Lock and Unlock a Study

Prevent further data entry or modifications after the data is reviewed and finalized.

You can lock or unlock a study only if the "Lock or Unlock Study" operation is assigned to the user role.

The Lock and Unlock options are available in all the three lifecycles: Production, Development, and Quality Control. However, the lock and unlock operation is applicable only to the Production lifecycle.

Lock a Study

The following validations are performed when you lock a study:

• Latest job's execution status for all the production lifecycle data loads (all input models - for example, InForm, Clinical One, file), transformations, and validation check jobs are either in Successful or Warning status (not in Failed or Executing status).
• User interface provides a list of the "Failed" and "Executing" status jobs for you to review with a message Please review the list below and choose to either 'Lock' or 'Cancel' to proceed.
• If you choose to lock the study, the system suspends all the scheduled jobs and does not allow any new job to execute. The currently "Executing" status jobs continue until completion. The system does not validate if the ongoing jobs fails or succeeds.

Once all validations are successful or if you choose to lock a study after reviewing the validation list, the study lock process does the following:

• Suspend the scheduled jobs and data loads only in the Production lifecycle.
• User interface displays the lock icon with the study name on all screens as the study is locked.
• Transformation loading data from another study does not trigger while the study is locked when the external study data is updated.

For a locked study, you can perform a data load, execute transformations/validation checks, and create/edit discrepancies. However, when you perform any of these tasks, a prompt appears to confirm if you want to proceed. These actions are displayed in the lock history report.

For a locked study, tasks that do not modify the data or discrepancies are allowed but are not displayed in the lock history report. For example, export, blinding, unblinding, and so on.

To lock a study:

1. On the Home page, select a study.
2. From the Action drop-down list, select Lock.
3. Select one of the following Lock Type options: Interim or Final.

   Note:

   Both the Interim and Final lock type options have the same functional behavior. These two options are provided only to capture the intent of the lock in the lock history report.
4. From the Lock Reason drop-down list (mandatory), select one of the following values:
   • Adverse Event Analysis
   • Interim Analysis
   • Others: If you select Others, enter a reason in the Other Reason field.
   • Study Audit
5. To create a snapshot label:

   Note:

   The label name of snapshots for interim and final lock types are in the format "Interim_Lock_<timestamp>" and "Lock_<timestamp>" respectively. This is to easily identify the snapshots taken as a part of the lock activity by looking at label name.
   1. Select the Create a snapshot label checkbox.
   2. Select a data model.
6. Click Lock Study.
7. Click OK.

Unlock a Study

If you do not have the "Lock or Unlock Study" operation assigned to the user role, the options to perform a data load, execute transformations/validation checks, and create/edit discrepancies are disabled for a locked study.

When you unlock a study, the system does the following:

• Resumes all the suspended data loads for all input models as previously configured before the study was locked.
• Sets back all the scheduled jobs to the original schedule that was set before the study was locked.
• Enables all user interface options and buttons that were disabled as part of study lock.
• Allows the transformation trigger from data changes from other studies.
• Updates the study status to Unlock and removes the lock icon from the study name in all screens.

To unlock a study:

1. On the Home page, select a study.
2. From the Action drop-down list, select Unlock.
3. On the Unlock Study confirmation page, click Unlock.
4. Click OK.

Lock and Unlock History Report

1. On the Home page, select a study.
2. From the Action drop-down list, select View Lock/Unlock History.

   The Lock/Unlock History dialog box appears that displays the audit information of all lock and unlock-related activities and any manual overrides that were done during the lock period. The report displays the timestamp, action, name of object involved in action, reason why was the study locked, username, and any additional detail. This report is accessible only to the users who have the "Lock or Unlock Study" operation assigned to them. You can download the report in a .CSV format.