5 Plan and Source Field Descriptions

This chapter presents field descriptions for screens, tabs, and dialog boxes in the application. All possible fields are included. If your edit mode is set to Quick or Basic, not every field included will be available to you. For details about the functions and options described here, see Chapter 2, "Working with Plans,"Chapter 3, "Creating Requests for Proposals and Reviewing Bids," and Chapter 4, "Maintaining Resource Information and Settings."

Home Page Fields

These fields always appear on the screen you have designated as your preferred home page.

Table 5-1 Home Page Fields

Field	Description	Notes
Edit menu	Add or edit plans, studies, products, templates, and portfolios.	There are no notes.
Report menu	Generate standard reports that are not plan-specific.	There are no notes.
Maintain menu	Define, select, and edit: Templates—A reusable plan that serves as a starting point when planning any study. Service providers—The service providers to whom you can assign work in a plan. Resources—Manage system-defined resources and add, edit, and delete user-defined resources. Billing rates—Define billing rates for service providers to whom you assign work. After you publish the billing rates, the application shares the rates between plans. Departments and functional areas—Map departments to labor and costs. Choose a mapping mode. GL codes—Map labor and costs to the general ledger. Exchange rates—Create and define your organization's standardized rates for each currency to be used in your plans. Reporting Regions—Group reporting regions for studies based on your global organizational structure and accounting practices. Custom Fields—Manage custom field models and custom fields.	Select Purge Deleted Items to permanently remove items.
Admin menu	Users shows all users currently defined and allows the system administrator to add, edit, delete, and restore users; reset a selected user's password; clear a session when a user is locked out; and reset a user account. A reset clears the user's security question and answer, unlocks the account, and forces the user to reset the password.	There are no notes.
Help menu	Display a Help screen associated with the screen currently displayed. View version and product information on the About Oracle Health Sciences ClearTrial Cloud Service dialog box. Contact technical support.	There are no notes.
User Name	View your user profile.	You can edit your profile and change your password.
Visit Support Center	Displays the application Support Center to access release information, documentation, and reference material or to contact Oracle Support.	There are no notes.
Logout	Sign out of the application.	There are no notes.
Show	Show or hide items based on selected criteria. All <items>—No filter is applied. All items appear. Active <items> Only—Items that are not deleted or marked as Study Complete or Archived appear. <Items> matching filter—Only items that match the criteria you selected from the custom filter drop-down list appear.	These choices appear on any screen with a Filter section.
Modify link	Define a custom filter on the Define <Item> Filter dialog box.	There are no notes.

Plans Screens, Tabs, and Dialog Boxes

This section documents the screens, tabs, and dialog boxes associated with plans.

Plans Screen

Table 5-2 Plans Screen Fields

Field	Description	Notes
New button	Create a new plan.	There are no notes.
Edit button	Edit the selected plan or open it to view details, the summary, or reports.	You can also a open a plan by double-clicking the plan name.
Delete button	Delete the selected plan.	Deleted plans are removed at a later time and can be restored.
Restore button	Restore a deleted plan.	To use this option, adjust the filters so that you can see inactive as well as active items.
Copy button	Make a copy of the selected plan.	There are no notes.
Compare button	Compare selected plans. You can specify service provider and location details and change the currency used to generate the costs and comparison reports.	There are no notes.
Other Actions... button	Access additional features, such as locking and unlocking plans, freezing, and unfreezing billing rates, copying a plan as a template, and so on.	There are no notes.
Plan name column	Unique identifier of plans.	There are no notes.
Study Name column	Name of study.	There are no notes.
Description column	Short description of the plan.	There are no notes.
Status column	Status of the plan: Incomplete—Basic assumptions have not been set for the plan. Draft—All input questions of the selected edit mode have been answered, but the plan owner or creator might still be working on the plan. Final—All input questions have been answered and the plan owner believes the plan will be used to conduct the clinical study. However, the plan has not yet been approved. Approved—The plan has been approved and is ready to go out as part of an RFP or proposal or to be used to conduct the trial. RFP—The plan has been approved and included as part of an RFP. Agreement reached; not started—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). In progress—The study has begun and is operating according to this plan Study Complete—The study has ended. Archived—The plan is being preserved for historical purposes only.	You cannot choose another plan status until you enter information on all tabs through the Provider tab.
Last Modified column	Date a user last modified this plan.	There are no notes.

Plans Screen Dialog Boxes

The following dialog boxes are associated with the Plans screen.

Define Plan Filter Dialog Box

Table 5-3 Define Plan Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes plans last edited and saved the specified number of days.	There are no notes.
Include deleted plans	Includes plans that have been previously deleted.	There are no notes.
Plan name starts with	Includes plans whose names start with the specified text.	There are no notes.
Created by	Includes only plans created by one of the selected users.	To include all plans, select Any User.
Last Modified by	Includes only plans last edited and saved by the selected user.	To include all plans, select Any User.
Status	Includes only plans with the selected status.	To include all plans, select Any Status.
Phases	Includes only plans pertaining to the selected Phase(s).	To include all plans, select the Any Phase.
Therapeutic Areas	Includes only plans pertaining to the selected Therapeutic Area(s).	To include all plans, select Any Therapeutic Area.
Indications	Includes only plans for the selected indication(s).	To include all plans, select Any Sponsor.
Save filter as	Name assigned to the filter.	There are no notes.

Configure List Options Dialog Box - Plans Screen

Table 5-4 Configure List Options Dialog Box Fields - Plans Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Plans screen.	There are no notes.
Sort By	Orders the plans based on your selections.	Change the order by clicking a column heading.
Show n plans per page	Number of plans displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Choose Study and Plan Template Dialog Box

Table 5-5 Choose Study and Plan Template Dialog Box Fields

Field	Description	Notes
Study Name study column	Unique name given to study by its creator.	Read-only.
Product/Compound study column	The product or compound being studied.	Read-only.
Phase study column	The study phase being planned. The application supports study phases I, II, IIa, IIb, III, IIIb, Phase IV with an IND, and Phase IV without an IND. The application supports Phase I for oncology and vaccine studies, as well as Phase I studies for healthy volunteers. Phase I Oncology or Phase I Vaccine studies more closely resemble Phase IIa trials.	Read-only.
Therapeutic Area study column	The therapeutic area or body system for which this study will be conducted. The application uses this selection to calculate monitoring time required, time for query resolution, data entry, and to provide other default values.	Read-only. Determines the choices available for the indication.
Indication study column	The reason selected to perform this study. Indications are classified into therapeutic areas. The application uses this selection to calculate monitoring time required, time for query resolution, data entry, and to provide other default values.	Read-only.
Template Name template column	Name of a plan or partial plan that can be used as a starting point for new plans for a study.	Read-only. Inactive template statuses (Deleted, Archived, Study Complete) are not available for selection.
Description template column	Information describing the template to help you recognize a particular scenario or purpose for the plan.	Read-only.
Applicable For template column	Study phase(s) for which the template has been defined.	Read-only.

Copy Plan Dialog Box

Table 5-6 Copy Plan Dialog Box Fields

Field	Description	Notes
Plan Name	Name of the copy.	There are no notes.
Use Cost Model from	Cost model to apply to the copy.	The default is the cost model of the plan being copied. The list includes all supported cost models beginning with 5.3.
Custom Field Model	Custom field model to apply to the copy.	There are no notes.

Compare Plan Dialog Box

Table 5-7 Compare Plan Dialog Box Fields

Field	Description	Notes
Available Comparisons	Comparisons to be made and details to include.	There are no notes.
Providers To Include	Service providers to include in the comparison.	There are no notes.
Reporting Currency	Currency to use for the comparison report.	There are no notes.

Copy Plan as Template Dialog Box Fields

Table 5-8 Copy Plan as Template Dialog Box Fields

Field	Description	Notes
Template Name	Name of the new template based on the plan.	There are no notes.
Use Cost Model from	Cost model to apply to the template.	The default is the cost model of the plan being copied. The list includes all supported cost models beginning with 5.3.
Custom Field Model	Custom field model to apply to the template.	There are no notes.

Change Plan Attributes Dialog Box

The attributes you can change vary depending on the number of plans you select and the status of the selected plans.

Table 5-9 Change Plan Attributes Dialog Box Fields

Field	Description	Notes
Plan Name	Unique name that identifies the plan.	If you select multiple plans, the name field is disabled to prevent you from changing the name of more than one plan to the same name.
Status	Status of the plan: Incomplete—Basic assumptions have not been set for the plan. Draft—All input questions of the selected edit mode have been answered, but the plan owner or creator might still be working on the plan. Final—All input questions have been answered and the plan owner believes the plan will be used to conduct the clinical study. However, the plan has not yet been approved. Approved—The plan has been approved and is ready to go out as part of an RFP or proposal or to be used to conduct the trial. RFP—The plan has been approved and included as part of an RFP. Agreement reached; not started—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). In progress—The study has begun and is operating according to this plan Study Complete—The study has ended. Archived—The plan is being preserved for historical purposes only.	There are no notes.
Cost Model	Cost model to apply to the plan.	The list includes all supported cost models beginning with 5.3.
Custom Field Model	Custom field model to apply to the plan.	There are no notes.
Short Description	Short description of the plan that appears on the Plans screen.	There are no notes.
Long Description	Detailed plan description.	There are no notes.
Update last modified date and user (plan history)	Updates the selected plans' Last Modified Date and Last Modified fields when changes are applied to the name, status, and/or description.	There are no notes.

Add Plans to Portfolio(s) Dialog Box

Table 5-10 Add Plans to Portfolio(s) Dialog Box Fields

Field	Description	Notes
Name column	Portfolios to which you can add the selected plan(s).	There are no notes.
Description column	Short description of the portfolio.	There are no notes.
# Plans Now column	Number of plans in the portfolio before adding the selected plan(s).	There are no notes.
# Plans After column	Number of plans in the portfolio after adding the selected plan(s).	There are no notes.
Also create a new portfolio and add the selected plans to it column	Create a new portfolio.	There are no notes.
Portfolio Name	Name for the new portfolio.	There are no notes.
Short Description	Short description of the portfolio. This description appears on the Portfolios screen.	There are no notes.
Default Reporting Currency	Default reporting currency for generating portfolio reports.	Determines the currency used to display monetary values on the Portfolios Summary tab.

Create Reforecast Dialog Box

Table 5-11 Create Reforecast Dialog Box Fields

Field	Description	Notes
Reforecast Name	Name of the new forecast.	There are no notes.
Reforecast Date	Reforecast date for all listed plans.	Changes to assumptions take effect on this date.
Prior Forecast Date	Date of the prior forecast plan.	There are no notes.
Study End Date	Date by which study is expected to be complete, defined as the date that all activity stops (usually the date the final report <CSR> is finalized).	There are no notes.
Use Cost Model from	Cost model to apply to the reforecast.	The list includes all supported cost models beginning with 5.3.
Custom Field Model	Custom field model to apply to the reforecast.	There are no notes.
Create reforecast based on	Actuals for reforecast based on actual tracked data or Plan for reforecast based on planned data.	Only available to users licensed to the Track module.

Reforecast Exch Rates (Create Reforecast) Dialog Box

Table 5-12 Create Reforecast Dialog Box Fields (Reforecast Exchange Rates)

Field	Description	Notes
Reforecast Date	Reforecast date for all listed plans.	You can edit the date for each plan individually.
Use Exchange Rates	Exchange rates reforecast method. To reforecast based on exchange rates as of a particular date, choose the first radio button and then specify that date. To reforecast based on exchange rates specified in a predefined published exchange rate table, choose the second option and choose the table by name from the list.	There are no notes.
Use Exchange Rates: as of (date)	Date from which to obtain exchange rates as they were at the close of market on that day.	There are no notes.
Use Exchange Rates: defined in (published exchange rates table)	Published set of exchange rates to apply.	There are no notes.
Reforecast Name column	Suggested name for each reforecast. You can either accept this name or type a new name.	There are no notes.
Prior Forecast Date column	Date of the last forecast per plan.	The new reforecast date must be later than this date.
Study End Date column	Date by which study is expected to be complete, defined as the date that all activity stops (usually the date the final report <CSR> is finalized).	There are no notes.
Reforecast Date column	Date from which to apply the newly chosen exchange rates for each plan.	Recommended option if progress was tracked and actuals are up to date.
Based on column	Base the reforecast on the actual progress, rather than on the predicted progress.	Only available to users licensed to the Track module and for plans whose studies are being tracked.

Create/Edit Plan or Template Screen (Overview Tab)

Table 5-13 Overview Tab fields

Field	Description	Notes
Plan Name	Unique name that identifies the plan.	There are no notes.
Project Activity Start Date	Date the study begins, defined as the date that vendors and the sponsor start identifying sites and vendors start billable activity.	There are no notes.
Status	Plan status.	There are no notes.
Start pre-study planning	Date a sponsor begins pre-planning activities. The default date is three months prior to the Project Activity Start Date.	Not used to calculate effort or costs for the study.
Study will be	Outsourcing option for the plan: Conducted Internally—Study is performed internally. Sets all responsibility radio buttons to Sponsor throughout the plan. Outsourced—Entire study is outsourced to an external service provider (excluding oversight of that service provider). Sets all responsibility radio buttons to Vendor throughout the plan. Combination—Study tasks are divided between an external service provider and the sponsor.	There are no notes.
Short Description	Short description of the plan that appears on the Plans screen.	There are no notes.
Long Description	Detailed plan description.	There are no notes.
Default Modeling Currency	Currency used to enter plan costs.	There are no notes.
Default Reporting Currency	Currency the application uses to generate reports.	There are no notes.
Use Exchange Rates	Exchange rates to use when converting between currencies. As if (specified date)—Exchange rates from a specific date. Defined in—User-defined exchange rate table. For more information on creating exchange rate tables, see Creating an Exchange Rate Table. As specified here—Override of one or more exchange rates with values you supply. As of plan created date—When creating templates, use exchange rates from the date the plan was created.	If you select a date the application does not support, it defaults to the most recent date for which exchange rates are available.
Drug Storage	Special handling considerations.	There are no notes.
Radio Labeled	Compound is radioactive.	Optional.
Study Difficulty	Unusual circumstances about a trial make aspects other than monitoring and data management more or less difficult than most clinical studies.	For example, multiple monitoring sites, complex ICF or other study regulatory documents, complex interaction with multiple groups at the study sites, additional interaction with the sponsor and or a DSMB.
Created By	Displays the name of the user who created the plan.	There are no notes.
Last Modified By	Displays the name of the user who last modified the plan.	There are no notes.
Created Date	Displays the date the plan was created.	There are no notes.
Last Modified	Displays the date the plan was last modified.	There are no notes.
Created as a copy of	Displays the plan that was copied.	There are no notes.
Original Template	Displays the template from which the plan was created.	There are no notes.

Override Currency Exchange Rates Dialog Box

Table 5-14 Override Currency Exchange Rates Dialog Box Fields

Field	Description	Notes
Currency Exchange Rates	Currency exchange rates based on data entry.	There are no notes.
1 US Dollar (USD) equals...	Default exchange rates for 1 US dollar as of the current date.	There are no notes.

Locations Tab

Table 5-15 Locations Tab Fields

Field	Description	Notes
Add Location(s) button	Add one or more locations on the Choose Locations dialog box.	There are no notes.
Remove Location(s) button	Remove selected location(s).	Removing a location from a plan does not delete that location from the application.
Add Language(s) button	Add one or more languages not suggested for the plan by the application.	There are no notes.
Remove Language(s) button	Remove a selected user-specified language.	There are no notes.
Location column	Name of a location (either the country or the region) where sites will be located and subjects enrolled.	There are no notes.
Number of Sites column	Number of sites for the location.	There are no notes.
Subjects to Randomize column	Number of subjects to randomize in this location. Should contain only the number of subjects that will actually be enrolled in the trial.	Must be a value between 1 and 999,999.
Avg Grant Amount column	Average grant amount is paid to each investigator for each subject the investigator enrolls in the study at the location.	Payment for a dropped subject is approximately 75% of the grant. Must be a value between 0.00 and 500,000.00 USD (or the equivalent in another currency).
MOH/FDA Delay column	Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time frame for each location.	Must be a value between 0 and 999.
Total/Avg column	Averages of the total sites, subjects to randomize, grant amount and MOH/FDA time delay.	There are no notes.
Language	Language into which study materials might need to be translated.	There are no notes.
Dialects/Variations	Number of dialects or variants of this language into which to translate study documents.	There are no notes.
Document Translations	Which documents are to be translated into the languages specified.	There are no notes.
Number of Translations/ Dialects	Total number of translations required.	There are no notes.

Choose Location Dialog Box

Table 5-16 Choose Locations Dialog Box Fields

Field	Description	Notes
Regions filter	Include locations by region.	There are no notes.
Countries filter	Include locations by country.	There are no notes.
Remove Language(s) filter	Remove the selected languages.	There are no notes.
Region column	Regions available for selection.	There are no notes.
Country column	Countries available for selection.	There are no notes.
Primary Language column	Primary language of the selected region or country.	There are no notes.
Primary Currency column	Primary currency of the selected region or country.	There are no notes.
MOH/FDA Delay column	Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time for each location.	There are no notes.

Choose Additional Languages Dialog Box

Table 5-17 Choose Additional Languages Dialog Box Fields

Field	Description	Notes
Language column	Languages available.	There are no notes.
ISO Code column	Internationally recognized country code associated with the language.	There are no notes.

Document Translations Required Dialog Box

Table 5-18 Document Translations Required Dialog Box Fields

Field	Description	Notes
Document Type	Type of document.	There are no notes.
Translate	Translates the document type to the languages indicated.	There are no notes.
Back Translate	Translates the document back into the language of the original text, from the translated version.	There are no notes.
As Pass-Through Cost	Translation costs are to be considered pass-through costs, not calculated costs.	There are no notes.
Apply these choices for:	Applies selected translation choices to other languages.	There are no notes.

Site Tab

Table 5-19 Site Tab Fields

Field	Description	Notes
Location column	Name of a location where sites will be located and subjects enrolled.	There are no notes.
Number of Sites column	Number of sites within the selected location.	There are no notes.
Site Approval Schedule column	Type of site approval schedule for the location. User Defined Schedule—Site approval schedule has been modified. ClearTrial Default Schedule—Site approval follows the application-defined schedule.	There are no notes.
Values apply to	Location for which the values apply. Select a single location or All Locations to enter information for all locations in the plan.	If you select a single location, click Save before selecting another location.
Number of sites	Number of sites in the location.	There are no notes.
Percent of sites identified by sponsor	Percentage of study sites that the study sponsor identifies. The application calculates the number of sites.	There are no notes.
Percent of sites requiring a pre-study site visit (in-person)	Percentage of sites that require an in-person pre-study site visit. The application calculates the number of sites.	There are no notes.
Percent of sites requiring a phone-based pre-study site visit	Percentage of sites that require a phone-based pre-study visit. The application calculates the number of sites.	There are no notes.
Percent of sites requiring site initiation visits (in-person)	Percentage of sites that require an in-person site initiation visit. The application calculates the number of sites.	There are no notes.
Percent of sites requiring only phone-based site initiation	Percentage of sites that require a phone-based site initiation visit. The application calculates the number o f sites.	There are no notes.
Percent of on-site close-out visits	Percentage of sites that require an on-site close-out visit. The application calculates the number o f sites.	There are no notes.
Percent of sites requiring only phone-based close-outs	Percentage of sites that require only phone-based close-outs. The application calculates the number of sites.	There are no notes.
Number of grant payments per site	Estimated number of grant payments per site.	The application derives a default value after the study duration is calculated. Assumes quarterly payments.
Percent of sites using local monitoring	Percentage of sites using a local monitor. The application calculates the number of sites.	There are no notes.
Percent of sites requiring overhead	Percentage of sites requiring overhead above the standard investigator grant. The application calculates the number of sites.	There are no notes.
Average percent overhead	Average overhead percentage for sites requiring overhead.	There are no notes.
Number of drug shipments per site	Estimated number of drug shipments for each site.	There are no notes.
Percent of sites requiring a QA audit	Percentage of sites requiring a quality assurance audit. The application calculates the number of sites.	There are no notes.
Percent of regulatory documents collected	Enter the percentage of regulatory documents to collect during the investigator approval process.	There are no notes.
Percent of sites using BOTH a central and local IRB/EC	Percentage of sites using both a central and local review board or ethics committee. The application calculates the number of sites and applies the percentage separately to each site.	IRB is applicable to US sites only. Other countries use either central or local ethics committees.
Percent of sites using ONLY a central IRB/EC	Percentage of sites using only a central review board or ethics committee. The application calculates the number of sites and applies the percentage separately to each site.	Exclude all university centers and sites that are affiliated with hospitals that require that their own ethics committees are used.
Percent of sites using ONLY a local IRB/EC	Percentage of sites using a local review board or ethics committee based on the percentage entered. The application calculates the number of sites.	Percentages are applied to the number of sites in each location and partial values are rounded up for central IRBs/ECs and rounded down for local IRBs/ECs.
Task Group column	Assignment group to which outsourcing responsibilities are applied.	For a list of tasks, see the online Help for the Sites tab.
Sponsor column	Assign all of the tasks in that group to the study sponsor.	There are no notes.
Vendor column	Assign all of the tasks in that group to the primary vendor assigned on the Provider tab.	There are no notes.
Mixed column	Assign some of the tasks to the sponsor and some to the vendor.	Make these assignments on the Assignment tab.
N/A column	None of the tasks in the group will be performed.	There are no notes.

