General Overview of Vestigo

Contents

1. General Overview
2. Home Screen
3. Navigation Menu
4. Protocol Snapshot
5. Download this Document

General Overview of Vestigo

Vestigo is an application to support investigation drug services for the management of the drug therapy used as part of a research protocol. Vestigo features tools to assist with protocol management, full electronic virtual inventory with drug accountability, dispensing and labeling of prescriptions, protocol billing management and reporting.

Vestigo is a web-based application developed by the McCreadie Group. Vestigo is compatible with Edge, Firefox, and Chrome browsers, and it is always recommended to use the latest version of these browsers for optimal performance.

Authentication

Each client will be provided with a specific URL to access Vestigo.

By default, all clients will have Okta, an identity management provider, enabled for authentication. Okta can support authenticating into Vestigo with email address and password, or with organizational credentials, also known as Single Sign-On (SSO). If using SSO, the email address used to create the account in Vestigo must match what is associated with the user’s network ID.

This integration will increase security to better align with organizational policies and help ensure that your account and Vestigo data stay secure. Granting roles (permissions) will continue in Vestigo.

When an account is created for a new user, users will receive an account activation link in their email to set their password. Users will also need to create a security question as a secondary form of security. Users will authenticate with the email address associated with their account in Vestigo.

On legacy Vestigo authentication, when an account is created for a new user, users will receive an account activation email with a password to use to log in with. The user can update their password under My Account, if desired.

In either instance, account usernames will still be used in Vestigo for all transactions as the recording party.

Forgot Password

If you have a login but have forgotten your password, you can click the Forgot Password link on the login screen.

In legacy Vestigo, on the Forgot Password screen, enter your username and click Reset Password. Vestigo will reset your password and send you a new one by email. Please note that the new password is sent immediately but can be delayed by hospital email systems. You should check any junk mail or spam folders in your email if it doesn’t show up in your inbox.

When Okta is enabled, the user will receive a link to reset their own password. The user will need to know the answer to the security question that they provided on initial login. If the user is unable to answer the question, they will need to contact support. If the site is authenticating with SSO, they do not need to reset their password.

If your account is locked, the system will not send a new password. A locked account will unlock automatically after 5 minutes. Neither Support nor a site System Administrator or other site role can unlock an account.

Select Facility

If your site has more than one  IDS facility and you also have a role in more than one facility, you may be presented with a screen asking you to select which facility you wish to log in.
Select the facility and then click the button to finish the login. If your site only has one facility or if your login is set to default to a particular facility, you will not see this screen.

For sites with multiple facilities, it is important you are logged into the correct facility. Being logged into the correct facility will ensure you are performing transactions with inventory in that facility’s inventory locations, and the visible alerts for the facility on the home page

If you have multiple facilities at your site and you need to switch to another facility, select the Switch Facilities option from the Main menu. This will bring up the screen to select the facility you wish to log in.

Vestigo Home Screen

The Vestigo home screen is the starting point for all Vestigo functions.

The home screen consists of the following elements:

1. Vestigo Blue banner consisting of Profile settings and the Help & Support menu
2. The green utility menu consisting of high-level functions and
3. Alerts for the facility currently logged into to.
4. Protocol search for finding protocols
5. Most recently used protocols – the last 5 protocols you’ve accessed
6. Login information including the user, the facility and the login time on the footer of the page

My Account

My Account screen provides users with a view of their account details. This section will also contain set-up for verification by PIN or fingerprint.

There are four sections to My Account:

• Profile: Details about User and Security User roles
• Competencies: Details regarding user competencies
• Sign-on: Default Log in Facility and option to change your password
• E-Signatures: PIN/Biometric Key set up, if functionality is enabled.

Profile Tab

This section displays demographics related to your contact in Vestigo. It will also display your security roles by facility. In Vestigo, users can have different security roles for each facility they belong to, but only one username/password per email address. Users should not be assigned to both a pharmacist and technician role as this may cause conflicts in user functionality.  

Sites can adjust permissions to meet their organizational needs and are responsible for granting access to Vestigo which includes read only access for study coordinators/internal auditors and monitors. Users can edit their own information.

Competencies Tab

This section will display the users completed competencies, the date they were completed, the user who registered the completion in Competency Management, and the recorded date (the date the competency was entered into the system). The user can also print the certificate of completion from this screen.

Sign On Tab

If a user has access to multiple facilities but uses one more frequently than another, they can set their own facility default. A user can use Switch Facilities in the top right corner, to change the facility they are logged into. The user will only be able to select a facility for which they have role assigned to them in.

On legacy Vestigo Authentication, users can change their existing password on this tab. The user will be required to enter their old password and then the new password twice to complete the change. Passwords will only be updated if they meet the password requirements displayed on the .

If using Okta SSO, updating your password on this screen has no effect on your account.

E-Signatures Tab

If functionality is turned on (in Application Administration), users with a role that provides the Verify permission, will set up their PIN or Biometric Key under E-Signatures.

