Form Configuration

Coder Tools > Study Settings includes a Form Configuration section, which lists the Forms collecting coding data within the selected Study. From here, you can assign Synonym Lists and Do Not Autocode Lists to a Form, enable dictionary-specific fields, and upversion to a new dictionary release.

Prerequisites

Configuration

To configure a form in Coder Tools, the Form Definition must exist and be enabled for coding in Studio. You must also first create a Synonym List and Do Not Autocode List to assign them to a form.

Required Permissions

Users with the standard CDMS Clinical Coder Administrator study role can perform the actions described above by default. If your vault uses custom Study Roles, your role must have the following permissions:

Type Permission Label Controls
Standard Tab Coder Tools Tab

Ability to access the Coder Tools tab
Functional Permission Manage Coder Study Settings

Ability to edit Study Settings 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.

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Accessing Coder Tools

To access the Coder Tools administration area, click the Tools tab in the primary navigation bar, and then click Coder Tools.

Access Coder Tools from the Tools Tab

Once in Coder Tools, you can click the sub-tabs to navigate to different areas within.

Configuration Needed to Begin Coding

In order for your organization to begin coding, complete the following configuration tasks:

  • Assign a Dictionary to the form
  • Optional: Assign a Synonym List to the form (this is required if autocoding from the synonym list)
  • Optional: Assign a Do Not Autocode List to the form
  • Optional: Configure the form’s coding method

Assign a Dictionary to a Form

Before coders can code on a form, you must assign a dictionary to code from. Your options are limited by the Form Type of the form (WHODrug versions for ConMed forms, MedDRA for AE and Medical History).

To assign a Dictionary Release to a Form:

  1. Locate the Form you want to edit in Coder Tools > Study Settings > Form Configuration.
  2. Hover over the Form to display the Actions menu.
  3. From the Actions menu, select Edit.
  4. In the Edit Form dialog, select a Dictionary.
  5. Click Save.
  6. In the confirmation dialog, click Confirm.

If there are submitted forms for the Form Definition already in the study, assigning a dictionary to a_ Form_ starts the Reconstitute Code Requests job, which creates Code Requests for those submitted forms.

Assign a Synonym List to a Form

Before Vault can use a Synonym List for autocoding, and before coders can request to add new Synonyms, you must first assign a Synonym List to a coding Form.

To assign a Synonym List to a Form:

  1. Locate the Form you want to edit in Coder Tools > Study Settings > Form Configuration.
  2. Hover over the Form to display the Actions menu.

  3. From the Actions menu, select Edit. Edit action

  4. In the Edit Form dialog, select a Synonym List.
  5. Click Save.
  6. Vault assigns the Synonym List to the Form. Vault now uses this Synonym List to inform autocoding on this Form.

You can edit the Synonym List assignment later.

Assign a Do Not Autocode List to a Form

Before Vault can use a Do Not Autocode List for autocoding, you must first assign a Do Not Autocode List to a coding Form.

To assign a Do Not Autocode List to a Form:

  1. Locate the Form you want to edit in Coder Tools > Study Settings > Form Configuration.
  2. Hover over the Form to display the Actions menu.

  3. From the Actions menu, select Edit. Edit action

  4. In the Edit Form dialog, select a Do Not Autocode List. Select a Stop List

  5. Click Save.
  6. Vault assigns the Do Not Autocode List to the Form. Vault now uses this Do Not Autocode List to inform autocoding on this Form.

You can edit the Do Not Autocode List assignment later. Note that if you edit the assigned list, all coded Forms are reset to the Uncoded status.

Upversion a Form

Once a new WHODrug or MedDRA dictionary release is available, you can upversion a Form and the form’s assigned Synonym List to reference that new dictionary version. Upversioning a Form itself and the Synonym List that the Form uses are separate actions, but both are required to update the Form.

See Upversioning to a New Dictionary Release for details.

Additional Coding Fields for WHODrug Forms

If a WHODrug form is configured to collect values for Indication and Route, you can configure the Form to display those values and use them to inform Code Request groupings.

Indication and Route are configured individually. You can select one, both, or neither of these fields.

Indication

Enabled
(Checkbox selected)		 When the Indication checkbox is selected:
  • Coder displays an Indication column in the Code Request Listing table to inform manual coding decisions.
  • Vault stores the Indication value in each Synonym and references it when autocoding from that Synonym List.
  • Indication informs how Vault groups Code Requests in Grouped view.
Disabled
(Checkbox not selected)		 When the Indication checkbox is not selected:
  • Coder does not display an Indication column in the Code Request Listing table.
  • Vault does not store Indication in Synonym records.
  • Indication does not inform how Vault groups Code Requests in Grouped view.

Route

Enabled
(Checkbox selected)		 When the Route checkbox is selected:
  • Coder displays a Route column in the Code Request Listing table to inform manual coding decisions.
  • Vault stores the Route value in each Synonym and references it when autocoding from that Synonym List.
  • Route informs how Vault groups Code Requests in Grouped view.
Disabled
(Checkbox not selected)		 When the Route checkbox is not selected:
  • Coder does not display a Route column in the Code Request Listing table.
  • Vault does not store Route in Synonym records.
  • Route does not inform how Vault groups Code Requests in Grouped view.

To enable WHODrug coding fields:

  1. Navigate to Coder Tools > Study Settings.
  2. Use the Study Selector to select your Study:
    • Type your study’s Name in the Search Studies field.
    • Click your Study to select it. Study Selector
  3. Locate the Form you want to update in the Form Configuration section.
  4. Hover over the Form to display the Actions menu.

  5. From the Actions menu, select Edit. Vault opens the Edit Form dialog. Edit action

  6. Select the Indication and Route checkboxes. Coding Fields checkboxes

  7. Click Save.
  8. In the confirmation dialog, click Confirm.

Enabling SAE Prioritization for MedDRA Forms

If a MedDRA form collects a Seriousness value, you can configure the form to display the collected Seriousness property during manual coding by enabling SAE (Serious Adverse Event) prioritization. Displaying the Seriousness of an adverse event allows coders to easily identify seriousness adverse events and prioritize them for coding.

Enabled (Selected) Vault displays a Seriousness column in the Code Request Listing page. The Seriousness value also informs how Vault groups Code Requests in Grouped view.
Disabled (Not selected) Vault does not display the Seriousness column, and Seriousness does not inform the grouping of Code Requests.

To enable SAE prioritization for a Form:

  1. Navigate to Coder Tools > Study Settings.
  2. Use the Study Selector to select your Study:
    • Type your study’s Name in the Search Studies field.
    • Click your Study to select it. Study Selector
  3. Locate the Form you want to update in the Form Configuration section.
  4. Hover over the Form to display the Actions menu.

  5. From the Actions menu, select Edit. Vault opens the Edit Form dialog. Edit action

  6. Select the Enable SAE Prioritization checkbox. Enable SAE Prioritization checkbox

  7. Click Save.
  8. In the confirmation dialog, click Confirm.

To disable SAE prioritization for a Form, edit the Form and clear the Enable SAE Prioritization checkbox.