Defining a Study Schedule

In this section:

• Maintaining Intervals
  
• Maintaining Phases
  
• Maintaining Periods
  
• Maintaining Sub-periods
  
• Assigning Planned Processes and Procedures
  

Maintaining Intervals

Note:

The Page Tracking feature has been deprecated from Oracle Clinical release 5.4 onward. However, pre-existing studies created on earlier Oracle Clinical versions with Page Tracking already enabled will continue to function as previously configured, hence the associated documentation pertaining to this use-case has been retained as below. This content is subject to be removed in future releases.

You can organize the expected progress of patients through a study into Intervals, creating a schedule, or timeline. The most general Interval is the phase. If necessary, you can create periods, which are divisions within a phase. You can create also sub-periods within periods. All three Interval types have the same attributes, except that you can view some randomization details at the phase level.

You can change the name of a phase at any time. You can also add a phase to a study at any time. You can delete a phase from a study if no CPEs are assigned to it; from the Design menu, select Schedule, then choose Events. The system cautions you if you attempt to delete a phase with periods assigned to it. In query mode, you can specify search criteria in this field.

Oracle Clinical imposes no restrictions on how you model the schedule. However, the way you define Intervals has implications for other parts of study design:

• Flexible Studies If you are creating a flexible study, bear in mind that you can enable Intervals and bypass to Intervals based on see Defining Intervals and CPEs for Flexible Studies.

• Page Tracking If you are using Page Tracking (for paper-based studies), define Intervals to enforce minimum and maximum Intervals for when a visit can occur; see Using CRF Page Tracking.

To create an Interval:

1. From the Design menu, select Schedule, then select Intervals. The Clinical Study Versions window opens.

2. Choose a study version and click Phases. The Maintain Intervals window opens.

3. Add a row.

4. Enter the Phase Name, which uniquely identifies a phase within a study. Sample phase names include Screening, Baseline, and Dosing.

   When you enter the phase name, the window populates its Short Name automatically.

5. Define the details of the phase:

   1. Choose a Phase Type from the list of values. The phase type classifies the phase according to its major objective, and the candidate values are drawn from the installation reference codelist PLAN STUDY INT TYPE CODE. In query mode, you can use this field to specify search criteria.

   2. Choose a Time Unit for this phase from the list of values.

   3. Choose a Blind Type code that describes the type of blinding for this phase of the study. The candidate values in this list are drawn from the installation reference codelist BLIND TYPE CODE. In query mode, you can use this field to specify search criteria.

   4. Enter the Minimum Duration value, which is a number that represents the minimum length of time for this phase of the study. This field, in conjunction with the Time Unit and Maximum Duration fields, describes the timespan for the phase.

      The Minimum Duration must be less than or equal to the value of the Maximum Duration field. The system uses the value in this field to identify Off-Target DCMs.

   5. Enter the Maximum Duration value. The system uses the value in this field to identify Overdue DCMs.

   6. Select the Opt? box if you want to indicate that the phase is optional for patients in the study. You can change this setting at any time.

   7. (Optional) Specify an End Date in DD-MON-YYYY format. This value is the date by which all patients are expected to complete this phase of the study.

6. Save.

Maintaining Phases

Companies typically use phases to classify different protocol objectives, such as screening and dosing. You can also control study design criteria like blinding at this level.

Your company specifies the types of phases, typically with values like Screening, Baseline, or Post_Study. The system does not restrict how you define these Intervals.

To create a phase:

1. Navigate to Design, Schedule, and then Intervals.
2. Select a study. The system orders the studies by study code sequence, then by version sequence within each study code. Fields here are display-only.
3. Click the Phases button to open the Phases window.
4. Specify the phases's details. You can query the multi-record window to view the phases assigned to the selected study. You can also click the Single button to see details of a selected study in one window.

   When you create a phase for a clinical study version, the system also creates a clinical study history to record any changes in assigned randomization access status types. The system records the phase's creator, the time of creation, and the time at which it received its randomization access planned study Intervals.

   You can also select and delete a phase in this window. You can delete a phase only if there are no CPEs linked to it. The system also deletes any associated periods or sub-periods. Oracle Clinical alerts you to confirm that you want to delete the phase.

5. Save.

There are two navigation buttons at the bottom of the window:

• The Periods button opens a window where you can subdivide a study's phases. See the following section for instructions.

• The Resequence button opens a window where you can re-order the study's phases. See Resequencing Phases, Periods and Sub-periods.