Edit Site Approval Schedule Dialog Box

Table 5-20 Edit Site Approval Schedule Dialog Box Fields

Field	Description	Notes
Site Approval Schedule	Type of site approval schedule for the location. User Defined Schedule—Site approval schedule has been modified. ClearTrial Default Schedule—Site approval follows the application-defined schedule.	There are no notes.
Default Site Approval Period	Default length of the site approval period.	There are no notes.
Additional Site Approval Weeks	Number of weeks added to the application-defined approval period.	There are no notes.
Total Number of Weeks of Site Approval	Total length of the site approval period for this location, accounting for the default site approval period plus any additional weeks applied.	There are no notes.
Week # column	Week number. within the site approval schedule.	There are no notes.
Week Of column	Start date of each week of the site approval period.	There are no notes.
Sites (Default) column	Number of sites expected to be approved (according to the ClearTrial Default Site Approval Schedule) each week.	Cumulative totals appear inside parentheses.
% (Default) column	Percentage of sites expected to be approved (according to the ClearTrial Default Site Approval Schedule) each week.	There are no notes.
Sites (User Defined)	Number of sites expected to be approved (according to the user-defined Site Approval Schedule) each week.	There are no notes.
% (User Defined) column	Percentage of sites expected to be approved (according to the user-defined Site Approval Schedule) each week.	There are no notes.
Total column	Total for each column.	There are no notes.
Restore Defaults button	Restore the default site approval schedule for this location.	There are no notes.
Apply button	Add the specified number of weeks to the site approval schedule.	There are no notes.
Copy Default Value button	Populate the user-defined site approval schedule with the application defaults.	Use to revise part of the schedule rather than entering a new set of assumptions.

Subject Tab

Table 5-21 Subject Tab Fields

Field	Description	Notes
Project Activity Start Date	Date the study begins, defined as the date that vendors and the sponsor start identifying sites and vendors start billable activity.	Appears here for easy reference.
First Subject In Date (FSI/FPI)	Date for the first subject visit (FSFV) to occur.	There are no notes.
Manage location-specific values	Manage location-specific values for the First Subject In (FSI) date. Globally—Changes you make to the application-calculated FSI date apply to each location based on the number of days you shift the date. Per Location—Enter the dates and enrollment periods for each location in the study on the Edit Subject Arrival Dates dialog box.	There are no notes.
Subjects to randomize	Number of subjects in the selected location or all locations.	There are no notes.
Additional percent of randomized subject as alternates	Percentage of the total subjects randomized to be screened as alternate subjects.	There are no notes.
Stipend per alternate subjects	Stipend provided each alternate subject.	There are no notes.
Screen failure rate	Percentage of subjects expected to fail to become study participants.	Value cannot be greater than 99.99%. Oracle recommends a value between 0 and 50%.
Number of subjects to screen	Calculated number of subjects to screen based on the percentage of subjects expected to fail.	There are no notes.
Investigator payment per screen failure	Amount paid to the investigator for a subject that fails study screening.	There are no notes.
Percent of screen failures paid for	Percentage of the expected screen failures for which investigators are paid.	There are no notes.
Screen failures allowed	Maximum number of screen failures for which investigators in this location will be paid.	Represents the cap on amounts paid for subjects that do not become subject participants.
Stipend per screen failure	Stipend amount provided for each screen failure.	There are no notes.
Number of CRF pages per screen failure	Number of CRF pages collected for each screen failure.	There are no notes.
Subject drop rate	Percent of subjects expected to not complete a full CRF due to early termination.	Must be a value between 0 and 99.
Subjects expected to complete all study visits	Number of subjects expected to complete all study visits/data, based on the percentage entered for subject drop rate.	There are no notes.
Manage location-specific values	Link to Edit Location-specific Screening and Drop Rate and Assumption dialog box to manage subject screen and drops by location.	There are no notes.

Edit Subject Enrollment Dialog Box

Table 5-22 Edit Subject Enrollment Dialog Box Fields

Field	Description	Notes
Update study level enrollment period to	Study-level enrollment period.	There are no notes.
Adjust first subject date for the selected locations by	Shifts the First Subject In date for the selected locations by the number of days (positive or negative).	There are no notes.
FSI column	First Subject In. Date that the First Subject First Visit (FSFV) is expected to take place.	There are no notes.
Enrollment Period column	Number of weeks during which subjects will be enrolled in the trial.	There are no notes.
Last Subject In Date column	Location -specific First Subject In date plus the enrollment period.	There are no notes.
Enrollment Rate column	Number of subjects expected to be enrolled per site per month.	There are no notes.

Edit Subjects Arrival Dates Dialog Box Fields

Table 5-23 Edit Subjects Arrival Dates Dialog Box Fields

Field	Description	Notes
Enrollment per Location	Defines subjects arrival dates per location.	There are no notes.
Adjust first subject date for the selected locations by	Shifts the First Subject In date for the selected locations by the number of days (positive or negative) entered.	There are no notes.
Apply button	Applies the FSI date shift value to the selected locations.	There are no notes.
Location column	Subject arrival region.	There are no notes.
FSI column	First Subject In date.	If a start date that is greater than the user-specified FSI date is selected, a warning appears in the FSI date indicating that the date is before the Project Activity Start Date.
Study Level column	Location-specific First Subject In date plus the enrollment period.	There are no notes.

Edit Enrollment Distribution Dialog Box

Table 5-24 Edit Enrollment Distribution Dialog Box Fields

Field	Description	Notes
Location option	Location for which the subject enrollment distribution is managed.	There are no notes.
Type of enrollment distribution option	Expected enrollment distribution. Acute—For indications where the subjects must present with the condition and will not be found by searching the medical records. Example: Anti-infective trials might experience an Acute or Acute Short Startup enrollment distribution. Acute Short Startup—For Acute indications AND when you expect that less than 75% of the sites will be approved at the time when the first subject enrolls. Bell Curve—Used only when the enrollment type is unclear to get an estimate of the study using an approach other than an even distribution of subjects across the enrollment period.	There are no notes.
	Block Enroll—For situations such as allergy studies where it is expected that patients will be enrolled quickly over the first two quartiles of the enrollment period and stragglers over the last two quartiles. Chronic—For studies where the subjects that meet the criteria are generally known and can be readily found by reviewing the patient charts and you expect all or most of the sites will be approved before the first subject visit takes place. Example: Chronic illness like diabetes, Alzheimer's, AIDs. Chronic Short Startup—For chronic indications when you expect that less than 75% of the sites will be approved at the time when the first subject enrolls. Even Distribution—Rarely used, and then only for general estimations. Custom...—To enter the percentage of the total subject population expected to be enrolled during each quartile of the enrollment period.	There are no notes.
Distribution resolution option	Resolution at which to manage the subject enrollment distribution.	There are no notes.
Period column	Period, quartile, or study week, during which subjects are planned to enroll.	There are no notes.
Subjects column	Number of subjects expected to enroll during a particular period or quartile.	There are no notes.
Percentage column	Percentage of subjects expected to enroll during a particular period or quartile.	There are no notes.

Edit Location-specific Screening and Drop Rate Assumptions Dialog Box

Table 5-25 Edit Location-specific Screening and Drop Rate Assumptions Dialog Box Fields

Field	Description	Notes
Location	Screening and drops region.	There are no notes.
Subjects to randomize	Number of subjects expected in the selected location or for All Locations.	There are no notes.
Additional percent of randomized subjects as alternates	Percentage of the total subjects randomized to be screened as alternate subjects.	There are no notes.
Stipend per Alternate subject	Stipend provided each alternate subject.	There are no notes.
Screen failure rate	Percentage of screened subjects expected to fail to become study participants.	Must contain a value between 0 and 99.99. Cannot be greater than 99.99%. Recommended values are between 0% and 50%.
Number of subjects to screen	Calculated number of subjects to screen based on the percentage of subjects that are expected to fail and the number of subjects that are expected to be screened.	Calculation: Number of Screen Failures Expected = Number of Subjects to be Randomized / (100 - Percent of Subjects that Fail Screen.
Investigator payment per screen failure	Amount that will be paid to the investigator for each subject that fails screening.	There are no notes.
Stipend per screen failure	Stipend to be paid to each potential subject that fails to pass the screening.	There are no notes.
Percent of screen failures paid for	Percentage of the expected screen failures investigators will still be paid.	There are no notes.
Number of screen failures allowed	Maximum number of screen failures for which investigators will compensated in this location.	There are no notes.
Subject drop rate	Percent of subjects that will not complete a full CRF due to early termination.	There are no notes.

Treatment Tab

Table 5-26 Treatment Tab Fields

Field	Description	Notes
Trial Design	Parallel or Cross-over study design. Parallel—Different subjects receive different treatments during the same period. Cross-over—Each subject receives all of the defined treatments, but in a different sequence.	Your choice determines which fields and sections appear. For example, if you select Parallel, you can also identify this as an endpoint study and select additional assumptions.
Will there be an electronic subject diary?	Whether there is an electronic subject diary.	There are no notes.
Is this an endpoint study?	Yes or No	An endpoint study is a study in which all patients conclude their participation on or around the same calendar date.
Weeks from FSI to endpoint	The number of weeks from the time the first subject is enrolled until the endpoint is expected to occur.	Must be a value between 0 and 999.
Subjects will visit every <n> weeks during the extended treatment period	The frequency of subject visits during the extended treatment period.	Must be a value between 0 and 999.
Endpoint date	The date the endpoint is expected to occur according to your entry for the number of weeks until the endpoint.	This is a display field.
Cost per bednight	Cost per night that a subject is confined to a study center during the treatment period.	Only applicable to PHIHV plans.
Currency drop-down list	Currency of the Cost per bednight.	Only applicable to PHIHV plans.
Number of CRF pages collected in the baseline visit	Total number of CRF pages collected for enrolled subjects during their screening visits and during the baseline visit.	Appears if the Trial Design is Cross-over. Must be a value between 0 and 99. If two or more patient visits occur in the same week, treat them as a single visit for calculation purposes.
Baseline visit monitoring time required (in minutes)	Minutes required to monitor pages collected during screening and baseline visits.	Appears if the Trial Design is Cross-over. Must be a value between 0 and 9,999.99.
Washout period duration	Length of the washout period, specified in weeks for late stage trials and in days for Phase 1 trial.	Appears if the Trial Design is Cross-over. Time between treatments in a cross-over trial in which subjects are not treated. Done to reduce or avoid residual effects of the prior treatment from skewing the data or compromising the validity of the subsequent treatment(s). Must be a value between 0 and 999.
Configure washout period	Link that displays the Edit Washout Period dialog box., where you can specify how much data is collect during the washout period between each treatment.	There are no notes.
Number of CRF Pages	The number of Case Report Form (CRF) pages that will be collected for each subject during this period.	Must contain a value between 0 and 999.
Monitoring Time (minutes)	Display of the calculated amount of time, in minutes, required to monitor the pages collected during this period.	You can override this value if necessary. Must be a value between 0 and 9,999.99.
Total number of CRF pages	Display of the total number of CRF pages to be collected for a single subject during each washout period.	There are no notes.
Number of bednights during the washout period	Number of nights that a subject is confined to a study center during the washout period.	Only applicable to PHIHV plans when Cross-over selected.
Add button	Add a new treatment.	You can add up to five treatments to the study.
Edit button	Edit a treatment on the Treatment Details dialog box.	There are no notes.
Copy button	Duplicate an existing treatment.	There are no notes.
Delete button	Remove a treatment.	Deleting a treatment removes all of its associated assumptions.
ID	Alphabetic identifier for the treatment entry.	There are no notes.
Number of subjects	Number of subjects to receive the treatment.	Included for parallel studies. Not included for cross-over studies because all subjects receive all treatments. Treatment sequence varies). Must be a value between 1 and 999,999.
Treatment duration	Treatment length, or time-on-trial, for each subject. For late-stage trials, specified in weeks. For Phase I trials, specified as days.	Must be a value between 2 and 999.
Visits per subject	Number of visits for each subject during the treatment. For late-stage trials, a visit is a week. For Phase I trials, a visit is a day on which one or more CRF pages are collected. For Phase I (Healthy Volunteers) trials, in which subjects are confined, each day is a visit.	Must be a value between 2 and 999.
Number of bednights	Number of nights subjects are confined to a study center during the treatment period.	Must be a value between 0 and 999. For PHIHV plans only.
CRF pages per subject	Number of Case Report Form (CRF) pages collected for each subject during this treatment.	Must be a value between 2 and 9,999.
QOL pages	Number of Quality of Life (QOL) pages collected during the treatment period.	Must be a value between 0 and 9,999.
Subject diary pages	Number of subject diary pages collected during the treatment period.	Must be a value between 0 and 9,999.
Pharmacoeconomic pages	Number of pharmacoeconomic pages collected during the treatment period.	Must be a value between 0 and 9,999.
Lab and diagnostic tests per subject.	Number of expected lab and diagnostic tests per subject per treatment arm.	Must be a value between 0 and 999. Available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Cohort escalation review.	Number of dose escalation reviews per treatment arm.	Must be a value between 0 and 999. Available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Average CRF pages per extended visit	The average number of CRFs that will be collected during each visit after a subject has completed the standard treatment.	This value should be inclusive of QOL (Quality-of-Life), pharmacoeconomic, and subject diary pages collect. Must contain a value between 0 and 99.
QOL pages per extended visit	How many of the pages collected during the extended treatment period are Quality-of-Life (QOL) pages.	Must contain a value between 0 and 99.
Subject diary pages per extended visit	How many of the pages collected during the extended treatment period are subject diary pages.	Must be a value between 0 and 99. Available in Advanced Edit Mode or higher.
Pharmacoeconomic pages per extended visit	How may of the pages collected during the extended treatment period are pharmacoeconomic pages.	Must be a value between 0 and 99. Available in Advanced Edit Mode or higher.
Monitoring minutes per CRF page	Number of minutes to monitor one regular CRF page. This field does not apply to monitoring for pages generated during the baseline visit. The application calculates the default value based on the study phase and therapeutic indication. You can override this value for each treatment. Overridden values do not affect minute per page values for the baseline visit or washout period for a crossover study. If endpoint study, applies to both the standard treatment period and the extended treatment period for the treatment arm. Does not apply to pages collected at baseline visit or during washout period. Those values can be configured through the washout configuration option or on the treatment schedule.	Available in Expert mode only. Must be a value between 1 and 100. Precision up to three decimal places appears. If the default value has more than 3 decimal places, the full numeric value appears when you hover the mouse over the field.
Name	Cross-over design that determines the sequences of treatments to which subjects are randomized. The application supports Latin Square and Balaam's Design. Balaam's design is only applicable to trials with exactly two treatments.	There are no notes.
Treatment Sequence	Order in which treatments are administered.	There are no notes.

Edit Washout Period Dialog Box

Table 5-27 Edit Washout Period Dialog Box Fields

Field	Description	Notes
Day	Integer representing day within washout period.	There are no notes.
Number of CRF pages	Number of Case Report Form (CRF) pages that will be collected for each subject during this period.	Must contain a value between 0 and 99.
Monitoring Time (minutes)	Calculated time (in minutes) required to monitor the pages collected during this period.	Must contain a value between 0 and 9,999.99.
Total number of CRF pages	Number of CRF pages to be collected for a single subject during each washout period.	There are no notes.

Edit Treatment Dialog Box (Details Tab, Schedule Tab, Notes Tab)

Table 5-28 Edit Treatment (Details Tab) Fields

Field	Description	Notes
Treatment duration	Treatment length for each subject. For late-stage trials, specified as weeks. For Phase I trials, specified as days.	Must be a value between 2 and 999.
Visits per subject	Number of visits for each subject during the treatment.	Must be a value between 2 and 999.
Number of bednights	Number of nights subjects are confined to a study center during the treatment period.	Must be a value between 0 and 999.
CRF pages per subject	Number of Case Report Form (CRF) pages collected for each subject during this treatment.	Must be a value between 0 and 9,999. This number should be inclusive of QQL, pharmacoeconomic, and subject diary pages collected.
QOL pages	Number of Quality of Life (QOL) pages collected during the treatment period.	Must be a value between 0 and 9,999.
Subject diary pages	Number of subject diary pages collected during the treatment period.	Must be a value between 0 and 9,999.
Pharmacoeconomic pages	Number of pharmacoeconomic pages collected during the treatment period.	Must be a value between 0 and 9,999.
Lab and diagnostic tests per subject	Number of expected lab and diagnostic tests per subject per treatment arm.	Must be a value between 0 and 999. Available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Cohort escalation reviews	Number of dose escalation reviews per treatment arm.	Must be a value between 0 and 999. Available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Location column	Location to which the treatment cost is applied.	There are no notes.
# Subjects column	Number of subjects expected to be randomized to this treatment in each location.	There are no notes.
Average Grant Amount	Average grant amount is paid to each investigator for each subject the investigator enrolls in the study at the location.	Payment for a dropped subject is approximately 75% of the grant. Must be a value between 0.00 and 500,000.00 USD (or the equivalent in another currency).
Procedure Cost column	Amount paid to the CPU for each subject to perform the standard/common procedures required by the trial.	Must be a value between 0 and 500,000 USD (or the equivalent in another currency). Only appears for PHIHV plans.
Special Procedure Cost column	Amount paid to the CPU for each subject to perform special or uncommon procedures required by this treatment.	Must be a value between 0 and 500,000 USD (or the equivalent in another currency). Only appears for PHIHV plans.
Stipend Per Enrolled Subject column	Amount paid to the subjects in this location.	Must be a value between 0 and 500,000 USD (or the equivalent in another currency).

Table 5-29 Edit Treatment (Schedule Tab) Fields

Field	Description	Notes
Monitoring minutes per CRF page	Number of minutes to monitor one regular CRF page. This field does not apply to monitoring for pages generated during the baseline visit. The application calculates the default value based on the study phase and therapeutic indication. You can override this value for each treatment. Overridden values do not affect minute per page values for the baseline visit or washout period for a crossover study.	Must be a value between 1 and 100.
Use example grant amount	Select to enter numeric values for each visit. The application converts these into percentage values.	The value is not saved; only the percentage is saved.
Day	Day within the treatment period, represented by an integer.	There are no notes.
Number of CRF Pages	Number of CRF pages expected to be collected during this period.	The total number of CRF pages should equal the Number of CRF Pages Per Completed Subject. The number of CRF pages per visit must be a value between 0 and 999.
Monitoring Time (minutes)	Number of minutes required for this visit.	There are no notes.
Percent of Grant	Percentage of the grant amount allocated to each visit.	Change the percentages to control how grants are accrued and payments distributed over the course of the trial.
Total Number of CRF Pages	Total number of CRF pages to be collected for a single subject during the course of this treatment.	There are no notes.
Total visits per subject.	Total number of visits for each subject for this treatment.	Must be a value between 2 and 999.
Total Grant Allocation	Total percentage of the grant allocated to the subject treatment schedule.	Must equal 100% for the schedule to be valid.
Clear CRF Defaults link	Overrides the entire calculated schedule.	There are no notes.
Restore CRF Defaults link	Restores default values for CRF pages and monitoring time.	There are no notes.
Clear Grant Overrides link	Restores default values for grant allocations.	There are no notes.

Table 5-30 Edit Treatment (Notes Tab) Fields

Field	Description	Notes
Notes	Information relevant to the treatment that you want to be available to other people who view this plan or reports.	There are no notes.

