Note: This feature is only available in Clinical Operations Vaults with Study Startup.
You can configure Vault to send surveys (Checklists) to external respondents. This allows you to poll contacts associated with an Organization in the context of a Site or Outreach Target. You can collect their responses without requiring them to have usernames and passwords, and keep all the information collected within Vault, streamlining your startup tasks. You can also include links to reference documents within your Vault that external respondents can view without the need to log in. You can include up to five (5) such links per question on your surveys.
An Admin must configure this feature, including the Send Checklist Based on Contacts action. You’ll then be able to see survey information on your Site and Outreach Target records.
When you trigger the Send Checklist Based on Contacts action on a Site or Outreach Target object, Vault confirms that the following is true about the object:
- It has a related Organization, and
- The related Organization record has at least one Contact Information record,
- At least one of those related Contact Information records has a value specified for email, and
- At least one of those Contact Information records with email has a Survey Respondent Type value matching that of the action configuration;
- Or if there is no related Organization, there is at least one Study Person with a value specified for email and a Survey Respondent Type value matching that of the action configuration;
- Any Study Person assigned as an email sender has both an active User record and a verified outbound email address, and
- There is only one Study Person for a given combination of From Survey Sender Type, Study, Study Country, Site, and Level (where level is implicit).
If all of those conditions are met, Vault creates a Checklist and invitations to it, and it sends out email notifications to the qualifying contact information records (see below).
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 30 days from when they are sent.
The Site Survey Invitation and Outreach Survey Invitation objects store a record for every invitation sent to a survey. From these records, you can:
- Generate New Link: Sets the existing record to Inactive state, 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 Inactive state and deactivates the associated unique link.
The Delivery Status column provides 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 status once per hour.
If a Site or Outreach Target survey fails to generate, Vault automatically sends a notification to the user that initiated the sending of the survey. Vault sends failure notifications when the survey creation fails. A notification will be sent if the sending of the survey is triggered via entry action into a particular lifecycle state or via user action.
Vault provides two other important status fields:
- Opened Date displays the date and time when a recipient first opened the email.
- Last Accessed Date displays the last date and time when someone clicked on the invitation’s corresponding link and was allowed into Vault to complete the survey.
You can configure completed surveys as related records in the Site and Outreach Target objects.
Red Flag Survey Responses
Out of the many questions in a survey, a select few are true “dealbreakers” (for example, the Site must be rejected based on the wrong answer) or “red flags” 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 red flags on available answers in checklists so that when users select those answers in a Site or Outreach Target survey, Vault copies the flag to the parent record. Similarly, if you deselect an answer with a response flag, Vault removes the value from the parent checklist. This allows you to have greater visibility over answers that potentially are red flags for Site Checklist and Outreach Target Checklist surveys. In order to mark specific checklist answers as red flags, you must configure the checklist questions and answers.