This article describes how you can manage and track study countries and view details in Oracle Health Sciences Activate. We've included the following sections:
Tracking study country status
Each study country has a details page where you will see all the information you need to manage and track all the country’s documents and submissions. While there are several ways to access the study country details page, here are two simple methods to access from the Activate home page:
- On the Documents tab, click on a country code or bar in the bar graph.
- On the Milestones tab, click on the hyperlinked country name at the left side of the country milestone dashboard.
Once the country's details page displays, you can optionally "favorite" the country as shown below. When you favorite a country, you can use the toggle control on your home page to toggle the bar graph display to all countries or favorite countries.
If enabled for your account, country status labels display in the persistent header. Activate users who have appropriate permissions may edit a country’s status label, if necessary.
The image above shows the Country tab view with the milestones timeline. From the country details page, you can also evaluate site status and milestone progress. Click the Dashboard tab for the site milestone dashboard view below. We've described this dashboard in detail in Study Sites.
|details||what you'll find on the country details page|
|overall country status||
If enabled by your account, country status labels display in the persistent header. Preconfigured status labels include: Planning, Submitted, Dropped, Approved, In activation, On hold, Completed/Maintenance, and Closed. When configuring Activate, your organization may have preferred to use alternate display values and those values will display instead.
On the site status tab, you'll see the percentage of sites in the country by status (activation, activated, on hold, or dropped).
You'll see the baseline planned and actual dates for the milestones your organization tracks. The baseline date is the original date you or another team member estimated that the milestone will be met. Enter a new projected date and it appears as the planned date on the milestone timeline.
If you re-plan a date, you are asked to enter a reason. When the activity associated with the milestone is complete, the actual date automatically appears on the timeline.
You'll see a list of sites in the study country. You can also add and manage study sites status from the sites tab.
Note: click the Dashboard tab to view the site milestone dashboard.
|notes & communications||
Each time you or another team member enters a note while completing an activity, that note appears on the Notes tab. You can also enter notes without activities by entering them directly on the tab.
You'll see the status of documents tracked on the Document Activities tab. If you are managing document files in Activate, you will also see those files.
You can plan and see the status of study country-level submissions tracked on the Submissions Activities tab.
You'll see the list of alerts for this study country. You can filter the list by alerts intended for your role or just you.
See the procedures:
Tracking the number of planned sites
If you have the appropriate business role permissions, you can enter the number of sites you plan for a study country. Once we set up your study country, enter this number.
- View study country details
- Favorite a study country
- Add a new study country
- Change the study country name and ID
- Enter number of planned sites for a country
View study country details
On the home page, from the Actions menu, select View study country and site details.
Favorite a study country
- On the home page, from the Actions menu, select View study country and site details.
- Click the star to the left of the country name.
Add a new study country
- On the home page, from the Actions menu, select Add new study country.
- At Country, select the country name.
- At Process, select the process (configuration) you want to use.
- Enter the number of planned sites.
- Click Done.
Change the study country name and ID
- On the study country details page, from the Actions menu select, Edit study country.
- Change the name or ID.
- Click Done.
Enter number of planned sites for a country
If you have the appropriate business role permissions, you can enter or edit the number of sites you plan for a study country.
- On the study country details page, from the Actions menu, select Edit study country.
- At number of planned sites, enter a new number.
- Click Done.
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