When E-signatures is turned on, a user can set up, edit, test or delete their PIN under My Account – E-Signatures. If the user doesn’t set up a PIN prior to verifying a prescription, they will be able to set it up directly from the prescription screen.

To “test” the PIN, a user will select “Test”, enter the PIN and select “Submit”. Once they do so, the screen will indicate if the E-signature is “applied” (correct) or “incorrect”.

If the site utilizes a Biometric Key, such as a fingerprint, the user can set up this under the same section.

Please see our manual titled “Entering a Prescription” for more information regarding E-Signature verification.

Searching Protocols

To search for a protocol, enter your search term in the search box. You can search by any of the protocol numbers, the IRB number, the sponsor, the primary investigator, or any part of the protocol title. Protocols that are closed or open can be found through this search (may need to toggle to include closed protocols). After clicking search, the matching results will be displayed for your selection. If only one match comes back, you will automatically be directed to the Protocol Snapshot.

Other Main Screen Options

The main screen contains several links and options to select.

Help Center

Vestigo and Vestigo Verify offer a Help Center with all documentation and manuals available to users. Vestigo users will be able to access the Vestigo Verify Help Center and view the documentation related to Vestigo Verify

Users can search all documents for a specific topic rather than looking through several manuals for the needed information. Additionally, from the Help Center users can submit a ticket using a form found in the Help Center

For situations that require immediate assistance, users can still call support at (734) 548-9007, extension #2 or email support at support@mccreadiegroup.com.

About Vestigo

Indicates the version of Vestigo being used. All client sites are on the same version and receive continuous updates.

Logging out

When you are finished using Vestigo, be sure to click the Log Out item on the menu. Logging out will prevent anyone else from using your session.

It is important to only have one window of Vestigo open at one time.

Vestigo Navigation Utility Bar

Across the top of the Vestigo screen there are 10 tools for additional functionality and reporting across all Vestigo facilities and protocols. Each tool is briefly described below. An 11^th option will be visible if you are a site user and a Billing Portal user. In depth information is provided within the manual related to functionality

Protocol Search

This is the Main landing page for Vestigo. Protocols and Alerts can be accessed from this screen. Users can also select the Main link in the top right corner to return to this screen.

Address Book

The address book contains contact information for all users and Protocol Contacts. External Monitors should not be added to the Address Book but rather through the monitor pathway. Users can enter contact specific and prescribing information such as DEA, NCI, CTEP and NPI Identifiers and Expiration Date, and Department or Service. This information will enable users to establish contacts on the protocol. Identifiers, designations, and expiration dates for identifiers will allow users to track and update prescribing information, as needed.

Any changes to a contact’s address book entry can be reviewed within the contact audit trail.

Site users can inactivate any address book contacts who are inactivated on all protocols and billing accounts.

Sites should continue to manage site user accounts within Application Administration – Add/Edit User Accounts.

For additional information, please see our Address Book and Protocol Contacts manuals for more information.

Billing Management

All billing functionality and reports are available in the Billing Management dropdown. Creating and managing fees that are used throughout Vestigo are done in this menu. Please review the Billing Management Manual for more billing information.

Inventory Management

There are six inventory related functionalities within this dropdown menu. Users can use the functionality within Inventory Management to perform:

• Cycle Count – Recording a cycle count for an inventory location
• Drug Search – Searches for drugs within the site instance
• Inventory Send Out (multiple protocols)
• Shipment Receipt search - Searches for receipts within the site instance
• Temperature Excursions – Recording a Temp Excursion
• Temperature Logs – Adding temperature documents to inventory locations

Protocol Management

There are six protocol related functionalities with this dropdown menu. Users can use the functionality with Protocol Management to:

• Competency Management
• Facility Documents
• Manage Templates
• Manage Workload Templates
• Manage Checklist Templates
• Monitor Visits

Reports

The Vestigo Reports screen serves as a repository for on-demand reports that can be executed across protocols. Many of these reports include filters to narrow down the results. The reports are organized into the following categories: Protocol, Inventory, Prescriptions, Workload, and Monitors.

Process Returns

Users can utilize Process Returns to access the participant’s dispensation returns pathway. By entering the Rx Number and refill number, users are directed to the appropriate pathway to document the returned prescription.

Search Subjects, Rx’s, and Patient Visits

Users can use the Search Subject option to review or confirm participant enrollment or to locate what protocols the participant is enrolled in.

Users can use Search Prescription to:

• View Rx Details
• Record a Patient Drug Return
• Review or upload Rx related documents
• Navigate to the Patient’s Profile screen

Users can use Search Patient Visits to review upcoming visits using the filters on the screen.

Calendar

The Calendar is facility-specific and displays all monitor visits, participant appointments, and any available slots that a monitor may request to access a protocol. All monitor requests must be approved by the site before access is granted. Please refer to our Calendar manual for a detailed overview of its functionality.

User Forum

Client sites use the User Forum to communicate with other Vestigo client sites. All users with an IDS level role have access to the forum. Other users can be granted access by adding the permission to their role.

Billing Portal

Only visible if your account has Billing Portal permissions. Generally reserved for finance users, however, this section allows users to run reports and view charges on a billing account if they are assigned as a Billing Account Contact with Billing Portal access.

