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.

Accessing Coder Tools

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

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. If code requests exist for a Form, but no coding has been completed, you can change the dictionary release assigned to the Form.

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.

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.

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

Route

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.
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.

6. Select the Indication and Route 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.

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.
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.

6. Select the 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.