Blind Breaks

Circumstances sometimes require going against data blinding controls to access information on treatment patterns for a particular patient.

If an Investigator opens an occluded label for a patient, you record the blind break this represents in this window. But you cannot disclose the treatment pattern assigned to a patient in this window.

Oracle Clinical provides an emergency mechanism for obtaining a patient's treatment details. If you use this mechanism, the system generates a blind break record. The system stores blind breaks you document and system-generated blind breaks together.

For more information, see:

• Creating, Reviewing, or Canceling Blind Breaks
  

Creating, Reviewing, or Canceling Blind Breaks

Associated with the Blind Breaks form are three windows, each accessed from a corresponding navigation button.

Note that you cannot delete records of blind breaks. You can cancel them, but the system retains a record of canceled breaks.

To create or review a blind break:

1. From the Design menu, select Patient Positions, then choose Blind Breaks.

2. Select the clinical study associated with the patent positions you want. If you have already accessed a clinical study during this Oracle Clinical session, the system presents it; otherwise this window lists all clinical studies.

3. Click the Patients button. The system displays the Patient Positions window.

In the Patient Positions window, you can choose to do the following tasks. Save your work when you finish.

• Viewing an existing blind break

  1. Select the patient position code with the blind break. The patient positions appear in patient code sequence.

  2. Click the Show Blind Breaks button.

     If there are no blind breaks for the selected patient position, this window does not appear; instead, a message states that no blind breaks exist. You can only select a blind break while in this window. You cannot insert, amend, or delete blind breaks here. The blind breaks appear in order of their creation.

• Canceling an existing blind break:

  1. Select the patient position code with the blind break. The patient positions appear in patient code sequence.

  2. Click the Show Blind Breaks button.

  3. Select the blind break to modify.

  4. Click the Modify Blind Breaks button.

  5. Enter a description of why you are canceling the blind break.

• Creating a new blind break:

  1. Click the Create Blind Break button.

  2. Enter the information about the blind break.