Edit Basic Information on the Overview Tab

The Overview tab includes general information about the plan such as start date, outsourcing options, currency selected, and exchange rates.

Your edit mode determines which fields are visible. For more information about any field, click its name to display context-sensitive help.

Note:

For CRO users, the Overview tab includes an additional assumption that gives you the option to include or exclude sponsor hours from your budget plan. By default, sponsor hours are excluded for CRO users.

1. In the General Information section, in the Plan Name field, enter a name for the plan.
   • Oracle recommends that your team establish a standard naming convention for plans and templates.
   • As you enter the plan name, it appears in the information about the plan displayed at the top of every page.

     Note:

     For CRO users, the sponsor name appears within the plan header information at the top center of the screen.
2. To select the Project Activity Start Date, click the Calendar icon.

   For studies that are outsourced (in whole or in part), the Project Activity Start Date is the date on which any service provider on the study begins billable work on the project. For studies conducted internally by the sponsor, it is the date on which project initiation activities begin requiring sponsor personnel.

   • The value for the Start pre-study planning field defaults to three months prior to the Project Activity Start Date. However, you can override this date to any date prior to the Project Activity Start Date.
   • If you change the project activity start date after entering other information, all dates will be adjusted according to the new start date.
3. Select the plan outsourcing option.
   • Conducted Internally—The study will be performed internally by the sponsor, with no outside service providers. This sets all responsibility radio buttons to Sponsor throughout the tabs for the plan.
   • Outsourced—The entire study will be outsourced to an external service provider (excluding oversight of that service provider). This sets all responsibility radio buttons to Vendor.
   • Combination—Some of the study tasks (in addition to oversight) will be performed by the sponsor, while others will be done by one or more external service providers that you specify on the Assignment tab.
4. In the Description section, in the Short Description and Long Description fields, enter descriptions to help you recognize a particular scenario or remind you of the purpose of the plan when you view a list of plans. The Long Description field is optional.
5. In the Currency Options section, from the Default Model Currency drop-down list, select the currency to use to enter most costs, determine the default value for monetary assumptions, and display on the Labor, Costs, Payments, and Summary tabs.

   Note:

   You can enter monetary assumptions in the currency of your choice at a later time.
6. From the Default Reporting Currency drop-down list, select the default currency for reports.

   Note:

   When you generate a report, you can choose any supported currency.
7. Indicate the option to use for exchanging or converting between currencies:

   • As of (specified date)—Select a specific date for calculating exchange rates. If ClearTrial doesn't have rates for the specified date, the date defaults to the first prior date with exchange rates.

   • Defined in (global exchange rates table)—Choose a published and named set of rates that can be shared across plans. For more information, see User-defined Exchange Rate Tables.
   • As specified here...—Override one or more exchange rates by selecting this link to display the Override Currency Exchange Rates screen. Enter the specific exchange rates ClearTrial should use when converting this plan's values to a currency other than the currency in which a value has been entered or calculated, and then click Ok.
   • As of plan created date—This is the recommended option to specify if you are creating this plan as a template. For each plan created from the template, the exchange rates date defaults to the latest available date.
8. In the Other Factors section, from the Drug Storage drop-down list, define other factors, such as special handling considerations.
9. If the product or compound is radioactive, select the Radio Labeled check box.
10. Select the difficulty of the study.

    Study difficulty applies to other aspects of the study (site training, multiple locations, unusual monitoring conventions, sponsor micro management, and so on) not covered by the usual assumptions. For example:

    • Several sites might require more than one location or visit or additional interaction with several clinical investigators or their staff; for example, a pharmacy or hospital medical unit or record room.
    • Sites might be approved and ready to receive a study drug in a very short time, requiring exceptional effort on the part of the vendor. However, drug accountability might be atypical.
11. Enter values for any user-defined fields that appear. For more information about using and specifying user-defined fields, see Add Custom Fields to a Plan (Enterprise Edition).
12. Click Next to save your changes and advance to the next tab.