Creating a Clinical Study in the Easy Study Design Window
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.
If you have access to the Maintain Planned Studies window, you can create a new planned study and maintain the planning information.
To create a study, follow these instructions:
When you save your changes, the system prompts designers with the appropriate role to specify the following:
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Does the study require second-pass data entry? Select Yes if your study will use Oracle Clinical data entry and you want to require that data entry operators enter data twice. You can then reconcile the two passes. Remote Data Capture (RDC) does not support second pass data entry. If you have access to the Maintain Study Statuses menu option, (from the Design menu, select Studies, then select Study Statuses), you can require second-pass entry.
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Is this a Flexible study? Select Yes if your study has an adaptive (or flexible) protocol. If you check this box, you can use the Enhanced DCI Books window to define Rules that make specified CRFs and Intervals expected for a particular patient based on data collected for that patient at specified points in the trial.
Select No if you do not need this functionality.
Note:
The Enhanced DCI Books window includes Start Page renumbering, copying, and navigational enhancements that are helpful in any study. Studies using Page Tracking cannot use the Enhanced DCI Books window; they must use the original DCI Books window.
See Traditional and Enhanced DCI Books and Designing a Flexible Study for further information.
The Clinical Studies window has the following navigation buttons for completing Easy Study Design tasks. Each task is described in a separate section below.
Table 3-1 Buttons in the Clinical Studies Window
Button | Objective |
---|---|
Intervals |
Displays the Maintain Planned Study Intervals window. Intervals are the time units that make up the study timeline. |
Events |
Displays the Events window, where you specify the number and type of visits. |
Treatment |
Displays the Treatment Patterns window. Treatment patterns are sequences of one or more treatment regimens. |
Create PP |
Displays the Create Patients window. Patient positions are the blinded place-holder records that represent the patients in the study. |
Delete PP |
Displays the Delete Patients window, where you can eliminate unnecessary patient positions. |
Display PP |
Displays the Existing Patients window, which displays the details of all the patient positions in the study. |
For more information, see:
- Planning Study Intervals
- Defining Clinical Planned Events
- Defining Treatment Patterns
- Creating Patient Positions
Parent topic: Easy Study Design
Planning Study Intervals
You can define time Intervals to set up a study schedule. See Maintaining Intervals and Defining Intervals and CPEs for Flexible Studies for more information.
From Easy Study's Clinical Studies window, click the Intervals button. In this window, you can create phases, which are the highest level Intervals. Phases can contain periods, which can contain sub-periods. You have full access to the Interval utility, limited to your current study. You have the same functionality available to define Intervals for your study as described in Maintaining Intervals.
It is most efficient to define Intervals before clinical planned events (CPEs). However, if no Intervals exist for a study when you first invoke the Events window, the system creates two Intervals for you to use in creating your events.
When you create a study using Easy Study Design, the system automatically creates a Phase Interval called DEFAULT STUDY PHASE. If you are creating a nonflexible study and you do not need to organize CPEs into Intervals you can assign all your CPEs to this Interval. If you are creating a flexible study you cannot use this default Interval and must explicitly create Intervals.
For more information, see:
Creating Periods
Use periods to divide phases into smaller Intervals. From the Design menu, select Studies, then select Easy Study Design, click the Intervals button, and then the Periods button. (See Maintaining Periods for more information about periods.)
Parent topic: Planning Study Intervals
Resequencing Periods
You can change the order of defined periods within phases from the Easy Study Design window by clicking the Intervals button, then the Periods button, and the Resequence button. (See Resequencing Phases, Periods and Sub-periods for more information.)
Parent topic: Planning Study Intervals
Creating Sub-periods
You can divide periods into sub-periods from the Easy Study Design window. Click the Intervals button, then the Periods button, and the Sub-Periods button. (See Maintaining Sub-periods for more information.)
Parent topic: Planning Study Intervals
Resequencing Sub-periods
You can change the order of defined sub-periods within periods from the Easy Study Design window by clicking the Intervals button, then the Periods button, the Sub-Periods button, and then the Resequence button. (See Resequencing Phases, Periods and Sub-periods for more information.)
Parent topic: Planning Study Intervals
Defining Clinical Planned Events
A clinical planned event (CPE) usually corresponds to a visit. You can also define a CPE for the purpose of associating it with DCIs (corresponding to CRFs) that you want to have available in a DCI Book without associating them with a particular visit, such as AEs or ConMeds. If you are defining Processes in Oracle Clinical, you can create a CPE to schedule a Process during an Interval.
If you are working in a flexible study, see Defining Intervals and CPEs for Flexible Studies.
For more information, see:
Create a Clinical Planned Event
To create a clinical planned event:
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From the Design menu, select Studies, then select Easy Study Design, select a Study, then select Events. The Clinical Planned Events window opens.
