Release Notes

Site Staff in Site Connect

This feature empowers sites to manage their own site staff within Site Connect. Sites can view the staff tracked by the Sponsor/CRO and request changes to the staff list as appropriate, without external communication. Site Staff actions are available from the Site Staff tab under Site Profiles.

• Site users can add new site staff or edit existing staff Start and End Dates, Roles, and Responsibilities.
• When a site user creates or updates staff details, the Sponsor/CRO receives a request to approve or reject the change.
• The site can view the request status updated in real time in Site Connect.
• If approved, the user is granted access to Site Connect on the requested start date.
• If rejected, the site user who initiated the change receives a notification with the rejection reason.
• Navigation Updates include:
  • Site Profiles now houses Site Staff and Site Addresses.
  • Study Admin is relabeled to Site Settings and is at the bottom of the Site Connect menu.
  • Study Contacts is a new option on the Site Connect menu.

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Copy Responsibilities When Adding Site Staff

When creating or editing Site Staff, site users can use the Copy From dropdown on the Responsibilities page. This allows users to select an existing Site Staff member and instantly copy their assigned responsibilities to the staff member being added or updated. The copied responsibilities are checked and ready for modification, so users can make any necessary adjustments. The option to copy significantly reduces the clicks and time needed to select Responsibilities, especially when adding multiple Site Staff with similar roles.

Remember Site Staff Roles & Responsibilities

To provide a more streamlined user experience for site users adding other site staff to a study, the system retains the Role and Responsibilities field values that were initially selected and associates those values with the site staff. Going forward, when the site staff is added again, the remembered role and responsibilities will be automatically populated. These fields can be modified if needed.

File to SiteVault Duplicate Document Detection

With this feature, the system now checks for existing document versions in SiteVault when a user performs the File to SiteVault action, thereby avoiding duplicates from being created.

When a user selects the File to SiteVault action from an individual document and a duplicate version is detected, the system will present a confirmation dialog, providing the user with information about the existing document in SiteVault. From this dialog, the user can choose to cancel the filing to avoid creating a duplicate or proceed with filing the document to SiteVault. In instances where documents are filed to SiteVault in bulk, duplicate versions will not be filed if detected.

This enhancement ensures data integrity, saves site users time and effort by avoiding unnecessary data duplication and cleanup, and provides users with control over how to handle potential duplicates.

Site Front Door in VeevaID

The VeevaID homepage (id.veeva.com) list of studies has been updated to clearly display which studies users have access to in each Sponsor/CRO Vault. When a study is selected, users are navigated to the selected study's System Links tab in Site Connect. Previously, users could access individual systems from the VeevaID homepage, but there was no indicator of a study's sponsor or CRO. This enhancement provides a single gateway for site users to access their studies with more visibility of the Sponsor/CRO-to-study connection.

Payment Information Enhancements

This release includes several payment-related enhancements that aim to improve feature usability for site users:

• Site users can view payment details, including Paid-to-date and Pending amounts, in their local currency on the Payment Information page. In cases where payment requests involve different local currencies, the system will display amounts in Vault currency.
• To ensure data protection, placeholder help text is added to text fields on the Payments Information page, reminding users not to enter any patient identifying information.
• Site users can download payment letters in PDF format only from the Payments Information section.
• Two new standard lifecycle states have been introduced for Payment Requests: Paid (indicating payment has been processed) and Payment Pending (indicating payment has been approved and is being processed). These states enable site users to view which requests are approved to be paid, pending payment, or have been paid.

Set Site Connect Reply To Email

A study's Sponsor or CRO has the option to set a specific email address for replies to Document Exchange emails that are requesting documents. When a reply email address is set, Document Exchange emails that are requesting documents will include a Click Here option. Selecting this will generate an email that is auto-addressed with the correct reply-to email address, email title, and email body. This email address will also be set as the Sponsor or CRO notification recipient when a site uploads the requested documents in Document Exchange.This feature creates process alignment across all site users responding to these requests, and reduces the need to access study contact lists with every response.

Additional USN Sign Up Enhancements

This feature enhances the site USN search and sign up experience, including updates to the instructions and FAQs. These enhancements are automatically available for all Vaults leveraging USN Sign Ups:

• Signing Up from a Site Survey: The First Name, Last Name, and Email fields are pre-filled using the individual's record from the survey invitation.
• Signing Up from Study Site Addresses: The First Name, Last Name, and Email fields are pre-filled using the current user’s information.
• Using the FAQs:
  • Information entered on the USN Search or Sign Up page will be retained if users navigate to the FAQ and back.
  • The set of FAQs available through Surveys will differ from the FAQs available through the Study Site Addresses tab, ensuring that only relevant FAQs are available to sites.