Manual Assessments [Setting Disclose = ‘Yes’]
Select the study in which you want to make a disclosure assessment.
Note: You can find the study you are looking for by using the search feature in the upper right corner of the screen.
Select Compliance from the Study Workspace.
Click ‘Check Out’ and select the corresponding Compliance Authority (in this example ClinicalTrials.gov).
On the ‘Manual’ column, double click on the field and set the disclosure to ‘Yes’. After setting the disclosure to Yes, specify a ‘Disclose Reason’ (for example, select ‘Required by law’ as a disclose reason).
‘Save’ your changes and ‘Check In’ the Study. The corresponding ‘Initial Protocol Registration’ Compliance Event is created.
Roles Automatically Added
Prerequisite:
The following steps assume that Steps 1 through 5 which are shown above are successfully completed and Protocol disclosure type is set to ‘Yes’.
Roles which are configured as "Is default" in the Decisions WF will get automatically added to the study.
Select Roles from the Study Workspace.
The corresponding ‘Initial Protocol Registration’ Compliance Event’s out of the box default roles have been added to the Study. These roles are added upon successfully assessing Protocol = ‘Yes’.
‘Check Out’ the Study. Once checked out, manually select which User(s) you wish to associate with each Role [users are selected from the corresponding dropdown].
Note: Click on the yellow highlighted area to view the dropdown arrow list.
After all the respective roles are assigned to the user, click on the ‘Save’ and ‘Check In’ tabs to confirm changes. The Roles for the ‘Initial Protocol Registration’ Compliance Event are now successfully assigned.
To manually add additional Protocol Roles by clicking on the ‘Add Roles’ icon and selecting additional Roles from the provided list.
Note: To apply this change, the study must be ‘Checked-Out’ first.