**Source URL:** https://clinical.veevavault.help/en/gr/62352/index.md

# Configuring Investigator Initiated Studies (IIS)

In Clinical Operations Vaults, you can track the internal processes of <a href="/en/gr/62358/">Investigator Initiated Studies</a> (IIS) by utilizing data already available in your Vault. This feature is fully customizable to fit the specific needs of your organization.

Vault includes the following standard components by default to aide in your setup of Investigator Initiated Studies:

-   _Investigator Initiated Study_ object with standard object fields, a custom page layout, and custom layout rules
-   _Investigator Initiated Study Documents_ document type
-   _Investigator Initiated Study_ shared document field
-   _Investigator Initiated Study_ tab
-   _Investigator Initiated Study Lifecycle_ with standard lifecycle states
-   _IIS External User_ security profile and _IIS External User Actions_ permission set

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: This feature is only available in Clinical Operations Vaults.</p>
    </div>
  </div>
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## Configuration Overview

Investigator Initiated Studies functionality is available in all Clinical Operations Vaults but requires some configuration for utilization:

-   [Configure Investigator Initiated Study Documents][2].
-   Update [permission sets][3] to grant users access to the _Investigator Initiated Study_ object and navigation tab.
-   Optional: [Configure access for external IIS users][4].
-   Optional: <a href="/en/gr/15057/#customizestandardobjects">Customize the _Investigator Initiated Study_ object</a> by adding fields, modifying the <a href="/en/gr/26387/">page layout</a>, and adjusting <a href="/en/gr/51632/">layout rules</a>.
-   Optional: <a href="/en/gr/30683/">Configure the _Investigator Initiated Study Lifecycle_</a> to meet your organization's business requirements.
-   Optional: <a href="/en/gr/33550/">Configure workflows</a> for the _Investigator Initiated Study_ object to meet your organization's business requirements.
-   Optional: <a href="/en/gr/52053/">Configure Lifecycle Stages</a> for the _Investigator Initiated Study_ object.

## Configuring Investigator Initiated Study Documents {#configuring-for-investigator-initiated-study-documents}

Use the _Investigator Initiated Study_ document type and document field to capture IIS-specific documents. For example, IIS budgets, contracts, principal investigator CVs, and protocols.

### Activating the Investigator Initiated Study Documents Document Type

<a href="/en/gr/618/#EnablingDocTypes">Activate</a> the _Investigator Initiated Study Documents_ document type to make it available to users. To do this:

-   Navigate to **Admin > Document Types** and click on **Investigator Initiated Study Documents**.
-   Select **Activate** from the **Actions** menu.

### Assigning the Investigator Initiated Study Shared Field {#ISS-shared-field}

Assign the _Investigator Initiated Study_ <a href="/en/gr/4884/#use-shared-field">shared field</a> to document types in your Vault so that users can add those document types to IIS records. To do this:

1.  Navigate to **Admin > Document Fields** and click on the document type that you want to assign the shared field to.
2.  Click **Add > Existing Shared Field**.
3.  Select the **Investigator Initiated Study** option from the picklist
4.  Click **OK**.

Users can only add documents to an IIS record if the document type is assigned the _Investigator Initiated Study_ shared field.

## Configuring Investigator Access {#configuring-investigator-access}

Assign Investigators the _IIS External User_ security profile with the _IIS External User Actions_ permission set so that they can submit their proposals directly in your Vault. This access includes the ability to create _Investigator Initiated Study_ records and to view IIS related records and documents in your Vault.

If additional permissions are needed, follow best practices to copy the standard permission set and <a href="/en/gr/45887/#assign-custom-permission-sets">assign custom permission sets to custom profiles</a>.

If needed, <a href="/en/gr/953/">configure groups</a> and <a href="/en/gr/2572/">document permissions</a> for external IIS users.

## Related Permissions {#related-permissions}

You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner profile.

If your Vault uses custom security profiles, your profile must grant the following <a href="/en/gr/22824/">permissions</a>:

<table class="wbord">
  <tr>
    <td>
      <p>
        Type
      </p>
    </td>
    <td>
      <p>
        Permission Label
      </p>
    </td>
    <td>
      <p>
        Controls
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Security Profile
      </p>
    </td>
    <td>
      <p>
        Objects: Investigator Initiated Study: Create, Edit
      </p>
    </td>
    <td>
      <p>
        Ability to create and edit <em>Investigator Initiated Study</em> records
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Security Profile
      </p>
    </td>
    <td>
      <p>
        Tabs: Investigator Initiated Studies: View
      </p>
    </td>
    <td>
      <p>
        Ability to view and access the <em>Investigator Initiated Studies</em> tab on the navigation bar
      </p>
    </td>
  </tr>
</table>

 [2]: #configuring-for-investigator-initiated-study-documents
 [3]: #related-permissions
 [4]: #configuring-investigator-access