create the Review Plan record, you must create a Review Plan Object Definition record for each Event, Form, or Item for which you want to specify an SDV or DMR requirement.

To create a Review Plan Object Definition:

  1. Navigate to the Review Plan Object Definition object, either by scrolling to the related object section on your Review Plan, or from Admin > Business Admin or a custom tab.
  2. Click Create.
  3. Enter a Name for your record.
  4. Enter the private key for your Event Definition, Form Definition, Item Group Definition, and Item Definition. You can obtain the Private Key value for each definition object by viewing the object record in Admin > Business Admin. Depending on how granular you would like your Review Plan to be, you can use all or only some of these. For example, you only need to enter an Event Definition if you want the SDV or DMR requirement to apply to all Items inside that Event. You only need to select an Event Definition and Form Definition if you want the SDV or DMR requirement to apply to all Items on a Form in a specific Event.
  5. Select a Requirement Mode.
  6. If this field is not auto-populated, select a Review Plan. (This occurs if you did not create the Review Plan Object Definition from a related object section of the Review Plan record.)
  7. Click Save.

Continue to create Review Plan Object Definition records until you have covered all of the Items in your Study. Note that you do not need to create a record for each individual Item in your study, as long all Items are covered within the scope of your review plan.

Object Definition Private Keys

On each object definition record, there is a Private Key field. Vault EDC automatically populates this field with a unique private key value. The private key identifies the object definition outside of any versioning.

To obtain a Private Key value for an object definition:

  1. Navigate to the Event Definition, Form Definition, Item Group Definition, or Item Definition object from Admin > Business Admin.
  2. Click the linked object record name to open the record’s Details page.
  3. Scroll to view the Private Key field. This field should contain a unique mix of numbers and letters. For example, bl9McTFkSFCfk42TECMhNg is the Private Key for the Deetoza study’s Hypersensitivity Constituents item definition.
  4. Make a note of or copy and paste this value to use when creating a Review Plan Object Definition.

SDV & DMR for Event Dates

Vault EDC supports SDV and DRM for Event Dates in vaults where the Review tab is enabled.

If your Study was created prior to the 19R1 release (April 2019), special configuration is required for you to include Event Dates in your review plan. See details here.

To create a Review Plan Object Definition for an Event Date:

  1. Navigate to the Review Plan Object Definition object, either by scrolling to the related object section on your Review Plan record, from Admin > Business Admin, or from a custom tab.
  2. Click Create.
  3. Enter a Name for your record.
  4. Enter the private key for your Event Definition. You can obtain the Private Key value for each definition object record by viewing the record in Admin > Business Admin.
  5. Select a Requirement Mode.
  6. If this field is not auto-populated, select a Review Plan. (This occurs if you did not create the Review Plan Object Definition from a related object section of the Review Plan record.)
  7. Select the Review State you completed earlier. Be sure to select the Review State Definition for your plan's Study.
  8. Click Save.

Continue to create Review Plan Object Definition records until you have covered all of the Event Dates in your Study that need SDV or DMR.

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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