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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.0 E36710-02 |
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# 8 Overview Tab

The Overview Tab is used to enter basic information about a plan, including name, project activity start date, description, status and currency preferences for your plan.

## 8.1 Plan Name

The plan name is a name that identifies a plan. Your organization should decide on a standard naming convention, but it is recommended that plan names be a combination of the study name and the version of the plan that you are creating.

## 8.2 Plan Status

The Status field allows you to indicate the state of a plan. However, if a plan has been set as the baseline plan, the status cannot be edited. This field is unavailable for baselined plans.

The available plan statuses include the following:

1. Incomplete: An incomplete plan does not have all of the input questions answered and the results are not expected to be accurate.

2. Draft: A draft plan has all of the input questions answered, but the plan owner may still be working on the plan.

3. Final: A final plan has all of the input questions answered and the plan owner believes that the plan will be used to conduct the clinical study, however the plan has not yet been approved by a person authorized to approve a study plan.

4. Approved: An approved plan has been authorized for use in conducting a clinical study, or to be a part of an RFP or a proposal.

5. RFP: A plan marked RFP, means that it has been approved and has been included as part of an RFP.

6. Agreement reached; not started: A plan marked Agreement reached means that an agreement has been reached on the plan and it is under contract (if an outsourced study) or ready for study activities to begin (if an internal sponsor-executed study).

7. In progress: A plan marked In progress means that the study has begun and is operating.

8. Study Complete: A plan marked Study Complete means that the study has completed execution.

9. Archived: A plan marked Archived means that this plan is being preserved for historical purposes only.

## 8.3 Project Activity Start Date

For outsourced studies, this is the date that any Service Providers on the study will begin billable work.

Note: This field impacts fees for project management and start up fees for vendors based on the FSI date.

For studies conducted internally by the sponsor, this is the date on which Project Initiation activities will begin utilizing sponsor personnel. This does not include Pre-Study Planning as that date is accounted for separately; (see Pre-Study Planning).

If you decide to change the Project Activity Start Date after other data has been entered and saved, the following items may need to be addressed:

- If you accepted the default First Subject Enrolled (FSI) date (on the Subject Tab), this date is updated automatically according to the changed Project Activity Start Date. But if you or another user has changed (overridden) the First subject enrolled date, then any change in the Project Activity Start Date will not automatically update the First Subject Enrolled date that was selected.

- ClearTrial will require you to re-visit and revise any dates you have overridden.

- If you select a start date that is greater than the user-specified FSI date then a warning appears in the FSI date indicating that the date is before the Project Activity Start Date.

## 8.4 Start Pre-Study Planning

The Pre-Study Planning date is the date, prior to the project start date, on which a sponsor begins pre-planning activities. The value for this date 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. This date does not currently drive any calculations of effort or costs for your study.

## 8.5 Study will be

The plan outsourcing option, or “Study will be” field, allows you to identify how the plan will be outsourced.

- Outsourced: Select Outsourced if the entire study will be outsourced to an external Service Provider (excluding oversight of that Service Provider). This will set all responsibility radio buttons to 'Vendor' through-out the tabs of the plan.

- Conducted Internally: Select Conducted Internally if the study will be performed internally by the sponsor only, with no outside Service Providers. This will set all responsibility radio buttons to 'Sponsor' throughout the tabs of the plan.

- Combination: Select Combination if 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.

## 8.6 Short Description

The short description field allows you to enter information that will be displayed when viewing a list of plans. This information may help you recognize a particular scenario or purpose of the plan.

## 8.7 Long Description

The long description field allows you to enter a detailed explanation of the assumptions upon which this plan is based.

## 8.8 Default Modeling Currency

This field allows you to select the Default Modeling Currency. The Default Modeling Currency is the currency in which you expect to enter most costs and determines the default value for the currency selection of monetary assumptions. If the plan has been set as the Baseline Plan, you will not be able to edit this field.

The default modeling currency also determines the currency in which values will be displayed on the Labor, Costs, Payments, and Summary Tabs.

Regardless of the chosen modeling currency, you can enter any monetary assumption in the currency of your choice as is appropriate to the assumption.

## 8.9 Default Reporting Currency

This field allows you to select the Default Reporting Currency, which is the default currency used to generate reports. You can also choose any supported currency when you generate a report.

## 8.10 Use Exchange Rates

There are three options to indicate which exchange rates are used to convert between currencies:

1. As of (specified date): This option allows you to select a specific date from which exchange rates should be used. If you enter or select a date that ClearTrial does not have exchange rates, the date defaults to the next prior date for which ClearTrial does have exchange rates. You will receive a message indicating the date that is used and the field is updated accordingly.

2. As specified here...: This option allows you to override one or more exchange rates to values you supply. The label for this option is an active link. When clicked, it launches the Override Currency Exchange Rates dialog to enable you to view and/or override exchange rates.

   Note: If you change the exchange rate date, by selecting the “as of (specific date)” option, and you have previously overridden exchange rates, ClearTrial removes the overridden values and restores all values to the exchange rates for the newly selected date.

3. Defined in: This options allows you to select a user-defined exchange rate table from the drop down list. This option is recommended when you need to use your own exchange rates, rather than the ClearTrial defined rates. User-defined exchanges tables are created with the Exchange Rates functionality available on the Maintain Menu.

   When creating templates, another option is available:

4. As of plan created date: Selecting this option indicates that for each plan created from the template, the exchange rates date defaults to the latest available date for which ClearTrial has obtained exchange rates as of the date that plan is created. This is the recommended option for templates, unless the purpose of the template includes storing pre-negotiated exchange rates that every plan created using this template should use.

## 8.11 Drug Storage

This field allows you specify special handling considerations that must be considered.

## 8.12 Radio Labeled

This checkbox allows you to indicate whether the compound is radioactive.

## 8.13 Portfolio List

The Portfolio List displays all of the portfolios that contain this plan. For more information on portfolios and how to create them, see Working with Portfolios.

## 8.14 History

The History section displays information regarding the version history of a plan. This information can be used to keep track of when a plan was created, what template was used, who created it, what template was used, and it was last modified by.