Vault allows you to send surveys (Checklists) to respondents outside of your Vault. The recipients can then complete the survey and view any reference files related to it within Vault, without requiring the recipient to have a user account. This enables you to quickly gather data from Sites and contacts external to your Vault without using a third-party tool, and the data remains inside Vault.
An Admin must configure your Vault to ensure users can send surveys to external respondents. See Creating & Using Surveys for External Respondents for more information about generating these surveys.
Note: This feature is only available in Clinical Operations Vaults with Study Startup.
Configuration Overview
- Navigate to Configuration > Checklist Types and enable or create Checklist Types for applicable target objects. Vault automatically enables the Site Survey and Outreach Target Survey Checklist Types.
- Configure the Send Checklists Based on Contacts action on applicable target object lifecycles.
- Optional: Configure Response Flags.
- Optional: Configure the filing and sending of complete survey documents.
- Configure actions for the Site Survey Invitation and Outreach Survey Invitation objects.
- Optional: Configure Custom Email Senders.
Configuring Response Flag Survey Answers
When survey respondents select configured Response Flag values on Available Answer Design records, these answers confirm electronic confidentiality, non-interest from a Site, or the survey requires additional evaluation. Vault populates the Response Flag value on to the parent Survey record when a respondent selects it.
To enable Response Flags on a survey type, navigate to Admin > Configuration > Checklist Types and select a Checklist Type record. Click Edit on the applicable Checklist Type record and enter Response Flag in the Optional Fields field in the Available Answer Design section.
To use Response Flags on Survey questions, activate the appropriate values in the Response Flag picklist in the Business Admin.
Configuring Electronic Confidentiality Agreements (eCDA)
You can configure Vault to generate eCDAs for surveys when users choose a specific answer for a question. To enable this feature, an Admin must perform the following steps in your Vault:
- Create an eCDA Formatted Output.
- Configure entry and user actions on the Completed state of Site Survey Lifecycle to file and send completed eCDA documents.
- Select the eCDA Confirmed values for the Notification Template to send survey respondents a copy of their completed survey. Vault files the document under the Document Type in the action.
In configured Vaults, to use Electronic Confidentiality Agreement:
- Add the Electronic Confidentiality Confirmed value to the Response Flag field on answers where the site agrees to terms included in the attached CDA.
- Example Answer: ‘Yes, I agree to the terms referenced in the attached CDA’
- Add the Confidentiality Recipient value to the Survey Respondent Type field on the Study Person records of the appropriate individual to confirm the eCDA.
Important: You can only add the Confidentiality Recipient value to the Survey Respondent Type field on Study Person records. An error occurs if you attempt to add the value to the Survey Respondent Type field on Contact Information records. A Vault can only have one active Study Person record with the Confidential Recipient value for a survey at a time.
Configuring Custom Email Senders
Before you can send surveys from custom email addresses, an Admin must perform the following configuration steps:
- Enable the Outbound Email Domains setting via a support ticket
- Configure the outbound email address
- Edit the Study Person page layout to include the Survey Sender Type field
- Optional: Add or update custom email banners
Configuring the Send Checklist Based on Contacts Action
When configured on target object lifecycles, the Send Checklist Based on Contacts action sends surveys to Organization Contacts or Study Persons with valid email addresses and matching Survey Respondent Types.
You can configure the Send Checklist Based on Contacts action as an entry or user action. You can also enable this action in bulk using the Send Checklists Based on Contacts Bulk action. When configuring the action on a target object lifecycle, complete the following configuration steps:
- Select the Checklist Type value that matches the Survey Template Type of the desired Survey Template.
- Select the Survey Respondent Type value that matches the Survey Respondent Type value on the corresponding Study Person or Organization record for the site that should receive the survey.
Configuring the Filing & Sending of Completed Survey Documents
You can configure your Vault to save the respondent’s completed survey in TMF and send the respondents a copy. To enable this functionality, an Admin must perform the following configuration steps:
- Add the Generate Document from Formatted Output action to the Study Site Survey and Outreach Target Survey objects.
- Optional: Add the Object Document field to the appropriate Classification and configure the field to point to the Study Site Survey and/or Outreach Survey objects.
- Configure the Generate Document from Formatted Output action on the Site Survey Lifecycle and Outreach Target Lifecycle. We recommend configuring the action as an entry action on the Completed lifecycle state.
- Optional: Add the Response Document column to the Site Survey section of the Study Site page layout and the Outreach Survey section of the Outreach Target page layout.
Configuring the Generate Document from Formatted Output Action
To configure the Generate Document from Formatted Output action to send survey respondents a copy of their completed survey:
- Navigate to Admin > Configuration > Lifecycles.
- Select the Site Survey Lifecycle or Outreach Target Lifecycle.
- Select an object lifecycle state. We recommend selecting the Completed lifecycle state.
- Select Edit for Entry Actions or User Actions. We recommend configuring the action as an entry action.
- Select a Condition Type. We recommend adding conditions based on Survey Type.
- In the Performs Action section, select the Generate Document from Formatted Output action.
- Select Site Survey Response or Outreach Target Survey Response for the Formatted Output Template.
- Select a Document Type. Vault creates the generated document as this Document Type in TMF.
- Optional: If your Vault has Subartifacts enabled, select a Document Subartifact.
- Select a Document Lifecycle.
- Optional: Select a Document Lifecycle State. This is the state that the generated document moves to during the action.
- Optional: Select an Object Field On Document. This is the field on the generated document.
- Select Response Document for the Document Field On Object field.
- Select the Send Copy to Survey Respondent checkbox.
- Select Download Survey Response in the Notification Template field.
- Click Save.
Note: Document generation fails if the selected Document Type contains missing required fields.
When the system or a user triggers the Generate Document from Formatted Output action, Vault generates a survey response document from the Formatted Output Template and files the document under the Document Type. The system also creates a link for the document in the Response Document field on the Site Survey and Outreach Target Survey objects.
The Download Survey Response notification template allows Vault to send the survey respondent a download link for the PDF copy of the survey response document. The link to the document expires 60 days after Vault sends the notification.
Configuring Actions for Invitation Object Lifecycles
Vault creates Invitation objects for each survey sent. You can configure actions for the Site Survey Invitation and Outreach Survey Invitation lifecycles. We recommend configuring the following user actions:
- Generate New Link: Deactivates the associated unique link and generates a new record for that recipient with a new unique link.
- Inactivate Link: Sets the existing record to the Inactive state and deactivates the associated unique link.
Configuring Survey Reminder Emails
Admins can configure the Send Site Survey Reminder and Send Outreach Survey Reminder object actions to trigger the reminder notification prior to the designated Next Reminder Date. These actions automatically update the Next Reminder Date to today and trigger a system job to send the reminder notification to the Respondents listed on the Invitation record.