Note: This feature is only available in Clinical Operations Vaults with Study Startup.
Vault allows you to send surveys (Checklists) to respondents outside of your Vault. The recipients can then complete the survey and view any reference documents related to it within Vault. This enables you to quickly gather data from external contacts without using a third-party tool, and the data stays inside Vault.
Survey Example
Randy Researcher at VernBio Pharma wishes to conduct Study 12345 and is considering Two Point Hospital as a possible study site. Prior to selecting Two Point Hospital as a site, VernBio Pharma wants to survey the site to ensure it meets their needs. Rather than using another survey method, Randy wants to accomplish this with Vault alone.
To do so, Randy designs a Checklist to act as the survey, setting it to the Site Survey type. VernBio Pharma then adds their contacts at Two Point Hospital to the appropriate Organization record, including email addresses and Survey Respondent Types.
Next, Randy adds a Site record, in the Candidate state, to Study 12345 and sets Two Point Hospital as the Organization. They then create an entry action for the Qualifying state of the Site and configures it to send surveys. When Randy starts the workflow, Vault sends the Checklist to all contacts with the matching Survey Respondent Type of Study Feasibility Survey.
Setting Up a Survey
- Start by designing a Checklist according to the needs of your Study or Outreach Campaign. Add Veeva standard Library Questions or create your own custom standard Library Questions as needed when designing the Checklist.
- Configure and enable the Checklist, assigning it the Checklist Type of either Site Survey or Outreach Survey.
- Site Survey has a target object of Site, and Checklist Design records can be set up to match to a specific Study.
- Outreach Survey has a target object of Outreach Target, and Checklist Design records can be set up to match to a specific Outreach Campaign.
- Vault will only allow one Checklist Design record for each combination of Object Type, Checklist Type, and specified matching field.
- Optional: Select the appropriate Response Flag for answers that confirm electronic confidentiality or are considered red flags and need additional evaluation. When an answer with a Response Flag is selected on a checklist, Vault copies up the flag to the parent survey record. Response Flag is only an option when creating checklist answers.
- Optional: Configure custom email senders.
- Optional: Select the Survey Sender for this survey.
- Configure entry actions and/or user actions on the target object lifecycle using the action Send Checklist Based on Contacts.
- The Checklist Type should match the Checklist Type of the desired checklist.
- The Survey Respondent Type should match the same field on your Contact records for the Organization that will receive the survey.
- Navigate to Admin > Business Admin.
- Select either a Site or Outreach Target, or Create a new record if necessary.
- Assign an Organization to the record, or confirm that the current selection is correct.
- Ensure that the chosen Organization has Contact Information records for everyone you intend to survey, each having an email address and matching Survey Respondent Type.
Once the above is configured and the action triggered, Vault will send surveys to all Organization Contacts with a valid email address and a matching Survey Respondent Type.
Vault creates Invitation objects for each survey sent. You can configure lifecycles for the Site Survey Invitation and Outreach Survey Invitation objects with their own workflows. We recommend configuring these two 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.
For more about working with active surveys, see Working with Surveys for External Respondents.
Configuring Electronic Confidentiality Agreements (eCDA)
You can configure Vault to generate eCDAs for surveys when select users choose a specific answer for a question. To enable this feature, an Admin must perform the following configurations:
- Add the Electronic Confidentiality Confirmed value to the Response Flag field on answers to questions that confirm the user’s need for an eCDA within a checklist template.
- Add the Confidentiality Recipient value to the Survey Respondent Type field on Study Person records of users who are approved to confirm eCDA.
- Configure the Site Survey Lifecycle to file and send completed eCDA documents and select eCDA Confirmed for the Notification Template field.
You can only add the Confidentiality Recipient value to the Survey Respondent Type field on Study Person records. An error will occur if you try to add the Confidentiality Recipient value to the Survey Respondent Type field on Contact Information records. Vault can only have one active Study Person record with the Confidentiality 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:
- 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 Survey Reminder Emails
Before you can send survey reminder emails, an Admin must perform the following on the Checklist Design Object:
- Enter the Reminder Email Subject text. This is the email subject for the survey reminder email.
- Enter the Reminder Email Text. This is the text for the survey reminder email.
- Enter the Reminder Notification Text. This is the text for the survey reminder.
Additionally, an Admin must set the Reminder Notification Frequency on the Site Survey Invitation or Outreach Target Survey Invitation object. This is the frequency, in days, that you wish Vault to send reminder emails.
Note: To enable this feature, you must activate the Daily Survey Reminders job. Vault will not send notifications if the job is not active.
Configuring the Filing & Sending of Completed Survey Documents
You can configure your Vault to send survey respondents a copy of their completed survey and save a copy of the survey in TMF. To configure this functionality, an Admin must perform the following:
- 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.
- Optional: Add an Object Document field to the appropriate Classification and configure the field to point to the Site Survey and/or Outreach Survey objects.
- Add the Generate Document from Formatted Output action on the Site Survey and Outreach Target 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.
To configure the Generate Document from Formatted Output action to send survey respondents a copy of their completed survey:
- Select the Site Survey Lifecycle or Outreach Target Lifecycle.
- Select an object lifecycle state.
- Select Edit for Entry Actions or User Actions.
- Select a Condition 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.
- 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 will fail when the selected Document Type contains missing required fields. Ensure you populate all required fields when generating a document by adding a default value for required fields or a Create Document action on the document lifecycle.
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.