Enabling Forms for Coding
You can easily identify coding Forms and configure them in Studio for clinical coders to code form data within Vault Coder.
Before you can enable a form for coding, you must first create a Form Definition for the form, as well as the item groups and items, and build the form in Studio > Schedule.
Users with the standard CDMS Study Designer study role can perform the actions described above by default. If your vault uses custom Study Roles, your study role must provide the following permissions:
|Standard Tab||Studio Tab||
Ability to access the Studio tab
|Functional Permission||Manage Coding Lists||
Ability to create, edit, import, and export Synonym Lists and Do Not Autocode Lists in Coder Tools
If your Study contains restricted data, you must have the Restricted Data Access permission to view it.
Learn more about Study Roles.
To access the Studio study design and configuration area, click the Studio tab in the primary navigation bar.
Once you click the Studio tab, you have the option to open either Studies, a listing of Studies in your vault, or Library. By default, this page shows automated deployment studies. You can select the Manual radio button to show your manual deployment Studies (those studies created prior to the 19R3 release that have not been upgraded to automatic deployments), or navigate to those manual studies directly from the breadcrumb menu.
From the My Studies page, you can click a Study Master to open the Study Instances page. Then, you can click a Study Instance to open Studio for that instance. For manual deployment Studies, clicking the Study opens the Studio area for that study right away.
Configuring a Form for Coding
To enable a Form for coding, you must assign a Form Type, a Dictionary Release, a Synonym List, a Do Not Autocode List, and a Verbatim Item. You can then also assign Related Items and make selections for Coding Method, and choose whether or not you’d like to copy an Indication from a Form Link.
Once Code Requests exist for a Form, Vault locks the coding configuration for that assigned Dictionary Release. You can no longer edit that selection. If you need to update the configuration, you can contact Veeva Services. They can work with you to update the configuration and existing Code Requests. See details below.
- Navigate to your Study Studio > Schedule.
- Open the form’s Properties panel:
- In the Coding Configuration section, click Edit. Vault opens the Coding Configuration dialog.
- Select a Form Type. See details about these options below.
- If you selected Other for Form Type, name that type in Form Type Other.
- Select a Verbatim Item.
- The remaining configuration in this dialog is optional. See details about Related Items below.
- Click Save.
Copy Indication from Link
When configuring a ConMed form for coding, you have the option to copy an Indication from a linked form. This feature allows you to link form records and use an entered Adverse Event symptom or Medical History condition as the Indication value on a Concomitant Medication form.
Note that to perform this configuration, you must have already created the Form Link in Studio > Form Links.
You can’t configure a restricted (blinded) Form for use with Vault Coder. A restricted form is a Form Definition that has the Restricted property selected.
To copy an indication from a link:
- In the Coding Configuration dialog, fill out the required fields and select Code with Indication under Coding Method.
- Click + Add Link under Copy Indication from Link and select the link to indicate which Form to copy from and the specific item to copy and paste into the Indication item field.
- Click Save.
Indication item must be a Text field to configure Form Linking.
What Data Entry Users See
In the Data Entry tab, users can link a form instance and copy the linked form’s configured item into the indication item by clicking the Link and Copy button shown in the below screenshot.
This will open the Link and Copy dialog, where users can choose which forms to link and copy from.
Users must have at least one Link and Copy definition saved in a Form’s Coding Configuration to Link and Copy in the Data Entry tab.
Editing Configuration with Existing Code Requests
When you make changes to your form configuration while your study is in execution (and there are existing Code Requests), Vault applies your configuration changes right away.
Vault does not allow you to update the Dictionary Release when there are existing requests without performing additional steps. If you need to switch to an earlier version, or switch dictionary type (MedDRA to WHODrug or vice versa), you can work with Veeva Services to make a mid-stream change.
If you need to update to a newer version of the dictionary, your organization’s coding administrator should upversion from Coder Tools.
Contact your Veeva Services representative about your needs. They can remove existing Code Requests and remove your configuration. Then, you can reconfigure your Form using the new dictionary selection. Lastly, a lead data manager can run the Reconstitute Code Requests job to recreate all the removed Code Requests using the updated configuration.
Which dictionary type applies to your Form depends on the Form Type you selected.
If you selected ConMed, WHODrug B3 and C3 dictionary versions are available for selection in Dictionary Release. If you selected AE, MedDRA dictionary versions are available for selection in Dictionary Release.
If you selected Other, you can choose from any available dictionary version. Which dictionary type you choose (WHODrug or MedDRA) informs which options are available to you for Related Items.
Adding Related Items
You can configure data collection Items on your Form to display their values in the Code Request Properties panel. Coders can then look at those values as a reference when making coding decisions.
You can define which Items display and their order from the Related Items section of the Coding Configuration dialog. Any Items that you add here display in the Code Request Properties panel. If you remove a Related Item, it no longer displays in that panel.
Based on your selection for Form Type, Vault automatically adds a set of Related Item rows. You can then select Items to pair to the Type in each row.
Don’t use an Item that allows unknown dates as a Start Date or Stop Date related item.
How to Add a Related Item
To add a Related Item:
- In the Coding Configuration dialog, click Add Related Item.
- Select an Item. The options here are all data collection Items on the Form you’re editing.
- Select a Type. Note that the available Types are limited by the Form Type.
- If you selected Other for Type, enter a name for the type in the If Type Other field.
- Click Save.
How to Reorder Related Items
The order of the Related Items in the Coding Configuration dialog determines the order in which those Items display in the Code Request Properties panel. You can change this order at any time.
To reorder Related Items:
- Locate the Related Item you want to move in the Coding Configuration dialog.
- Click and drag a Related Item into a different position in the list.
- Repeat steps 1 and 2 until finished.
- Click Save.
How to Delete a Related Item
You can delete Related Items to remove them from the coding configuration.
This action does not remove the Item from the Form or delete the Item Definition record.
To delete a Related Item:
- Locate the Related Item you want to delete in the Coding Configuration dialog.
- Click Delete (X). Vault deletes the Related Item configuration.
- Click Save.