Design questions with an auto-lock

Study designers can now restrict site users from editing subject data after subject screening, randomization, dispensation, or visit completion.

Study designers can now configure a new predefined rule when configuring a question's settings. The Auto-lock rule option restricts site users from modifying questions once a subject has completed a key event during the study, such as screening, randomization, drug dispensation, or when the visit has been completed.

Locking subject data during the study conduct period allows sponsor users to protect essential data used in system decision-making from updates made by the site users without sponsor intervention. A site user can request the unlocking of a question from a sponsor user for editing. The sponsor user must first manually unlock the item to edit, which will be modified, and then locked again.

Details for study designers

If you're assigned to a study role that includes the Design Forms permission, you can now add an Auto-lock rule to a question in a form's design.

Upon selecting the Auto-lock predefined rule, you can specify the condition of when the auto-lock of a question should occur. The following four options are available:

• Subject Screened: a question should be automatically locked after a subject is screened.
• Subject Randomized: a question should be automatically locked after a subject is randomized.
• Subject Dispensed: a question should be automatically locked after a subject is dispensed the kit.
• Visit Completion: a question should be automatically locked after a visit is completed.

In a live study, when the rule is applied, data related to the question with the auto-lock rule becomes read-only for site users after the defined condition is completed.

The auto-lock rule can be applied to all form types (one-section, two-sections, and lab forms) and all question types (including hidden questions), whether they're optional or required. However, instructional text items and clinical supplies forms do not support auto-lock rules.

You can add, delete or update an auto-lock rule as part of a study version change or when using the Advanced Study Versioning (ASV) feature. Only data where the precipitating event has not already occurred will be locked. Data where the precipitating event occurred before the ASV is applied will need to be manually locked.

Sponsor users will receive the Auto-lock failure notification if the rule locking is unsuccessful.

Details for site users

If you need to update a question that was automatically locked, this is what you should know:

Note:

The details listed below describe a workflow that occurs outside of the Oracle Clinical One Platform. You can contact your sponsor team through other means to request an approval for updating an automatically locked question.

• You need to request approval from a sponsor user, sponsor support representative, CRA, data manager, or medical monitor to indicate that you need to update a locked question.
• In the change request, you must follow the process defined by the sponsor user.

You can find additional information in the Frequently Asked Questions section from the Site User Guide after the Release Assessment Environment (RAE) upgrade completes.

Impact to reporting and analytics

Updates to the following reports are introduced to support auto-lock rules:

• Study Design Report shows the auto-lock rule changes in the Action Rules column.
• Annotated Case Report Form shows the auto-lock rule changes in the Validations column as an Action item.
• Subject Data Report shows the auto-lock rule changes in the Type of Change column.

You can find additional information in the Reporting Guide and the Analytics User Guide after the Release Assessment Environment (RAE) upgrade completes.