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Enter values in the following fields:
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Enter an Event Name for the clinical planned event. The Event Name must be unique within this study version. You may want to take page numbering into consideration when you name your CPEs, especially in a flexible study; see Sample Numbering Schemes.
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Choose an Interval Name from the list of values. Each CPE occurs during an Interval, and you can choose a phase, period, sub-period, or the entire study as the Interval for this event.
Note:
The system prevents you from changing a CPE's Interval if the study is flexible and has an active DCI Book that contains Interval rules. If the DCI Book is provisional, the system sets its validation status to Pending. When you activate the book or run the validation job explicitly, the job determines if the changes are valid.
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Enter a Visit Number. A CPE's visit number must be unique within this study version. The Visit Number for each CPE controls the order in which they occur in the DCI Book and in the study. CPEs with a lower Visit No. cannot occur after a CPE with a higher Visit No., so be sure to give CPEs the right Visit No. relative to one another. You can add a CPE later, but you must renumber all subsequent CPEs to maintain the correct relative order.
Note:
The system prevents you from changing Visit No. order in flexible studies when the CPE is used in an active Enhanced DCI Book. It is possible to change visit order when the CPE is used in an active traditional DCI Book, but if the change makes the Book invalid you will not be able to use the Book for data entry.
You can always add a CPE to the end of the study. You can add a CPE before the end if you also renumber all subsequent visits.
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Indicate if the CPE is optional or required by checking or unchecking the Optional checkbox.
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If this event describes the termination visit, choose a Termination Code. Valid codes are "early" or "normal." You can change this field at any time, provided the study has at most one early and one normal termination visit.
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Populate the Offsets from Interval Start fields:
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Minimum enter the minimum amount of time that must elapse between the start of the Interval and the start of the event, in the time unit specified in the last field.
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Maximum enter the maximum amount of time that must elapse between the start of the Interval and the start of the event, in the time unit specified in the last field.
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Time Unit enter the unit that applies to the Minimum and Maximum fields.
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Save.
Note:
You cannot access a clinical planned event previously created in the Maintain Clinical Planned Events window from the Easy Study Design window.
Parent topic: Defining Clinical Planned Events
Defining Treatment Patterns
Patterns impose a centralized control over the codes that identify treatment patterns in analysis and reports. To add treatment patterns, click the Treatment button and choose from the list of values. If you do not require this control, define some dummy pattern codes. (For more information, see Maintaining Treatment Patterns.) The Treatment Patterns window allows you to create, amend, or delete treatment patterns. When you enter the window the system displays all existing treatment patterns for the study.
You can delete a treatment pattern only if no treatment assignments exist for the treatment pattern. To add a treatment pattern, enter the code for the treatment pattern.
Treatment patterns are sequences of one or more treatment regimens. To add a treatment pattern, enter the code of the treatment pattern you want to add. Use the List function to select from the available codes. The system displays both the predefined code and description. Save your changes. Note: You can only delete a treatment pattern if it has no treatment assignments.
Creating Patient Positions
To create a range of patient positions, enter the range of patients for the type(s) of patient positions you want to create. To add patient positions, click the Create PP button and choose from the list of values. For example, to create ten screening patient positions, enter the low value for the range in the Screening Patients Start Code field, and the high value in the Screening Patients End Code field. If you are creating just one patient position, type the same code in both the Start Code and End Code fields. Click the Create Patient Positions button. (See Maintaining Patient Positions for more information.)
To view existing patient positions, click the Display Existing Patient Positions button.
For more information, see:
Displaying Patient Positions
You can display patient positions by study or by site.
Viewing by Study
The Existing Patients window shows you all patient positions assigned to a study. All fields in this window are display-only. You can also navigate to this window by clicking the Display Existing Patient Positions button, from either the Create Patients or the Delete Patients window.
The system displays all the patient assignments from this window, including any changes you make in the Create or Delete Patient Positions windows. Note: If the system displays a 'Please see details' message in the Investigator Name field for a range, the range is assigned to more than one study site. Click the Display Existing Patient Positions by Site button to view the patient positions as they are arranged across sites.
Viewing by Site
The Display Existing Patient Positions by Site button in the Existing Patients window takes you to the Existing Patients by Sites window. This window sorts a particular range of patient positions by site.
This configuration can show multiple patient position assignments in the event that the same patient positions have been assigned to more than one site.
Parent topic: Creating Patient Positions
Deleting Patient Positions
From the Easy Design - Clinical Studies window, you can delete patient positions. Click the Delete PP button. Enter the range of patient of the type(s) of patient positions you want to delete. If you are deleting just one patient position, enter the patient's code in both the Start Code and End Code fields. Click Delete Patient Positions.
To see the existing patient positions, click the Display Existing Patient Positions button. See Sites, Investigators, and Patient Positions for more information on patient positions. The fields in the Delete Patients window are identical to standard design's Create Patients window.
Parent topic: Creating Patient Positions