Initial PLS Compliance Event
NOTE: This functionality is available to all users upon implementation of the 2.18.3 release, but only those with the PLS license will have access to the PLS assessments and dedicated tracking. Please talk to your account manager if you would like to discuss managing PLS.
Step 1: Add a new Compliance Authority
Step 2: Select “Company” and click “Add”
Step 3: Under the “Company” Compliance Authority, “Plain-Language Summary (PLS)” will now display as a new Compliance Event
Step 4: Assess “Plain-Language Summary (PLS)” compliance event to “Yes” and Check In the study
Step 5: “Initial PLS” will now display in the Compliance Event manager
Step 6: Select “Initial PLS” compliance event to view compliance event details. Refresh the page in case you do not see the tasks under Workflow Manager.
Step 7: Assign users to each task
Task 8: Complete workflow
Task 9: Compliance event and workflow will be marked as “Completed”
Add an Attachment with PLS Attachment Type
Task 10: Navigate to the Attachment Screen and select “Add Attachment”
Task 11: Select attachment and select which PLS attachment type you are looking to attach. Allowable languages are: Spanish • German • French • Portuguese • Swedish • Chinese • Turkish • Dutch • Polish • Russian • Slovak • Greek • Hebrew • Italian • Japanese • Korean • Czech • Danish • Finish • Thai • Norwegian • Romanian • Bulgarian • Hungarian • Belarusian • Ukrainian • Arabic • Lithuanian • Latish • Moldovan • Malaysian • Serbian • Estonian
Task 12: New attachment will be added to the study
Adding Manual Plain-Language Summery (PLS) Compliance Event
Task 13: Check Out the study
Task 14: Select “Add” on the Compliance Event toolbar
Task 15: Select “Additional PLS” as the Compliance Event Type. Once “Additional PLS” is selected, the Attachments will be filtered to only those that start with “PLS…”
Task 16: Once “Title”, “Due Date”, and “Reason” are entered, select “Save”
Task 17: New manual compliance event will trigger
Task 18: Select the new compliance event to view the compliance event details and workflow manager
Task 19: Assign users to each task
Task 20: Complete workflow
Task 21: Navigate back to the compliance screen and both the compliance event and workflow will be marked as completed
Exporting to ST
User has the ability to submit attachment to ST/Engage just like any other attachment currently in the system
Ensure that the PLS attachment types are configured to be included in ST Submission by checking the settings in the Admin Portal
Admin/Data Dictionary/ST Submission