Data Tab

Table 5-31 Data Tab Fields

Field	Description	Notes
Data Collection Method	Data collection method for the study. Paper (Traditional Monitoring)—Monitors visit the sites to collect data. Electronic Data Capture (EDC)—Study data is collected electronically. The application calculates associated direct labor fees and indirect costs based on the level of EDC proficiency. EDC-3rd Party—The application does not calculate labor fees related to EDC. Instead, you can create or adjust pass-through costs to account for these expenditures. Faxed CRFs—Case Report Forms (CRFs) are completed at the investigator site and faxed to the data management location. Investigator Site Data Entry—Data is entered into a data capture system or web-based system by someone at the site.	If there is no data monitoring for the study, select Paper (Traditional Monitoring) and set monitoring responsibilities to N/A. Electronic Data Capture (EDC) is the default data collection method.
EDC Maturity Level	Level of EDC proficiency for the study. Enter if you selected Electronic Data Capture (EDC) or EDC-3rd Party data collection method. Stage 1: Pilot/Single Study—Actively conduct experimental EDC implementations within a single study or within a limited number of trials. Stage 2: Limited Standardization—Use EDC in a limited number of studies. Stage 3: Standardization—Use EDC for all new trials. Stage 4: Enterprise Deployment—EDC is fully integrated for all of your trials.	Default data collection method is EDC Maturity Level 3 for all new plans.
Query Rate	Average percentage of queries expected for every 100 pages of Case Report Form (CRF) data.	Must be a value between 0 and 999.99.
Percent of database data to audit	Percent of database information that is audited.	Default value is 10%.
Minutes for Data Entry per CRF page	Number of minutes required to enter one Case Report Form (CRF) into the database.	There are no notes.
Minutes for Data Coordination per CRF page	Number of minutes required to coordinate Case Report Form (CRF) data, calculated by the application based on the phase and therapeutic indication of the study.	Assumes double data entry.
Total number of data transfers	Number of expected data transfers.	If the sponsor is performing data management, enter 0.
Number of interim analyses to be performed	Number of interim analyses to be performed.	The default value is 0. Must be a value between 0 and 9, but Oracle recommends a value between 0 and 3.
Number of third-party vendors/data sources	Number of third-party vendors or data sources used to capture study-related data.	Must be a value between 0 and 99.
Total number of data imports from third-party vendors	Total number of imports from third-party vendors expected throughout the study.	Must be a value between 0 and 9,999.
Number of Unique Pages	Number of unique pages in the Case Report Form (CRF) that are not duplicates of another CRF page or screen.	Minimum value is 1.
Number of screens per CRF page	Number of screens needed to capture one paper Case Report Form (CRF) page.	Must be a value between 1 and 10.
CRF page NCR ply	Type of paper on which the Case Report Form (CRF) prints.	2, 3, or 4 ply NCR paper.
Cost per page to print CRF	Cost per page for printing the Case Report Form (CRF).	Between 1.00 and 1.60 USD per page, depending on ply. Must be a value between 0.00 and 10.00 USD (or the equivalent in another currency).
Number of Unique Data Tables	Number of unique data tables.	The application calculates a default number based on the Number of Unique Pages field.
Number of Repeat Data Tables	Number of repeat data tables.	The application calculates a default based on the Number of Unique Pages field. Must be a value between 0 and 99.
Number of Unique Data Listings	Number of unique data listings.	The application calculates a default number based on the Number of Unique Pages field.
Number of Repeat Data Listings	Number of repeat data listings.	The application calculates a default number based on the Number of Unique Pages field.
Number of Unique Figures and Graphs	Number of unique figures and graphs.	The application calculates a default number based on the Number of Unique Pages field.
Number of Repeat Figures and Graphs	Number of repeat figures and graphs.	The application calculates a default number based on the Number of Unique Pages field.
Number of Unique PK/PD Data Tables	Number of unique PK/PD related tables.	There are no notes.
Number of Repeat PK/PD Data Tables	Number of repeat PK/PD related tables.	There are no notes.
Number of Unique PK/PD Data Listings	Number of unique PK/PD related listings.	There are no notes.
Number of Repeat PK/PD Data Listings	Number of repeat PK/PD data listings.	There are no notes.
Number of Unique PK/PD Figures and Graphs	Number of unique PK/PD related figures or graphs.	There are no notes.
Number of Repeat PK/PD Figures and Graphs	Number of repeat PK/PD figures and graphs.	There are no notes.
Number of newsletters per site	Number of newsletters to provide per site.	Indicate how many timed the newsletters will be generated. For example, if the study has 120 sites and there will be 12 newsletters, enter 12.
Will there be an ICF Video/DVD?	Whether there will be an ICF Video/DVD.	There are no notes.
Number of years to archive data	Number of years study data must be kept after the study completes.	Default value is 5 years. Must be a value between 0 and 30.
Number of online EDC training sessions	Additional training sessions that occur for EDC. This is not the training at the Investigator meeting or initial CRA training.	Default value is 3. Required if you selected EDC or EDC-3rd Party as the data collection method.
Number of pages in the Investigator Brochure	Number of pages in the Investigator Brochure.	The Investigator Brochure can be a few pages or more than 250 pages. Deselect the Write IB task on the Assignment tab if the Investigator Brochure was previously written.
Number of manuscripts	Number of documents, other than the final Clinical Summary Report.	Must be a value between 0 and 99.
Days from LSO/LPO until Database Lock	Number of days from last subject observation (LSP/LPO) until the database lock.	Default values are 30 days for Stage 1, 20 days for Stage 2, 12 days for Stage 3, and 8 days for Stage 4. The minimum value is 1.
Days from Database until Statistical Report is due	Number of days from the database lock date until the statistical report is delivered.	Default values are 45 days for Stage 1, 38 days for Stage 2, 36 days for Stage 3, and 34 days for Stage 4. Minimum value is 1.
Days from Database Lock until Draft Report is due	Number of days from the database lock date until the draft clinical report is delivered.	Default values are 73 days for Stage 1, 70 days for Stage 2, 67 days for Stage 3, and 65 days for Stage 4.Minimum value is 1.
Days from Database Lock until Final Report is due	Number of days from the database lock until the final clinical summary report (CSR) is delivered.	Default values are 98 days for Stage 1, 95 days for Stage 2, 90 days for Stage 3, and 85 days for Stage 4.Minimum value is 1.
SAE rate as a percent of randomized subjects	Percentage of anticipated serious adverse events (SAEs) in terms of a percent of the total subject population.	Must be a value between 0 and 9,999.99.
SAEs	Number of serious adverse events (SAEs) calculated by the application.	There are no notes.
Hours medical monitor will spend with each SAE	Number of hours a medical monitor spends with each serious adverse event (SAE).	There are no notes.
Expected percent of SAE Reports to be expedited	Percentage of serious adverse event (SAE) reports to be expedited to regulatory agencies and ethics committees.	There are no notes.
Expedited SAEs	Number of expedited serious adverse events (SAEs) calculated by the application.	There are no notes.
Provide data to the DSMB	How often data is reported to the Data Safety Monitoring Board (DSMB).	There are no notes.
IVRS Usage	Tasks for which an Interactive Voice Response System (IVRS) is used.	There are no notes.
Expected Protocol Amendments	Add one or more protocol amendments.	There are no notes.
An amendment is expected to occur	The number of days before or after a specific milestone this amendment is expected to occur	There are no notes.
Milestone nearest to the protocol amendment	The selected milestone from which the application calculates the approximate date of the amendment.	There are no notes.
Add another amendment	Add additional protocol amendments to the study.	There are no notes.
Task Group column	Assignment groups to which outsourcing responsibilities are applied.	For a list of tasks, see the online Help for the Sites tab.
Sponsor column	Assign all of the tasks in that group to the study sponsor.	There are no notes.
Vendor column	Assign all of the tasks in that group to the primary vendor assigned on the Provider tab.	There are no notes.
Mixed column	Assign some of the tasks to the sponsor and some to the vendor on the Assignment tab.	There are no notes.
N/A column	None of the tasks in the group will be performed.	There are no notes.

Monitoring Tab

Table 5-32 Monitoring Tab Fields

Field	Description	Notes
Monitoring will be performed	Whether monitoring will be done in-person, by phone, or by a combination of these methods.	There are no notes.
Manage monitoring schedule values	Management of monitoring schedules. Globally—Assumptions entered on the Monitoring tab apply to all the locations in the study. Per Location—Modify schedules for each location within the study by clicking the Per Location link.	There are no notes.
Monitor every	Frequency, in weeks that a monitor visits the study sites during each period of the monitoring schedule.	There are no notes.
Until LSO/LPO	Site monitoring continues at the entered frequency until the end of the treatment period.	There are no notes.
Until Week	The week during the study the monitoring frequency changes.	There are no notes.
Total visits	Total number of monitoring visits during the study. The application calculates the total visits based on the number of sites, monitoring frequency, and subject enrollment rate.	Must be a value between 0 and 999,999.
Monitoring Travel Strategy	Travel strategy for monitoring trips. Spoke—Monitors returns to their home or office between each site visit. Loop—Monitor travels to each site before returning to their home or office.	There are no notes.
Percentage of time monitors spend in the field	Percentage of time monitors spend in the field.	The application assumes the remainder of the time is used for management activities.
Percentage of monitoring done by CRAs (vs. Senior CRAs)	Percentage of monitoring and site management conducted by Clinical Research Assistants (CRAs) versus Senior CRAs.	There are no notes.
Percentage of monitoring done by Regional Monitors	Percentage of monitoring regional monitors complete.	There are no notes.
Avg travel time (in hours) for site monitors	Average travel time, in hours, for site monitors.	There are no notes.
Percent of source document verification	Percentage of safety and efficacy data to be source verified while monitoring the data.	There are no notes.
Time to review queries from previous visit (minutes)	Number of minutes required to review queries and Case Report Form (CRF) data from a previous monitoring visit.	The application calculates this value based on the therapeutic area and indication.
Manage location-specific values	Include monitoring approach assumptions for each location by selecting the Edit Location Specific Overrides link. This opens the Edit Per Location Monitoring Schedule Dialog Box dialog box.	There are no notes.
Total CRF pages generated (without subject drops)	Number of predicted Case Report Form (CRF) pages generated, assuming no subjects drop out of the study.	There are no notes.
Total CRF pages monitored (accounting for subject drops)	Number of predicted Case Report Form (CRF) pages that are monitored, accounting for any subjects that drop out of the study.	There are no notes.
Estimated number of FTE (full-time equivalent) Medical Monitors	Estimated time medical monitors serve as the team leaders. Medical monitors support the Clinical Research Assistant (CRA) staff and the study investigators.	In cost models 5.5 and above, field only available to Phase I (Healthy Volunteer) trials.
24/7 coverage	Indicates the number of times the medical monitor will perform medical data listing reviews.	Only available in cost models 5.5 and above. Not available in Phase I (Healthy Volunteers) trials.
Number of medical data listing reviews	The number of times the medical monitor will perform medical data listing reviews.	Must be a value between 0 and 999. Only available in cost models 5.5 and above. Not available in Phase I (Healthy Volunteers) trials.
Will there be additional drug accountability visits?	Whether additional drug accountability visits are required.	There are no notes.
Additional drug accountability visits performed by	Who will perform additional drug accountability visits, if applicable.	There are no notes.
Additional drug accountability visits per site	Number of additional drug accountability visits to be made per site.	There are no notes.

Edit Per Location Monitoring Schedule Dialog Box

Table 5-33 Edit Per Location Monitoring Schedule Dialog Box Fields

Field	Description	Notes
Monitoring will be performed	Whether monitoring will be done in-person or by phone or by a combination of these methods.	There are no notes.
Monitor every	Frequency, in weeks that a monitor visits the study sites during each period of the monitoring schedule.	There are no notes.
until LSO/LPO	Indicates that site monitoring will continue at the specified frequency throughout the end of the treatment period.	There are no notes.
until period	Week at which the specified frequency for monitoring will change	This is the week number of the START of the next monitoring period and must be greater than or equal to the value for the monitoring frequency for the prior period.
Total visits	Value derived from the total number of sites, monitoring frequency, and subject enrollment rate.	There are no notes.
Monitoring Travel Strategy	Travel strategy to be used for most of the monitoring trips.	There are no notes.
Call every	Week at which the specified frequency for monitoring changes.	Must be greater than or equal to the value for the monitoring frequency for the prior period
Total calls	Total number of calls. This value is derived from the phone-based monitoring frequency and the subject enrollment rate.	Must be a value between 0 and 999,999.
Average hours per visit	Average number of hours required to perform a phone-based monitoring visit, including preparation and follow-up activities.	There are no notes.
Total Visits	Total number of visits across all locations.	There are no notes.
Total Calls	Total number of calls across all locations.	There are no notes.
Manage location-specific values	Monitoring approach assumptions for each location.	There are no notes.

Edit Per Location Monitoring Approach Dialog Box

Table 5-34 Edit Per Location Monitoring Approach Dialog Box Fields

Field	Description	Notes
Restore Defaults	Click to restore the monitoring assumptions to the global values for a specific location.	There are no notes.
Restore All Defaults	Click to restore the monitoring assumptions to the global values for all locations.	There are no notes.
Percentage of time monitors spend in the field	Indicates the percentage of time monitors spend in the field. It is assumed that the remainder of their time is then spent on site management activities.	There are no notes.
Percent of source document verification	Specify the percent of key safety and efficacy data to be source verified while monitoring the data.	There are no notes.
Percentage of monitoring done by CRAs (vs. Senior CRAs)	Indicates the percentage of monitoring and site management that will be done by normal Clinical Research Assistants (CRAs) versus Senior Clinical Research Assistants (SCRAs).	There are no notes.
Percentage of monitoring done by Regional Monitors	Indicates the percentage of monitoring that will be done by Regional Monitors.	There are no notes.
Avg travel time (in hours) for site monitors	The average number of hours a monitor will need to travel to sites	There are no notes.

Provider Tab

Table 5-35 Provider Tab Fields

Field	Description	Notes
Add Provider(s) button	Add providers.	There are no notes.
Remove Provider(s) button	Remove providers.	There are no notes.
Set as Primary Provider button	The primary, or default, provider for tasks.	There are no notes.
Replace Provider button	Replace the selected provider with another provider.	There are no notes.
Freeze Billing Rates/Unfreeze Billing Rates button	Freeze or unfreeze the rates for the plan.	The application copies the current rates for the current providers and stores them with this plan.
Provider Name column	Provider name.	There are no notes.
Provider Type column	Provider type.	There are no notes.
Rate Year in Effect column	Rate Year used to look up billing rates for the resources for this service provider for this plan.	There are no notes.
Back-Office Billing Rate Location column	Location used to determine the default billing rates for centralized tasks or tasks conducted at a central location.	To change this or other provider-specific values, click the provider name to open the Provider Details dialog.

Choose Service Providers Dialog Box

Table 5-36 Choose Service Providers Dialog Box Fields

Column	Description	Notes
Name	Name of the service provider.	There are no notes.
Type	Provider type.	There are no notes.
Last Updated	Date and time when service provider was last updated.	There are no notes.
Updated By	User who last updated the service provider.	There are no notes.

Specify Provider-Specific Details Dialog Box

Table 5-37 Specify Provider-Specific Details Dialog Box Fields

Field	Description	Notes
Rate Year in effect	Rate year, associated with the billing rate, selected from the drop-down list.	There are no notes.
Discount rate to apply to this study	Discount rate negotiated for the study, as a percentage.	There are no notes.
Inflation rate to apply to year 2 of study	Percentage to be added to billing rates in year 2 to offset inflation.	There are no notes.
Inflation rate to apply to subsequent years of study	Percentage to be added to billing rates after year 2 to offset inflation.	There are no notes.
Compound inflation annually	Whether or not to calculate inflation by compounding it annually.	There are no notes.
Back-Office Billing Rate Location	Location used to determine the default billing rates for centralized tasks or tasks conducted at a central location.	There are no notes.
Line Item Discount	Negotiated line-item discount established with this particular provider.	Must be a positive value between 0 and 999,999 USD (or equivalent value if non-USD). Default is 0. If there is more than one provider for a plan, each could offer a different discount.
Currency	Currency in which line-item discount is calculated.	If provider is replaced, currency selection remains in effect.
Billing Rate Currency	Currency type for billing rate.	There are no notes.
Currency Exchange Rates	When converting between currencies, whether to select rates from the Overview tab or to define the rates for each country on this dialog box.	There are no notes.
1 US Dollar (USD) equals...	Exchange rate for the dollar in other currencies.	Appears if you select Use Rates as defined below... for the Currency Exchange Rates field.
Project Manager utilization prior to FSI/FPI	Percentage of project manager resources required before the first patient has enrolled.	There are no notes.
Project Manager utilization after FSI/FPI	Percentage of project manager resources required after the first patient has enrolled.	There are no notes.
Resource Allocation Factor	Percentage of each full workday that the service provider's team works on the project.	There are no notes.
Number of sponsor affiliates	The number of affiliates that the provider is to work with.	There are no notes.
Type of reporting to affiliates	The types of reporting to sponsor affiliates by the provider.	There are no notes.
Additional type of vendor with which this service provider will work	Relationship this service provider has with another provider.	There are no notes.
Will this provider manage the CTMS	Whether or not this service provider will enter data into the sponsor's Clinical Trial Management System.	There are no notes.

Choose Replacement Provider Dialog Box

Table 5-38 Choose Replacement Provider Dialog Box Fields

Column	Description	Notes
Name	Name of the service provider.	There are no notes.
Type	Provider type.	There are no notes.
Last Updated	Date and time when service provider was last updated.	There are no notes.
Updated By	User who last updated the service provider.	There are no notes.

Meetings Tab

Table 5-39 Meetings Tab Fields

Field	Description	Notes
Edit button	Edit a meeting.	There are no notes.
Copy button	Copy a meeting.	There are no notes.
Include button	Include a meeting.	There are no notes.
Exclude button	Exclude a meeting.	There are no notes.
Delete button	Delete a meeting.	There are no notes.
Name column	Meeting name.	There are no notes.
Type column	Meeting type.	There are no notes.
Location column	Meeting location.	There are no notes.
Occurs column	Meeting frequency.	There are no notes.
Planner column	Meeting organizer.	There are no notes.

Define New Meeting Dialog Box

Table 5-40 Define New Meeting Dialog Box Fields

Field	Description	Notes
Name	Meeting name.	There are no notes.
Type	Meeting type.	There are no notes.

Meeting Details Dialog Box: Meeting Details Tab, Attendees Tab, Site Attendees Tab

Table 5-41 Meeting Details Dialog Box (Meeting Details Tab) Fields

Field	Description	Notes
Name	Meeting name.	There are no notes.
Type	Meeting type.	There are no notes.
Code	Meeting code.	The application uses the code as a prefix for the task associated with the meeting type.
Organizer/Planner	Meeting planner.	There are no notes.
Location	Meeting location.	There are no notes.
City	Name of the city where the meeting takes place.	There are no notes.
Non-travel event costs	Non-travel meeting costs.	There are no notes.
Occurs	Meeting frequency.	There are no notes.
Starts	Meeting start date.	There are no notes.
Until	Meeting end date.	There are no notes.
# Meetings	Displays the number of meetings.	There are no notes.
Meeting Duration	Enter the number of hours each meeting lasts.	There are no notes.
Provider	Service providers attending the meeting.	There are no notes.
Location	Personnel from sites in the chosen location attending the meeting.	There are no notes.
% Sites Attending	Percentage of sites in this location sending participants to the meeting.	There are no notes.
# Sites Attending	Number of sites attending the meeting from this location.	There are no notes.

Table 5-42 Meeting Details Dialog Box (Attendees Tab) Fields

Field	Description	Notes
Service Provider	Service provider for which you are editing or viewing meeting attendees.	There are no notes.
Add button	Add additional meeting attendees.	There are no notes.
Delete button	Delete meeting attendees.	You can only delete user-defined attendees.
Duplicate button	Copy a meeting attendee.	There are no notes.
Expand All Billable Hours link	View details about billable hours for each meeting attendee.	There are no notes.
Attendees column	Number of meeting attendees for the associated resource type.	There are no notes.
Resource Type	The resource type attending the meeting.	There are no notes.
Billing Rate Location column	The billing rate location for the meeting attendee.	There are no notes.
Attendance Method column	Attendee travel method.	There are no notes.
Billable Hours column	Number of billable hours for the meeting attendee.	There are no notes.
Preparation column	Number of hours of preparation expected by this resource.	Appears if the Expand All Billable Hours or Edit links are selected. Must contain a value between 0 and 999.99.
Travel column	Number of hours of travel expected by this resource.	Appears if the Expand All Billable Hours or Edit links are selected. Must contain a value between 0 and 999.99.
Attendance column	Number of hours that this resource is expected to attend the meeting.	Appears if the Expand All Billable Hours or Edit links are selected. Must contain a value between 0 and 999.99.
Follow Up column	Number of follow up hours expected by this resource.	Appears if the Expand All Billable Hours or Edit links are selected. Must contain a value between 0 and 999.99.
Indirect Costs column	Indirect costs for the meeting attendee.	There are no notes.
Travel column	Total travel indirect costs for each meeting attendee.	There are no notes.
Other column	Other indirect costs for each meeting attendee.	There are no notes.

Table 5-43 Add Provider Attendees Dialog Box Fields

Field	Description	Notes
Resource Name	Resource you can add to the task.	There are no notes.
Code	Code for a resource you can add to the meeting.	There are no notes.

Table 5-44 Site Attendees Tab Fields

Field	Description	Notes
Attendees/Site	Number of attendees attending from each site for the selected location.	There are no notes.
% Sites	Percentage of sites attending that send this number of attendees by this attendance method.	There are no notes.
# Sites	Number of sites attending that send this number of attendees by this attendance method.	There are no notes.
Source Location	Location from which each meeting attendee is coming.	There are no notes.
Attendance Method	How attendees attend the meeting, such as Travel Domestic, Travel International, Teleconference, and No Travel.	Modifying this field populates the default travel cost and hours for these attendees.
Travel Cost	Travel cost expected by the site attendees for this location.	There are no notes.
Other Cost	Miscellaneous other costs expected by the site attendees for this location.	There are no notes.
Total Costs	Total indirect costs for each meeting attendee.	There are no notes.

Table 5-45 Meeting Details Dialog Box (Notes Tab) Fields

Field	Description	Notes
Notes	Description and notes about the meeting.	Any user who has permission to edit the plan can view and edit these notes.

Assignment Tab

Table 5-46 Assignment Tab Fields

Field	Description	Notes
Values apply to	Assign responsibility for a specific country or region to a specific service provider.	If you select Centralized Tasks/Locations Defaults, your task assignments apply to all locations in the study. If you select the country or region, the task assignments you make only apply to that country or region.
Default service provider for outsourced tasks	Default service provider for outsourced tasks.	There are no notes.
Show Tasks link	List of assignment groups and tasks.	There are no notes.
Hide Tasks link	List of assignment groups and tasks.	There are no notes.
Override Resources or Rates	Override Resources or rates.	There are no notes.
Assignment Group/Task column	Available assignment groups and tasks.	There are no notes.
Assign to column	Service provider to which the task is assigned.	There are no notes.
Billing Rate Location column	Billing rate location.	The application uses this location to calculate resource costs for the task.
Pinned column	Save your assignments for a specific task or assignment group.	Pinning a task or assignment group ensures your selections are not lost due to other changes in the work breakdown structure. Pinned settings are lost if the associated locations or service providers are removed from the plan. If you replace a service provider, your pinned settings are saved.

