Randomization Maintenance

You can perform the following tasks by navigating to Design, Randomization, and then Randomization Maintenance:

• Replicating a Randomization
  
• Mirroring Randomization
  
• Maintaining Randomization Statuses
  
• Creating or Revoking an Access View
  
• Cohort Views
  
• Managing Patient Treatment Assignments
  
• Linking Patient Treatment Assignments
  
• Disclosing Patient Treatment Assignments
  

Replicating a Randomization

Replicating randomizations is a similar process to replicating clinical studies. The system records information you enter in this module into system tables, including Treatment Pattern Block Definitions, Treatment Assignments, and Randomizations.

You cannot replicate a randomization between studies. You must replicate the study first, then add the randomization to it.

To replicate a study's randomization:

1. From the Design menu, select Randomization, choose Randomization Maintenance, and then Replicate Randomization. The Replicate a Clinical Study form appears, displaying the Study Selections window.
2. Click the Replicate Randomization button.
3. Use the list function to select from the studies with randomizations available for replication.
4. Use the list function to select the study to which to replicate the randomization (the target study).
5. Click the Replicate Randomization button.

Mirroring Randomization

Mirror randomization takes an existing randomization and creates a new randomization of replacement treatment assignments starting at a new code. For example:

1 to 10 NORMAL, 100 to 110 REPLACEMENT.

The main use is when a site receives supplies for a group of patients and a corresponding set of replacement patients. Then there is an instruction that if, for example, patient 7 drops out, enroll the next patient into 107. This maintains balance in the study's randomization.

1. From the Design menu, select Randomization, choose Randomization Maintenance, and then Mirror Randomization.
2. Choose the study to which to add mirrored treatment assignments.
3. Click Show Randomizations. The Copy Randomizations window displays the selected study's randomization details.
4. Click Copy. A pop-up window appears where you can specify the starting code.

Maintaining Randomization Statuses

This section describes updating the status of the randomization. The information you enter here is a basis for creating clinical study history records.

To update clinical study statuses:

1. From the Design menu, select Randomization, choose Randomization Maintenance, and then Randomization Statuses.
2. Select the study of interest.

   Use the list and query functions, if necessary, to locate the study.

3. Enter the study status code.

To modify the study's randomization access, click the Phases button. A window appears titled Amend the Randomization Access Status.

Clicking the Amend the Study Status button lets you change the planning status only, and even to do this, you must have planning attributes privileges. You can modify the Randomization Access Status only if you have access to the randomization attributes. The studies display in study code sequence. You can scroll or query to the study of interest. You can only modify a clinical study's status; you cannot insert or delete studies here.

When you click the Phases button, the system displays the phases of the live version of the current study. You can work with only the live version of a study while you are in the Amend Study Statuses module. If there is no live version of the current study, the system alerts you with a message.

Creating or Revoking an Access View

An access view enables specified users to see the true randomization within a study without un-blinding the study to everybody. The randomization only appears in the view while the randomization status of the study is set to ACCESS.

This technique controls who can perform an interim analysis, for which study, and when. If necessary, you can edit the view to additionally limit the data it displays. For example, you can limit it to display only the first 50 patient treatment assignments, or only patients who have completed the study.

Note:

If you are working in a UNIX environment, put double quotes around the $ sign in the account names. For example, OPS"$"ABCD.

For more information, see:

• Creating an Access View
  
• Revoking an Access View
  

Creating an Access View

The PSUB form Create Access View creates an access view for a study. It is a standard PSUB submission form. To access this form, from the Design menu, select Randomization, choose Randomization Maintenance, and then Create Access View.

Revoking an Access View

The PSUB form Revoke Access Grants revokes the select privilege from a user on an access view for a study. It is a standard PSUB submission form. To access this form, from the Design menu, select Randomization, choose Randomization Maintenance, and then Revoke an Access View.

Cohort Views

Oracle Clinical provides the cohort view to show patients assigned to their correct cohorts (groups) without revealing which treatment pattern each cohort is for.

For more information, see:

• Creating a Cohort View
  
• Revoking Cohort View Grants
  

Creating a Cohort View

To access this form, from the Design menu, select Randomization, then Randomization Maintenance, and choose Create Cohort View. The view has the same security safeguards as the Access View. You can use the PSUB submission form to create the view.

The system assigns dummy codes to the study's treatment patterns by a hidden algorithm. The algorithm decodes the real treatment pattern into letters—A, B, C, etc., then generates the cohort view.

To access the cohort view, the study must have randomization access status, regardless of your privileges.

Note:

If you are working in a UNIX environment, put double quotes around the $ sign in the account names. For example, OPS"$"ABCD.

Revoking Cohort View Grants

Use the Revoke Cohort Grants PSUB submission form to control the grants to access a study's cohort view. From the Design menu, select Randomization, then Randomization Maintenance, and choose Revoke Cohort View.

Managing Patient Treatment Assignments

Take the Patients window as a starting point to manage patient positions.From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, and click the Patients button. The system lists the patient positions in patient code sequence.

Select the patient position to manage. You can only select a patient position while in this window. You cannot insert, update, or delete a patient position.

The operations you can perform from this window are:

• Disclosing a Patient Position's Treatment Pattern
  
• Changing the Latest Treatment Assignment to a Different Treatment Pattern
  
• Replacing a Patient Position with Another Patient at the Same Site
  
• Replacing a Patient Position with Another Patient in the Same Study
  
• Linking a Patient Position to an Existing Treatment Assignment
  
• Creating a New Treatment Assignment
  
• Removing a Treatment Assignment
  

Disclosing a Patient Position's Treatment Pattern

From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and the Disclose button, selecting the appropriate study and patient position, to the Treatment Patterns Assigned to Patient form. The system displays the treatment pattern records in assignment time sequence.

