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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide
Release 5.4
E63096-01
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1 Getting Started: Basic Functions and Common Tools

Oracle® Health Sciences ClearTrial Cloud Service is license-based software as a service (SaaS) for clinical trial planning, sourcing and tracking. ClearTrial Cloud Service offers embedded intelligence to help life science companies manage the costs and plan their clinical trials and projects on time and within budget.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.

ClearTrial Plan and Source Cloud Service products leverage embedded industry intelligence and clinical knowledge to optimize your clinical study planning and sourcing and rationalize the deployment of your R&D spending. The cloud-based software enables you to compress study timelines while reducing costs; accelerate the delivery of accurate, defensible, and achievable budgets; and reduce outsourcing cycle times while increasing negotiation leverage.

The activity-based planning methodology in ClearTrial Plan and Source encompasses the detailed tasks and costs required to plan a clinical study—enabling you to build study plans and Request for Proposal (RFP) documents from the bottom up by entering your clinical assumptions. Delivered as cloud-based, software as a service (SaaS) applications, ClearTrial Plan and Source products offer industry-proven algorithms for more than 200 therapeutic indications, specific clinical development data and clinical research organization (CRO) labor rates for 90 countries, and detailed clinical, cost, and resource reports.

This chapter covers the basic functions and tools you can use to plan, budget, and forecast clinical studies.

Products, Studies, and Plans

You Conduct Studies on Products

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.

View Currently Defined Products on the Products Screen

  1. From the Edit menu, select Products.

    The Products screen appears.

  2. Filter the products as necessary. For more information, see Define Product Filter Dialog Box Fields.

Adding or Editing a Product

  1. On the Products screen, click New or select a product checkbox and click Edit.

    The Create Product screen or Edit Product screen appears.

  2. Enter or edit the fields as necessary.

  3. Click Save.

  4. Click Close.

    The application adds the product to the Products screen or changes the values as requested.

Plans Are Based on Studies

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.

View Currently Defined Studies on the Studies Screen

  1. From the Edit menu, select Studies.

    The Studies screen appears.

  2. Filter the studies as necessary. For more information, see Filtering Allows You to Show or Hide Items Based on Criteria.

The Four Study Phases

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.

Creating or Editing a Study

  1. From the Edit menu, select Studies.

    The Studies screen appears.

  2. 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.

  3. Enter general information.

    • 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.

  4. Enter therapeutic area and indication 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).

  5. Add a description or note.

  6. To save the study, click Save.

    or

    To create a plan for the study, click Create Plan.

A Tabbed Interface Guides You through Plan Creation and Modification

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.

Your Entries Cascade throughout the Plan

The selections you make on the Overview tab cascade throughout the plan and affect the defaults used on subsequent data entry screens.

Use the Plans Screen to Create or Edit a Plan for a Study

  1. From the Edit menu, select Plans.

    The Plans screen appears.

  2. Filter the plans as necessary. For more information, see Filtering Allows You to Show or Hide Items Based on Criteria.

Creating or Editing a Plan

  1. From the Plans screen, click New.

    The Choose Study and Plan Template dialog box appears.

    1. Select the radio button of the study for which to create a plan.

    2. Select the radio button corresponding to the template to use.

    3. Click Ok.

      The Create Plan screen appears.

      or

      Select the plan checkbox and click Edit.

      The Edit Plan screen appears.

  2. Enter general information.

  3. Enter short and long descriptions.

  4. Specify currency options. For more information, see Select Currencies and Exchange Rate Options.

  5. Define other factors, such as special handling considerations including radioactivity, and study difficulty issues.

  6. Add a note. For more information, see The Notes Feature Allows You to Annotate Every Page of Your Plan.

  7. To save the plan, click Save.

    or

    To continue defining plan assumptions, click Next.

Edit Modes Control the Detail of Your Plan

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.

Preferred versus Maximum Edit Modes

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.

Selecting Your Preferred Edit Mode

  1. On the menu bar, click your user name or role.

    The User Profile screen appears.

  2. Click Edit Profile.

    The Edit User screen appears.

  3. 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 User Profile Screen Fields.