Resource Overrides Dialog Box

Table 5-47 Resource Overrides Dialog Box Fields

Field	Description	Notes
Values apply to	Locations affected by the overrides.	There are no notes.
Default service provider for outsourced tasks	Service provider whose resources or rates are to be overridden.	There are no notes.
Resource Name	Resource name.	There are no notes.
Billing Rate Location	Billing Rate Location.	There are no notes.
Rate	Billing rate.	This field must contain a value between 0.00 and 9,999 USD or the equivalent in another currency.
% Adjust	Percentage adjustment applied to the billing rate.	This field must contain a value between 0 and 999.99.
Pinned	Save overridden values.	There are no notes.
Clear Overrides link	Restore the default resources and rates for the associated service provider.	There are no notes.

Labor Tab

For details about the ClearTrial-defined major tasks, see the Help topic for the Labor tab.

Table 5-48 Labor Tab Fields

Field	Description	Notes
Show hours and fees for	Service provider for which hours and fees appear.	There are no notes.
Show major tasks with no planned effort for the selected provider	Select—All major tasks appear, even if the selected service provider is not assigned to any of these tasks. Deselect—Only major tasks assigned to the selected service provider appear.	There are no notes.
New Major Task button	Create a major task. Opens the Task Manager dialog box.	There are no notes.
Edit Major Task button	Edit the selected major task. Opens the Task Manager dialog box.	There are no notes.
Delete Major Task button	Delete the selected user-defined major tasks.	Permanently deletes the major task and its tasks, resources, algorithms, and overrides. You cannot restore deleted major tasks.
Adjust Hours of Fees button	Adjust the labor unit hours and fees for the selected major task and service provider on the Task Manager dialog box.	There are no notes.
Pin Labor button	Pin all labor units, costs, hours and distributions.	There are no notes.
Unpin Labor button	Unpin all labor units, costs, hours and distributions.	There are no notes.
Major Task column	Major task type.	For a description of each major task, see the online Help for the Labor tab.
Unit Hours column	Level of effort (in hours) for the selected service provider to complete one unit of work for the major task.	Displayed values are rounded to the nearest 10th. Hover over the value to see the actual value.
Unit Cost column	Total cost for the selected service provider to complete one unit of work for the major task.	Displayed values are rounded according to the conventions of the currency.
# Units column	Total number of units of work expected (or, in the case of a re-forecast, remaining).	Some major tasks have a single unit of work; for example, Study or Database. Hover over the value to see the number of units.
Ext Hours column	Total level of effort (in hours) for the selected service provider to complete the major task.	The application multiplies the Unit Hours by the # Units. Displayed values are rounded to the nearest 10th. Hover over the value to see the actual value.
Ext Cost column	Total cost for the selected service provider to complete the major task.	Displayed values are rounded to the nearest whole number. Hover over any value to see the value rounded according to the conventions of the currency.
Total Ext Hours column	Total level of effort in hours for the selected service provider to complete the major task.	Determined by multiplying the Unit Hours by # Units.
Total Ext Cost column	Total cost for the selected service provider to complete the major task.	Determined by multiplying Unit Cost by # Units.

Task Manager Dialog Box (Major Task Details Tab, Adjustments Tab, Distribution Tab)

Table 5-49 Task Manager Dialog Box (Major Task Details Tab) Fields

Field	Description	Notes
Name	Name of the major task.	Must be unique within a plan.
Description	Detailed description of the major task.	There are no notes.
Labor	Whether associated tasks vary by location or centralized. If you select varies by location, the associated tasks are completed at the study sites.	There are no notes.
Unit of Measure	Unit of work this major task represents.	Custom units of work appear in italicized type followed by an asterisk.
New Task button	Create a new task for the selected major task.	There are no notes.
Edit Task button	Edit the selected task.	There are no notes.
Delete Task button	Delete the selected task.	There are no notes.
Edit Assignments button	Edit service provider assignments for the selected task.	There are no notes.

Table 5-50 Task Manager Dialog Box (Adjustments Tab) Fields

Field	Description	Notes
Show hours and fees for	Service provider, whose unit hours or fees are to be adjusted.	There are no notes.
Expand All	View all hours and fees in each location for the selected service provider.	There are no notes.
Collapse All	Close the expanded view of hours and fees and display only planned and adjusted extended hours and extended cost.	There are no notes.
Clear Overrides	Restore all fields to the application default values.	There are no notes.
Location column	Location (countries/regions or centralized) where the service provider is conducting work on the major task.	There are no notes.
Planned column	Planned number of units, unit hours, and unit cost for the major task.	There are no notes.
Adjusted column	Adjusted number of units, unit hours, and unit cost for the major task.	You can override these fields. Enter the number of unit hours and unit cost or a percentage.
Pinned column	Saves the number of units, unit hours, and unit costs preventing changes from cascading through the plan.	There are no notes.
Extended Hours column	Total plan hours for each location.	The application calculates this number based on plan assumptions.
Extended Cost column	Total cost for each location.	The application calculates this number based on plan assumptions.

Table 5-51 Task Manager Dialog Box (Distribution Tab) Fields

Field	Description	Notes
Distribute completed units of work according to	How to distribute completed units of work across time.	There are no notes.
Default range	Start and end date for the labor distribution, based on the number of days before or after the selected milestone.	This field is only available when you select an Even or Custom Distribution.
Start	Number of days before or after a selected milestone to start the distribution.	There are no notes.
End	Number of days before or after a selected milestone to end the distribution.	There are no notes.
Service Provider	Service provider to which these assumptions apply.	There are no notes.
Location	Location to which to apply these distribution assumptions.	There are no notes.
Start	Date on which the service provider begins work in the selected location.	If using an Even Distribution or Custom Distribution, you can select the number of days before or after a selected milestone to start the distribution of this work unit.
End	Date on which the service provider completes work in the selected location.	If using an Even Distribution or Custom Distribution, you can select the number of days before or after a selected milestone to end the distribution of this work unit.
Period column	Period during which the number or percentage of units are expected to be completed.	There are no notes.
Percentage column	Percentage of units expected to be completed during the associated period.	There are no notes.
Total column	Total percentage of work completed during the work periods.	There are no notes.

Task Manager: New Task Dialog Box (Task Details Tab, Task Assignments Tab)

Table 5-52 Task Manager: New Task Dialog Box (Task Details Tab) Fields

Field	Description	Notes
Name	Name for the task.	There are no notes.
Code	Code for the task that the application will use as a prefix to the selected task name.	There are no notes.
Description	Detailed description of the task.	Appears as Help text and as the task description on the Assignment tab.
Assignment Group	Assignment group to which the task belongs.	Determine which group the task appears in the Responsibilities section.
Summary Category	Summary category to which the task belongs.	Determines how the hours and fees are summarized on the Summary tab and Summary report.
Add Resource button	Add a resource to this task.	There are no notes.
Edit Resource button	Change details about the resource effort or rates for this task. resource	There are no notes.
Delete Resource button	Remove a resource from this task.	There are no notes.
Resource Name column	Resource typically assigned to this task.	There are no notes.
Substitutions column	Resource overrides for a resource.	There are no notes.

Table 5-53 Task Manager: New Task Dialog Box (Task Assignments Tab) Fields

Field	Description	Notes
Location column	Location in which task is performed.	For centralized tasks, All Locations appears.
Included column	If selected, the task is included in the study, for the location.	Deselect to exclude a task for a specific location.
Service Provider column	Service provider who performs the task for this location.	There are no notes.
Billing Rate Location column	Billing rate location for each location. If you select Local, the application uses the location from where the subject data are collected for the billing rate calculations. If you select a country, the application uses the billing rate data for that country. If you select Back Office, the application uses the location specified as the back office billing rate location for the assigned service provider.	You can choose a different billing rate location for each resource for each location.
Pinned column	Saves your task settings so that changes made at general levels do not affect the task.	There are no notes.
Add Resource button	Add a resource to this task.	There are no notes.
Edit Resource button	Change details about the resource effort or rates for this task. resource	There are no notes.
Delete Resource button	Remove a resource from this task.	There are no notes.
Resource Name column	Resource typically assigned to this task.	There are no notes.
Substitutions column	Resource overrides for a resource.	There are no notes.

Task Manager: Select Resources Dialog Box

Table 5-54 Task Manager: Select Resources Dialog Box Fields

Field	Description	Notes
Resource Name	Resource you can add to the task.	There are no notes.
Code	Code for a resource you can add to the task.	There are no notes.

Task Manager: Edit Resource Dialog Box (Resource Details Tab, Algorithm Tab, Billing Rate Location Tab, Rates & Substitutions Tab, Unit Hours Tab)

Table 5-55 Task Manager: Edit Resource Dialog Box (Resource Details Tab) Fields

Field	Description	Notes
Name	Resource name.	You may have overridden the named resource with another resource on the Billing Rates tab or at the plan level or plan-location level. This field displays the name of the originally expected resource.
Description	Detailed description of the resource.	There are no notes.
Location column	Location in which the resource performs the work.	There are no notes.
Service Provider column	Service provider to which the resource belongs.	There are no notes.
Department column	Department to which this resource belongs when performing the task.	There are no notes.
GL Code column	General Ledger code for fees associated with this resource when performing the task.	There are no notes.

Table 5-56 Task Manager: Edit Resource Dialog Box (Algorithm Tab) Fields

Column	Description	Notes
Location	Location to which the algorithm applies.	There are no notes.
Calculate as hours	Default number of hours the selected resource must spend performing this task to complete one unit-of-measure for this location.	Must be a value between 0 and 10,000.000.
per (percentage)	Percentage amount to increase or decrease the number of units for the selected unit-based assumption.	There are no notes.
of (cost driver)	Work unit to use for this Level of Effort (LOE) algorithm.	Custom units of work appear in italicized type followed by an asterisk.
Unit Hours	Number of unit hours the selected resource must spend performing this task to complete one unit-of-measure for this location.	There are no notes.
(hours) Ext. Hours	Total hours for the selected resource to complete the task for this location.	There are no notes.

Table 5-57 Task Manager: Edit Resource Dialog Box (Billing Rate Location Tab) Fields

Column	Description	Notes
Location	Name of the location where sites and subjects are located.	There are no notes.
Service Provider	Service provider assigned to handle this task for sites and subjects in the listed location.	There are no notes.
Pinned	When pinned, changes made at more general levels will not affect your settings for this resource.	Your pinned settings are lost if the associated locations or service providers are removed from the plan.

Table 5-58 Task Manager: Edit Resource Dialog Box (Rates & Substitutions Tab) Fields

Column	Description	Notes
Location	Location where sites and subjects are located.	There are no notes.
Service Provider	Name of the service provider assigned to this task for the listed location.	There are no notes.
Substitute	A different resource to perform this task in the location.	By default, the application uses the billing rate of the selected resource.
Rate	Hourly billing rate for the selected resource to perform the task.	Override standard billing rates on a case-by-case basis.
% Adjust	Percentage adjustment applied to the rate of the selected resource performing the task.	Must contain a value between 0 and 999.99.
Pinned	When pinned, changes made at more general levels will not affect your settings for this task.	Your pinned settings are lost if the associated locations or service providers are removed from the plan.

Table 5-59 Task Manager: Edit Resource Dialog Box (Unit Hours Tab) Fields

Column	Description	Notes
Location	Location where sites and subjects are located.	There are no notes.
Service Provider	Service provider assigned to this task for the listed location.	There are no notes.
Unit Hours	Specific number of hours for the selected resource to perform the task in the location.	Must be a value between 0 and 10,000.
% Adjust	Specific percentage adjustment to apply to the calculated hours for the selected resource to perform the task in the location.	Must be a value between 0 and 1,000,000.
# Units	Number of units as per the unit of measure defined by the major task.	There are no notes.
Ext. Hours	Extended hours for this location.	The application calculates this number by multiplying the unit hours by the number of units expected.

Task Manager: Major Task Descriptions

Table 5-60 Task Manager: Major Task Descriptions

Field	Description	Notes
Project Initiated	Activities associated with getting the study started for all sites at all locations	There are no notes.
Study Setup	Centralized start up activities such as negotiation of the all the central labs, design of study documents, development of Investigator Brochure, ICF, diary and protocol translations, and design of the randomization system.	There are no notes.
Study Setup Per-Location	Start up activities that are specific to individual locations, such as printing and distribution of the IB; distribution and collection of training materials and investigator meeting materials; development of country-specific ICF; clinical trial application approvals and negotiation of central IRB/IEC.	There are no notes.
A Written Protocol	For a protocol provided by the sponsor or CRO, create, edit, and review the protocol draft.	There are no notes.
Protocol Amendment	Amendments to the protocol.	There are no notes.
Protocol Amendment per Location	Amendment to the protocol by location.	There are no notes.
Unique CRF Page Developed	The development of a single unique CRF page or the electronic equivalent, including creation of the edit specifications.	There are no notes.
CRF Book Printed	Activities associated with the printing of the CRF; does not apply to electronic data capture.	There are no notes.
Meetings - Kickoff Meeting	Activities for kickoff meetings.	There are no notes.
Meetings - Investigator Meeting	Activities for investigator meetings.	There are no notes.
Meetings - Face to Face Meeting	Activities for face to face meetings.	There are no notes.
Meetings - Status Update to Sponsor (Teleconference Meetings)	Activities for teleconference meetings.	There are no notes.
Meetings - Internal Team Meeting	Activities for internal team meetings.	There are no notes.
Meetings - Other	Other tasks related to meetings.	There are no notes.
Meetings - End of Study	Activities for end of study meetings.	There are no notes.
Site Identified by Sponsor	Sites that have been identified and screened by the sponsor and not by the vendor.	There are no notes.
Site Identified by Vendor	Sites that have been identified and screened by the CRF provider and not by the sponsor.	There are no notes.
Pre-study Site Visit (PSSV)	The activities that are associated with a pre-qualification visit to an investigator site; includes preparation, follow-up, and travel time.	There are no notes.
Pre-study Site Visit (PSSV) by phone	Pre-study site qualification activities conducted by telephone versus in person.	There are no notes.
Site Approved	Activities for the identification and approval of an investigative site. Includes regulatory document preparation, collection and approval, site contract negotiation, and drug shipment to site. It does not include the Pre-study or Site Initiation Visits.	There are no notes.
Site Initiation Visit	The activities for the initiation of a study investigator site and staff; includes preparation, follow-up and travel time.	There are no notes.
Site Initiation Visit by Phone	Site initiation by phone.	There are no notes.
Drug Packaging and Supply Audit	Audit activities of the drug packaging and supply facility.	There are no notes.
Study Drug Shipment Tracked	Tracking of the drug shipment to all study sites.	There are no notes.
Completed Statistics & Analysis Plan (SAP)	Development of the Statistical Analysis plan for the final report and performance of the analysis.	There are no notes.
Database Designed	Activities for the design and programming of the clinical data base.	There are no notes.
Data Entry Screen Developed	The development of a data entry screen for the internal or external data entry for the CRF pages or EDC equivalent.	There are no notes.
IVRS Setup	The set up and management of an interactive voice response system.	There are no notes.
Subject/Volunteer Randomized	Tracking the randomization of subjects in any given study.	There are no notes.
Project Management Week prior to FSI	The project management activities that are associated with the clinical trial from study start through First Subject Enrolled.	There are no notes.
Project Management Week after FSI	The project management activities that are associated with the clinical trial from First Subject Enrolled through the Final Report.	There are no notes.
SAE Database Programmed	SAE Database Programmed (an independent activity from Safety and Medical Management).	No longer available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
SAE Processed	All of the tasks for the reporting of Serious Adverse Events, including writing the relevant narratives.	In cost models prior to 5.5, still named SAE Report Completed. Renamed in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Expedited Safety Report Completed	Preparation of SAEs that are reportable events to health authorities. These are events that are being reported for the first time.	In cost models prior to 5.5, still named Expedited SAE Report Completed. Renamed in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Medical Data Listing Review	Review data from the clinical database, safety database, or other source to identify the presence or lack of safety issues with respect to the protocol.	Available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Subject Monitored	Subject-specific monitoring.	Available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Cohort Escalation Review	Medical safety review to determine appropriate changes in dosage.	Must be a number between 0 and 999. Available in cost models 5.5 and above for all trials except Phase I (Healthy Volunteers) trials.
Monitored Clean CRF Page	The on-site Source Document Verification (SDV) and retrieval of paper CRF pages, or the review of electronic equivalents, and related on-site activities.	There are no notes.
Onsite Monitoring Visit - Prep, Travel, Reporting, and Follow-up	The non-source document verification tasks associated with monitoring visits, including preparation, travel, and follow-up.	There are no notes.
One Hour of Phone-based Monitoring	One hour of phone-based monitoring, in lieu of on-site monitoring. Formal trip reports will be completed.	There are no notes.
Separate Drug Accountability Visit	A separate visit to an investigator site to account for drug to keep the CRO vendor monitor blinded to the study drug.	There are no notes.
Newsletter Prepared	The preparation and distribution of newsletters to clinical investigators.	There are no notes.
CRF Page Entered into Database	The double keyed data entry of a paper CRF into the data base; tracking and logging of CRF pages, coding and data coordination, which does not apply to electronic data capture.	There are no notes.
Query Resolution - by Monitor	Resolution of Data Clarifications Forms (DCF) by the study monitor. Can be conducted on-site or remotely. Does not include resolution by the data management group.	There are no notes.
Interim Analysis	All activities for the development of an interim analysis of the study data.	There are no notes.
Site Audited	All activities for performing a clinical compliance audit of an investigator site.	There are no notes.
Annual IND Report Activities	Preparation of the annual IND safety update tables and listings for each active year of the study.	There are no notes.
Site Close-out Visit	Activities associated with study close out of an investigator site.	There are no notes.
Site Close-out by Phone	Site close out activities completed by phone versus in person.	There are no notes.
Third-party Data Import	Import of third party data at a defined frequency throughout the life of the study.	There are no notes.
All Data Cleaned and Database Locked	The ongoing data query process and cleaning of the clinical data from first patient enrolled through database lock.	There are no notes.
Data Transfer	The transfer of clinical data to the sponsor one or more times.	There are no notes.
Final Data Audit	An internal audit of the database, conducted by the provider responsible for data management, defaulted to 10% of the data, but can be edited by you.	There are no notes.
Issued Unique PK/PD Summary Table	Activities required to issue a unique summary table.	There are no notes.
Issued Unique PK/PD Summary Listing	Activities required to issue a unique data listing.	There are no notes.
Issued Unique PK/PD Summary Figure/Graph	Activities required to issue a unique data figure or graph.	There are no notes.
Issued Repeat PK/PD Summary Table	Activities required to issue a unique summary table.	There are no notes.
Issued Repeat PK/PD Summary Listing	Activities required to issue a unique data listing.	There are no notes.
Issued Repeat PK/PD Summary Figure/Graph	Activities required to issue a unique data figure or graph.	There are no notes.
Issued Unique Summary Table	Includes activities for specifications, programming, and quality control to issue unique tables.	There are no notes.
Issued Unique Summary Listing	Includes activities for specifications, programming, and quality control to issue unique data listings.	There are no notes.
Issued Unique Summary Figure/Graph	Includes activities for specifications, programming, and quality control to issue unique data figures/graphs.	There are no notes.
Issued Repeat Summary Table	Includes activities for specifications, programming, and quality control to issue repeated tables.	Tasks include: Complete Repeat Summary Table Specification Complete Repeat Summary Table Programming Complete Repeat Summary Table Quality Control
Issued Repeat Summary Listing	Includes activities for specifications, programming, and quality control to issue repeated summary listings.	Tasks include: Complete Repeat Summary Listing Specifications Complete Repeat Summary Listing Programming Complete Repeat Summary Listing Quality Control
Issued Repeat Summary Figure/Graph	Includes activities for specifications, programming, and quality control to issue repeated figures or graphs.	Tasks include: Complete Repeat Summary Figure/Graph Specifications Complete Repeat Summary Figure/Graph Programming Complete Repeat Summary Figure/Graph Quality Control
PK/PD Report	Activities required to issue the PK/PD Report.	There are no notes.
Stat Report	The development of the statistical report section of the Clinical Summary Report.	There are no notes.
Draft Report	All of the activities associated with one draft of the Clinical Summary Report.	There are no notes.
Final Report (CSR)	The activities associated with taking the draft report and finalizing it for publication/submission.	There are no notes.
Prepared Publication	Manuscripts or journal articles other than the Clinical Summary Report that are prepared for publication.	There are no notes.
EDC Help Desk	Set-up of the software and necessary hardware for the study. Assist the investigator site personnel with access to the on-call clinical expert or medical monitor to address questions related to trial matters.	There are no notes.
EDC Training	Responsible for activities related to EDC training management. Includes initial and one round of refresher training.	There are no notes.
Sponsor Oversight	All of the management activities associated with oversight of the outsourced tasks. This does not include time that a sponsor spends on any of the project tasks conducted internally.	There are no notes.

Costs Tab

Table 5-61 Costs Tab Fields

Field	Description	Notes
Show: Excluded Cost(s) filter	Displays costs that have been previously excluded.	Excluded costs are not included in the plan budget.
Show: Categories where costs total 0.00 filter	Displays cost categories where the total cost equals 0.00. Deselect to hide cost categories where the total cost equals 0.00.	There are no notes.
New button	Opens the Define New Category dialog box to create a user-defined cost.	There are no notes.
Edit button	Opens the Edit or Adjust Cost dialog box to display the breakdown of costs by location and adjust the cost category type, department, and GL code.	If the Edit button is disabled, you have selected more than one cost. Deselect the additional costs.
Exclude button	Excluded the selected costs from the plan budget totals.	Excluded costs are not deleted. They appear with a line through them.
Include button	Restores the selected excluded costs.	Set the filter to show excluded costs.
Delete button	Permanently delete the selected user-defined costs.	You cannot delete default application costs. You cannot restore deleted user-defined costs.
Name column	Name referring to a specific cost or cost type.	For a description of each cost, see the online Help for this tab.
Type column	Whether the cost type is a pass-through or another type of indirect cost.	There are no notes.
Calculated column	Application-calculated cost based on the assumptions entered on other tabs.	There are no notes.
Adjustment column	Total amount of adjustments entered on the Adjustments tab of the Edit or Adjust Dialog box.	There are no notes.
Total column	Total calculated cost, including any adjustments.	Must be zero or greater.

