Assigning Review Plans to Sites


With Targeted SDV (Source Data Verification) and DMR (Data Management Review), your organization 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.

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. 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. You can manage these assignments from EDC Tools > Review Plan Assignment.

Prerequisites

To perform the actions described below, Site Review Plan Assignment must first be enabled in your Study.

To enable the Review Plan Assignment area of EDC Tools, you must update the Study Configuration record for each Study you want to use this feature in.

  1. Navigate to Admin > Business Admin > Study Configurations.
  2. Locate your study’s Study Configuration record in the list.
  3. Click to open your study’s record.
  4. Click Edit.
  5. Select Yes for the Review Plan Override field.
  6. Optional: You can choose to also configure your study-level template plans at this time. See details below.
  7. Click Save.

Before you can assign Review Plans to sites, a study designer must first create Review Plans in Studio.


The following permissions are required to perform the actions described below.

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 security profile or CDMS Lead Data Manager study role can perform the actions described above by default. If your vault uses custom study roles, you must have the following permissions:

Type Permission Label Controls
Functional Permission EDC Tools Tab

Ability to access the EDC Tools tab

Functional Permission Manage Review Plan Assignments

Ability to access EDC Tools > Review Plan Assignments and update the study- and site-level templates

Learn more about Study Roles.

Users must also have the Vault Owner security profile, or a custom security profile including the Object: Study Configuration: Edit permission, to assign study-level template plans.

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 Permission Label Controls
Security Profile Object: Study Configuration: Edit Ability to edit Study Configuration records.
Security Profile Object: Review Plan Site: Create, Edit Ability to create and edit Review Plan Site records.
Security Profile Object: Review Plan Casebook: Edit Ability to edit Review Plan Casebook records.
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.


Accessing EDC Tools

To access the EDC Tools administration area, click the Tools tab in the primary navigation bar, and then click EDC Tools.

Access EDC Tools from the Tools Tab

By default, once you open EDC Tools, Vault displays a list of automated deployment Studies. You can use the Automatic and Manual radio buttons to switch between these listings. Select Manual to access your manual deployment Studies.

Select Automatic or Manual

For manual deployment Studies, click on the Study to open EDC Tools for that Study. For automatic deployment Studies, click on the Study to open the Deployments page. From here, you can click on an Environment to open EDC Tools for that study environment.

Once you’ve entered the EDC Tools area, select your Study if you have access to more than one Study. To return to the study list, click Back to Study Listing.

Viewing Review Plan Assignments

In EDC Tools > Review Plan Assignment, Vault lists each Site in your Study with the Review Plans assigned to that site. You can search for individual Sites, as well as filter this listing by Site Status and Country.

Search field in EDC Tools > Review Plan Assignment

You can hover over the values in the Override SDV Plan and Override DMR Plan columns to view the Override Ordinals for that Site.

Override Subjects for an Override SDV Plan

Default & Override Plans

The Default SDV Plan and the Default DMR Plan are the Review Plans that Vault assigns to subjects by default. These are typically low- to medium-risk plans that are widely applicable. Your organization may also have defined a higher-risk plan, for use with inexperienced sites or high-risk subjects. You can use this Review Plan as the override. Vault can also apply the override plan assignment to defined subjects.

Subject Ordinals

While you can assign override plans manually by updating the subject-level Review Plan assignment, Vault can also apply override plans automatically to certain Subjects as they are created using “subject ordinals.”

Subject ordinals are numbers and ranges of numbers, representing Subjects as they are created in the Site. 1 would be the first Subject, 2 the second, 5 the fifth, and so on.

For example, if you enter “1, 5, 10, 20-30” in the SDV Subject Ordinals field, Vault would apply the Override SDV Plan to the first, fifth, tenth, and twentieth through thirtieth Subjects created in the Site.

If subjects already exist in your study, Vault applies the override plan to subject ordinals prospectively, meaning that if you enter “1,” the override plan applies to the first Subject created after you define the subject ordinals. You can run the SDV and DMR re-assignment jobs to reset the order, so that Vault applies override plans with your first Subject in the first ordinal (1).

