Creating Design Definitions for Study Objects


A design definition object record is a record that Vault copies into an “execution” object record during casebook creation. For example, Vault creates a copy of your Event Definition record as an Event, or visit, record for each casebook. See details about Vault EDC’s data model here. To design your study, you’ll need to create definition records for every component of your study’s design, including events, forms, units, and more.

EDC Studio does not display Definition for each object name in the Studio user interface. Even though the objects aren’t labeled with Definition, you are creating definition object records whenever you are working in Studio.

How to Create Design Definitions

You can access the listing page for each type of study object from Studio’s Navigation panel. Create records in each of the objects listed in the Study Objects section. See the instructions below.

To create a Codelist Definition:

  1. Open Studio > Codelists. Studio > Codelists, Codelist Definition Listing
  2. Click + New Codelist. New Codelist button
  3. Enter a Name.
  4. Optional: Enter a Description.
  5. Fill the required fields to create Codelist Definition Items.
  6. Optional: Select the Hide checkbox for any codelist items you don’t want to display to data entry users.
  7. Click Save.
  8. In the Properties panel, click Edit.
  9. Edit properties for your new Codelist as needed.
  10. Click Save.

To create an Event Group Definition:

  1. Open Studio > Event Groups. Studio > Event Groups, Event Group Definition Listing
  2. Click + New Event Group. New Event Group button
  3. Enter a Label. New Event Group dialog
  4. Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespace with underscores.
  5. Select an Event Group Type. Learn more about the available types here.
  6. Optional: If you selected EDC for Event Group Type, you can choose to select the Repeating checkbox to make your Event Group a repeating one.
  7. Optional: Enter an External ID. If you don’t enter an External ID, Vault automatically generates one.
  8. Optional: Click Advanced to show additional properties. From here, you can enter Description and Help Content. Learn more about those properties here.
  9. Optional: Click Save and New to save this Event Group and immediately create another one.
  10. Click Save.
  11. In the Properties panel, click Edit.
  12. Edit properties for your new Event Group as needed.
  13. Click Save.

To create an Event Definition:

  1. Open Studio > Events. Studio > Events, Event Definition Listing
  2. Click + New Event. New Event button
  3. Enter a Label. New Event dialog
  4. Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespace with underscores.
  5. Select an Event Type.
  6. Enter a Short Label.
  7. Optional: Enter an External ID.
  8. Optional: Click Advanced to show additional properties. From here, you can enter Description and Help Content. Learn more about those properties here.
  9. Optional: Click Save and New to save this Event and immediately create another one.
  10. Click Save.
  11. In the Properties panel, click Edit.
  12. Edit properties for your new Event as needed.
  13. Click Save.

To create a Form Definition:

  1. Open Studio > Forms. Studio > Forms, Form Definition Listing
  2. Click + New Form. New Form button
  3. Enter a Label. New Form dialog
  4. Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespace with underscores.
  5. Select the Repeating checkbox to make your Form a repeating one. Then you can set a Repeat Maximum. Learn more about those properties here.
  6. Enter a Short Label. This label displays in areas where the Label is too long to display, such as the form carousel or in Design view.
  7. Optional: Enter an External ID. If you don’t enter an External ID, Vault automatically generates one.
  8. Optional: Click Advanced to show additional properties. From here, you can enter Description and Help Content. Learn more about those properties here.
  9. Optional: Click Save and New to save this Form and immediately create another one.
  10. Click Save.
  11. In the Properties panel, click Edit.
  12. Edit properties for your new Form as needed.
  13. Click Save.

To create a Item Group Definition:

  1. Open Studio > Item Groups. Studio > Item Groups, Item Group Definition Listing
  2. Click + New Item Group. New Item Group button
  3. Enter a Label. New Item Group dialog
  4. Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespace with underscores.
  5. Optional: Click Save and New to save this Item Group and immediately create another one.
  6. Click Save.
  7. In the Properties panel, click Edit.
  8. Edit properties for your new Item Group as needed.
  9. Click Save.

To create a Item Definition:

  1. Open the Studio > Items. Studio > Items, Item Definition Listing
  2. Click + New Item. New Item button
  3. Enter a Label. New Item dialog
  4. Optional: Update the Name. Vault automatically generates the Name from your entered Label by converting it to lowercase and replacing whitespace with underscores.
  5. Optional: Click Save and New to save this Item and immediately create another one.
  6. Click Save.
  7. In the Properties panel, click Edit.
  8. Edit properties for your new Item as needed.
  9. Click Save.

To create a Unit Definition:

  1. Open Studio > Units. Studio > Units, Unit Definition Listing
  2. Click + New Unit. New Unit button
  3. Enter a Name.
  4. Optional: Select a Unit Type.
  5. Enter a Label.
  6. Optional: Enter a Description.
  7. Fill the required fields to create Unit Definition Items.
  8. Click + Add Unit Definition Item to add another Unit Item to your Unit. Add Unit Definition Item button
  9. Select a unit as default using the Default radio button. Default radio button
  10. Optional: Select the Hide checkbox for any unit items you don’t want to display to data entry users.
  11. Click Save.
  12. In the Properties panel, click Edit.
  13. Edit properties for your new Unit as needed.
  14. Click Save.


Naming Recommendations

We recommend that you don’t use any of the values below for an item definition’s Name or OID. These values are used by standard Vault EDC objects and fields, and naming Items with these names can cause errors on SAS conversion.

  • Study ID
  • Country
  • Site
  • Subject ID
  • Event
  • Event Date
  • Event Sequence
  • Form
  • Form Sequence
  • Item Group
  • Item Group Sequence

Vault EDC captures these data points in those standard object fields already. For example, when a data entry user enters a date for an Event, Vault records that entry in the Event Date field on the Event object.

How to Delete Data Collection Object Definitions

You can delete object records from Studio if the record is not in a relationship with the Casebook Definition (not added into any higher-level component from Studio > Schedule).

To delete an object record in Studio:

  1. Click an object record to open the Properties panel.
  2. Click Delete.
  3. Click Continue.
  4. Vault deletes the object record from the Vault.

Note that if you delete a Codelist Definition or Unit Definition object record, Vault also deletes all Codelist Item Definition or Unit Item Definition records related to that record.

If the object record you are trying to delete is in a relationship within the Casebook Definition (for example, your event is placed within an event group in Schedule), Vault does not allow you to delete the object record. You must first remove the object record from its relationship by removing it from the design palette in Schedule.

Study Update Restrictions

After you publish the initial version of your Casebook Definition, Vault prevents you from making certain changes in any later versions you may create. If you were to make these changes, it could cause errors during the casebook amendment process.

See Study Update Restrictions for a list of disallowed changes and available workarounds.


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