  4. 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. However, if you configured a field only accessible in a higher edit mode, you must set your preferred edit mode to that edit mode or higher for the fields to be displayed and editable.

Changing Your Edit Mode Mid-plan

You can change the edit mode for a plan.

  1. From the Edit menu, select Plans.

    The Plans screen appears.

  2. Select the plan checkbox and click Edit.

    The Edit Plan screen appears.

  3. 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.

Managing Your Password

You can change your password at any time.

  1. On the menu bar, click your user name or role.

    The User Profile screen appears.

  2. Click Change Password.

    The Change Password screen appears.

  3. In the Current Password field, type your password.

  4. In the New Password and Verify New Password fields, type the new password.

  5. Click Save.

    The application confirms your password change in an email message.

If You Forget Your Password

For security, the application does not support the recovery of existing passwords. If you forget your password, you must request a password reset.

  1. On the ClearTrial Login screen, click the Forgot Your Password link.

    The Reset Password dialog box appears.

  2. Enter your Customer ID, Login Name, and Email Address.

  3. 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.

Setting Your Preferred Home Page

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.

  1. On the menu bar, click your user name or role.

    The User Profile screen appears.

  2. Click Edit Profile.

    The Edit User screen appears.

  3. From the Preferred Home Page drop-down list, select the screen to appear when you log in.

  4. Click Save.

Setting Your Preferred Locale

The preferred locale determines how dates and numbers appear on screens. You specify your preferred locale on your user profile.

  1. On the menu bar, click your user name or role.

    The User Profile screen appears.

  2. Click Edit Profile.

    The Edit User screen appears.

  3. From the Preferred Locale drop-down list, select the location.

  4. Click Save.

Filtering Allows You to Show or Hide Items Based on Criteria

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 items.

Defining or Modifying a Filter

  1. Click the Modify link.

    The Define <item> Filter dialog box appears.

  2. Complete the Filter Criteria and Save Filter sections.

  3. Click Ok.

List Configuration Options Allow You to Customize Columns

The Configure List Options link appears along with the Filter section and allows you to select which columns you want to display on the Plans, Studies, Products, Portfolios, RFPs, Bids, Templates, Resources, Departments, GL Codes, and Exchange Rate screens. You can also select the order of the columns from left to right.

Configuring or Modifying Columns

  1. On any screen with a Filter section, click the Configure List Options link.

    The Configure List Options dialog box appears. Each dialog box is tailored to the list screen with which it is associated.

  2. From the Configure Columns section, select the checkboxes of the columns to include in listings.

  3. In the Sorting and Paging section, specify up to three sort levels.

    1. From the Sort By drop-down list, select a field or category by which to group the items in the listing. Available choices appear in boldface type.

    2. From the first and then drop-down list, select a sort order within the first sorting criterion selected.

    3. From the second and then drop-down list, select a sorting order for the second sorting criterion.

  4. Click Ok.

Built-in Warnings and Information Provide Guidance

The application provides warnings and guidance as you enter assumptions for a plan. Advice is available when an information (i) symbol appears to the right of a value. Double-click the symbol to read the advice.

Color coding provides additional information.

  • Yellow !—A value or piece of data might be outside of standard ranges.

  • Red !—The entry is invalid.

The Notes Feature Allows You to Annotate Every Page of Your Plan

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.

Adding Notes to a Plan

  1. From the Edit menu, select Plans.

    The Plans screen appears.

  2. Select a plan checkbox.

  3. Click Edit.

    The Edit Plan screen appears.

  4. Click Notes.

    The Notes dialog box appears.

  5. 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.

  6. Click Save & Close.

Viewing Notes Attached to a Plan

  1. From the Edit menu, select Plans.

    The Plans screen appears.

  2. Select a plan checkbox.

  3. 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.

  4. Click Notes.

    The Notes dialog box appears and you can view all notes for the plan.

  5. Click Close.

Accessing Basic Functions

The List screens include a row of buttons that provide access to basic and advanced functions, Basic functions include:

  • 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, context-specific buttons appear. For example, on the RFPs screen, there are three additional buttons: Import Bid, Compare Bids, and Download Bid Grid.

For a description of each button, see the associated screen in Chapter 5, "Plan and Source Field Descriptions".

