Note: This feature is only available in Clinical Operations Vaults with Study Startup.
In Vaults with this feature configured, you can create and send surveys (Checklists) to external respondents, allowing you to poll contacts associated with an Organization in the context of a Study or Outreach Campaign. You can collect responses without requiring external respondents to have usernames and passwords, and keep all collected information within Vault, streamlining your startup tasks. These surveys can also reference Vault documents and media that external respondents can view without logging in. You can include up to five reference documents per question on your surveys.
Creating Survey Templates
To send surveys to recipients, you must first create a Survey Template (checklist_design__sys).
To create a Survey Template record:
- Navigate to Admin > Business Admin > Objects > Survey Templates.
- Click Create.
- Select the Study Site Survey or Outreach Target Survey object type from the drop-down menu.
- Enter a Survey Name.
- Select a Survey Type from the drop-down menu.
- Optional: For Study Site Survey Template records, select a Study. For Outreach Target Survey Template records, select an Outreach Campaign.
- Optional: Fill out any additional fields.
- Click Save.
When configured by an Admin, you can select the Deep Copy Checklist action on an existing Survey Template record to create a copy of the record.
Once you save your Survey Template record, Vault opens it in the Visual Checklist Designer. If you prefer to design a survey using the traditional design options described on this page, click View Record Detail Page. In either view, you can design your survey by adding sections, questions, and dependencies.
Once approved, users can use the Survey Template record to send surveys to respondents.
Study Site Survey object type Template records have the Site target object and can match a specific Study. Outreach Target Survey object type Survey Template records have the Outreach Target target object and can match a specific Outreach Campaign.
Note: Vault only allows one Survey Template record with a given Survey Type to match a specific Study or Outreach Campaign record.
Using the Send Checklist Based on Contacts Action
In configured Vaults, the Send Checklist Based on Contacts action on Study Site and Outreach Target objects sends recipients surveys based on the corresponding Survey Template record.
When you trigger the Send Checklist Based on Contacts action on a Study Site, Vault confirms the following requirements are met:
- The Study Site has at least one related Study Person record with a valid Email value and a Survey Respondent Type value matching the same field value on the configured Send Checklist Based on Contacts action
- The Study Site has an available Survey Template record in the Approved state
- If using Custom Email Senders:
- Any Study Person assigned as an email sender has an active User record and a verified outbound email address
- There is only one Study Person for a given combination of Survey Sender Type, Study, Study Country, Study Site, and level
When you trigger the Send Checklist Based on Contacts action on an Outreach Target, Vault confirms the following requirements are met:
- The Outreach Target has at least one related Outreach Survey Person record or Organization record. The related Organization record must have at least one Contact Information record with a valid Email and a Survey Respondent Type value matching the same field value on the configured Send Checklist Based on Contacts action
- The Outreach Campaign has an available Survey Template record in the Approved state
- If using a Custom Email Senders:
- Any Outreach Survey Person record assigned as an email sender has an active Contact Information record with a verified outbound email address
- Only one Outreach Survey Person record exists for a combination of Survey Sender Type, Outreach Campaign, and Outreach Target.
When you trigger the action and the above conditions are met for Study Sites or Outreach Targets, Vault creates Survey and Survey Invitation records and sends email notifications to the qualifying respondents. A Survey can have multiple associated Survey Invitations which are specific to each respondent.
Working with Survey Invitations
When Vault sends out these surveys, the email contains a unique, encrypted link for a combination of a given survey and Contact Information record (with email). This link provides access to a special, limited version of Vault. All irrelevant controls are hidden, and only the controls needed to complete the included survey are displayed.
Once the respondent completes the survey, their unique link no longer works. Links expire 60 days from when they are sent. When configured, select the Generate New Link action to create a new Survey Invitation record with a new link.
The Delivery Status field on Survey Invitations provide the following statuses:
- Sent: Vault has sent the email.
- Delivered: The email has arrived in the recipient’s mailbox.
- Opened: The recipient has opened the email.
- Error: An error occurred while trying to send the invitation. Check the email address listed to see what may have gone wrong.
Vault updates the Delivery Status once per hour.
Vault provides two other important status fields:
- Opened Date: The date and time when a recipient first opened the email.
- Last Accessed Date: The last date and time when someone clicked on the invitation’s corresponding link and was allowed into Vault to complete the survey.
If a Study Site or Outreach Target survey fails to generate, Vault automatically sends a notification to the user that initiated the sending of the survey.
Sending Survey Reminder Emails
Once you have sent the initial survey invitations, Vault can automatically send reminder emails based on how you have configured the Study Site or Outreach Target Survey Templates. You can also generate reminder emails on an as-needed basis from the Study Site or Outreach Target Survey Invitation record by using the Send Outreach Survey Reminder and Send Site Feasibility Survey Reminder object actions.
The reminder email contains the subject line and text configured in the survey template. When Vault sends reminder emails, the Date, Last Reminder Sent, the Next Reminder Date, the Reminder Notification Frequency, and the Reminder Delivery Status fields are updated on the corresponding Survey Invitation records.
About Response Flag Survey Answers
Out of the many questions in a survey, a select few are true “dealbreakers” (for example, the Site must be rejected based on a specific answer) that require a closer review (for example, if the Site is missing a key piece of equipment that the Sponsor/CRO may be able to provide). You can define Response Flags on available answers in surveys so that when users select those answers in a Study Site or Outreach Target survey, Vault populates the Response Flag value on to the parent Survey record when a respondent selects it. This allows you to have greater visibility over answers that are potential flags for Study Site and Outreach Target surveys when reviewing survey responses.
In order to mark specific survey answers as response flags, you must configure the survey question as a Multiple Choice Question to be able to define specific flags for pre-defined answers.
About Electronic Confidentiality Agreement (eCDA) Survey Responses
Once configured in Vault, respondents can agree to eCDAs when completing a survey.
When a respondent, who has a Study Person record with the Confidentiality Recipient value in the Survey Respondent Type field, selects a configured answer on a survey and attempts to complete the survey, Vault displays a dialog box for the respondent to enter their Full Name and the unique verification code. Veeva automatically sends this unique verification code to the email listed on the Study Person record. The verification code is only valid for ten minutes after Vault sends the email.
Once the respondent enters the verification code and completes the survey, if configured, Vault generates a CDA document from a Formatted Output Template then files it as a designated Document Type in eTMF and sends a copy of the document to the survey respondent. 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.
Filing & Sending Completed Surveys
Once survey respondents complete their survey, Vault can generate a copy of the completed survey to save in TMF and send to the survey respondent. When an Admin configures this feature, Vault generates a survey response document and files the document under the designated Document Type in TMF and sends the survey respondent a download link for the PDF copy. The link to the document expires 60 days after Vault sends the notification.