Step 7: Configure Review Plans
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.
Item Requirement Modes
For each Item in a Review Plan there are three (3) Requirement Modes available: Required, meaning that the users must complete SDV or DMR for the item, No Review, and Optional. 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 or Optional.
Navigating the Review Plan Editor
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.
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.
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:
- Navigate to Studio > Review Plans.
Click + New Review Plan.
- Enter a Name for your review plan.
- Select a Review Task:
- SDV: Select to create a targeted SDV plan
- DMR: Select to create a targeted DMR plan
- 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.
- Optional: Enter a Description with details about your review plan.
- Set the requirement mode for Items on all Forms requiring review. See details below.
- Click Save.
How to Add & Remove Items
To update an item’s Requirement Mode:
- In the Review Plan Editor, locate the Form in the Driving panel.
- Click the Form to open it in the Form panel.
To set the requirement mode for the entire Form, you can click Required, No Review, or Optional in the Set As dropdown menu.
In the Form panel, click Required for each Item you want to require review for. To mark Required items as No Review or Optional, click again. You can click Required on an Item Group header to indicate that all Items in that group should be Required, No Review, or Optional. Clicking the Required icon more than once cycles through the available statuses: Required > No Review > Optional > Required.
- Repeat steps 1-4 until you have finished adding and removing Items from your Review Plan.
- Click Save.
How to Bulk Add & Remove Forms
You can set Forms as Required or No Review in bulk from the Driving panel: