| Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.2 E49540-01 |
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PDF · Mobi · ePub |
| Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.2 E49540-01 |
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PDF · Mobi · ePub |
Oracle® Health Sciences ClearTrial Cloud Service integrates clinical operations, resource planning, project management, and finance into a single application that provides your organization with dramatic efficiencies and cost savings from planning through payment in research and development operations.
This chapter covers the basic functions and tools you can use to plan, budget, and forecast clinical studies.
A product is a compound, a medical device, or a combination product on which you conduct a study. You can conduct multiple studies on a product.
A plan is one scenario or design for a study. You can create as many plans for a study as necessary to determine the most cost-effective or time-efficient scenario for a study.
You create a plan on the Create Plan screen. You modify plans on the Edit Plan screen. Both screens provide access to a set of data entry screens accessed by clicking tabs on the left side of the screen. The tabs appear in a specific order that provides a logical approach for creating or modifying a plan.
As you complete a tab, you can click Next to go to the next related tab. The application highlights the corresponding tab on the left.
The four edit modes give you control over how much detail you include in the plan. The tabs and fields included on the tabs vary by edit mode. The more details you enter, the more accurate the representation of costs the application produces. The inactive tabs appear grayed out.
Quick mode—Includes the least amount of detail. Use Quick mode when you have minimal information about the study or want to perform a high-level budget estimate or long-term planning before you have specifics about the study.
Basic mode—Includes a few more assumptions than Quick mode. For example, you enter site information in Basic mode but not in Quick mode.
Advanced and Expert modes—Include all of the tabs and fields. Use these modes when you have detailed specifications about how you plan to conduct the study and are ready to prepare a Request for Proposal, bid on a project, or submit a budget to Management for review and approval.
Your preferred edit mode is the mode to which the application defaults to when you create or edit a plan or template. Your maximum edit mode is the highest edit mode you are authorized to use. You can set your preferred edit mode in your user profile, but the system administrator sets your maximum edit mode.
On the menu bar, click your user name.
The User Profile screen appears.
Click Edit Profile.
The Edit User screen appears.
From the Preferred Edit Mode drop-down list, select the edit mode.
For more information about a field, click the field name.
For more information about the screen, see topic name-Edit Profile.
Click Save.
At any time, you can change your preferred edit mode. Plans configured in a higher or lower edit mode keep all their configured values, but, if you configured a field only accessible in a higher edit mode, for example, you will need to set your preferred edit mode to that edit mode or higher for the fields to be displayed and editable.
You can change the edit mode for a plan.
From the Edit menu, select Plans.
The Plans screen appears.
Select the plan checkbox and click Edit.
The Edit Plan screen appears.
From the Current Edit Mode drop-down list, select a different edit mode.
The screen refreshes, reflecting the change to the edit mode you selected.
You can change your password at any time.
On the menu bar, click your user name.
The User Profile screen appears.
Click Change Password.
The Change Password screen appears.
In the Current Password field, type your password.
In the New Password and Verify New Password fields, type the new password.
Click Save.
The application confirms your password change in an email message.
For security, the application does not support the recovery of existing passwords. If you forget your password, you must request a password reset.
On the ClearTrial Login screen, click the Forgot Your Password link.
The Reset Password dialog box appears.
Enter your Customer ID, Login Name, and Email Address.
Click Reset Password.
You will receive an email with instructions on how to reset your password.
Note:
If your organization does not allow user account information to be sent by email, your System Administrator needs to communicate the customer code, login name, and temporary password through a secure form of communication.The preferred home page is the screen that appears when you log into the application. You can change your home page by editing your user profile.
On the menu bar, click your user name.
The User Profile screen appears.
Click Edit Profile.
The Edit User screen appears.
From the Preferred Home Page drop-down list, select the screen to appear when you log in.
Click Save.
The preferred locale determines how dates and numbers appear on screens. You specify your preferred locale on your user profile.
On the menu bar, click your user name.
The User Profile screen appears.
Click Edit Profile.
The Edit User screen appears.
From the Preferred Locale drop-down list, select the location.
Click Save.
Filtering allows you to specify which plans, studies, products, templates, portfolios, service providers, resources, billing rates, departments, GL codes, exchange rates to show on plan-related screens. You always have a choice of showing all items, active items only, or items matching filters you have defined.
On any screen with a Filter section, select which items to show:
All <items>—No filter is applied.
Active <items> Only—Items that have not been deleted or marked as Complete or Archived.
<items> matching filter—Items that match the criteria defined in the filter you select from the drop-down list.
The screen refreshes to show the selected plans.
Click the Modify link.
The Define <item> Filter dialog box appears.
Complete the Filter Criteria, Save Filter, and Sorting and Paging sections.
For more information about a field, click the field name.
For more information about the screen, see Define Plan Filter Dialog Box, Define Product Filter Dialog Box Fields, Define Study Filter Dialog Box Fields, Define Template Filter Dialog Box Fields, Define GL Code Filter Dialog Box Fields, Define Portfolio Filter Dialog Box, Define Resource Filter Dialog Box Fields, Define Department Filter Dialog Box Fields, and Define Exchange Rate Table Filter Dialog Box Fields.
Click Ok.
The application provides warnings and guidance as you enter assumptions for a plan. Advice is available when a symbol appears to the right of a value. Double-click the symbol to read the advice.
Blue i—Additional information is available.
Yellow !—A value or piece of data may be outside of standard ranges.
Red !—Entry is invalid.
You can add notes to your plan to include additional detail, clarify selected options, or coordinate planning with other team members. Notes can be public or private. Private notes can be seen by your internal team. Public notes can be included on reports generated on the Reports tab.
From the Edit menu, select Plans.
The Plans screen appears.
Select a plan checkbox.
Click Edit.
The Edit Plan screen appears.
Click Notes.
The Notes dialog box appears.
Enter public notes in the first section and private notes in the second section.
All notes appear on the Assumptions report, below the table of assumptions for each functional area. You can control whether public and private notes are displayed when you print the Assumptions report. For more information about the Assumptions report, see Generating a Report.
Click Save & Close.
From the Edit menu, select Plans.
The Plans screen appears.
Select a plan checkbox.
Click Edit.
The Edit Plan screen appears. If a screen has an attached note, a notes icon appears to the left of the Notes button.
Click Notes.
The Notes dialog box appears and you can view all notes for the plan.
You create and edit plans, studies, products, templates, and portfolios from the Edit menu. The main screen for all of these items provides filtering as well as these functions:
New—Define a new item.
Edit—Edit a selected item.
Delete—Delete a selected item.
Restore—Restore a deleted item. To use this option, adjust the filters so that you can see inactive as well as active items.
Copy—Create a copy of a selected item.
In addition, you can lock and unlock plans and templates and compare plans.
From the Edit menu, select Products.
The Products screen appears.
Filter the products as necessary. For more information, see Define Product Filter Dialog Box Fields.
On the Products screen, click New or Edit.
The Create Product screen or Edit Product screen appears.
Enter or edit the fields as necessary.
For more information about the field, click the field name.
For more information about the screen, see Create/Edit Product Screen Fields.
Click Save.
The application adds the product to the Products screen. You can now create studies for this product.
From the Edit menu, select Studies.
The Studies screen appears.
Filter the studies as necessary. For more information, see Filtering Allows You to Show or Hide Items Based on Criteria.
The application supports four study phases:
Phase I, Screening for safety—Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase I, For healthy volunteers—Researchers test healthy subjects, who might have no symptoms, to assess the safety of the product. This is testing the drug for the first time in a human (typically called first in man studies).
Phase II, Establishing the efficacy of the drug, usually against a placebo—Researchers provide experimental treatment to a larger group of people (100–300) to see if it is effective and to further evaluate its safety.
Phase III, Final confirmation of safety and efficacy—The treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
Phase IV with and without IND support— These post-marketing studies delineate additional information, including the treatment's risks, benefits, and optimal use. You can design studies with and without Investigational New Drug (IND) support.
From the Edit menu, select Studies.
The Studies screen appears.
Click New.
The Create Study screen appears.
or
Select the study checkbox and click Edit.
Some fields are read only.
Changes to Phase, Therapeutic Area, Indication, and Sponsor cannot be cascaded to locked plans whose calculated values have been frozen based on the current configuration of this study.
The Edit Study screen appears.
Enter general information.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Study Screen Fields.
If the product entry has not already been created, from the Product/Compound drop-down list, select New to display the Create Product dialog box and define a new product.
Enter description information.
Indications are classified into therapeutic areas. The application uses the selected therapeutic area and indication to calculate monitoring time required, time for query resolution, and data entry, and to provide other default values. You can override these calculated values if necessary.
By selecting the Substitute the names below for therapeutic area and indication checkbox, you can specify an alias for the selected therapeutic area and/or indication. The alias appears on the Studies screen, the plan header, and on all study-related reports.
You should use a therapeutic area or indication alias if there are no therapeutic areas or indications included on the predefined list that describe your study.
To view a list of all therapeutic areas and their associated indications, from the Reports menu, select Therapeutic Area/Indications Mapping.
When no therapeutic area or indication seems to fit, choose the most appropriate body system/therapeutic area for the study you are planning.If you cannot find the specific therapeutic area or indication you need:
Select a similar therapeutic area or indication from the available list and then use the Alias fields to substitute the name of the actual therapeutic area or indication.
Select Other from the list of therapeutic areas and choose either a similar indication or Other (Complex), Other (Routine), Other (Simple), or Other (Very Complex).
Contact cleartrial-support_ww@oracle.com or your Clinical Services Director and request that the therapeutic area/indication be added.
Add a description or note.
To save the study, click Save.
or
To create a plan for the study, click Create Plan.
From the Edit menu, select Plans.
The Plans screen appears.
Filter the plans as necessary. For more information, see Filtering Allows You to Show or Hide Items Based on Criteria.
From the Plans screen, click New.
The Choose Study and Plan Template dialog box appears.
Select the radio button of the study for which to create a plan.
Select the radio button corresponding to the template to use.
Click Ok.
The Create Plan screen appears.
or
Select the plan checkbox and click Edit.
The Edit Plan screen appears.
Enter general information.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Plan Screen (Overview Tab).
Enter short and long descriptions.
Specify currency options. For more information, see Select Currencies and Exchange Rate Options.
Define other factors, such as special handling considerations including radioactivity, and study difficulty issues.
Add a note. For more information, see The Notes Feature Allows You to Annotate Every Page of Your Plan.
To save the plan, click Save.
or
To continue defining plan assumptions, click Next.
Using a template to create a plan saves time by storing frequently used values and choices. Templates also enforce standard operating procedures. Unlike a copy of a plan, which remains linked to its original study, you can create a plan based on a template for any study.
From the Edit menu, select Templates.
The Templates screen appears.
Filter the templates as necessary. For more information, see Filtering Allows You to Show or Hide Items Based on Criteria.
On the Templates screen, click New.
The Select Template Defaults dialog box appears.
Select the sponsor, phase, therapeutic area, and indication from the drop-down lists.
These are the defaults the application uses when you create a plan based on this template. You can override these values in your plan, or change the defaults by editing the template.
Click Ok.
The Create Template screen appears.
Enter or override the information shown on the Overview tab.
For more information about a field, click the field name.
For more information about the screen, see Templates Screen Fields.
Click Next to display the next tab or click a specific tab. Grayed-out tabs are not available.
Work through the tabs until you have completely defined the template.
Click Save.
On the Templates screen, select a template checkbox click Edit.
The Edit Template screen appears.
On the Overview tab, edit the information.
Step through the rest of the tabs by clicking Next or a specific tab. Grayed-out tabs are not available.
Add a note. For more information, see The Notes Feature Allows You to Annotate Every Page of Your Plan.
To save the changes to the template, click Save.
You can use portfolios to group plans by study, product, phase, or indication. Portfolios provide aggregate forecasts, such as monthly budget, monthly resource demand, and time lines across multiple plans. You can also see the effect of adjusting start and end dates.
Portfolios allow you to:
Obtain visibility into multiple project plans.
Create what-if scenarios for adding, removing, or delaying studies.
Assess the financial feasibility of acquiring new compounds.
Decide which studies to conduct.
After you have created a portfolio, you can:
Develop a forecast for a full set of studies within a given budget cycle (1-year, 3-years, 5-years, and so on).