Group Related Plans into a Portfolio

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.

The portfolio costs include any inflation and line-item discount that exist on a plan within the portfolio.


Note:

Portfolios are designed for rapid scenario planning, not for precise, to-the-penny forecasting.

Viewing the Portfolios You Can Use

  1. From the Edit menu, select Portfolios.

    The Portfolios screen appears.

  2. Filter the portfolios as necessary. For more information, see Filtering Allows You to Show or Hide Items Based on Criteria.

Creating or Editing a Portfolio

  1. On the Portfolios screen, click New.

    The Create Portfolio screen appears.

    or

    Select the portfolio checkbox, and click Edit.

    The Edit Portfolio screen appears.

  2. 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).

  3. To display the Plans screen, click Next.

    or

    Click a specific tab. Grayed-out tabs are not available.

  4. 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.

  5. 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.

    • In the Portfolio Fees, Hours, and Pass-Through Costs section, if inflation and/or line-item discount exist in the plans included in the portfolio, inflation and line-item discounts appear as separate line items.

    • For more information about a field, click the field name.

    • For more information about the screen, see Create/Edit Portfolio Screen (Summary Tab).

  6. To print the Portfolio Summary report, click Print.

  7. On the Reports tab, generate additional reports.

    • You ca n 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).

  8. Click Save.

Cost Model Versions

The ClearTrial application calculates the level of effort, costs, distributions, and timelines for plans using the logic and work breakdown of the current release. This set of calculations is referred to as a "cost model" and each cost model is identified by the ClearTrial release with which it is associated. For example, ClearTrial release 5.3 has a cost model of "5.3." Each ClearTrial release, beginning with release 5.3, will have its own cost model available. ClearTrial releases earlier than 5.3 do not have a cost model available.

When a new ClearTrial release is made available, the cost model for the new release is updated to reflect changes in the industry standards. Any unlocked plan or template will continue to use the same cost model calculations that were in effect at the time the plan or template was created, allowing the budgets, forecasts, and dates to remain consistent from release to release. You do not need to lock your existing plan if you do not want the plan's cost model to be upgraded to the new released cost model; however, you might want to lock your plans if you do not want users to change assumption values.

If you want the billing rates to remain the same from release to release, ClearTrial recommends that you freeze rates prior to a new ClearTrial release as billing rates are not preserved as part of the cost model. For more information, see Freeze and Unfreeze Rates.


Note:

When you change the cost model on a plan, you should expect to see changes to the plan fees and costs as the plan will be recalculated according to the new cost model.

Viewing the Cost Model of a Plan

You can add the cost model as a column on the Plans screen. For more information, see Configuring or Modifying Columns.

When a plan is open, a message stating which cost model is being used appears in the upper right-hand corner of the screen.

Custom Assumptions to a Plan

If you have purchased the Plan Enterprise feature of the ClearTrial application, you can create your own custom assumptions. You might want to create a custom assumption when ClearTrial does not have a defined assumption that meets your need for calculating a custom task or for use as a unit of measure for billing.There are two concepts related to custom assumptions. They are:

  1. Custom field—The data field that allows a user to enter a custom assumption value.

    • Custom fields can only be created by users who have been assigned the additional role/capability of Custom Fields Designer. This additional capability is available only to users who already have Clinical or System Administrator as their assigned role.

    • Custom fields, which are developed and published for use in plans, are grouped and versioned as a custom field model. You can assign a custom field model to a plan to display and use the custom fields of that model in your plan.

    • Custom fields have a default of 0. It is recommended that you click the field label to display the Help text for the custom field and review any guidance for default values that may have been provided by your custom field designer

  2. Custom assumption—The value of the assumption.

    • Custom assumptions behave like ClearTrial-defined assumptions. They appear on the Assumptions report, vary by location, if appropriate, and have associated Help text.

    • Any user who has permission to edit the value of a ClearTrial default assumption can edit the value of a custom assumption.

Deleting a Product, Study, Plan, Template, or Portfolio

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.

Restoring a Product, Study, Plan, Template, or Portfolio

  1. 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.

  2. Select the checkbox(es) of the deleted item(s).

  3. Click Restore to revert the items to their state before deletion.