Define New/Edit Category Dialog Box (Definition Tab, Assignments, Algorithm/Adjustments Tab, Distribution Tab)

Table 5-62 Define New /Edit Category Dialog Box (Definition Tab) Fields

Field	Description	Notes
Name	Name for the user-defined cost, containing up to 45 characters.	The name must be unique to the plan.
Type	Whether the cost is a pass-through or miscellaneous cost, or associated with a specific department.	There are no notes.
Costs or Cost and Adjustments	Whether the cost or credit varies by location or is calculated at study-level.	There are no notes.
Mapping Key	System-defined code that is included as part of the mapping key in the bid grid export found in the RFP feature.	There are no notes.
Include in Payment Schedule	Includes this cost in the recurring payments plotted on the Cash Flow Chart.	Edit the recurring payments schedule on the Payments tab.
Include in Resources by Department/GL Code Report	Includes this cost in the Resources by Department and treat indirect costs as billable items or allocated to one or more resources.	There are no notes.
Apply inflation over time	Includes inflation for this cost in resulting calculations.	Selection of this checkbox deselects the Treat as Credit checkbox.
Treat as Credit	Treats this cost as a credit.	Selection of this checkbox deselects the Apply inflation over time checkbox.
Notes	Additional notes or comments about the cost.	Displayed as help content for user-defined costs.
Created By	Name of the user who created the cost.	There are no notes.
Created Date	Date the cost was created.	There are no notes.
Last Modified By	Name of the user who last modified the cost.	There are no notes.
Last Modified	Date the cost was last modified.	There are no notes.

Table 5-63 Define New/Edit Category Dialog Box (Assignments Tab) Fields

Field	Description	Notes
Provider	Service provider associated with a cost.	There are no notes.
Department	Department associated with the cost.	There are no notes.
GL Code	Association of a cost or set of costs with a particular entry in the General Ledger.	There are no notes.

Table 5-64 Define New/Edit Category Dialog Box (Algorithm Tab) Fields

Field	Description	Notes
Calculate as: or Apply adjustment of:	Per unit cost.	Must contain a value between 0 and 99,999,999 USD (or the equivalent in another currency).
Currency	Currency of the per unit cost.	There are no notes.
per (percentage amount)	Specify a percentage amount that will increase/decrease the number derived from the underlying assumption for the driver.	Must contain a value between 0 and 999.99.
of (cost driver)	Unit-based assumptions that drive this cost calculation.	Custom units of work appear in italicized type followed by an asterisk.
Location	Location with which a cost is associated.	Applies only to costs that are defined to vary by location.
Calculated (cost)	System-calculated cost value.	There are no notes.
Costs	Cost or credit value calculated for each location- or study-level expression as the monetary value multiplied by the specified percentage of the number of units expected for the chosen assumption.	There are no notes.
Total	Total calculated costs or credits for all expressions in the algorithm, including any adjustments made by you or another user.	Must be zero or greater.

Table 5-65 Define New/Edit Category Dialog Box (Distribution Tab) Fields

Field	Description	Notes
Distribute according to	How a cost will be distributed for each location in your plan. You can allocate costs based on an application schedule, evenly between two dates, or create a custom distribution.	Frequency includes week, month, and quarter.
and shift	Number of days earlier or later to offset the distribution from an application-defined distribution curve.	Applies to custom distribution. Must contain a value between 0 and 999.
Default range	Start and end date for the cost distribution, based on the number of days before or after the selected milestone.	If you select an application-defined distribution, you cannot edit this field.
Start	Number of days before or after a selected milestone to start the distribution of this cost.	The calculated distribution start date cannot be less than the pre-study planning date.
End	Number of days before or after a selected milestone to end the distribution of this cost.	You can distribute the cost up to 10 years after the Final Report date. The calculated distribution end date should be less than the Final Report date plus 10 years.
Location	Location for which you are defining a custom distribution or custom Start and End dates.	There are no notes.
Start	Date to start the distribution of this cost.	Click Apply to recalculate the distribution according to the date.
End	Date to end the distribution of this cost.	Click Apply to recalculate the distribution according to the date.
Period	Each week, month, or quarter that the cost incurs.	There are no notes.
Percentage	Percentage of the total cost paid during the associated period.	There are no notes.
Total	Displays the total of the cost distribution.	There are no notes.

Cost Category Descriptions

Table 5-66 Cost Category Descriptions Fields

Field	Description	Notes
Advertising (additional)	Advertising costs for finding subjects, not included in the investigator grants.	The application does not calculate this cost.
Call Center	Costs associated with a subject enrollment call center.	The application does not calculate this cost.
Clinical Trial Insurance	Costs based on the location of the sites and the number of sites for a particular clinical trial. The total clinical trial insurance is the sum of these costs for all sites you select on the Locations tab and are entered as Pass Through Costs.	There are no notes.
Consultants	Fees associated with outside consultants that are not part of CRO Vendor fees.	The application does not calculate this cost.
CRF Printing	Costs for printing the CRF books, based on the number of pages per CRF book, the number of subjects in the study, the ply of the NCR paper, and the cost per page that you indicate on the Data tab. The costs for CRF distribution are the costs to package and ship the CRF books to each site.	The application assumes you print an average of fifteen percent of CRF Books. The application calculates this cost, however, you can enter adjustments to raise or lower this value.
Drug Distribution - Special Handling	These costs apply to special costs associated with shipping the study drug/test article. Examples include the use of dry ice, custom fees, and central pharmacy shipping fees.	The application does not calculate this cost.
Drug Distribution - Standard Shipping	The application bases these costs on the location of the sites and which company is handling the distribution of the study drug or device being studied. These are estimated costs for storing and distribution of the study drug (test article) to the sites based on the frequency of shipments of the material being shipped.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Drug Packaging	Costs associated with the actual packaging and storage of the test article prior to routing to the distribution center. The application bases these costs on the location of the sites and which company is handling the packaging of the study drug. The method of packaging is a significant driver of these costs.	If your study drug or device requires special packaging and labeling, Oracle recommends that you override the estimate the application calculates. The application calculates these costs, however, you can enter adjustments to raise or lower this value.
DSMB Reporting	Costs associated with compiling and reporting information to the Data Safety Monitoring Board (DSMB).	The application calculates these costs based on several factors, including how often you report data to the Data Safety Monitoring Board. This assumption is on the Monitoring Tab. The application calculates these costs, however, you can enter adjustments to raise or lower this value.
EDC - 3rd Party Costs	Costs associated with Electronic Data Capture (EDC) that is managed by a third party.	There are no notes.
EDC Hosting	Costs associated with Electronic Data Capture (EDC) Hosting. This is a centralized cost and calculates based on the EDC maturity level you select. The start date is 28 days prior to the First Subject In (FSI) and the End Date is the date of the Database Lock.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
EDC Licensing	Costs associated with Electronic Data Capture (EDC) Licensing. This is a centralized cost and calculated based on the EDC maturity level selected. The Start Date is the Project Activity Start Date and the End Date is the Final Report Date.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
EDC Setup	Costs associated with setting-up Electronic Data Capture (EDC) with a Third Party. This is a centralized cost and is calculated based on the EDC maturity level selected. The start date is 30 days prior to the global First Subject In (FSI) date and the End Date is the FSI date.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Electronic Data Capture (EDC)	Costs associated with Electronic Data Capture (EDC), including hardware costs, configurations costs, training costs, telecommunication fees, and monthly maintenance fees.	This cost category only applies to plans that were created prior to ClearTrial release 4.2.0. As of release 4.2.0, this item is replaced by tasks and costs covering setup, hosting, and licensing.
Event Committee Costs	Costs associated with Event Committee costs, not including Initial and Annual IRB fees estimates.	The application does not calculate this cost.
FDA Audits	Costs associated with FDA audits. Actual FDA audits are not typically covered in bids from CROs, as these audits are typically conducted by the sponsor. When the FDA requires an audit, the CRO or sponsor handles this as a change order. If you know or expect a certain number of audits to occur, enter an estimated value here.	The application does not calculate this cost.
Investigator Grants - Grant Payments	All fees paid per subject to the investigator sites for enrollment into the study and in accordance with the study protocol. The application calculates this value based on the grant amount you enter on the Locations tab, by country, specifically for the numbers of subjects in each country. The grant amount calculation includes the number of subjects to randomize and the subject drop rate. The grant calculation for dropped subjects assumes each dropped subject only completes 75% of a completed CRF book. The grant calculation for a completed subject assumes 100% of the CRF is complete.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Investigator Grants - Overhead	All fees paid to sites requiring overhead and the percentage of overhead allowed per site specified on the Site tab.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Investigator Grants - Screen Failures	Screen failure payments made to the investigator sites. The application calculates this value based on various user input including the screen failure rate and the payment per screen failure.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Investigator Meetings	Costs associated with the Investigator meetings as specified on the Meetings tab. The application calculates this cost category based on the number of attendees from each site plus the expected vendor staff and sponsor staff as specified on the Meetings tab for each Investigator Meeting. This calculated value does not include any meeting planning fees, but does include the travel costs for the meeting planner, in addition to all other meeting attendees. If you plan to use a third-party meeting planner, the fees associated with the third party vendor should be added as a separate pass through cost. The pass through costs for investigator meetings include travel costs to and from the meeting venue(s) for the Vendor, Sponsor and Investigator and his or her representatives (study coordinator, sub investigator, etc). They also cover costs for the meals, meeting rooms, and other miscellaneous travel expenses for all parties. These costs are apportioned by vendor and the bulk of these expenses are apportioned to the planner of the investigator meeting as specified for each Investigator Meeting on the Meetings tab.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
IRB and Annual Renewal Fees	Initial and annual renewal fees for IRB or Ethics Committee Submissions. These are not part of the investigator grant and are paid by the sponsor for each site. These fees are calculated based on the number of Local and Central IRBs that are required for the study, specified on the Site tab, and the number of sites participating in the study.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
IVRS - Central Randomization	Includes IVRS Fees. If IVRS is not assigned to one of the plan providers, you should enter the costs associated with the IVRS or Central Randomization vendor here. This cost should include the setup, maintenance and close out of the IVRS system.	If IVRS is assigned to a CRO, the application calculates these costs, however, you can enter adjustments to raise or lower this value. If IVRS is assigned to the sponsor or a third-party vendor, the application does not calculate these costs.
IVRS - Hardware Only	Any costs directly associated with an Interactive Voice Response System (IVRS). This value should not include other costs associated with an IVRS.	The application does not calculate this cost.
Labs - Central Lab	All fees paid to the Central Lab for analysis of safety labs. The application calculates these costs based on the number of subject visits, factors specific to the locations in which the sites and subjects are being treated, and the number of subjects being treated. These fees are an estimate for central laboratory analyses for standard safety labs (CBC, chemistry panel and urinalysis) and assumes that safety labs are done on all subjects at least 66.667% of all visits. These fees do not include costs that some Central Labs may charge for shipment of samples. You should add lab shipment fees either by adjusting this cost line item or entering costs under the Pass-Through Line Item labeled Drug Distribution - Special Handling.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Labs - Core Labs (e.g., Holter monitoring)	These costs are typically different than the central lab costs. They may include PK analysis, Central EKG Lab, Holter monitoring, specialized lab analysis, etc.	The application does not calculate this cost.
Labs - Efficacy Labs (not included in Central lab)	The application calculates and estimates the Central Safety lab costs, however, there may be additional costs that need to be included in the costs of the study. For example, costs related to efficacy.	The application does not calculate this cost.
Labs - Other Lab Costs	Lab fees not covered in core lab fees.	The application does not calculate this cost.
Meeting - Face to Face Meeting (CT Internal Training Sponsor)	All costs associated with face to face meetings for the internal training sponsor.	There are no notes.
Meeting - Face to Face Meeting (Major CRO)	All costs associated with face to face meetings for the major CRO.	There are no notes.
Meeting - Investigator Meeting (CT Internal Training Sponsor)	All costs associated with investigator meetings for the internal training sponsor.	There are no notes.
Meeting - Investigator Meeting (Major CRO)	All costs associated with investigator meetings for the major CRO.	There are no notes.
Meeting - Kickoff Meeting (CT Internal Training Sponsor)	All costs associated with kick-off meetings for the internal training sponsor.	There are no notes.
Meeting - Kickoff Meeting (Major CRO)	All costs associated with kick-off meetings for the major CRO.	There are no notes.
Meeting - Primary Provider Internal Team Meeting (CT Internal Training Sponsor)	All costs associated the primary provider internal team meeting for the internal training sponsor.	There are no notes.
Meeting - Primary Provider Internal Team Meeting (Major CRO)	All costs associated the primary provider internal team meeting for the Major CRO.	There are no notes.
Meeting - Status Update to Sponsor (Major CRO)	All costs associated with meetings for status updates to sponsor for the major CRO.	There are no notes.
Meeting - Status Update to Sponsor (CT Internal Training Sponsor)	All costs associated with meetings for status updates to sponsor for the internal training sponsor.	There are no notes.
Meeting - Status Update to Sponsor (Major CRO)	All costs associated with meetings for status updates to sponsor for the major CRO.	There are no notes.
Miscellaneous Costs	Costs associated with miscellaneous minor expenses, such as copying, faxing, and sending letters to sites.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Other Costs	Any other known or expected costs that are not part of a pre-defined or user-added category.	The application does not calculate this cost.
Printing (not including CRF Printing)	Applies to any printing costs other than printing the CRF. This covers the cost of printing Investigator Brochures, newsletters, and other general correspondence.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Protocol Amendment IRB Submissions	Covers costs associated with submissions to Institutional Review Boards or Ethics Committees with respect to changes in the protocol.	There are no notes.
Protocol Distribution	Distribution of the protocol. Costs are driven by the number of sites to which each provider is distributing the protocol.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Recruitment Costs (additional)	Subject recruitment costs not included in the investigator grants	The application does not calculate this cost.
Regulatory Approval Outside the USA	Any fees to be paid to other regulatory bodies if required. For instance, if there are fees assessed by a local MOH, then you should adjust this cost by that amount.	The application does not calculate this cost.
Shipping (not including study drug/test article shipping)	Applies to costs associated with shipping for CRFs, Investigator Brochures, and other printed media (both to and from the site). These costs are separate from shipping related to the study drug/test article. Note that additional costs are added to this category when a third-party vendor is expected to perform translations. Translated documents must be printed and shipped to all sites.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Shipping - Central Lab Test Kits	Includes costs associated with shipping test kits to the central lab prior to treatment start. Test kits include supplies for use during treatment.	There are no notes.
Stability Studies Fees & Expenses	Stability studies are routinely performed throughout the drug development process. If stability studies are a part of the protocol being modeled, those costs should be captured here.	The application does not calculate this cost.
Subject Stipends - Enrolled	Payments made to enrolled subjects to pay for travel and parking.	There are no notes.
Subject Stipends - Screen Failures	Accounts for costs associated with subjects who fail the screening to cover travel and parking.	There are no notes.
Translation Services - 3rd Party	Applies to translations being done by a third-party Vendor. If you specified any of the document translations as pass-through costs (see the Locations tab), those costs should be entered here.	The application does not calculate this cost.
Travel - Monitoring Travel Expenses	Applies to costs associated with all travel to and from investigator sites for monitoring, including Pre-Study Site Visits (PSSV), Site Initiation Visits, Interim Monitoring, and Site Close-out Visits. Travel for Site Audits are not included here, but are calculated separately under Travel Fees for Site Audits. Travel costs are determined in part by the monitoring frequency (more trips require more travel costs, however multiple-day monitoring visits require more overnight accommodations), as well as the monitoring strategy (loop visits tend to decrease travel costs, but increase costs associated with overnight accommodations; spoke visits tend to require more travel). You should examine the Monitoring Schedule reports to help plan the optimal frequency and strategy.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Travel - Other Travel Expenses	Other travel costs, such as drug accountability travel. The application calculates these costs separately from other travel costs.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.
Travel - Site Audit Travel Expenses	Travel costs specifically for site audits. The application calculates these separately from other travel costs.	The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Payments Tab

Table 5-67 Payments Tab Fields

Field	Description	Notes
Set Payment Terms button	Open the Payment Terms dialog box to specify the number of days from invoice to payment is expected for each service provider.
Edit Recurring Payments button	Open the Recurring Payments dialog box to define the frequency of payments for any listed unit of work or pass-through cost.	Defining the frequency as <milestone> indicates that the fees associated with that item are included in payments made in response to the occurrence of one or more milestones.
Add Milestone button	Opens the Create Milestone dialog box to add a user-defined milestone to this plan.	Adding milestones allows you to add payments in response to events not currently defined in the application.
Edit Milestone button	Opens the Edit Milestone dialog box to edit a user-defined milestone.	You can edit a previously added milestone to change its name and properties, which determine when it occurs.
Delete Milestone button	Delete a user-defined milestone.	To not make a payment at a system-defined milestone, define the percentage as 0.
Milestone column	The milestone at which payments can be made or received.	There are no notes.
Inv. Date column	Displays the date on which the milestone is expected to occur and trigger an invoice.	There are no notes.
Service Provider (Payment Percentage and Amount) column	The payment percentages and amounts to be received by the service provider.	For example, Major CRO, Medium CRO, Premium CRO.
Total column	Total amount paid to all service providers at this milestone.	Includes line-item discounts for the providers. The discounted values are allocated to the milestones based on the default or overwritten percentages.
Budget Total column	Total payment percentage and amount for all plan milestones.	Includes line-item discounts for the providers.

Payment Terms Dialog Box

Table 5-68 Payment Terms Dialog Box Fields

Column	Description	Notes
Provider	Service provider.	There are no notes.
Payment Term	Number of days between the invoice date and the date of payment.	There are no notes.

Recurring Payments Dialog Box

Table 5-69 Recurring Payments Dialog Box Fields

Column	Description	Notes
Item Name	Major task or pass-through cost that can be set as a milestone triggering a recurring payment.	There are no notes.
Specific Service Provider	For each service provider, the milestone when the recurring payment is to be made.	There are no notes.

Create/Edit Milestone Dialog Box

Table 5-70 Create/Edit Milestone Dialog Box Fields

Field	Description	Notes
Name	Name of user-defined milestone.	The name must be unique to the plan.
Occurs	The number of days before or after the application-defined milestone that this milestone occurs.	The application calculates user-defined milestones in relation to application-defined milestones.
Before or After	Whether to calculate the estimated date for this milestone as a number of days prior to an application-defined milestone or following an application-defined milestone.	There are no notes.
Milestone	The application-defined milestone before or after which this user-defined milestone occurs.	There are no notes.
Code	A 3-6 character abbreviation for the milestone.	The application displays the code on reports where the full name does not fit.
Description	Additional information to describe the milestone.	There are no notes.

Summary Tab

Table 5-71 Summary Tab Fields

Field	Description	Notes
Included Providers	Selected service provider checkboxes identify which service providers' fees. hours, and costs appear on the Summary Tab.	Dates and metrics are not affected.
Startup Fees	All fees, hours, and FTEs associated with the start up of the study from Project Activity Start Date to the First subject enrolled date (FSFV).	There are no notes.
Clinical Monitoring Closeout and Site Audit Fees	All fees associated with site monitoring, site management, telephone monitoring, query resolution, site close outs, and clinical compliance audits	SAE Management. activity falls under the Safety and Medical Management summary group for cost models 5.5 and above, but is included here for cost models prior to 5.5.
Safety and Medical Management	All fees associated with medical monitoring, SAE processing and safety oversight.	Available in late phase plans with cost models 5.5 and above.
Data Management	All fees, hours, and FTEs associated with database design, data entry data coordination, cleaning the data, database audits, and the annual IND update.	There are no notes.
Biostatistics	All fees, hours, and FTEs associated with table listings and graphs, randomization procedures, statistical and analysis plans, and interim analysis.	There are no notes.
Project Management/ Study Oversight	All fees, hours, and FTEs associated with project management of the study from beginning to end.	There are no notes.
Medical Writing/ Final Report	All fees, hours, and FTEs associated with delivering the statistical report, draft report, and final report (CSR).	There are no notes.
Other	All fees, hours, and FTEs associated with other tasks not included in any other line item.	There are no notes.
Total Fees	Which line item appears depends on the criteria met.	Possible line items: Total Fees without inflation and discount Inflation (Fees) Line-Item Discounts Total fees before discount Total fees before inflation
Total Fees	All fees associated with the study.	There are no notes.
Total Hours	Total hourly effort associated with the study.	There are no notes.
Total FTEs	Total of all FTEs associated with this study, by functional area.	There are no notes.
CPU Pass-Through Costs	All costs associated with the Clinical Pharmacology Unit.	Applicable for Phase I (Healthy Volunteers) trials.
Other Pass-Through Costs	All indirect costs not associated with the CPU Total Pass-Through Costs.	There are no notes.
Total Pass-Through Costs	All third-party, pass-through, and miscellaneous costs in the study.	There are no notes.
Inflation (Pass-Through Costs)	Costs incurred due to inflation applied to pass-through costs.	There are no notes.
Total Study Costs	Total study costs, including vendor fees, pass-through costs, sponsor internal costs, and any applicable inflation and line-item discount.	There are no notes.
Pre-Study Activity Start Date	Date on which the earliest activity or cost occurs.	There are no notes.
Project Activity Start Date	Date the study begins, defined as the date that vendors and the sponsor start identifying sites and vendors start billable activity.	There are no notes.
Study End Date	Date the study is complete, defined as the date that all activity stops (usually the date the final report (CSR) is finalized).	There are no notes.
Total Study Duration	The total study duration (in elapsed days), defined as the end date minus the start date.	There are no notes.
Duration of Active Treatment Phase	The total duration of the active treatment phase (in days), defined as the last subject observation (LSLV) minus the First Subject Observation (FSFV).	There are no notes.
Cost per Completed Subject	The expected cost per each completed subject.	Calculated as the total study costs divided by the number of subjects expected to complete all scheduled subject visits.
Number of Subjects/Site/Month	The average expected number of subjects monitored at each site each month.	There are no notes.