You can also navigate to the Amending Treatment Patterns Assigned to Patient window via the Change... button. See the next section for instructions on changing treatment pattern assignments.

Changing the Latest Treatment Assignment to a Different Treatment Pattern

To change the treatment pattern assigned to a patient position without creating a new treatment assignment, you work from the Amending Treatment Patterns Assigned to Patient window. From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and the Change button, selecting the appropriate study and patient position. (This window is also available from the Change button in the Treatment Patterns Assigned to Patient window.)

Changing an assignment indicates that the treatment a patient receives is different from the treatment the randomization assigned to the patient. This is the way you can correct mistakes in packaging or labeling.

1. Enter the treatment code to change in the Treatment Code for this Assignment field.
2. Complete the Date and Reason for Change fields.
3. Select the row of the pattern to change the treatment to from the Code/Pattern fields.
4. Click the Change Select Treatment Assignment To This Treatment Pattern button. You must click this button to save your work.

Replacing a Patient Position with Another Patient at the Same Site

You can replace the current patient position with a replacement patient already assigned to the same site. From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Site Replace button, selecting the appropriate study and patient position. The system displays the Patient Replacement at the Same Site popup window, with the replacement patient controlled by the Patient Replacement Rule Type.

A code on the clinical study version, the Patient Replacement Rule Type, controls how this part of the module operates. Study designers set it in either the Clinical Studies or Easy Study Design modules. The Patient Replacement Rule Type has one of three values:

• NONE – No replacement of patient positions allowed.

• NEXT – The next sequential replacement patient position not currently enrolled, regardless of treatment.

• SAME – The next replacement patient position not currently enrolled that is assigned the same treatment pattern as the one being replaced.

The Replace Selected Patient With This One button confirms the patient position replacement and sets the patient enrolled date on the replacement patient to the current date.

Replacing a Patient Position with Another Patient in the Same Study

To replace the current patient position with a replacement patient not linked to any study site, from the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Study Replace button, selecting the appropriate study and patient position. The system displays the Patient Replacement not assigned to any site popup window, with the replacement patient controlled by the Patient Replacement Rule Type.

A code on the clinical study version, the Patient Replacement Rule Type, controls how this part of the module operates. Study designers set it in either the Clinical Studies or Easy Study Design modules. The Patient Replacement Rule Type has one of three values:

• NONE – No replacement of patients allowed.

• NEXT – The next sequential replacement patient position not currently enrolled, regardless of treatment.

• SAME – The next replacement patient position not currently enrolled that is assigned the same treatment pattern as the one being replaced.

Clicking the Replace Selected Patient With This One button confirms the patient position replacement and sets the patient enrolled date on the replacement patient to the current date.

Linking a Patient Position to an Existing Treatment Assignment

To link the current patient position to an existing treatment assignment, from the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Link Asg button, selecting the appropriate study and patient position. A popup window appears, Link Treatment Assignment.

This function is most useful in studies where the Kit codes or Treatment Assignment codes are not the same as the patient codes. The differences could be a result of a second randomization in the study, or of management of limited drug supplies.

Clicking the Link Selected Patient To This Treatment Assignment button confirms the patient position linkage and assigns the new treatment code to the patient.

Creating a New Treatment Assignment

You may have patients who receive more than one randomization during a study and, at the end, you have to assign the patients a reporting treatment pattern for analysis. For these, and similar circumstances, Oracle Clinical provides a utility to create a new treatment assignment to assign to a patient position.

From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Create Asg button, selecting the appropriate study and patient position. The Create and Assign Treatment to Patient window provides a new treatment assignment code field and a list acceptable treatment patterns to assign to it. After you enter the fields and select a treatment pattern, you must click the Create a New Treatment Assignment Using This Treatment Pattern button to confirm the patient treatment assignment and create a new treatment assignment to allocate the selected treatment pattern to this patient.

Removing a Treatment Assignment

You can break the link between a patient position and a treatment assignment. The treatment assignment is then available for reassignment. From the Design menu, select Randomization, choose Randomization Maintenance, select Patient Treatment Assignments, click the Patients button, and then the Unlink Asg button, selecting the appropriate study and patient position. In the Unlink the Treatment Assigned for Patient window, you see a list of all the treatment assignments for the selected patient position. Select the treatment assignment you want to unlink, and click the Unlink/Remove This Treatment Assignment From The Selected Patient button, confirming the patient treatment unlink and breaking the link between the patient position and the treatment assignment.

Linking Patient Treatment Assignments

Oracle Clinical provides a separate menu path to the Link Patients and Treatment Assignments window: From the Design menu, select Randomization, choose Randomization Maintenance, then select Link Patient Treatment Assignments, click the Patients button, and then the Link Asg button.

This method can be used to allow a blinded user to link patient positions to treatment assignments without knowing what treatment pattern is involved.

Disclosing Patient Treatment Assignments

Oracle Clinical provides a facility for study management members who must disclose the treatment assigned to a patient for emergency medical reasons, but do not have RXC_RAND privileges (see Randomization Privileges), and do not have access to the Maintain Treatment Assignment, Disclose Asg menu path. The system creates a blind break with each disclosure.

From the Design menu, select Randomization, choose Randomization Maintenance, then select Disclose Patient Treatment Assignments, click the Patients button, selecting the appropriate study and patient position. The treatment pattern records display in assignment time sequence. Select the patient and click Disclose.

If you have the role RXC_DER, the system generates a blind break record before displaying the patient's current treatment assignment. Select Yes to confirm the disclosure and continue, or No to cancel the request and exit. This action always creates a blind break and should be your last choice. Use the Disclose option in the Maintain Treatment Assignments form to avoid creating a blind break whenever possible.