Assess the impact on your budget of including, excluding, or delaying a particular plan or study.
View the resulting monthly budgets, resource requirements, cycle times, and milestones across a group of studies.
Account for the likelihood that a plan will come to fruition by discounting the costs associated with the plan.
Make on-the-fly adjustments and see the immediate impacts on budgets and resource requirements.
You can exclude plans from a portfolio to see how the exclusion affects the overall fees, costs, and hours of a portfolio. When you exclude a plan from the portfolio, it remains listed in the portfolio with a line through it and it can be included again.
Note:
Portfolios are designed for rapid scenario planning, not for precise, to-the-penny forecasting.From the Edit menu, select Portfolios.
The Portfolios screen appears.
Filter the portfolios as necessary. For more information, see Filtering Allows You to Show or Hide Items Based on Criteria.
On the Portfolios screen, click New.
The Create Portfolio screen appears.
or
Select the portfolio checkbox, and click Edit.
The Edit Portfolio screen appears.
On the Overview tab, enter a name for the portfolio, short and long descriptions, and the currency to use for portfolio reports.
Portfolio reports show all values for all plans in the portfolio rolled up into the single default reporting currency. Each plan in the portfolio uses its own exchange rate rules to convert from the plan values to the reporting currency. When you generate a report, you can override the currency.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Portfolio Screen (Overview Tab).
To display the Plans screen, click Next.
or
Click a specific tab. Grayed-out tabs are not available.
On the Plans tab, add plans to or remove plans from the portfolio or include or exclude plans from the portfolio.
You cannot add more than 200 plans to a portfolio.
After a plan has been added to a portfolio, it is automatically included, which means that the costs and milestones associated with the plan are added into the portfolio.
You can see the effect of postponing one or more plans by specifying a Start Offset.
To adjust the start date forward (earlier), enter a negative number.
To postpone a plan, enter a positive number.
This feature does not make adjustments for inflation. This is because the billing rate year associated with a plan does not change when you use Start Offset.
In the Probability field, you can specify the probability of a plan being implemented. The application reduces the costs associated with the plan according to the percentage. For example, if you set the probability to 50%, the application adds half of the plan's costs to the portfolio. The plan itself is not affected.
On the Summary tab, review the portfolio.
You can adjust the time frame by constraining the start and end dates, and you can include or exclude particular plans.The Summary tab reflects only costs and hours from included plans. Costs and hours from excluded plans are not added to the costs and hours of the portfolio.If any of the included plans has a probability of less than 100%, the costs and hours are reduced accordingly. For example, if you set probability to 50%, the costs and hours shown reflect only half of the costs and hours. �If any of the included plans have an offset start date, the costs and hours associated with the plan begin on the offset date, not on the original start date of the plan.The Cost Distribution graph provides a view of when costs occur over the time range specified. The shaded blue area represents the time frame you selected.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Portfolio Screen (Summary Tab).
To print the Portfolio Summary report, click Print.
On the Reports tab, generate additional reports.
You can view each report in a separate window, print it, export it to Microsoft Excel, or convert it to PDF.The reports reflect only costs and hours from included plans. Costs and hours from excluded plans are not added to the costs and hours of the portfolio and, therefore, do not appear in reports.If any of the included plans have a probability of less than 100%, the costs and hours are reduced accordingly. For example, if you set probability to 50%, the costs and hours reflect only half of the plan's costs and hours.If any of the included plans has an offset start date, the costs and hours associated with the plan begin on the offset date, not on the original start date.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Portfolio Screen (Reports Tab).
Click Save.
To delete an item, click Delete.
You can delete a single, multiple, or all items displayed on a screen. If you want to delete multiple items, use filtering options to group and display them for easier deletion.
Deleted data is not removed immediately. Rather, the application marks the data as deleted and then purges it on a scheduled basis.
Automatic purging, which takes place nightly, permanently removes items that have been deleted more than a specified number of days prior to the current date.
Clear the Active <items> Only filter.
Either choose to display all items, or use a defined filter that has the Include deleted items option selected to display deleted items. If you want to restore multiple items, use filtering options to group and display them.
Select the checkbox(es) of the deleted item(s).
Click Restore to revert the items to their state before deletion.
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