Use MyVeeva Studio to create, view, and edit the survey collections for your study.
Collections include the following, which represent your study protocol:
- Surveys (ePRO and eClinRO)
- Languages and translations
- Schedules and notifications
Collections exist in a draft state until they’re approved.
Only approved collections are shared with sites in SiteVault and assigned to participants and/or caregivers.
Navigating to the MyVeeva Studio
You can access MyVeeva Studio from your Clinical Operations Vault if you have read access to the study and if you have access to the Launch MyVeeva Studio action.
Complete the following steps to access MyVeeva Studio from your Clinical Vault:
- Navigate to and open the study record.
- From the All Actions menu, select Launch MyVeeva Studio.
Viewing Collections For a Study
You can maintain and view all previous collections that have been created for a study even if they’ve been upversioned or superseded. From the Collections page of MyVeeva Studio, you can review the number of surveys, schedules, and languages for each collection in your study. If a collection was created by upversioning an existing collection, it may have an associated summary of changes
From the Collections list, you can view all collections that have been created for your study and their details, which include:
- Version: The version number of the collection, which is tracked in major versions.
- Status: The status of the collection. Collection statuses include Draft, Approved, Superseded, and Deleted.
- Draft: The collection hasn’t been approved yet and can be edited or deleted. Approving a draft collection supersedes the collection that’s currently approved.
- Approved: The collection is approved for the study. Only one approved collection can exist for a study at one time.
- Superseded: The collection was previously approved but has since been replaced by a new version. Each site will continue using the superseded version until they approve the more recent version in SiteVault.
- Deleted: The collection was deleted while still in a draft state. It was never shared with sites or assigned to participants. No other versions were affected. Approved On: The date the collection was approved, if any.
- Surveys: The number of surveys in the collection.
- Schedules: The number of survey schedules in the collection.
- Patient and Site Languages: The number of languages in the collection.
- When all translations for all languages in a collection are uploaded, the value will be shown in green font. Hover over the value to see the list of completed languages.
- When one or more translations for languages in a collection haven’t been uploaded, the value will be shown in red font. Hover over the value to see a list of the completed and incomplete languages.
- Summary of Changes: The summary of changes is only provided when UAT is started on a collection that was created by upversioning. Only collections that have entered UAT show a summary of changes.
Creating a Collection
You can create a collection in the MyVeeva Studio to begin configuring your study’s surveys, languages, schedules, and notifications.
Complete the following steps to create a new collection:
- Launch MyVeeva Studio from a study in your Clinical Vault
- On the Collections page, select Create New in the upper-right corner
- On the new Collection page, the following actions are available to you from the left menu > Actions (ellipses) menu:
- Delete Collection: You can delete the collection if created in error.
- Copy UAT Setup Code: See Performing User Acceptance Testing (UAT) on a Collection.
- Generate New Overview: See Exporting PDF Overviews of a Collection
- The following tabs are available in the left menu:
- Study Details: The details shared here populate the Study Home screen in MyVeeva for Patients. You can use this space to communicate important study information to patients and upload your logo. Study Home will also include a space for sites to provide primary contact information.
- Surveys: Manage your current list of surveys or add new surveys (create new or add from a library).
- Languages: Configure which languages are available for your collection and manage their translations.
- Events: Create and manage study events to designate the visits and study milestones at which surveys are assigned to patients and site staff.
Viewing the Source of a Survey
To see if a survey in your collection was sourced from the Veeva Library, your customer library, or is specific to your study, complete the following steps:
- Open a collection.
- In the Surveys tab, find the Source column.
- In the Source column, hover over the dot for the survey. The survey’s source is displayed.
Tracking Reviewed Surveys
When a survey requires review from the agency or practitioner who owns it before it can be used in your study, you can track its review status in MyVeeva Studio. Surveys sourced from a library inherit the value of the field in the library survey. Generally, once a survey has been reviewed by an agency or practitioner, it doesn’t need to be reviewed again for use in a new study; however, contact the agency or practitioner to confirm.
To change the review status for a survey, complete the following steps:
- Navigate to a collection.
- In the Surveys tab, locate the Reviewed column.
- In the Reviewed column of the survey, select Yes, No, or N/A.
Tracking Licensed Surveys
When a survey requires licensing from an agency or practitioner for its use in your study, you can track its license status in MyVeeva Studio. Generally, a survey owned by an agency or practitioner needs to be licensed for each new study using it. By selecting a Licensed status of Yes, you attest that you obtained a license for the survey.
To change the license status for a survey, complete the following steps:
- Navigate to a collection.
- In the Surveys tab, locate the Licensed column.
- In the Licensed column of the survey, select Yes, No, or N/A.
Exporting PDF Overviews of a Collection
You can generate and export a ZIP file of PDF overviews containing information about your study’s surveys, including:
- ePRO surveys (eClinRO surveys are not included)
- Additional details about surveys, if applicable
- Survey preview links
- Languages supported by the study and their associated translations
- Definitions of terms
- Approval date
- Version history and a list of changes, if applicable
- Study Home preview
PDF overviews are generated for each supported language. The source English content is always included for comparison.
This overview can be used to aid your study’s local or central IRB or EC approval as it compiles all the material that participants and/or caregivers will see for your study’s ePRO.
Complete the following steps to generate and export a ZIP of PDF overviews:
- Select a collection from the Collections list.
- To generate a new overview, from the Actions menu, select Generate New Overview.
- Note: Large files may take up to one hour to complete. You can navigate away from this page and return later to download the overview.
- To download the latest generated overview (if available), from the Actions menu, select Latest Overview.