Clinical Operations Vaults include Veeva Standard Questions, which are industry-standard clinical survey questions with common available answers. Admins can also create custom Standard Questions. Standard Questions are typically used in external respondent surveys in Vault Study Startup.
Standard Questions are stored as Library Question records and allow Vault to save survey responses as Stored Response records. Vault uses the Stored Response records to automatically populate the responses in future surveys sent to the same site or Principal Investigator. Standard Library Questions are provisioned in every Vault, but reusable response functionality is available only for site surveys in Vaults with Study Startup enabled.
Standard Question Types
All Standard Questions have an associated reusable response type: Organization or Principal Investigator. All Veeva Standard Questions are Organization questions, while custom Standard Questions can be configured as Organization or Principal Investigator questions. Vault uses the reusable response type to determine whether a survey respondent must enter or request a Universal Site Number (USN) to complete their survey, or to determine what information is used to retrieve stored responses.
Universal Site Number
If a survey includes one or more Standard Questions with the Organization reusable response type, the respondent is required to enter or request a USN, which is a unique identifier that Veeva assigns to each site that responds to Organization Standard Questions. When a respondent opens a survey that includes at least one Organization Standard Question, Vault displays a banner at the top of the survey which prompts the respondent to enter or select their USN.
The respondent can click View USN Suggestion in the banner to open a dialog where they can enter their USN, if known, or search for and select the USN associated with their site. If they cannot find their USN, they can request a USN. They must either select their USN or sign up for a USN before they can complete their survey. Veeva reviews the USN application and either approves or rejects the USN request.
For surveys that do not contain any Standard Questions or contain only Principal Investigator Standard Questions, a USN is not required.
Storing and Retrieving Responses
Once a respondent completes their survey, Vault creates a Stored Response record for each Standard Question. If the respondent requested a USN, Vault does not create Stored Response records until Veeva approves the request and issues the USN. For Veeva Standard Questions, Stored Response records are stored in both the customer Vault and a central registry.
For Organization Standard Questions, Vault saves the Organization and USN in the Stored Response record. For Principal Investigator Standard Questions, Vault saves the Principal Investigator and Principal Investigator Email.
After a survey is created for a site, Vault queries the Study Site’s Stored Response records for any standard Library Questions in the survey. For Veeva Standard Questions, Vault queries the central registry. Vault populates answers in the survey with the answer values in the Stored Response records. If a response’s Last Confirmed Date value is past the Reusable Response Expiration (Years) value, Vault does not populate the answer, and the respondent must manually answer the question.
When a survey respondent submits a survey that contains Standard Questions that already have Stored Response records, Vault updates the record’s Response Text, Site Survey, and Last Confirmed Date values.
Adding Standard Questions to Survey Templates
You can add Standard Questions to Survey Templates using the Visual Checklist Designer. To add a Standard Question in the Visual Checklist Designer, click Add Question from Library (
) and select the question. When you add a Veeva Standard Question, a Veeva icon (
) is displayed next to the question in the Visual Checklist Designer.
You can also add a Standard Question to a Survey Template by selecting a Library Question on the Survey Template’s Question Design record.
Managing Standard Questions
Veeva Standard Questions and custom Standard Questions are stored as Library Question records. Navigate to the Question Library to view and manage Library Question records.
You can create custom Standard Questions by creating Library Question records with the Reusable Response field set to Yes. See Checklist Question & Answer Setup for information about the other available fields.
You cannot create, edit, or delete Veeva Standard Questions.
Creating Custom Standard Questions
Create a Library Question record and populate the following fields when creating a custom Standard Question:
- Question Category: Select the Question Category.
- Reusable Response: Select Yes to configure this question as a custom Standard Question and enable Stored Response record creation for the question.
- API Name: Enter a unique API Name for the question. This field is required when Reusable Response is set to Yes.
- Reusable Question Type: Select whether Stored Response records created from this question are related to the Organization or a Principal Investigator. This field is required when Reusable Response is set to Yes. Vault uses this value to determine the type of reuse that should be leveraged when a survey is sent.
- Reusable Response Expiration (Years): Optionally, enter an expiration date in years for the Stored Response. Vault compares the specified expiration date to the Last Confirmed Date of the Stored Response to determine whether to reuse the response.
- Locked: When you save a Library Question record with the Reusable Response field set to Yes, Vault automatically sets the Locked field to Yes.
Modifying Custom Standard Questions
Library Question records for Veeva Standard Questions and their Available Answer records are locked and cannot be created, edited, or deleted.
You cannot edit or delete custom Library Question records for Standard Questions when they have associated Stored Response records. To edit or delete the question, delete its Stored Response records first.
Vault automatically sets Library Question records for custom Standard Questions to Locked on creation and they must be unlocked before editing or deleting. To unlock a custom Standard Library Question record, select Unlock Library Question from the Actions menu. Once it is unlocked, the Reusable Question Type, Reusable Response Expiration (Years), and Reusable Response fields are cleared. If the question is currently used in a survey, any edits you make to the question are not reflected on the survey.