Protocol Snapshot

The protocol snapshot is the main view of the protocol and consists of eight tabs of information.

At the top of the page is a protocol information panel that lists out the protocol title and other key information. This panel will be repeated on all screens that are in the context of a single protocol.

The protocol snapshot tabs are:

Item	Description
Protocol	Key information about the protocol
Inventory	Functions related to managing the inventory
Patients/Subjects	A list of enrolled patients/subjects and functions to enroll and manage participant enrollment
Protocol Documents	Documents related to this protocol
Transaction Documents	Documents attached to various transactions
Temperature Documents	Documents related to inventory locations used on the study
Billing	Functions to view charges and add ad-hoc charges to this protocol
Workload	Displays workload tracking, ad hoc additional workload
Competency Access	Manage and review details related to competency on the protocol
Contacts	Contains the protocol’s contacts
Checklists	Set up and manage various tasks to complete for the protocol
Budget	Set up and manage budgets for the protocol
Billing	Review, ad hoc and manage charges and fees
Workload	Review, ad hoc and manage workload effort
Access Codes	URL links and passwords related to a specific protocol
Reports	Key protocol specific reports
Monitor Visits	Optional pathway to provide access to monitors for this protocol

Tabs of a Protocol

Protocol Tab

The protocol tab contains key information about the protocol including the status, sponsor, study design, protocol group, binder location, facilities where the protocol is available, and a description of the protocol. You can also print a protocol binder cover sheet or print a protocol label from this tab. Depending on your security role, you may also have options to edit the protocol, close out the protocol and view the audit trail.

Inventory Tab

The inventory tab displays the drugs in the protocol and provides access to functions like receiving or adjusting inventory.

Patients/Subjects Tab

The Patients/Subjects tab lists out the patients/subject enrolled in the study. From the list, you can click on the medical record number to go to the participant’s profile. There are also links to enroll new participants and manage existing participants.

Protocol Documents Tab

Protocol documents are various documents, manuals, communications, and such related to the protocol and daily functions of the protocol.

Document Section	Examples of File Types
Protocol Information	Protocol versions, Pharmacy Manual, IB, MSDS
Dispensing Guidelines	Summary sheets, Fast Facts
Communication/Memos	Expiry memos, correspondence
Order Documents Viewed on Dispense	Documents that pop-up for viewing after selecting an Order when dispensing to a participant
Other	Miscellaneous
Master Protocol Forms	Temperature Excursion Forms, Reorder Forms, Preparation Worksheets
Historical Prescriptions	Orders, IWRS/Treatment assignments, completed preparation worksheets uploaded to protocol prior to Vestigo 5.1
Historical Shipping Receipts	Shipping receipts uploaded to protocol prior to Vestigo 5.1

 

Transaction Documents tab

Transaction Documents will be those linked or associated to a particular transaction within Vestigo. This associates a given file with exactly one transaction and allows files to be searched and managed easily within that pathway. The files will then be reflected within the corresponding Document Section on the Transaction Documents tab.

Document Section	Associated Transaction Pathway
Shipment Receipts	Receive Shipment
Prescriptions	1. Search Prescriptions 2. Dispense on the participant profile of the protocol
Temperature Logs	Inventory Management > Temperature Logs
Patient-specific documents (Consent, Enrollment, Randomization)	Participant Enrollment
Historical Shipping Receipts	Files previously uploaded on the Shipment Receipt, prior to Vestigo 5.1

Temperature Documents tab

Temperature Documents are entirely added and controlled in the utility menu Inventory Management – Temperature Documents. If temperature documents were uploaded to the Inventory Location in the utility menu and the protocol has inventory that matches those locations, the documents will automatically pull in. For additional information, please see our manual and video on Temperature Documents.

 

Document Section

Temperature Logs

Calibration Certificates

Temperature Excursions

Other

 

Competency Access

Create and manage all protocol related training to be completed before use of the study per user role.

Contacts

Contains the protocol’s contacts including their role, email, phone number, and whether they are an authorized prescriber. Please see additional information on contacts such as External Monitors, Study Coordinators and Internal Reviewers in this guide.

Checklist

Create and manage various checklists to ensure all tasks are completed and documented as needed.

Budget

Create and manage various budgets to be negotiated and documented for the study. These can be pulled into the fees automatically.

Billing Tab

The billing tab allows you to view or modify charges, as well as adding an ad-hoc charge to the protocol.

Workload

Review and capture effort in terms of minutes for completing tasks and maintaining the protocol.

Access Codes

Vestigo can save access codes for specific protocols. These codes can be restricted to a specific person or accessible to all protocol users. Users can save login details, passwords, URLs, and comments. Multiple access codes can be added, but passwords must be hidden when saving the information.

Reports Tab

The reports tab contains essential protocol reports, including the Current Inventory Report and dispensing reports, but many more.

Monitor Visits tab

This section allows you to add an external monitor to the protocol and schedule visits with them. You can also view all visits scheduled on this protocol or any notes and actions that the monitor took during a visit.