Database Locking

Summary

This article addresses incremental and final locking of ClinSpark data fields, including the implications of locking at each level, in support of stable data exports for analysis. At all levels, locking may be reversed (‘unlocking’) with full auditability.

Locking Hierarchy

ClinSpark supports data locking at various “levels”. Starting at the highest level for a study, down to each discrete item data, the following represents the general hierarchy of data lock levels as it would relate to data collection:

Study - Locks all data levels for a given study
Subject - Locks all data levels for a given subject
Cohort - Locks all forms and lower data levels (item groups, items) associated with activated activity plans for every subject in a given cohort
Study Event - Locks all forms and lower data levels (item groups, items) for a given subject, associated with a study event
Form - Locks all item groups and items in a given instance of a form, for a given subject
Item Group - Locks all items in an item group
Item - Locks individual items

Database locking activities typically start at lowers levels, such as Forms, and works upwards towards higher levels.

Audits

When a lock action takes place, ClinSpark stores an audit record at the level that the lock occurred, even if that means lower level data is also locked. For example - when a Form is locked - so are the lower level item groups and items on the form. However the audit record for the lock action is stored as part of the Form details.

This is by design and consistent with other actions that can take place against data, such as cancellations. Audits are recorded where the user performed the discrete action.

Locking by Form (per Subject, per Instance)

Forms may be locked on a per-subject, per-instance basis, meaning that locking at the Form level will only lock the specific Form against which the lock action occurs and will not transcend other subjects or timepoints. This is particularly useful in situations where locking at a higher level (i.e. by Study Event, Cohort, or Subject) is not feasible because the higher level is still in use for data collection and/or data cleaning. A great example is the locking of AE Forms for interim analysis. In this case, it may be desirable to lock only completed and closed AE Forms while allowing interaction with open AEs and creation of new AEs; a scenario that Study Event, Cohort, or Subject locking would not facilitate.

These actions ARE NOT permitted against a locked Form:

Data Collection
Data Updates

These actions ARE permitted against a locked Form:

Data Export
Study Assessments
Sample Processing
Laboratory Review
ECG Review
Data Review
Query Initiation and Continuation
Medical Coding

To lock a Form for a specific subject and instance, navigate to Study > Data and perform the following steps:

Click the Form hyperlink in the Timepoint column

2. Click the Lock icon

3. Click OK in the confirmation window

4. The Form is now locked only for the subject against which locking occurred

Locking by Study Event (per Subject)

Study Events may be locked on a per-subject basis, meaning that locking at the Study Event level will only lock Forms within the containing Study Event for a specific subject. This is particularly useful in situations where a subject has completed a visit, data cleaning for that visit has occurred, and locking at a higher level (i.e. by Cohort or Subject) is not feasible because the higher level is still in use for data collection and/or data cleaning. A great example is the locking of screening and lead-in visits for subjects who have ultimately enrolled into the trail. In this case, it may be desirable to lock only completed visits while allowing interaction with ongoing visits; a scenario that Cohort or Subject locking would not facilitate. Note that even though a Study Event is locked, unscheduled Forms may still be added to the locked Study Event.

These actions ARE NOT permitted against a locked Study Event:

Scheduled Data Collection
Scheduled Data Updates

These actions ARE permitted against a locked Study Event:

Data Export
Unscheduled Data Collection
Unscheduled Data Updates
Study Assessments
Sample Processing
Laboratory Review
ECG Review
Data Review
Query Initiation and Continuation
Medical Coding

To lock a Study Event for a specific subject, navigate to Study > Data and perform the following steps:

