Understanding Study License Agreements
Study Licenses Agreements (SLA) are legal documents, signed by both TrialKit and the Company using Trialkit. Study licenses are contracted in advance of study start via a study licensing agreement (SLA). Licensing is normally set up on monthly terms and are applied one month prior to the expected "go-live" through one-month post study completion.
Moving a study live, locking it, or setting it as completed are all statuses controlled by the user.
Once the study is finished with data entry, The Study Manager / Administrator can lock your database to prevent users from changing anything. At that point, TrialKit still considers the study live as far as licensing is concerned. The way to stop licensing is to complete a Study Close Out Form (available in the on-line help within TrialKit) allows you to archive or delete a study.
Note: A 30 day notice is required once the Close Out Form is received to close or archive a study.
Archiving removes all users from accessing the database, but keeps it in its current state and continually backed up for the long term. Studies can also be UN-archived at any point via re-initiation of the study license.
A nominal archiving fee is applied to each archived study. With the fee kept current, an archived study will remain in the system indefinitely or until removal is requested. If the archive fee lapses or is discontinued, there is a 60-day grace period before the study is removed. Notification messages are sent during this period to the primary account Administrator listed on the Account Manager page.
For more details on how to close a study, click here.