Reports Tab

There are three types of reports in the application: Clinical Indicator, Costs, and FTE/Resources Reports.

Clinical Indicators Reports

Table 5-72 Clinical Indicator Reports Descriptions

Field	Description	Notes
Assumptions	Assumptions based on data entry.	Includes custom assumptions.
Currency Exchange Rates	Currency exchange rates based on data entry.	There are no notes.
Responsibilities	Responsibilities based on data entry.	There are no notes.
Site Approval Schedule - Cumulative	Cumulative site approval curve for the entire study by week.	There are no notes.
Site Approval Schedule By Location	Site approval curve by week for each location in the study.	There are no notes.
On-Site Monitoring Schedule - Total Hours	Total hours for all on-site monitoring visits for the entire study.	There are no notes.
On-Site Monitoring Schedule By Location	Average hours per on-site monitoring visit for each location in the study.	There are no notes.
CRF Pages - Cumulative	Cumulative CRF pages generated per week.	There are no notes.
CRF Pages By Location	CRF pages generated per week for each location in the study.	There are no notes.
Subject Enrollment - Cumulative	Cumulative subject enrollment per week.	There are no notes.
Subject Enrollment by Location	Subject enrollment per week by location.	There are no notes.
Metrics	Various performance and cost metrics.	The following metrics include line-item discount and inflation, if report parameters are selected for inclusion: Direct fees per Enrolled Subject Cost per subject per site per week Total study cost per on-site monitoring day Total study cost per CRF page
Milestone Dates	Critical dates in the study.	There are no notes.
Milestones Timeline Chart	Graphical view of key milestones.	There are no notes.

Costs Reports

Table 5-73 Costs Reports Descriptions

Field	Description	Notes
Plan Summary	Printable view of the Plans Summary Tab.	Includes line-item discount and inflation.
Fees by Major Task	Fees by major task.	Includes inflation (when selected for inclusion) and line-item discount.
Fixed Unit Prices	Fixed unit prices.	Includes inflation (when selected for inclusion) and line-item discount.
Pass-Through and 3rd Party Costs	Pass-through and 3rd party costs.	There are no notes.
Monthly Budget	Monthly budget.	Includes inflation (when selected for inclusion) and line-item discount.
Monthly Budget By Reporting Region	Monthly budget by reporting region.	Includes inflation (when selected for inclusion) and line-item discount.
Labor Adjustments	Breakdown of unit level adjustments by major task.	Includes inflation (when selected for inclusion) and line-item discount.
Cash Flow	Planned value (PV) versus payments.	Includes inflation and line-item discount.
Milestone Payment Schedule	Schedule of payments at each milestone.	Includes inflation and line-item discount.
Meetings Report	Meeting costs and assumptions.	There are no notes.
Summary Grid by Major Task	Plan/Provider-specific report showing selected values by major task.	Includes line-item discount.
Inflation Rates	Inflation rates by location and year.	There are no notes.

FTE/Resources Reports

Table 5-74 FTE/Resources Reports Descriptions

Field	Description	Notes
Resource/FTE Demand Summary	Summary of the plan resources and FTE demands.	Includes inflation (when selected for inclusion) and line-item discount.
Resources By Major Task	Resources by major task.	Includes inflation (when selected for inclusion) and line-item discount.
Resources By Department	Resources by department.	Includes inflation (when selected for inclusion).
Resources By GL Code	Resources by GL code.	Includes inflation (when selected for inclusion).
Resource Demand by Date	Resources by demand date.	Cost view includes inflation (when selected for inclusion) and line-item discount.
Resource Demand Chart	Graphical view of resource demand by date.	There are no notes.
Billing Rates by Resource Name	Billing rates by resource name.	There are no notes.

Studies Screen Fields

The following screens and dialog boxes are associated with studies.

Studies Screen Fields

Table 5-75 Studies Screen Fields

Field	Description	Notes
New button	New study.	There are no notes.
Edit button	Edit a study.	There are no notes.
Delete button	Delete a study.	There are no notes.
Restore button	Restore a deleted study.	There are no notes.
Create Plan button	Create a plan based on a study.	There are no notes.
Study Name column	Studies in the application.	There are no notes.
Product/Compound column	Product or compound the associated study is based on.	There are no notes.
Phase column	Study phase of the associated study.	There are no notes.
Therapeutic Area column	Therapeutic area the associated study is based on.	There are no notes.
Indication column	Indication the associated study is based on.	There are no notes.
Status column	Study status.	There are no notes.

Create/Edit Study Screen Fields

Table 5-76 Create/Edit Study Screen Fields

Field	Description	Notes
Study Name	Study name.	There are no notes.
Protocol	Protocol ID.	The protocol ID number identifies the protocol for this study.
Product/Compound	Product or compound the associated study is based on.	There are no notes.
Phase	Study phase.	There are no notes.
Sponsor	Study sponsor.	There are no notes.
Status	Study status.	There are no notes.
Billing Code	Study billing code.	There are no notes.
Therapeutic Area	Therapeutic area the study is based on.	There are no notes.
Indication	Indication the study is based on.	There are no notes.
Substitute the names below for therapeutic area and indication	Substitute names for the chosen therapeutic area and/or indication.	The substitute names are available on the Studies screen and displayed on all reports related to the study.
Therapeutic Area (Alias)	Substitute name for the chosen therapeutic area.	Use a therapeutic area alias if there are no therapeutic areas included on the pre-defined list that describe your study.
Indication (Alias)	Substitute name for the chosen indication.	Use an indication alias if there are no indications included on the pre-defined list that describe your study.
Description	Study description	There are no notes.

Define Study Filter Dialog Box Fields

Table 5-77 Define Study Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes studies created or modified within the number of days selected from the drop-down list.	There are no notes.
Include deleted studies	Includes studies that have been previously deleted.	There are no notes.
Study name starts with	Includes studies whose names begin with the text entered. Filters out all other studies.	There are no notes.
Created by	Includes studies created by the selected users.	To display all studies regardless of who created them, select Any User. To display more users to choose from, click the Expand list... link.
Last Modified by	Includes studies last edited and saved by the selected users.	To display studies regardless of who last updated them, select Any User. To display more users to choose from, click the Expand list... link.
Status	Includes studies with the selected statuses.	To display studies regardless of their status, select Any Status.
Phases	Includes studies pertaining to the selected phases.	To display studies regardless of the phase, select Any Phase.
Therapeutic Areas	Includes studies pertaining to the selected Therapeutic Areas	To display studies regardless of the Therapeutic Area, select Any Therapeutic Area.
Sponsors	Includes studies for the selected sponsors.	To display studies regardless of the sponsor, select Any Sponsor.
Save filter as	Name to assign to the filter.	There are no notes.

Configure List Options Dialog Box Fields - Studies Screen

Table 5-78 Configure List Options Dialog Box Fields - Studies Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Plans screen.	There are no notes.
Sort By	The list of studies can be ordered according to your selection, rather than by the first displayed column.	Change the order by clicking a column heading.
Show n studies per page	Number of studies to be displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Create Product Dialog Box Fields

Table 5-79 Create Product Dialog Box Fields

Field	Description	Notes
Product ID	Unique product identifier, typically and alphanumeric code used to identify the product/compound.	There are no notes.
Name	Name used to refer to the product.	There are no notes.
Description	Description of the product.	There are no notes.

Products Screen Fields

The following screens and dialog boxes are associated with products.

Product Screen Fields

Table 5-80 Product Screen Fields

Field	Description	Notes
New button	Add a product.	There are no notes.
Edit button	Edit a product.	There are no notes.
Delete button	Delete a product.	There are no notes.
Restore button	Restore a deleted product.	There are no notes.
Product Name column	Products in the application.	There are no notes.
Description column	Product description.	There are no notes.
Last Updated column	Date and time the product was lasted modified.	There are no notes.
Updated By column	User who modified the product.	There are no notes.

Create/Edit Product Screen Fields

Table 5-81 Create/Edit Product Screen Fields

Field	Description	Notes
Product ID	Product ID.	There are no notes.
Name	Product name.	There are no notes.
Description	Product description.	There are no notes.

Define Product Filter Dialog Box Fields

Table 5-82 Define Product Table Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes products created or modified within the number of days selected from the drop-down list..	There are no notes.
Include deleted products	Includes products that have been previously deleted.	There are no notes.
Product name starts with	Includes products whose names begin with the text entered. Filters out all other products.	There are no notes.
Created by	Includes products created by the selected users.	To display all products regardless of who created them, select Any User. To display more users to choose from, click the Expand list... link.
Last Modified by	Includes products last edited and saved by the selected users.	To display products regardless of who last updated them, select Any User. To display more users to choose from, click the Expand list... link.
Save filter as	Name to assign to the filter.	There are no notes.

Configure List Options Dialog Box Fields - Products Screen

Table 5-83 Configure List Options Dialog Box Fields - Products Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Plans screen.	There are no notes.
Sort By	The list of products can be ordered according to your selection, rather than by the first displayed column.	Change the order by clicking a column heading.
Show n products per page	Number of products to be displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Portfolios Screens, Tabs, and Dialog Boxes

The following screens and dialog boxes are associated with portfolios.

Portfolio Screen

Table 5-84 Portfolio Screen Fields

Field	Description	Notes
Show filter	Show or hide portfolios based on selected criteria: All Portfolios—No filter is applied. All portfolios appear.� Active Portfolios Only—Portfolios that are not deleted or marked as Study Complete or Archived appear. Portfolios matching filter—Only portfolios that match the criteria you selected from the custom filter drop-down list appear.	There are no notes.
Modify link	Define a custom filter on the Define Portfolio Filter dialog box.	There are no notes.
New button	Create a new portfolio on the Create Portfolio screen (Overview tab).	There are no notes.
Edit button	Edit the selected portfolio or open it to view details, the summary, or reports.	There are no notes.
Delete button	Delete the selected portfolio.	Deleted portfolios are permanently removed at a later time.
Restore button	Restore a deleted portfolio.	To use this option, adjust the filters so that you can see inactive as well as active items.
Copy button	Make a copy of the selected portfolio.	There are no notes.
Portfolio Name column	Name of the portfolio.	There are no notes.
Description column	Description of the portfolio.	There are no notes.
Number of plans column	Number of plans included in the portfolio.	There are no notes.
Last Modified column	Date a user last modified this portfolio.	There are no notes.

Portfolio Screen Dialog Boxes

Define Portfolio Filter Dialog Box

Table 5-85 Define Portfolio Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes portfolios created or modified within the number of days selected from the drop-down list.	There are no notes.
Include deleted portfolios	Includes portfolios that have been previously deleted.	You can recover, or restore, portfolios that have been deleted. Deleted portfolios are, however, permanently deleted and purged, after 30 days.
Portfolio name starts with	Includes only portfolios whose name begins with the specified text.	There are no notes.
Created by	Includes only portfolios created by one of the selected users.	To include portfolios regardless of their creator select Any User.
Last Modified by	Includes only portfolios last edited and saved by one of the selected users.	To include portfolios regardless of their creator select Any User.
Save filter as	Name to assign to the filter.	There are no notes.

Configure List Options Dialog Box Fields - Portfolio Screen

Table 5-86 Configure List Options Dialog Box Fields - Portfolio Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Plans screen.	There are no notes.
Sort By	Sort order for the Portfolios screen. Sort according to this selection, rather than by the first displayed column. Up to three levels of sorting are permitted.	Change the order by clicking a column heading.
Show n portfolios per page	Number of portfolios to be displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Create/Edit Portfolio Screen (Overview Tab)

Table 5-87 Create/Edit Portfolio Screen (Overview Tab) Fields

Field	Description	Notes
Portfolio Name	Unique name for the portfolio.	There are no notes.
Short Description	Details that appear on the Portfolios screen to help you recognize the portfolio.	There are no notes.
Long Description	Detailed description of the portfolio.	There are no notes.
Default Reporting Currency	Default reporting currency that is used to generate portfolio reports.	Each plan in the portfolio uses its own exchange rate rules to convert from the plan values to the reporting currency.
Created By	Name of the user who created the portfolio.	Edit Portfolio screen only.
Created Date	Date the portfolio was created.	Edit Portfolio screen only.
Last Modified By	Name of the user who last modified the portfolio.	Edit Portfolio screen only.
Last Modified	Date the portfolio was last modified.	Edit Portfolio screen only.

Create/Edit Portfolio Screen (Plans Tab) Fields

Table 5-88 Create/Edit Portfolio Screen (Plans Tab) Fields

Field	Description	Notes
Add Plans button	Add plans to the Portfolio on the Choose Plans dialog box.	You cannot add more than 200 plans.
Remove Plans button	Remove plans from a portfolio.	There are no notes.
Include Plans button	Restores an excluded plan to a portfolio.	There are no notes.
Exclude Plans button	Excludes a plan from the portfolio.	Excluded plans have a line through them on the Plans tab.
Plan Information column	Plan name and description.	There are no notes.
Start Date column	Plan project activity start date.	There are no notes.
Start Offset column	Effects of beginning a plan, or plans, earlier or later than originally scheduled. To move the start date earlier, enter a negative number of days. To postpone the start date, enter a positive number of days.	No adjustments are made for inflation. Must contain a value between -999 and 9,999.
Probability column	Likelihood that the plan is going to occur on schedule, expressed as a percentage.	There are no notes.

Create/Edit Portfolio Screen (Summary Tab)

Table 5-89 Create/Edit Portfolio Screen (Summary Tab) Fields

Field	Description	Notes
Start	By default, start date of the earliest plan in the portfolio, including any offset dates.	There are no notes.
End	By default, end date of the final plan in the portfolio.	There are no notes.
Cost Distribution Graph	Graphical view of when costs occur over the time range specified. Costs inclusive of line-item discount and inflation.	The blue shaded area represents the time frame selected in the Summary Portfolio dialog box.
Reset button	Resets Start and End values to portfolio defaults.	There are no notes.
Plan Name column	Displays the plan name.	There are no notes.
Study Name column	Displays the study for the plan.	There are no notes.
Plan Cost column	Displays the total plan cost inclusive of inflation and line-item discount.	There are no notes.
Start-up Fees	All fees, hours, and FTEs associated with the start up of the study from Project Activity Start Date to the First subject enrolled date (FSFV).	There are no notes.
Clinical Monitoring Closeout and Site Audit Fees	All fees, hours, and FTEs associated with site monitoring, site management, telephone monitoring, query resolution, site closeouts, and clinical compliance audits.	SAE Management activity falls under the Safety and Medical Management summary group for cost models 5.5 and above, but is included here for cost models prior to 5.5.
Safety and Medical Management	All fees associated with medical monitoring, SAE processing, and safety oversight.	Available in late phase plans with cost models 5.5 and above.
Data Management	All fees, hours, and FTEs associated with database design, data entry data coordination, cleaning the data, database audits, and the annual IND update.	There are no notes.
Biostatistics	All fees, hours, and FTEs associated with table listings and graphs, randomization procedures, statistical and analysis plans, and interim analysis.	There are no notes.
Project Management / Study Oversight	All fees, hours, and FTEs associated with project management of the study from beginning to end.	There are no notes.
Medical Writing / Final Report	All fees, hours, and FTEs associated with delivering the statistical report, draft report, and final report (CSR).	There are no notes.
Other	All fees, hours, and FTEs associated with other tasks not included in any other line item.	There are no notes.
Total Fees	All fees associated with the study.	There are no notes.
Total Hours	Total hourly effort associated with the study.	There are no notes.
Total Pass-Through Costs	All third-party, pass-through, and miscellaneous costs in the study.	There are no notes.
Total Portfolio Costs	Total portfolio costs, including vendor fees, pass-through costs, and sponsor internal costs.	There are no notes.

Create/Edit Portfolio Screen (Reports Tab)

There are three types of portfolio reports in the application: Clinical Indicator, Costs, and FTE/Resources Reports.

Clinical Indicator Reports Descriptions

Table 5-90 Create/Edit Portfolio Screen (Reports Tab), Clinical Indicator Reports Descriptions

Field	Description	Notes
Portfolio Milestones Timeline Chart	Displays a graphical view of key milestones in the portfolio.	There are no notes.

Costs Reports Descriptions

Table 5-91 Create/Edit Portfolio Screen (Reports Tab), Costs Reports Descriptions

Field	Description	Notes
Portfolio Summary	Displays a printable view of the Portfolio Summary Tab.	There are no notes.
Fees by Major Task	Displays fees by major task.	Includes inflation (when selected for inclusion) and line-item discount.
Monthly Budget	Displays monthly budget.	Includes inflation (when selected for inclusion) and line-item discount.

FTE/Resources Reports Descriptions

Table 5-92 Create/Edit Portfolio Screen (Reports Tab), FTE/Resources Reports Descriptions

Field	Description	Notes
Resource Demand Summary	Displays a summary of the portfolio resources demands.	Includes inflation (when selected for inclusion) and line-item discount.
Resource Demand by Date	Displays a summary of the portfolio date demands.	Includes inflation (when selected for inclusion) and line-item discount.
Resource Demand Chart	Displays resources demand chart.	There are no notes.

Portfolio Reports Descriptions

There are three types of portfolio reports in the application: Clinical Indicator, Costs, and FTE/Resources Reports.

Portfolio Clinical Indicator Reports Descriptions

Table 5-93 Portfolio Reports, Clinical Indicator Reports Descriptions

Field	Description	Notes
Portfolio Milestones Timeline Chart	Graphical view of key milestones in the portfolio.	There are no notes.

Portfolio Costs Reports Descriptions

Table 5-94 Portfolio Reports, Costs Reports Descriptions

Field	Description	Notes
Portfolio Summary	Printable view of the Portfolio Summary Tab.	There are no notes.
Fees by Major Task	Fees by major task.	Includes inflation (when selected for inclusion) and line-item discount.
Monthly Budget	Monthly budget.	Includes inflation (when selected for inclusion) and line-item discount.

Portfolio FTE/Resources Reports Descriptions

Table 5-95 Portfolio Reports, FTE/Resources Reports Descriptions

Field	Description	Notes
Resource Demand Summary	Summary of the portfolio resources demands.	There are no notes.
Resource Demand by Date	Summary of the portfolio date demands.	Includes inflation (when selected for inclusion) and line-item discount.
Resource Demand Chart	Resources demand chart.	Includes inflation (when selected for inclusion) and line-item discount.

RFPs and Bids Screens, Tabs, and Dialog Boxes

The following screens and dialog boxes are associated with RFPs and bids.

RFPs Screen

Table 5-96 RFPs Screen Fields

Field	Description	Notes
New button	Create a new request for proposal.	There are no notes.
Edit button	Edit the selected RFP or open it to view details, the summary, or reports.	You can also a open an RFP by double-clicking the plan name.
Delete button	Delete the selected RFP(s).	Deleted RFPs are removed at a later time and can be restored.
Restore button	Restore a deleted RFP.	To use this option, adjust the filters so that you can see inactive as well as active items.
Import Bid button	Upload a bid received from a vendor.	There are no notes.
Compare Bids button	Compare the bids associated with the selected RFPS.	There are no notes.
Download Bid Grid button	Generate and download the Bid Grid for the selected RFP.	There are no notes.
Plan name column	Unique identifier of plans.	There are no notes.
Scope/Provider column	Provider representing the scope of work on which the RFP is based.	There are no notes.
Description column	Short description of the RFP.	There are no notes.
Number of Bids column	The number of bids associated with the RFP.	There are no notes.

RFPs Screen Dialog Boxes

The following dialog boxes are associated with RFPs.

Define RFP Filter Dialog Box

Table 5-97 Define RFP Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes RFPs last edited and saved the specified number of days.	There are no notes.
Include deleted RFPs	Includes RFPs that have been previously deleted.	When you delete an RFP, the application does not permanently delete and purge it until 30 days later.
Created by	Includes only RFPs created by one of the selected users.	To include all RFPs, select Any User.
Last Modified by	Includes only RFPs last edited and saved by the selected user.	To include all RFPs, select Any User.
Save filter as	Name assigned to the filter.	There are no notes.

