Step 3: Create a Study Schedule

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Key Terms

Once you have created all of your definition records, you can create your study schedule. Your study schedule represents the order of events in your study, what forms need to be filled at each event, as well as what items (fields) display on each form.

In EDC Studio’s Design view, you can drag and drop object definitions from the Components panel onto the Design palette to design your study schedule and forms.

Components panel & Design palette

To add a component to the design palette, click and drag it from the Components panel to the Design palette. When you can drop your component, you’ll see a green line or a green plus (+) with an orange highlight.

To add your Event Groups and Events to your study schedule:

  1. Open Studio > Schedule.
  2. Click Event Groups to see a list of all the Event Groups available for your study.
  3. Click and drag the first event group in your study onto the design palette. When you can drop your event group, a green plus (+) displays on your cursor.
  4. Click and drag the next event group onto the design palette. Repeat this step for each additional event group.
  5. Remove the Event Groups filter and click Events.
  6. Click and drag your first event into your first event group. An Event must be within an Event Group.
  7. Click and drag the next event onto the design palette, and then drop it onto an Event Group. To place the Event in the next Event Group, repeat step 5.
  8. Repeat steps 5 and 6 for all of your Events.
  9. Optional: Click the Trash icon to remove Event Groups and Events from your schedule. Note that this does not delete the object definitions. This only removes that object from the design palette and the study’s schedule.

Now that you have added your Event Groups and Events to your schedule, you can add Forms to each Event.

To add your Forms to your Events in your study schedule:

  1. Remove the Events filter and click Forms.
  2. Locate your first Form in the list. You can search for forms as needed. Use the Name of the Form as your search term.
  3. Click and drag your first Form into your first Event. A Form must be within an Event.
  4. Click and drag any additional Forms for that Event below the first Form. When you can drop a Form, Studio displays a green line.
  5. Repeat steps 2 and 3 for all of your Forms.
  6. Optional: Click the Trash icon to remove Forms from your schedule. Note that this does not delete the object definitions. This only removes that object from the design palette and the study’s schedule.

From Studio > Schedule, you can also design each of your forms by adding Item Groups and Items to each Form.

  1. Click the Pencil icon on a form.
  2. Click Item Group to view a list of available Item Groups from your Study.
  3. Click and drag your Item Groups onto the design palette.
  4. Remove the Item Groups filter and click Items.
  5. Click and drag your Items into an Item Group. Items must be within an Item Group. You can create a two-column layout by dragging an Item to the left or right of another Item. When you can drop the item, Studio displays a green line. For example, you can place items for Systolic Blood Pressure and Diastolic Blood Pressure next to each other.
  6. You can click Schedule to return to your event schedule without closing a form. You can also click the X to close your form’s tab.

Once you have set up your schedule and designed all of your forms in Studio, Vault EDC uses your study design when an Investigator clicks + New Casebook.


Studio

Roles

Key Terms