TrialKit offers flexibility in how locking and closing of a database can take place. The main steps are:
- Exporting all data
- Cancellation of study licensing
The following steps outline all the possible steps that are made in the process of closing a study:
1. Change study status to Locked
This is done in the period leading up to study closure. When a study is locked, new data past the date of lock cannot be entered. Existing data can still be modified and reviewed. This is reversible.
2. Change the status to Completed
This will put all data into a "read-only" state, but can still be accessed. This is also reversible. Note, this will not impact study licensing or invoicing (see step 4 below).
3. Export data.
This is done in four primary areas to get the main data, query data, audit history, and paper CRFs:
- Data Extraction
- Queries Report
- Audit History of events (optional step)
- CRFs (PDF format)
4. The final step is to determine if the source database needs to be retained in long-term archival by Crucial Data Solutions, or if the database will be permanently deleted. Archived studies do incur a minimal annual cost and are something to consider if requesting long-term storage or future access. Please contact your Project Manager, or firstname.lastname@example.org to initiate either one of these options and end the study licensing.