| Oracle® Clinical Creating a Study Release 5.1 E52787-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Creating a Study Release 5.1 E52787-01 |
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PDF · Mobi · ePub |
Easy Study Design is a subset of the standard design modules that creates only a study's essential elements. In one Oracle window you can create a live study version. To open the window, from the Design menu, select Studies, then select Easy Study Design.
This chapter describes Easy Study Design in these sections:
Oracle Clinical's Easy Study Design window provides a simplified method to create a live version of a study. From this single window you can access streamlined versions of the main design utilities: planned study, clinical study, Intervals, events, patterns, and patient positions. After completing these essential components, you can refine the details of your study with any of the standard design forms.
You can create a new study using Easy Study Design only under one of the following conditions:
No planned study and no clinical study exists with the study name.
A planned study exists with the study name, but no clinical study exists with the study name. (To plan a study, from the Plan menu, select Planned Studies.)
A clinical study with the study name exists, but no versions exist.
After initial setup, you can use any of the standard design forms to add or modify other objects for your study. You can modify any object that originates in Easy Study Design with the equivalent standard design window, with these limitations:
You can add new objects created with standard design forms.
You cannot necessarily modify objects that originate in standard design forms as replacements for Easy Study Design objects.
Some standard design-created objects include fields not available in the equivalent Easy Study windows. The system does not make these objects available to the equivalent Easy Study Design window. You must use standard design forms to access these objects.
There are five design functions available from Easy Study Design: clinical studies, planned study Intervals, clinical planned events, treatment patterns, and patient positions. You can use Easy Study Design to create all these components, some of them, or none of them.
Since the purpose of Easy Study Design is to provide a faster means of creating live studies, the window sets its version to live. In fact, you can only access studies with live versions in the Easy Study Design window.
The structure of the data created by Easy Study Design is consistent with the data created by the standard study design modules. This means that studies created in Easy Study Design are accessible in the standard study design forms.
For instance, you can modify the clinical planned events for a study created in Easy Design via the Maintain Clinical Planned Events window. However, the same is not generally true working the other way: Objects created through standard study design forms are not always accessible from Easy Design. Because many fields are not accessible through Easy Study Design windows, if you want to modify studies that have data in these fields, access the data through standard study design forms.
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:
From the Design menu, select Studies, then choose Easy Study Design.
All fields in this window are mandatory.
Enter a value for the study code.
You can use the list function to display all planned studies with no corresponding clinical studies. It is not necessary to pick a study from the list of values. Easy Study Design lets you create both the planned study and the clinical study if you have the necessary database privileges; you must have access to the Maintain Planned Studies option from the Plan menu. Without this access, you first plan the study.
If the study code you enter exists in the planned studies table, the system sets the value of the Study Title field. In addition, the system populates the Program Code, Project Code, Organization Code, and Region Code fields with the data from the planned study.
The system prompts you for a different name if there is already a live version of a study with this name.
If no study exists with this name, you are creating a new live version of a clinical study.
Enter the version of the study. If a planned study exists and the system populates these fields, go to Step 7.
The system creates a live version when you save your work. Versions facilitate building and comparing variations on one basic study design. They permit altering one component, such as stratification, without forcing you to redesign the entire study.
If the Study Title field is empty, enter a name of up to 80 characters. The system displays the study title in lists of studies and on DCF reports.
Enter a program code for the study. A list of values is available for programs. After you select a program, the description of the program displays to the right of the program name.
Enter values for the Project, Organization, and Region Code fields. Lists of values are available, with descriptions.
Choose a time unit for events for the study. The default value is DAY. This is the time unit of the study's Intervals.
Enter the estimated maximum study duration in the unit of measure specified in the Time Unit for Events field.
Select the Available for Replication Flag box if you expect this study to be distributed to more than one location.
Enter a patient replacement rule in the Patient Repl. Rule field; a list of values is available. The default is NONE.
Save your changes.
When you save your changes, the system prompts designers with the appropriate role to specify the following:
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.
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. You must check No if you plan to use the Page Tracking feature, which is useful in paper-based studies.You can change this setting and turn on Page Tracking in the Maintain Clinical Study States window under Conduct.
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 |
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Intervals |
Displays the Maintain Planned Study Intervals window. Intervals are the time units that make up the study timeline. |
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Events |
Displays the Events window, where you specify the number and type of visits. |
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Treatment |
Displays the Treatment Patterns window. Treatment patterns are sequences of one or more treatment regimens. |
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Create PP |
Displays the Create Patients window. Patient positions are the blinded place-holder records that represent the patients in the study. |
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Delete PP |
Displays the Delete Patients window, where you can eliminate unnecessary patient positions. |
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Display PP |
Displays the Existing Patients window, which displays the details of all the patient positions in the study. |
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.
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.)
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.)
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.)
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.)
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.
To create a clinical planned event:
From the Design menu, select Studies, then select Easy Study Design, select a Study, then select Events. The Clinical Planned Events window opens.
Enter values in the following fields:
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".
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.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.
Indicate if the CPE is optional or required by checking or unchecking the Optional checkbox.
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.
Populate the Offsets from Interval Start fields:
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.
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.
Time Unit enter the unit that applies to the Minimum and Maximum fields.
Save.
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Note: You cannot access a clinical planned event previously created in the Maintain Clinical Planned Events window from the Easy Study Design window. |
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.
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.
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.
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 Chapter 4 for more information on patient positions. The fields in the Delete Patients window are identical to standard design's Create Patients window.
To make your study operational you can complete these tasks from within the standard design modules:
Assign the study to one or more study sites. See "Assigning Sites to a Study".
Assign an Investigator to each of your study sites. See "Assigning Investigators to Study Sites".
Allocate patient positions to the study sites. See "Assigning Patient Positions to Sites".
To refine the definitions of the objects you create in Easy Study Design, you can use the standard study design forms.
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