Configure List Options Dialog Box - RFPs Screen

Table 5-98 Configure List Options Dialog Box Fields - RFPs Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Plans screen.	There are no notes.
Sort By	Orders the RFPs based on your selections.	Change the order by clicking a column heading.
Show n RFPs per page	Number of RFPs displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Choose Plan for RFP Dialog Box

Table 5-99 Choose Plan for RFP Dialog Box Fields

Field	Description	Notes
Plan Name column	Unique name given to the plan by its creator.	Read-only.
Study Name column	Name of the study with which the plan is associated.	Read-only.
Phase column	The study phase being planned. The application supports study phases I, II, IIa, IIb, III, IIIb, Phase IV with an IND, and Phase IV without an IND. The application supports Phase I for oncology and vaccine studies, as well as Phase I studies for healthy volunteers. Phase I Oncology or Phase I Vaccine studies more closely resemble Phase IIa trials.	Read-only.
Indication column	The reason selected to perform this study. Indications are classified into therapeutic areas. The application uses this selection to calculate monitoring time required, time for query resolution, data entry, and to provide other default values.	Read-only.
Status column	The status of the plan: Incomplete—Basic assumptions have not been set for the plan. Draft—All input questions of the selected edit mode have been answered, but the plan owner or creator might still be working on the plan. Final—All input questions have been answered and the plan owner believes the plan will be used to conduct the clinical study. However, the plan has not yet been approved. Approved—The plan has been approved and is ready to go out as part of an RFP or proposal or to be used to conduct the trial. RFP—The plan has been approved and included as part of an RFP. Agreement reached; not started—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). In progress—The study has begun and is operating according to this plan Study Complete—The study has ended. Archived—The plan is being preserved for historical purposes only.	Read-only.
Template Name column	Name of a plan or partial plan that can be used as a starting point for new plans for a study.	Read-only.
Description column	Information describing the template to help you recognize a particular scenario or purpose for the plan.	Read-only.
Applicable For column	Study phase(s) for which the template has been defined.	Read-only.

Create RFP Dialog Box

Table 5-100 Create RFP Dialog Box Fields

Field	Description	Notes
Scope of Work/Assigned to Provider	Name of the service provider assigned to the desired scope of work in the plan associated with this RFP.	There are no notes.
Short Description	Label by which you will recognize this RFP on the RFPs screen.	Must be between 8 and 40 characters. Not included on the bid grid.
Bid Grid Title	Header that will appear on every page of the bid grid.	There are no notes.
Comments	Notes relevant to this RFP.	There are no notes.

Edit RFP Screen (Details Tab)

Table 5-101 Edit RFP Screen (Details Tab fields)

Field	Description	Notes
Short Description	Label by which you will recognize this RFP on the RFPs screen.	Must be between 8 and 40 characters. Not included on the bid grid.
Bid Grid Title	Header that will appear on every page of the bid grid.	There are no notes.
Comments	Notes relevant to this RFP.	There are no notes.
History section	Date a sponsor begins pre-planning activities. The default date is three months prior to the Project Activity Start Date.	Not used to calculate effort or costs for the study.
Created By	User who created this RFP.	There are no notes.
Created Date	Date and time the RFP was created.	There are no notes.
Last Modified By	Name of the user who last changed this RFP.	There are no notes.
Last Modified	Date and time this RFP was last changed.	There are no notes.
Download Bid Grid link	Regenerate the bid grid with the most recently saved Bid Grid Title.	There are no notes.

Edit RFP Screen (Labor Tab)

Table 5-102 Edit RFP Screen (Labor Tab Fields)

Field	Description	Notes
Include Inflation Checkbox	Include the impact of inflation in the values displayed	There are no notes.
Major Task column	Major task type.	For a description of each major task, see the online Help for the Labor tab.
Unit Hours column	Level of effort (in hours) for the selected service provider to complete one unit of work for the major task.	Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.
Unit Cost column	Total cost for the selected service provider to complete one unit of work for the major task.	Displayed values are rounded to the hundredths or according to the conventions of the currency.
# Units column	Total number of units of work expected (or, in the case of a re-forecast, remaining).	Some major tasks have a single unit of work; for example, Study or Database. Hover over the value to see the number of units.
Ext Hours column	Total level of effort (in hours) for the selected service provider to complete the major task.	The application multiplies the Unit Hours by the # Units. Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.
Ext Cost column	Total cost for the selected service provider to complete the major task.	Displayed values are rounded to the hundredths or according to the conventions of the currency.
Total Ext Hours column	Total level of effort in hours for the selected service provider to complete the major task.	There are no notes.
Total Ext Cost column	Total cost for the selected service provider to complete the major task.	There are no notes.

Edit RFP Screen (Costs Tab)

Table 5-103 Edit RFP Screen (Costs Tab Fields)

Column	Description	Notes
Name	Name referring to a specific cost or cost type.	For a description of each cost, see the online Help for this tab.
Total	Total calculated cost, including any adjustments.	There are no notes.
Inflated Total	Total calculated cost, including applicable inflation.	There are no notes.

Edit RFP Screen (Bids Tab)

Table 5-104 Edit RFP Screen (Bids Tab Fields)

Field	Description	Notes
Compare button	Compare the selected bids.	There are no notes.
Delete button	Delete the selected RFPs.	There are no notes.
Restore button	Restore the selected deleted RFPs.	There are no notes.
Download button	Download the bid grid file received from the vendor.	There are no notes.
Update Status button	Display a dialog box from which to choose a new status for the selected bid(s).	There are no notes.
Version column	The version of the bid, if you imported more than one bid for the same RFP from the same vendor.	There are no notes.
Created Date column	The date the bid was imported.	There are no notes.
Status column	The current status of the bid. Active statuses include: Pending Review Proposal - Under Review Proposal - Pending vendor action Proposal - Selected Contract - Under Review Contract - Pending vendor action Change Order - Under Review Change Order - Pending vendor action Change Order - Accepted Final Inactive statuses include: Proposal - Rejected Proposal - On Hold Proposal - Canceled Contract - Rejected Contract - Complete Change Order - Rejected Change Order - Complete	Upon vendor bid upload, the default status is Pending Review.
Total Fees column	The total fees for each bid inclusive of line-item discounts.	There are no notes.
Total PTC column	The total pass-through costs for each bid.	There are no notes.

Import Bids Screen and Dialog Boxes

Import Bid Dialog Box

Table 5-105 Import Bid Dialog Box Fields

Field	Description	Notes
Vendor Name	Vendor who submitted the bid.	There are no notes.
Bid Grid File to Upload	Name of bid file to upload. Browse for file on your PC.	There are no notes.
Short Description	Label by which you will recognize this bid on the RFPs screen.	Must be between 8 and 40 characters. Not included on the bid grid.
CRO Bid Number	Number by which the vendor can identify this bid.	Optional
Comments / CRO Information	Notes relevant to this RFP.	Up to 4000 characters.

Import Bid Issues Dialog Box

Table 5-106 Import Bid Issues Dialog Box Fields

Field	Description	Notes
Severity column	Status of the issue.: Warning, Serious, Fatal.	Fatal errors will prevent the file from successfully importing. Warnings or Serious issues will not prevent a successful import.
Message column	Type of issue and how it will be handled by the application.	There are no notes.
Sheet column	Sheet within bid grid workbook on which error appears.	There are no notes.
Row column	Number of row on sheet that error appears.	There are no notes.
Download Issues link	Saves the list of issues in a spreadsheet.	There are no notes.
Cancel button	Abort the loading of the bid.	There are no notes.
Continue button	Load the bid with the issues uncorrected.	The bid will fail to load if any of the issues have a severity level of Fatal.

Vendor Bid Comparison Options Dialog Box

Table 5-107 Vendor Bid Comparison Options Dialog Box Fields

Field	Description	Notes
Major Task and Cost Summary	Compare values aggregated by major task and cost.	Includes line-item discount comparison.
Detailed Fees and Costs by Location, Task, Resource	Compare values by resource per task per location.	Includes line-item discount comparison.
Include RFP i n comparison	Include the RFP values in the comparison.	Selected by default.
Show variances relative to RFP	Compare the selected bids to the RFP values.	Selected by default when the user uses the RFP as the baseline. If selected, turns off Show variances relative to a selected bid.
Show variances relative to a selected bid	Compare bids to the bid selected. The following data is displayed: Service Provider Version Short Description Created Date	Enabled when user selects a bid as baseline. You can select a single bid to compare other bids to. Turns off Show variances relative to RFP.
Variance Analysis Section	Assumptions displayed depend on which comparison is selected.	There are no notes.
Include Variance Analysis	For Major Task and Cost Summary comparison, includes: Highlight total cost variances above (user-defined %). Default is 10%. Highlight total hours variances above (user-defined %). Default is 10%. When turned off, all options below it are disabled and all % fields contain either the default or overridden value as read-only. For Detailed Fees and Costs by Location, Task, Resource comparison, includes: Highlight unit cost variances above (user-defined %). Default is 10%. Highlight unit hours variances above (user-defined %). Default is 10%. Highlight base billing rate variances above (user-defined %). Default will be 10%. Highlight inflated billing rate variances above (user-defined %). Default will be 10%. Highlight total cost variances above (user-defined %). Default is 10%. Highlight total hours variances above (user-defined %). Default is 10%. When turned off, all options below it are disabled and all % fields contain either the default or overridden value as read-only.	There are no notes.
Highlight total cost variances above	Highlights the unit cost variances outside the specified range.	There are no notes.
Highlight total hours variances above	Highlights the unit hours variances outside the specified range.	There are no notes.
Highlight base billing rate variances above	Highlights the billing rates variances outside the specified range.	There are no notes.
Highlight inflated billing rate variances above	Highlights the inflated billing rates variances outside the specified range.	There are no notes.
Report Format	Formats include HTML, PDF, XLS, and CSV.	There are no notes.

Bids Screens and Dialog Boxes

Bids Screen

Table 5-108 Bids Screen Fields

Field	Description	Notes
Edit button	Edit the selected bid.	You can also a open a bid by double-clicking the plan name.
Delete button	Delete the selected bid(s).	Deleted bids are removed at a later time and can be restored.
Restore button	Restore a deleted bid.	To use this option, adjust the filters so that you can see inactive as well as active items.
Update Status button	Display a dialog box in which to choose a new status for the selected bids.	There are no notes.
Compare button	Compare the selected bids or a single bid with the RFP.	There are no notes.
Download button	Download the original bid grid (Excel file) that was uploaded.	There are no notes.
Plan name column	Unique identifier of plans.	There are no notes.
Scope column	Provider representing the scope of work on which the bid is based.	There are no notes.
Vendor column	The name of the vendor from which each bid was received.	There are no notes.
Version column	The version of the bid, if you imported more than one bid for the same RFP from the same vendor.	There are no notes.
Description column	Label by which you will recognize this bid on the RFPs screen.	There are no notes.
Status column	The current status of the bid. Active statuses include: Pending Review Proposal - Under Review Proposal - Pending vendor action Proposal - Selected Contract - Under Review Contract - Pending vendor action Change Order - Under Review Change Order - Pending vendor action Change Order - Accepted Final Inactive statuses include: Proposal - Rejected Proposal - On Hold Proposal - Canceled Contract - Rejected Contract - Complete Change Order - Rejected Change Order - Complete	Upon vendor bid upload, the default status is Pending Review.
Created Date column	The date the bid was imported.	There are no notes.

Edit Bid Screen (Details Tab)

Table 5-109 Edit Bid Screen (Details Tab fields)

Field	Description	Notes
Short Description	Label by which you will recognize this bid on the Bids screen.	Must be between 8 and 40 characters. Not included on the bid grid.
CRO Bid Number	A vendor-defined value to identify this bid.	There are no notes.
Status	Status to assign to the bid.	There are no notes.
Comments	Notes relevant to this bid.	There are no notes.
Created By	User who created this bid.	There are no notes.
Created Date	Date and time the bid was created.	There are no notes.
Last Modified By	Name of the user who last changed this bid.	There are no notes.
Last Modified	Date and time this bid was last changed.	There are no notes.
Download Imported Bid link	Download the file that was imported to create this bid.	There are no notes.

Edit Bid Screen (Labor Tab)

Table 5-110 Edit Bid Screen (Labor Tab Fields)

Field	Description	Notes
Include Inflation Checkbox	Include the impact of inflation in the values displayed.	There are no notes.
Major Task column	Group of tasks related to a specific unit of work.	For a description of each major task, see the online Help for the Labor tab on the Edit Plans screen.
Unit Hours column	Level of effort (in hours) the vendor requires to complete one unit of work for the major task.	Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.
Unit Cost column	Total fees the vendor requires to complete one unit of work for the major task.	Displayed values are rounded to the nearest hundredths or according to the conventions of the currency.
# Units column	Total number of units of work expected (or, in the case of a re-forecast, remaining).	Some major tasks have a single unit of work; for example, Study or Database. Hover over the value to see the number of units.
Ext Hours column	Total level of effort (in hours) the vendor requires to complete the major task.	The application multiplies the Unit Hours by the # Units. Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.
Ext Cost column	Total fees the vendor requires to complete the major task.	Displayed values are rounded to the nearest hundredth or the conventions of the currency.
Total Ext Hours column	Total level of effort in hours the vendor requires to complete the major task.	There are no notes.
Total Ext Cost column	Total fees the vendor requires to complete the major task.	There are no notes.

Edit Bid Screen (Costs Tab)

Table 5-111 Edit Bid Screen (Costs Tab Fields)

Column	Description	Notes
Name	Name referring to a specific cost or cost type.	For a description of each cost, see the online Help for this tab on the Edit Plans screen.
Total	Total calculated cost, the vendor expects to incur.	If line-item discounts have been entered in the bid by the service provider, the Total Fees and Total columns include the applicable line-item discount value. The Bid Labor tab footer will include any line-item discount imported from the bid grid.

Edit Bid Screen (Issues Tab)

Table 5-112 Edit Bid Screen (Issues Tab Fields)

Field	Description	Notes
Download link	Download the file that was imported to create this bid.	There are no notes.
Severity column	Level of concern for the issue encountered. WARNING—Identifies missing information or data entry that differs from expected format. SERIOUS—Warrants inspection of the bid to ensure it accurately reflects the file that was uploaded. FATAL—Prevents the bid from being imported. Must be fixed for the import to proceed.	There are no notes.
Message column	Description of the issue.	There are no notes.
Sheet column	Name of the worksheet on which the issue was encountered.	There are no notes.
Row column	The row number where the issue was encountered.	There are no notes.

Change Bid Status Dialog Box

Table 5-113 Change Bid Status Dialog Box Fields

Field	Description	Notes
Status	Status of the bid.	There are no notes.
Update Bid History	Add to the history section included on the Edit Bid screen.	There are no notes.

Maintain Menu Screens and Dialog Boxes

Template Screen Fields and Dialog Boxes

Template Screen Fields

Table 5-114 Template Screen Fields

Field	Description	Notes
New button	Add template.	There are no notes.
Edit button	Edit a template.	There are no notes.
Delete button	Delete a template.	There are no notes.
Restore button	Restore a deleted template.	There are no notes.
Copy button	Copy a template.	There are no notes.
Lock Templates button	Lock templates.	There are no notes.
Unlock Templates button	Unlock templates.	There are no notes.
Template Name column	Template name.	There are no notes.
Phase column	Study phase.	There are no notes.
Therapeutic Area column	Therapeutic area of the associated template.	There are no notes.
Indication column	Indication of the associated template.	There are no notes.

Define Template Filter Dialog Box Fields

Table 5-115 Define Template Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes templates created or modified within the number of days selected from the drop-down list.	There are no notes.
Include deleted templates	Includes templates that have been previously deleted.	There are no notes.
Template name starts with	Includes templates created or modified within the number of days selected from the drop-down list.	There are no notes.
Created by	Includes templates created by the selected users.	To display all templates regardless of who created them, select Any User. To display more users to choose from, click the Expand list... link.
Last Modified by	Include templates last edited and saved by the selected users.	To display templates regardless of who last updated them, select Any User. To display more users to choose from, click the Expand list... link.
Status	Include templates with the selected statuses.	To display templates regardless of their status, select Any Status.
Phases	Include templates pertaining to the selected phases.	To display templates regardless of the phase, select Any Phase.
Therapeutic Areas	Include templates pertaining to the selected Therapeutic Areas.	To display templates regardless of the Therapeutic Area, select Any Therapeutic Area.
Sponsors	Includes templates for the selected sponsors.	To display templates regardless of the sponsor, select Any Sponsor.
Save filter as	Name to assign to the filter.	There are no notes.

Configure Lists Options Dialog Box Fields - Templates Screen

Table 5-116 Configure Lists Options Dialog Box Fields - Templates Screen

Field	Description	Notes
Sort By	Orders the plans based on your selections.	Change the order by clicking a column heading.
Show n templates per page	Number of plans displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Select Template Defaults Dialog Box Fields

Table 5-117 Select Template Defaults Dialog Box Fields

Field	Description	Notes
Sponsor	Default sponsor for the template.	There are no notes.
Phase	Phase from which to derive values when creating the template.	The plan you create uses the values and assignments stored in the template, but calculates according to the study phase.
Therapeutic Area	Therapeutic Area from which to derive values when creating the plan template.	The plan you create uses the values and assignments stored in the template, but calculates according to the study therapeutic area and indication.
Indication	Indication from which to derive values when creating the plan template.	There are no notes.

Copy Template Dialog Box Fields

Table 5-118 Copy Template Dialog Box Fields

Field	Description	Notes
Template Name	Name of the copied template.	There are no notes.
Use Cost Model from	Cost model to apply to the templates.	The default is the cost model of the template being copied.
Custom Field Model	Custom field models to apply to the plan.	There are no notes.

Change Template Attributes Dialog Box Fields

Table 5-119 Change Template Attributes Dialog Box Fields

Field	Description	Notes
Template Name	Unique name that identifies the template.	Disabled if multiple templates are selected.
Status	State of the template: Incomplete—Not all input questions have been addressed and the results are not expected to be accurate. Draft—All input questions have been answered, but the template owner or creator is still working on the template. Final—All input questions have been answered; however, the template is waiting approval by a person authorized to approve study templates. Approved—The template is approved and ready to go out as part of an RFP or proposal, or to be used to conduct the trial. RFP—The template has been approved and has been included as part of an RFP. Agreement reached; not started—An agreement has been reach on the template and it is under contract (if an outsourced study) or ready for study activities to begin (if an internal sponsor-executed study). In progress—The study has begin and is operating according to this template. Study Complete—The study has completed execution. Archived—This template is being preserved for historical purposes only.	There are no notes.
Cost Model	Cost model to apply to the template.	There are not notes.
Custom Field Model	Custom field model to apply to the template.	There are not notes.
Short Description	Information displayed when viewing a list of templates.	If multiple templates are selected, this field is disabled.
Long Description	Detailed explanation of the assumptions upon which this template is based.	If multiple templates are selected, this field is disabled.
Update last modified date and user (template history)	If checkbox is selected, updates the selected templates' last modified date and last modifier (user) when you apply changes to the name, status, cost model, custom field model, or descriptions.	Oracle recommends that you select this option. However, if you or other users often filter by the last modified date or user and do not want bulk changes to status, clear the checkbox before saving.

Service Providers Screen Fields

Service Providers Screen Fields

Table 5-120 Service Providers Screen Fields

Field	Description	Notes
Show filter	Service providers that appear on the Service Providers screen.	You can select sponsors, vendors, and deleted service providers.
New button	Create a service provider.	There are no notes.
Edit button	Edit a service provider.	There are no notes.
Delete button	Delete a service provider.	There are no notes.
Restore button	Restore a service provider.	There are no notes.
Billing Rates Report button	Display the Billing Rates report for a service provider.	There are no notes.
Name column	Service provider name.	There are no notes.
Type column	Service provider type.	There are no notes.
Last Modified column	Date and time the service provider was last edited.	There are no notes.
Last Modified By column	User who last edited the service provider.	There are no notes.

Create/Edit Service Provider Screen Fields

Table 5-121 Create/Edit Service Provider Screen Fields

Field	Description	Notes
Provider Name	Name that will appear in reports and on screens when you assign work to this provider.	There are no notes.
Provider Type	Type of service provider: Sponsor or Contract Research Organization (CRS).	There are no notes.
Description	Description to differentiate this provider.	Oracle recommends that you not particular specialties or limitations of this provider.
Billing Rates Currency	Currency of the hourly billing rates associated with the service provider.	All billing rates defined for this service provider must be expressed in this currency.
Back-Office Billing Rate Location	Determines the default billing rates for tasks that are typically centralized or conducted at a central location, such as Protocol Preparation and Data Management.	You can override the billing rate location in a plan for any specific task in the Task Manager or on the Assignment tab.
Created By	User who created the service provider.	There are no notes.
Created Date	Date and time this service provider was created.	There are no notes.
Last Modified By	User who last edited the service provider information.	There are no notes.
Last Modified	Date the service provider information was last modified.	There are no notes.
Update Billing Rates link	Enter and publish billing rates for this service provider.	There are no notes.

Resources Screen Fields

Define Resource Filter Dialog Box Fields

Table 5-122 Define Resource Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes resources created or modified within the number of days selected from the drop-down list.	There are no notes.
Include deleted resources	Includes previously deleted resources.	You can restore resources that have been deleted until they are permanently purged.
Resource name starts with	Includes resources with names starting with the specified text.	There are no notes.
Save filter as	Name assigned to the filter.	There are no notes.

Configure List Options Dialog Box Fields - Resources Screen

Table 5-123 Configure List Options Dialog Box Fields - Resources Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Plans screen.	There are no notes.
Sort By	The list of resources can be ordered according to your selection, rather than by the first displayed column.	Change the order by clicking a column heading.
Show n resources per page	Number of resources to be displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Resources Screen Fields

Table 5-124 Resources Screen Fields

Field	Description	Notes
Show filter	Resources that appear on the Resources screen.	You can include All Resources, Active Resources Only, or resources matching a filter.
New button	Add a resource.	There are no notes.
Edit button	Edit a resource.	There are no notes.
Delete button	Delete a resource.	There are no notes.
Restore button	Restore a resource.	There are no notes.
Name button	Resources in the application.	There are no notes.
Name column	Resource name.	There are no notes.
Last Updated column	Date and time the resource was last updated.	There are no notes.
Updated By column	User who last modified the resource.	There are no notes.

