Closing a study and submitting for subscription suspension or termination
The following outlines the steps required to properly close out a single study in TrialKit.
After all internal data management, clinical, and site tasks (as defined by your organization) are completed, the following steps should be taken prior to closing a study.
1. Change Study Status to “Locked” (aka “Soft Lock”)
When a study is locked, no new data beyond the date of lock can be entered, however, the “Locked” status is reversible by the Client at this point. Existing data can still be modified and reviewed, and the TrialKit database provides full accessibility to the study as long as contracted monthly fees are paid in accordance with the accepted terms.
2. Export Primary Data
Subject data extraction - Be sure to do this separately for each version of the study that subjects reside on:
Subject data entry audits
3. Export Supplemental Data
Along with data extraction, it is helpful to export several other components for future reference:
Consent report (if applicable for the study)
4. Change Study Status to “Completed” (aka “DB Lock” or “Hard Lock”)
This is where licensing fees will stop for the study on the month following the status change. Completed status puts all data into a “read-only” state. Existing data in the study database may still be viewed, but cannot be modified.
Once the study is set to “Completed,” it cannot be moved back to “Live”. Do not move the study to "Completed" until all study activities (including data exports) are completed.
Study status function comparison
| Locked | Completed | Archived | Deleted |
Create New Reports | ||||
Report Viewing | ||||
Data Exports | ||||
Access/View Subject Casebooks | ||||
Modify Data | ||||
New data Entry | ||||
Change study status | ||||
Data retention | Retained on primary servers | Retained on primary servers | Retained on primary servers | Backed up for 90 days and then deleted |
In summary, both archived and deleted studies will become inaccessible to users. Archived studies are retained and backed up indefinitely with supporting archive licensing. Deleted studies will become unrecoverable after 180 days.
If users were last logged into a study that becomes archived or deleted, the user will be auto-redirected to the first available study in their list.