Set up a question to lock automatically

Lock questions using an Auto-lock rule to prevent site users from editing subject data during the study conduct period, after a specific subject event.

Note:

As a sponsor user, know that the level of detail in a protocol addressing question reviews can vary, and each team should define its own criteria.

To create an auto-lock rule, you must create a form first and include at least one question in the form. The form must be assigned to the appropriate visits. For step-by-step instructions, see the Forms and Question types and settings chapters.

For step-by-step instructions on how to create an auto-lock rule, see Define an Auto-lock rule.

You can configure the Auto-lock rule to trigger at a specific time during the study conduct period based on the following subject events:

• Subject is screened: a question is automatically locked after a subject is screened.
• Subject is randomized: a question is automatically locked after a subject is randomized. This includes randomization and re-randomization events.
• Subject is dispensed the kit: a question is automatically locked after a subject is dispensed the kit.
• Visit is complete: a question is automatically locked after a visit is completed.

The Auto-lock rule triggers and locks a specific question only after a site user completes the conditioned action. For example, if you configured Question A to get automatically locked when a subject is screened, the question is locked only after you complete the subject's screening.

If you configure multiple auto-lock rules for the same question, the question only becomes locked after the site user completes the first condition of a rule. For example, you configure two auto-lock rules for Question B: one is triggered after a subject is screened and the second one is triggered after a subject completes a visit. If a subject is screened first, Question B becomes locked from that moment on.

If the auto-lock of a question fails, users with the appropriate permissions receive the Auto-lock failure notification after five unsuccessful attempts of locking a question.

Impact on data collection and visits

• You can apply the auto-lock rule to most question types (text, number, age, and multiple-choice questions), as well as questions that are required, optional, and hidden in a form.
• If a subject is successfully screened, then screen failed, and screened a second time (by undoing the screen fail), no additional lock actions are applied.
• A question marked for automated locking during a randomization or screening visit gets locked if it's associated with a current or previous visit from when the subject is successfully screened or randomized. However, a question won't get locked if it appears in a visit that occurs after a subject's randomization or screening.
• When triggered, the auto-lock rule will lock a question whether it's answered, empty, read-only, or data-flagged. The exception will be in repeating and two-section forms, where the lock will not apply for not started or data entered after the lock triggering event.
• Questions do not lock if the option Visit Completion is selected as a trigger for not started repeating forms. 
• In a visit, if a repeating or two section forms is in an Not Started status or if data is entered after the lock triggering event occurs, the lock will not apply.
• If a site user skips a visit that would trigger an auto-lock rule, a question with the auto-lock rule applied remains unlocked. If a site user later unskips the visit and answers questions after the locking condition was fulfilled, the question remains unlocked.

Impact on custom JavaScript rules

• A custom rule for an automated query doesn't trigger the auto-lock rule if it targets only one question. If you need to apply an auto-lock rule to an automated query's target field, choose a second target question when you expect the rule to generate a query.
• You can change the validation rule after the event happens, which does not impact its state.
• You cannot apply an auto-lock rule for instructional text items and label questions.
• If an auto-lock rule is triggered for a question included in a visit that is not started, the data still gets locked.
• For repeating forms, the lock applies to all instances of the questions.
• Dynamically displayed (child) questions, questions on dynamic forms, or dynamic visits will be locked after the site users enter a specific answer configured to that question containing a Show Question rule for the triggering visit to be considered complete. If the questions display subsequently, they will not be retroactively locked, and a sponsor user must be closed manually.

Impact on study version updates

• If the event has already occurred for the subject, Advance Study Version changes have no impact on auto-lock rules. If the event has not yet occurred, then the lock will happen upon event completion.
• If a site's associated study version is changed after a visit with an auto-lock rule was already started, the question with the auto-lock rule applied to it won't get locked anymore, even if the started visit exists in the newer study version, and even if the condition of the rule was fulfilled.

• Define an Auto-lock rule
  An Auto-lock rule blocks site users from editing subject data during the study conduct period and after a specified event.