Click the Study Event hyperlink in the Timepoint column

2. Click the Lock icon

3. Click OK in the confirmation window

4. Forms in the containing Study Event are now locked only for the subject against which locking occurred

5. Although the Study Event is locked for the subject, unscheduled Forms may still be added to that locked Study Event

Locking by Subject

All data fields for a Subject may be locked via Subject locking. This is particularly useful in situations where a subject has completed all visits, data cleaning for all of the Subject’s visits has occurred, and locking at a higher level (i.e. by Cohort or Study) is not feasible because the higher level is still in use for data collection and/or data cleaning. A great example is the locking of all data for a Subject who has completed the trial while other Subjects (including, perhaps, Subjects in the same Cohort as the Subject-to-be-locked) are still participating in the trial or are still undergoing data cleaning; a scenario that Cohort or Study locking would not facilitate. Note that once a Subject is locked, unscheduled Forms may no longer be added to any Study Event for that Subject.

These actions ARE NOT permitted against a locked Subject:

Scheduled Data Collection
Unscheduled Data Collection
Scheduled Data Updates
Unscheduled Data Updates
Study Assessments
Laboratory Review

These actions ARE permitted against a locked Subject:

Data Export
ECG Review
Data Review
Query Initiation and Continuation
Medical Coding

To lock a Subject, navigate to Study > Data and perform the following steps:

Click the Subject hyperlink in the Subject column

2. Click the Lock icon

3. Click OK in the confirmation window

4. All data fields are now locked for the Subject against which locking occurred

5. Once a Subject has been locked, unscheduled Forms may no longer be added to any Study Event as the ‘Add’ button is disabled

Locking by Cohort

All scheduled data fields for all Subjects in a Cohort may be locked via Cohort locking. This is particularly useful in situations where a Cohort of Subjects has completed all visits, data cleaning for all of the Subjects' visits has occurred, and locking at a higher level (i.e. by Study) is not feasible because the higher level is still in use for data collection and/or data cleaning. A great example is the locking of all scheduled data for all Subjects in a Cohort that has completed the trial while other Cohorts are still participating in the trial or are still undergoing data cleaning; a scenario that Study locking would not facilitate. Note that once Subjects are locked via Cohort locking, unscheduled Forms may still be added to any Study Event for any Subject.

These actions ARE NOT permitted against a locked Cohort:

Scheduled Data Collection
Scheduled Data Updates

These actions ARE permitted against a locked Cohort:

Data Export
Unscheduled Data Collection
Unscheduled Data Updates
Study Assessments
Sample Processing
Laboratory Review
ECG Review
Data Review
Query Initiation and Continuation
Medical Coding

To lock a Cohort, navigate to Study > Configure and perform the following steps:

Click the Epoch hyperlink containing the Cohort to be locked

2. Click the Cohort hyperlink containing Subjects to be locked

3. Select Actions > Edit

4. Check the ‘Data Locked’ check box and provide a Reason for Change

5. Click Save

6. All scheduled data fields are now locked for all Subjects contained in the Cohort against which locking occurred

7. Although the Cohort is locked, unscheduled Forms may still be added to any Study Event for any Subject

Locking by Study

Consider Study-locking to be the final database lock - the point at which data is fully stable. This action locks all data fields to read-only; and most post-data collection actions are blocked.

These actions ARE NOT permitted against a locked Study:

Scheduled Data Collection
Unscheduled Data Collection
Scheduled Data Updates
Unscheduled Data Updates
Study Assessments
Sample Processing
Laboratory Review
ECG Review
Data Review
Query Initiation and Continuation
Medical Coding
Modification of study lab panel/test result details

These actions ARE permitted against a locked Study:

Data Export

To lock a Study, navigate to Study > Configure and perform the following steps:

Click Edit

2. Set the Status field to Locked

3. Provide a Reason for Change and click Save

4. All data fields are now locked for all Subjects in the locked Study

5. Once a Study has been locked, unscheduled Forms may no longer be added to any Study Event as the ‘Add’ button is disabled

Lab Results in Locked Studies

ClinSpark has been designed to support the import of lab results after database lock to mitigate against data loss. However, lab result data obtained after study lock is not displayed for PIs to review in Study > Lab Data component, and will not update lab counts in dashboard components.