Oracle's goBalto Activate is a web-based tool that sponsors, CROs, and sites use to collaborate, manage, and track site activation activities. Because Activate is hosted in the cloud, study teams get real-time, anywhere access to study startup status, metrics, and data.
This article provides an introduction to Activate workflows and describes how users navigate. We've included the following sections:
- Activate workflows
- Activate navigation
Workflows reflect your SOPs and drive the work
Activate workflows guide you to complete and track the specific documents and activities required for any country, investigator, or study based on your SOPs. If your requirements change, just update Activate’s workflows accordingly.
Activities guide the work
Activate automatically records when each activity starts and ends. No need to compile status reports — now everyone sees real time study progress in Activate.
Activate’s default configuration manages these common scenarios:
- Track documents and submissions for a study country or site (for an initial protocol)
- Protocol amendments
goBalto Project Manager
Track investigator and staff-specific documents with goBalto templates that define:
- Documents and submissions required in each study country
- Activities required to process each document or submission
- Business roles and permissions that a team member must have to complete each activity
- Activities that must be complete before others start (dependencies)
Get study status in real-time
Activate shows everyone on your study team which sites have started or completed documents and submissions and how long it took to complete them.
Team members see the status of sites, documents, submissions, and notes in one place. All team members see status at a glance.
See activities when it is time to complete them
Once your workflows are defined, they automatically create the activities required to track documents and tasks you care about.
You can use Activate’s Workflow Wizard at anytime to create new activities. For example, when there is a protocol amendment, you can use the Workflow Wizard to specify the country or investigator documents that are impacted; Activate will create the activities required to track them.
Add ad-hoc documents as needed
Activate’s workflows are configured for all the documents your organization wants to track, but sometimes you need to track others you did not expect. You can easily add new documents and select from several preconfigured workflows to track them.
Top navigation bar
Activate’s top navigation bar allows easy access to major areas of the application from any page. Hover over the dropdown menu items to expand them and click any item to navigate to that page. To access your study document library, click the Study library menu item.
Activate also features a persistent header, just below the top navigation bar, which displays study, country, and site information. You can use the study, country, and site dropdown menus in the persistent header to quickly navigate to any corresponding page that you have business permission to access.
You can use the global search feature, located to the right of the Activate logo, to navigate to any study, country, or site page. Study sites can be queried by the institution name, site number, or a PI/staff member name associated to that site.
You can also refine queries by typing multiple keywords into the search box, separated by spaces. Click on a search result to navigate to that page, or use arrow keys and press Enter on your keyboard to select a page to view.
To use Global Search, enter the leading characters of your study name, country name, PI name, institution name, or CRO ID (e.g., Study name: Contract test, you can search starting with Con). Your search term must start with the leading characters of a string of text within any of the above fields.
You can also search with leading characters directly after a separator (e.g., CRO ID 1234/5678 - you can search for 1234 or 5678 because the space and the / are separators).
Access your profile
At the upper right of any Activate page, hover over your first name and click My profile to see your profile. Here, you can change your email address, manage email reminders, see your password expiration date, or create a new password.
Getting around Activate
Familiarize yourself with a few basic screens to understand how to navigate from one page to the next.
- Home page
- Country details page
- Site details page
To get back to the home page at any time, click the Activate logo at the top left of any screen.
On the Home page, you can access studies, manage activities, plan milestones in bulk, and view alerts across studies and sites.
The Home page has two distinct dashboard views, Document Dashboard and Milestone Dashboard. Activate users can set either dashboard as their default view for all studies using a “Display settings” control at the upper right of the Home page. When viewing either dashboard, users can toggle between document and milestone view as preferred.
The image below shows an example of a Home page that is set to display the Document Dashboard. To navigate to the country details page, click the country bar chart or the country code label beneath it; you can also click Actions, then click View study country and site details, and select the country.
The image below shows an example of a Home page that is set to display the Milestone Dashboard. The dashboard is highly interactive and allows for on-the-fly changes to the view. Users can quickly add, remove, and optionally save filters for countries and milestones; enable/disable display of milestone statuses; select dates or a date range for the timeline; and toggle from month to week view.
Most data points on the dashboard are interactive:
- Country names and all circles along a country’s timeline bar link to the country level page.
- Status circles in the icon key above the dashboard are clickable to enable/disable. Disabled status(es) do not display in the dashboard view.
- For unplanned milestones, a calendar icon at the far right of the country timeline bar indicates the number that are unplanned per country. Users can click this icon to view the unplanned milestone(s) and click a pencil icon to display the planning pop-in.
- When users hover over a status circle in the dashboard, an overview tooltip displays:
- country and country status
- number of milestones (e.g., 1 of 5) if multiple milestones are set for the same date
- milestone names and dates
- the name of the user who added a note about a re-planned milestone and note icon. Users can click the note icon to view the note text
Country details page
On this page, you can view your list of sites and their status, access country-level notes and communications, manage country-level documents and submissions, and view country-level alerts. You can also view the site list and click through to see the study site details page(s).
You can “favorite” a country so you can filter the country list to show just those you are interested in. Favorites display at the top of the list and have an orange star to the left of the country name.
You can also Favorite a site to highlight those sites you in which you are interested. Again, Favorite sites will display at the top of the site list and have an orange star.
To get to the site details page, on the country details page, click the site name. You can also use the persistent header to select a new site from the sites dropdown menu or update the status of your current site with the site status dropdown menu.
Site details page
On the site details page, you can view individual site status, site notes and communications, manage site documents, submissions, and staff, and view site-specific alerts.
Tracking work with activity widgets
Activate guides your work with smart activity widgets. A widget is part of a web page that performs a specific, useful function. For all activities to be performed by someone with your job role, you will see activities listed in the Alerts section of the study country and site details pages. Just click the alert to expand the activity widget and indicate activities that are complete; Activate updates the status and metrics accordingly.
Activate includes four widgets to manage:
- IP release reviews
See the Managing and tracking contracts article for workflow details.
See the Managing and tracking documents article for workflow details.
See the Planning and tracking submissions article for workflow details.
IP release review widget
See the Managing and tracking IP release reviews article for workflow details.
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