Maintaining Periods

You can divide a phase into periods, if necessary. If you delete a period, the system deletes its sub-periods. You can only delete a period if there are no CPEs (visits) assigned to it.

To create, update, or delete periods of the selected phase:

1. From the Design menu, select Schedule, then select Intervals.
2. Select a study. Studies are displayed by study code sequence, then by version sequence within each study code. Fields here are display-only.
3. Click the Phases button to open the Phases window.
4. Select the phase to modify periods. You can only view periods linked to the phase you select.
5. Click the Periods button. The system displays the details of the periods currently assigned to the selected phase.
6. Enter a new period, delete, or modify the current periods' details.

   Selecting the Opt? box sets the Interval as optional for patients in the study. Clear the box to make the Interval mandatory.

There are two navigation buttons at the bottom of the window:

• The Sub-periods button opens a window where you can subdivide a study's periods. See the following section for instructions.

• The Resequence button opens a window where you can re-order the study's phases. See Resequencing Phases, Periods and Sub-periods for instructions.

Maintaining Sub-periods

You can further divide study Intervals by adding sub-periods to periods. To create, update, or delete sub-periods of the selected period, click the Sub-periods button in the Periods window. The fields in the Sub-periods window function in the same way as those in the Periods window. See Maintaining Periods for instructions for this window, substituting the term "sub-periods" for "periods."

For more information, see:

• Resequencing Phases, Periods and Sub-periods
  

Resequencing Phases, Periods and Sub-periods

This section describes resequencing phases, periods, and sub-periods of a clinical study version. You may need to add a phase, period, or sub-period, or change the sequence, among existing ones. Each Phases, Periods, and Sub-periods window has a Resequence button.

To resequence:

1. Select the phase, period, or sub-period to resequence.

2. Select the Resequence button on the toolbar.

3. To mark the insertion point in the series, enter the name of the phase, period, or sub-period to precede the one you named in Step 1.

   For example, to change the phase sequence A-B-C-D-E to the new sequence A-C-B-D-E:

   1. Select C on the Phases window.

   2. Select the Resequence navigation button.

   3. Enter A as the new previous phase.

   To make a phase the first phase—that is, to make D first in the sequence ABCD:

   1. Select D and resequence it to come after A, giving ADBC.

   2. Select A and resequence it to come after D.

Assigning Planned Processes and Procedures

In this section:

• Maintaining Processes
  
• Maintaining Clinical Procedures
  

Maintaining Processes

The use of Oracle Clinical processes is optional and is not included in the Easy Study Design utility. When you define a Clinical Planned Event (CPE) you must assign a process to it, but you can use a default value for most or all of your CPEs.

A process can serve two purposes:

• Since Oracle Clinical imposes no restrictions on what constitutes an event, assigning processes to events can, for example, help identify screening visits or dosing visits (though assignment to Intervals can accomplish the same thing), or differentiate between CPEs that correspond to visits and those used for AEs or ConMeds.

• Grouping Clinical Procedures You can define treatment details called "procedures" and assign one or more of them to a process.

You can delete a clinical planned process only if it is not assigned to any CPE.

To assign a process to link a version of a study:

1. Navigate to Design, Schedule, and then Processes.
2. Select a study version.
3. Click the Processes button. The system displays only those clinical planned processes linked to this version, in order of process name.
4. Create a new process, or modify or delete an existing process. If you delete a clinical planned process, the system also deletes all its clinical procedures.

Note:

The time unit in the Clinical Processes window is not the same as the time when the events should take place. This time unit defines what happens at the event.

The Clinical Processes window has one navigation button, Procedures, which displays the Clinical Procedures window.

Maintaining Clinical Procedures

Clinical procedures specify time ranges within a process when treatment regimens should take place. You can define the minimum and maximum time units relative to the start of the procedure or other procedures. You can also specify that a regimen take place under certain circumstances, which you define in the Trigger Condition field. Typically, a process contains more than one procedure.

From the Design menu, select Schedule, choose Processes, click the Processes button, and then the Procedures button to open the Procedures window. It lists all clinical procedures associated with the selected process. The clinical procedures display in description sequence.

Enter values for one or both of the following sets of timing specifications. These fields are informational only (unlike similar fields in CPEs). They are not actually used by any functions.

• Min Offset Start and Max Offset Start (range since the start of the procedure)

• Min Offset Prev. and Max Offset Prev. (range since the end of the last procedure)

  Note:

  Trigger Condition has nothing to do with the trigger condition that is part of a Rule defined for a flexible study in an enhanced DCI Book.