Study & Site Templates

Vault uses your selections for default and override plans at the Study level as a “template” for assigning those plans to each Site in your Study. Vault applies those selections to each Site. As Subjects are created in that Site, Vault uses the site-level assignments as a template for assigning Review Plans at the Subject level.

You can override these templates and manually assign Review Plans to Sites and Subjects from Tools > Review Plan Assignments. See details below.

Site assignments

Assign the Study Template Plans

You can assign the default and override Review Plans, as well as the subject ordinals for override plans, from the Study Configuration object record for your Study.

We recommend that you perform this task before creating Sites for your Study. This allows Vault to apply your default plan selections to each of your Sites. If you perform this task after creating Sites, you will need to manually update the Review Plan assignments for each of your sites.
  1. Navigate to Admin > Business Admin > Study Configuration.
  2. Locate your study’s Study Configuration record in the list.
  3. Click the record name to open.
  4. Click Edit.
  5. Fill the following fields related to Review Plans:
    • In the Default SDV Plan field, select the SDV Review Plan that you want to use by default in your Study.
    • In the Default DMR Plan field, select the DMR Review Plan that you want to use by default in your Study.
    • In the Override SDV Plan field, select the SDV Review Plan that you want to use when overriding the default plan in your Study.
    • In the Override DMR Plan field, select the DMR Review Plan that you want to use when overriding the default plan in your Study.
    • In the SDV Subject Ordinals field, enter the numbers and ranges (comma-separated) of subjects added to apply the Override SDV Plan to.
    • In the DMR Subject Ordinals field, enter the numbers and ranges (comma-separated) of subjects added to apply the Override DMR Plan to.
  6. Click Save. Vault saves your selections and applies them to all future Sites. Saved Study Configuration with Default and Override Plans

Editing Site Templates

You can edit the Review Plan assignments and Override Ordinals that Vault automatically applies to Sites from the Study-level template. These changes apply to all Subjects in that Site.

To edit a Site Template:

  1. Navigate to Tools > EDC Tools > Review Plan Assignment.
  2. Select the Site or Sites that you want to edit.
    • To edit a single site, select Edit Site Templates from the site’s Actions menu.
    • To edit multiple sites, select the checkbox for each Site and then click Edit Site Templates.
  3. In the Edit Site Templates dialog, make any required changes. Note that the Override Subjects fields for each section (SDV and DMR) map to the SDV Subject Ordinals and DMR Subject Ordinals fields at the study-level. Edit Site Template dialog

  4. Click Save. Vault updates the Site to begin using your new selections right away. To apply your new selections to existing Subjects, you can run the re-assignment jobs to update review requirements on those Subjects.

Manually Assigning Review Plans to Subjects

You can manually assign Review Plans to Subjects as needed, separate from the application of override plans.

To manually assign Review Plans to Subjects:

  1. Navigate to Tools > EDC Tools > Review Plan Assignment.
  2. Click into the Site containing the Subject or Subjects you want to update.
  3. Select one or more Subjects to update.
  4. Click Assign Review Plans or select Assign Review Plans from the subject’s Actions menu. Assign Review Plans button

    Assign Review Plans action

  5. In the Assign Review Plans dialog, select an SDV Plan and a DMR Plan. Assign Review Plans dialog

  6. Click Save. Vault updates the Review Plans for the subjects and begins SDV Re-assignment and DMR Re-assignment jobs.

Removing Manual Overrides

If you have previously manually assigned a Review Plan to a subject, you can remove that override assignment later if required. When you remove a manual override, Vault resets that subject’s assignment to either the default or override plan, depending on the site’s Override Ordinals.

To remove manual overrides:

  1. Navigate to Tools > EDC Tools > Review Plan Assignment.
  2. Click into the Site containing the Subject or Subjects you want to update.
  3. Select a Subject to update.
  4. Select Remove Manual Overrides from the subject’s Actions menu. Remove Manual Overrides action

  5. In the confirmation dialog, click Remove.
  6. Click Save. Vault updates the Review Plans for the subjects and begins SDV Re-assignment and DMR Re-assignment jobs.