Before, making changes to study status, be sure to understand the difference between Provider sites and Administrative sites.
Studies can be set with the following statuses:
When a new study is created, its status will be "In Development." Subjects can be enrolled and tested from any Administrative sites. Note, once a study has been moved lived, it will not be able to go back to In Development unless the study status is reset.
When the study is Live, any site can enroll new subjects as long as IRB approval and site documents are completed as dictated b the study design.
This option will not appear unless the study is live. Suspending a study can be done at any time to temporarily close the study. During this time, provider sites will be unable to enroll subjects or edit existing subject records. Due to the ability to run multiple versions of a study, suspending a study due to protocol amendments is not necessary.
When a study is Locked, provider sites cannot enroll new subjects or create new records for existing subjects after the lock date. Using this option is a good way to shut down a study but still allow sites to complete data entry on past records.
When a study is completed or closed, provider sites cannot enter any data. All records are read-only.
After selecting a new status, enter a reason (required), and select the "Change Study Status" button.