The Create New Trial page allows users to build new clinical trials. Please see the entire process outlined below.
To create a new clinical trial:
1. From the CTAM dashboard, select the Create New Trial button.
2. Input the Trial Name, Start Date, and Projected End Date. Click the Create Trial button.
NOTE: The Trial Name must be unique.
3. On the Applications tab, click Add Applications to display available applications in the right-side panel. Place checkmarks next to the desired applications. Click the Save button.
NOTES:
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- The list of available applications are the applications the CTAM Admin has associations with in Secure Access Manager (SAM).
- Once the applications are saved, the role name and role info for each of the application (if) specified will show on the right-side panel.
4. Navigate to the Study Members tab. Click the Add study members button.
5. Search for the desired members. Select the + icon to add the members to the trial.
NOTE: Once the study members are added, the Subscription Status, Application Name, and Assigned Role for each selected study member display in the right-side panel under the Applications tab.
6. Select the desired role from the Assign Role dropdown. The status changes with a yellow indicator and a – symbol from where the user can cancel the role request. Click the Save button to send the role request.
NOTE: A confirmation message displays.
7. Use the toggle provided per application to request subscriptions. Click the Save button to send the subscription request.
NOTE: A confirmation message displays.
Subscription Status Icons:
- Green shield with tick mark means the member is subscribed to the application.
- Grey Toggle button mean the member is not subscribed or or the subscription request was not sent.
- Green toggle button mean the subscription request was sent.
- Yellow shield with tick mark mean the subscription was suspended.
- Disabled grey toggle button mean the subscription request was denied.
8. Navigate to the Investigators tab. Select the Add Principal Investigator option and search for the required person.
NOTE: Users can add multiple Principal Investigators.
9. Select the Add Sub Investigator option. Search the desired members.
NOTE: Once investigators have been added, the Subscription Status, Application Name, and Assigned Role pertaining to the selected Principal or Sub Investigator(s) display on the left. The admin can now assign and request a role, as well as request an application subscription for the Principal Investigator and Sub Investigator using the same steps above.
10. Navigate to the Sites tab.
- To add an existing site, complete a search. Click Add Site. The Site Details display in the right-hand column.
- To add a new site, select Create New Site. Complete the Site Details in the right-hand panel. Click the Create & Add button.
11. Once you complete all trial details, click Done.
NOTE: The trial details can be saved at any time during the workflow by clicking the Done button.