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 or by Subject status using Dynamic Review Plans. 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 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.


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
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.


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

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. The screenshot below is an example of version 1.

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 all Review Plan Assignment criteria and Manual Assignments. You can search by Review tasks using the search bar.

Review Plan Assignment

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).

Dynamic Review Plans

You can also create SDV Review Plans based on Subject Status in addition to creating plans by Site. Review plans based on Subject Status can be applied to a subset of subjects and has multiple parameters for identifying subjects for verification.

How to Enable Dynamic Review Plans

Dynamic Review Plans will be automatically enabled for new studies but will need to be configured for already existing studies.

To configure Dynamic Review Plans:

  1. Navigate to Business Admin > Study Configuration.
  2. Locate your Study in the list of records.
  3. Click your study’s Name to open it.
  4. Click Edit.
  5. Set Review Plan Assignment Version to “3.”
  6. Click Save.

How to Create a Dynamic Review Plan

To utilize Dynamic Review Plans after configuration, follow the steps below:

  1. Navigate to Tools > EDC Tools > Review Plan Assignment.
  2. Click + New Assignment Criteria to add a new Review Plan.
  3. Select your Review Task.
  4. Select your Base Plan and Override Plan. Your Base Plan is the plan that applies to most of the subjects and your Override Plan is the plan that applies to the subjects specified by the Override Subject Ordinals and Override Coverage Percentage. All Review Plans are configured in Studio > Review Plans.
  5. Fill in your Override Subject Ordinals and/or Override Coverage Percentage fields if you selected an Override Plan in the previous step. Override Subject Ordinals and Override Coverage Percentage determine which subjects your Override Plan applies to. They can be used together to apply to a very specific subset of subjects (e.g. 25% of every 5 subjects, as shown in the screenshot below) or used separately to apply to a larger group of subjects. Dynamic Review Plan Assignment

  6. Choose the Study Countries and Sites that your Review Plan should apply to. When a Study Country is selected, only Sites outside that Country can be selected in the Sites field. The Sites field is used to specify additional Sites outside the selected Study Country that the Review Plan should apply to, but is not a subset of the Study Countries field.
  7. Optional: Select a Subject Status that your Review Plan should apply to. Only Subjects with the chosen status will be affected by your Review Plan.
  8. Click Save.

Please note that Override Subject Ordinals apply to all Study Countries in totality, rather than each Study Country individually. The Override Coverage Percentage field, however, applies to all Assignment Criteria in totality.

Study & Site Templates

Review plans can also be configured at the Study level via the Study Template configuration in Studio > Review Plans. When creating Review Plans for your Study, a study designer selects a Default Plan, an Override Plan, and Override Subjects to use as a “template” for assigning Review Plans to your sites. 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

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

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

  2. 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.

Form-level Overrides with Rules

Your study may also include Override Review Plan rules. These rules override the assigned review plan at the form level, based on user-entered data. For example, the rule may assign a 100% required SDV plan when an Adverse Event form’s seriousness item is set to Yes.

The SDV and DMR Re-assignment jobs do not override the Review Plan assigned by an Override Review Plan rule.

Running the SDV and DMR Re-assignment Job at the Site Level

You can run the SDV and DMR Re-assignment job at the Site level in addition to the Study level.

To run an SDV or DMR Re-assignment Job:

  1. Navigate to Tools > EDC Tools > Jobs.
  2. Click *+ New Job**.
  3. Select SDV Re-assignment or DMR Re-assignment for Type.
  4. Click Select Sites below the dropdown menu.

Assign at the Site level