Create/Edit Resource Screen

Table 5-125 Create/Edit Resource Screen Fields

Field	Description	Notes
Code	Alphanumeric code representing this resource.	Example: CRO1.
Name	Job title or classification. Not the name of an individual resource.	Example: Medical Monitor. Two resources cannot have the same name.
Description	List of job responsibilities.	For system-defined resources, the list is read-only.
Rate Year	Rate year for each service provider.	Applies only to the Create Resource screen.
Auto Fill	Billing rates for each service provider.	Applies only to the Create Resource screen.

Billing Rates Screen Fields

Billing Rates Screen Fields

Table 5-126 Billing Rates Screen Fields

Field	Description	Notes
Show rates for	Service provider for which billing rates appear on the Billing Rates screen.	There are no notes.
For Rate Year	Year for which billing rates appear on the Billing Rates screen.	There are no notes.
Include Deleted Rates	Include deleted rates.	There are no notes.
New button	Add billing rates.	There are no notes.
Edit button	Edit billing rates.	There are no notes.
Delete button	Delete billing rates.	There are no notes.
Restore button	Restore deleted billing rates.	There are no notes.
Copy button	Copy billing rates.	There are no notes.
Publish button	Publish billing rates.	There are no notes.
Show Revision History button	Revision history of the selected billing rates.	There are no notes.
Rates for column	Service provider who charges the billing rates.	Service providers can charge different rates to different sponsors.
When performing work for column	Organization for whom the service provider is performing the work when these rates apply.	There are no notes.
Rate Year column	Billing rate year.	There are no notes.
Status column	Billing rate status.	Billing rates can be published or drafts.
Last Modified column	Date and time the billing rates were last edited.	There are no notes.
Last Modified By column	User who edited the billing rates.	There are no notes.

Create/Edit Billing Rates Screen

Table 5-127 Create/Edit Billing Rates Screen Fields

Field	Description	Notes
When	Service provider who charges these billing rates.	Required when creating a new set of billing rates.
Performs work for	Sponsor that will be charged these rates.	There are no notes.
For Rate Year	Year for which these billing rates apply.	There are no notes.
Base Rate Location	Location chosen by the user for initial data entry of billing rates by resource. The ClearTrial application suggests values for all other locations based on the rate variance percentages. You can accept these suggested values or override either the rate variance percentages or the resource billing rates for one or more locations.	The country or region whose RATE VARIANCE % is 100.00% is the base rate location. The application derives all other locations' rates as a variance of the base rate.
Currency	Currency in which the billing rates are expressed.	There are no notes.
RATE VARIANCE %	The application calculates the country-specific rates per the variance value that appears in this row.	You can change the variance for any country or override a specific rate for a particular resource in any location.
REGION	Country or region for which the base rate applies.	There are no notes.
Resource	Each row represents a job title or type of employee who performs work during a study.	The application multiples the hourly rate by the number of hours calculated to be required for the resource to complete the work. See the online Help for a list of responsibilities associated with each resource.
Country/Region columns	Enter the hourly rate for each resource for each country and region.	Regional rates represent the average billing rates for all locations within a defined region.
Export rates to Excel link	Export the billing rates you defined to a Microsoft Excel spreadsheet.	There are no notes.
Save button	Preserves the values in a draft state.	There are no notes.
Publish button	Publish the currently displayed set of billing rates and makes them available as the active rated used by the application to calculate fees and costs associated with tasks assigned to the chosen vendor.	There are no notes.

Copy Billing Rates Dialog Box Fields

Table 5-128 Copy Billing Rates Dialog Box Fields

Field	Description	Notes
Copy from	The version of billing rates to copy.	If there is only one version, this field is ready-only.
Apply percentage adjustment	Percentage adjustment, positive or negative, to apply to the copied billing rates.	Must contain a value between -999 and 999.

Show Revision History Dialog Box Fields

Table 5-129 Show Revision History Dialog Box Fields

Field	Description	Notes
Status	Status of the billing rates.	Billing rates are drafts or published.
Last Modified	Date and time the billing rates were last edited.	There are no notes.
Last Modified By	User who last edited the billing rates.	There are no notes.
Show Rates	Billing rates of the prior versions.	There are no notes.

Inflation Profiles Screen Fields

Inflation Profiles Screen Fields

Table 5-130 Inflation Profiles Screen Fields

Field	Description	Notes
Show Profile for filter	Include only those inflation profiles associated with the selected provider.	To display inflation profiles for all providers, select Any Provider.
for Rate Year filter	Include rates associated with the selected year.	To display inflation profiles for all years, select Any Year.
Include Deleted Rates filter	Select to include inflation profiles that have been deleted.	There are no notes.
New button	Define a new inflation profile.	There are no notes.
Edit button	Edit the selected inflation profile.	There are no notes.
Delete button	Delete the selected inflation profiles.	There are no notes.
Restore button	Restore the selected deleted inflation profile.	There are no notes.
Copy button	Copy the selected inflation profile.	There are no notes.
Publish button	Make the currently selected draft inflation profile active and available to all plans using the associated vendor and effective rate year.	There are no notes.
Show Revision History button	View a history of the revisions made to the selected inflation profile.	There are no notes.
Profile for column	Provider with whom the inflation profile is associated	Multiple profiles can be associated with a service provider.
When performing work for column	Organization for whom the service provider is performing the work when this inflation profile applies.	There are no notes.
Rate Year column	Billing rate year associated with the inflation profile.	There are no notes.
Status column	Status of the inflation profile: Published or Draft.	There are no notes.
Last Modified column	Date and time the inflation profile was last edited.	There are no notes.
Last Modified By column	User who edited the inflation profiles.	There are no notes.

New Inflation Profile Dialog Box Fields

Table 5-131 New Inflation Profile Dialog Box Fields

Field	Description	Notes
When	The vendor for which this inflation profile applies.	There are no notes.
Performs work for	The sponsor that will be charged these rates.	There are no notes.
For Rate Year	The year for which these rates apply	There are no notes.

Create/Edit Inflation Profile Screen Fields

Table 5-132 Create/Edit Inflation Profile Screen Fields

Field	Description	Notes
When	The vendor for which this inflation profile applies.	There are no notes.
Performs work for	The sponsor that will be charged these rates.	There are no notes.
For Rate Year	The year for which these rates apply	There are no notes.
Base Rate Location	The country or region for the rates in the Base Rate column.	The country or region whose RATE VARIANCE % is 100.00% is the base rate location. The application derives all other locations' rates as a variance of the base rate.
Add Year button	Copy the contents of the last row to a row added to the bottom of the grid.	There are no notes.
Delete Year button	Delete the selected year row.	There are no notes.
Publish button	Publish the currently displayed inflation profile.	There are no notes.
Export rates to Excel button	Export the data to a Microsoft Excel spreadsheet.	There are no notes.

Copy Inflation Profile Dialog Box Fields

Table 5-133 Copy Inflation Profile Dialog Box Fields

Field	Description	Notes
Copy from	The version of billing rates to copy.	If there is only one version, this field is ready-only.
Apply percentage adjustment	Percentage adjustment to apply to the copied billing rates.	There are no notes.

Show Revision History Dialog Box Fields

Table 5-134 Show Revision History Dialog Box Fields

Field	Description	Notes
Status	Status of the billing rates.	Billing rates are drafts or published.
Last Modified	Date and time the billing rates were last edited.	There are no notes.
Last Modified By	User who last edited the billing rates.	There are no notes.
Show Rates	Billing rates of the prior versions.	There are no notes.

Departments Screen Fields

Departments Screen Fields

Table 5-135 Departments Screen Fields

Field	Description	Notes
Show filter	Departments that appear on the Departments screen.	You can show all departments, active departments only, or select a department filter.
New button	Add a department.	There are no notes.
Edit button	Edit a department.	There are no notes.
Delete button	Delete a department.	There are no notes.
Restore button	Restore a deleted department.	There are no notes.
Map Labor and Costs button	Edit department mappings.	There are no notes.
Name column	Department name.	There are no notes.
Code column	Department code.	There are no notes.
Description column	Department description.	There are no notes.
Last Updated column	Date and time the department was last edited.	There are no notes.
Updated By column	User who last edited the department.	There are no notes.

Define Department Filter Dialog Box Fields

Table 5-136 Define Department Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes departments created or modified within the number of days selected from the drop-down list.	There are no notes.
Include deleted departments	Include departments that have been previously deleted.	There are no notes.
Department name starts with	Includes departments with names starting with the specified text.	There are no notes.
Save filter as	Name to assign to the filter.	There are no notes.

Configure List Options Dialog Box Fields - Departments Screen

Table 5-137 Configure List Options Dialog Box Fields - Departments Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Departments screen.	There are no notes.
Sort By	The list of departments can be ordered according to your selection, rather than by the first displayed column.	Change the order by clicking a column heading.
Show n departments per page	Number of departments to be displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Create/Edit Department Screen Fields

Table 5-138 Create/Edit Department Screen Fields

Field	Description	Notes
Code	Alphanumeric code representing the department.	There are no notes.
Name	Department name.	Two departments cannot have the same name.
Description	Description of the department.	There are no notes.

Edit Department Mapping Screen Fields

Table 5-139 Edit Department Mapping Screen Fields

Field	Description	Notes
Mapping by <> Change	Displays the currently active mapping mode: resource, location, task, or rule.	To change modes, click the change link.
Restore ClearTrial Defaults	Restore department mappings to the application default mappings.	Discards any mappings you created.
Resource	Resources to which departments can be mapped.	Includes ClearTrial-defined and user-defined resources.
Internal	Department to apply when the resource performs work for an internal provider.	Includes ClearTrial-defined and user-defined departments
Outsourced	Department to apply when the resource performs work for an outsourced provider.	Includes ClearTrial-defined and user-defined departments
Location	Locations to which departments can be mapped.	There are no notes.
Internal	Department to apply when an internal provider is assigned to the location.	Includes ClearTrial-defined and user-defined departments.
Outsourced	Department to apply when an outsourced provider is assigned to the location.	Includes ClearTrial-defined and user-defined departments.
Task Group	Task groups to which departments can be mapped.	The application applies the department selected for a task group as the default for all tasks in that group.
Task	Tasks to which departments can be mapped.	Includes only ClearTrial-defined tasks.
Internal	Department to apply when an internal provider is assigned to the task or task group.	Includes ClearTrial-defined and user-defined departments.
Outsourced	Department to apply when an outsourced provider is assigned to the task or task group.	Includes ClearTrial-defined and user-defined departments.
Add Rule button	Add a rule for mapping labor to departments.	There are no notes.
Edit Rule button	Edit a selected rule.	There are no notes.
Delete Rule button	Delete a selected rule.	There are no notes.
Criteria column	Criteria that determine which department is applied.	There are no notes.
Department column	The department associated with the rule.	There are no notes.
Drag to Order column	Use the mouse to reorder the rules by your own priority.	Rules at the top of the list take priority over the bottom.

Create Department Mapping Rule Dialog Box

Table 5-140 Create Department Mapping Rule Dialog Box Fields

Field	Description	Notes
Department	The department to be assigned when the rule matches the criteria.	There are no notes.
Providers (Any) tab	Select providers to be matched according to this rule.	Selecting the Internal and Outsource checkboxes include all the service providers in that group. Selecting Any Provider includes all providers.
Locations (Any) tab	Select locations to be matched according to this rule.	Select Any Location to include study-scoped locations as part of the match.
Tasks (Any) tab	Select tasks to be matched according to this rule.	Select Any Task to include all tasks and task groups. Include ClearTrial-defined and user-defined tasks by selecting their associated task or task group.
Resources (Any) tab	Select resources to be matched according to this rule.	Select Any Resource to include all resources.

GL Codes Screen Fields

GL Codes Screen Fields

Table 5-141 GL Codes Screen Fields

Field	Description	Notes
Show filter	GL codes that appear on the GL Codes screen.	You can show all GL codes, active GL codes only, or select a GL code filter.
New button	Create a new GL code.	There are no notes.
Edit tab	Edit the selected GL code.	There are no notes.
Delete tab	Delete the selected GL code.	There are no notes.
Restore tab	Restore the selected deleted GL code.	There are no notes.
Map Labor and Costs tab	Edit GL code mappings.	There are no notes.
Name column	GL code name.	There are no notes.
Code column	Code associated with the GL code.	There are no notes.
Description column	GL code description.	There are no notes.
Last Modified column	Date and time the GL code was last edited.	There are no notes.
Modified By column	User who last edited the GL code.	There are no notes.

Define GL Code Filter Dialog Box Fields

Table 5-142 Define GL Code Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes GL codes created or modified within the number of days selected from the drop-down list.	There are no notes.
Include deleted GL Codes	Includes GL Codes that have been previously deleted.	There are no notes.
GL Code name starts with	Includes GL codes with names starting with the specified text.	There are no notes.
Save filter as	Name to assign to the filter.	There are no notes.

Configure List Options Dialog Box Fields - GL Codes Screen

Table 5-143 Configure List Options Dialog Box Fields - GL Codes Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the GL Codes screen.	There are no notes.
Sort By	Order the list of GL codes according to your selection, rather than by the first displayed column.	Change the order by clicking a column heading.
Show n GL codes per page	Number of GL codes to be displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

Create/Edit GL Code Screen Fields

Table 5-144 Create/Edit GL Code Screen Fields

Field	Description	Notes
Code	Alphanumeric code representing the General Ledger code.	There are no notes.
Name	GL code name.	You cannot create two GL codes with the same name.
Description	GL code description.	There are no notes.

Edit GL Code Mapping Screen Fields

Table 5-145 GL Code Mapping Screen Fields

Field	Description	Notes
Mapping by <>Change	Displays the currently active mapping mode: resource, location, task, or rule.	To change modes, click the change link.
Restore ClearTrial Defaults	Restore GL code mappings to the application default mappings.	Discards any mappings you created.
Mapping by Resource	Displays the mapping mode currently being used.	To change modes, click the change link.
Resource	Resources to which GL codes can be mapped.	Includes ClearTrial-defined and user-defined resources.
Internal	GL code to apply when the resource performs work for an internal provider.	Includes ClearTrial-defined and user-defined resources.
Outsourced	GL code to apply when the resource performs work for an outsourced provider.	Includes ClearTrial-defined and user-defined resources.
Location	Locations to which GL codes can be mapped.	There are no notes.
Internal	GL code to apply when an internal provider is assigned to the location.	Includes ClearTrial-defined and user-defined GL codes.
Outsourced	GL code to apply when an outsourced provider is assigned to the location.	Includes ClearTrial-defined and user-defined GL codes.
Task Group	Task groups to which GL codes can be mapped.	The application applies the GL code selected for a task group as the default for all tasks in that group.
Task	Tasks to which departments can be mapped.	Includes only ClearTrial-defined tasks.
Internal	GL code to apply when an internal provider is assigned to the task or task group.	Includes only ClearTrial-defined GL codes.
Outsourced	GL code to apply when an outsourced provider is assigned to the task or task group.	Includes ClearTrial-defined and user-defined GL codes.
Map by Rule Advanced Mode	Map labor to GL codes by user-defined criteria.	There are no notes.
Add Rule button	Add a rule for mapping labor to GL codes.	There are no notes.
Edit Rule button	Edit a selected rule for mapping labor to GL codes.	There are no notes.
Delete Rule button	Delete a selected rule for mapping labor to GL codes.	There are no notes.
Criteria column	Criteria that determine which GL code is applied.	There are no notes.
GL Code column	The GL code associated with the rule.	There are no notes.
Drag to Order column	Use the mouse to reorder the rules by your own priority.	Rules at the top of the list take priority over the bottom.

Create GL Code Mapping Rule Dialog Box

Table 5-146 Create GL Code Mapping Rule Dialog Box Fields

Field	Description	Notes
GL Code	The GL code to be assigned when the rule matches the criteria.	There are no notes.
Providers (Any) tab	Select providers to be matched according to this rule.	Selecting the Internal and Outsource checkboxes include all the service providers in that group. Selecting Any Provider includes all providers.
Locations (Any) tab	Select locations to be matched according to this rule.	Select Any Location to include study-scoped locations as part of the match.
Tasks (Any) tab	Select tasks to be matched according to this rule.	Select Any Task to include all tasks and task groups. Include ClearTrial-defined and user-defined and user-defined tasks by selecting their associated task or task group.
Resources (Any) tab	Select resources to be matched according to this rule.	Select Any Resource to include all resources.

Exchange Rate Tables Screen Fields

Exchange Rate Tables Screen Fields

Table 5-147 Exchange Rate Table Screen Fields

Field	Description	Notes
Show filter	Exchange rate tables that appear on the Exchange Rate Tables screen.	You can show all exchange rate tables, only active ones, or tables matching a filter.
New button	Add an exchange rate table.	There are no notes.
Edit button	Edit an exchange rate table.	There are no notes.
Delete button	Delete an exchange rate table.	There are no notes.
Restore button	Restore a deleted exchange rate table.	There are no notes.
Publish button	Publish an exchange rate table.	There are no notes.
Set Default button	Set the default exchange rate table.	There are no notes.
Description column	Exchange rate table description.	There are no notes.
Status column	Exchange rate table status.	Exchange rate tables can be published or drafts.
Last Updated column	Date and time the exchange rate table was last edited.	There are no notes.
Updated By column	User who last edited the exchange rate table.	There are no notes.

Define Exchange Rate Table Filter Dialog Box Fields

Table 5-148 Define Exchange Rate Table Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes exchange rates created or modified within the number of days selected from the drop-down list.	There are no notes.
Include deleted exchange rate tables	Includes exchange rate tables that have been previously deleted.	There are no notes.
Exchange Rate Table name starts with	Includes exchange rates with names starting with the specified text.	There are no notes.
Created by	Includes exchange rate tables created by he selected users.	To display all exchange rate tables regardless of who created them, select Any User. To display more users to choose from, click the Expand list... link.
Last Modified by	Includes exchange rate tables last edited and saved by the selected users.	To display exchange rate tables regardless of who last updated them, select Any User. To display more users to choose from, click the Expand list... link.
Save filter as	Name to assign to the filter.	There are no notes.

Configure List Options Dialog Box Fields - Exchange Rate Tables Screen

Table 5-149 Configure List Options Dialog Box Fields - Exchange Rate Tables Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Exchange Rate Tables screen.	There are no notes.
Sort By	The list of exchange rate tables can be ordered according to your selection, rather than by the first displayed column.	Change the order by clicking the column heading on which to sort the list.
Show n exchange rate tables per page	Number of exchange rate tables to be displayed on each page.	A paging tool appears at the lower right, allowing you to move to the next page.

Create/Edit Exchange Rate Table Screen Fields

Table 5-150 Create/Edit Exchange Rate Table Screen Fields

Field	Description	Notes
Name	Name for this set of exchange rates.	This name appears as a choice in the defined in drop-down list on the Overview tab. If you change the name and save the changes as a draft table, the draft name does not appear on the Exchange Rate Tables screen. Only published tables appear.
Status	Status of the exchange rate table: Draft—Visible only on the Exchange Rate Tables screen and not available when you create a plan. Published—Available for use when planning studies and represents the currently active conversion rates. Published with Draft—Has pending draft version associated with it that is not yet available for plans, while the previously published version remains active, available, and it use. When editing an exchange rate table in this state, the currently published values appear in a column to the right of the pending changes.	There are no notes.
Description	Short description that identifies the exchange rate table.	The description appears only on the Exchange Rate Tables screen.
Use rates as of	Populates the exchange rates as of the chosen date.	This might be a starting point for specifying custom exchange rates.
Apply button	Apply the specified date to establish the values in the exchange rate fields.	There are no notes.
1 <currency> equals...	Fields for specify the conversion rate from the source currency rate to each destination currency.	The source currency is the currency used for the exchange rate table.

Reporting Regions Screens and Dialog Boxes

Edit Reporting Regions screen

Table 5-151 Reporting Regions Screen Fields

Field	Description	Notes
New Reporting Region button	Add a reporting region.	There are no notes.
Map Countries to Reporting Regions button	Select a reporting region for a country.	There are no notes.
Reporting Region Name column	Reporting regions.	There are no notes.
# of Countries Mapped column	Number of countries that are mapped to the associated reporting regions.	There are no notes.
Total Number of Countries Mapped to Reporting Regions column	Total number of countries mapped to reporting regions.	There are no notes.

Map Countries to Reporting Regions Dialog Box

Table 5-152 Map Countries to Reporting Regions Dialog Box Fields

Field	Description	Notes
Country button	Country to be mapped.	There are no notes.
Reporting Region button	User-defined reporting regions that you can map the country to.	There are no notes.

Purge Deleted... Screen

Table 5-153 Purge Deleted... Screen Fields

Field	Description	Notes
Purge Selected Items button	Perform the purge.	There are no notes.
Items to delete column	Item type to be purged.	There are no notes.
deleted at least n days ago column	Number of days since an item of the selected type was deleted and will be purged when you select the Purge Selected Items button.	To purge all deleted items of the selected type, enter 0.

Custom Field Models Screen Fields

Custom Field Models Screen Fields

Table 5-154 Custom Field Models Screen Fields

Field	Description	Notes
Open button	Display the custom fields defined for the selected model on the Custom Fields screen.	There are no notes.
Checkout button	Check out the DRAFT custom field model for editing.	Enabled only if no other user has checked out the draft model.
Check-In button	Save any changes made to the DRAFT custom field mode.	Enabled only for the user who checked out the DRAFT model and the system administrator.
Cancel Checkout button	Cancel the checkout of the DRAFT custom field model.	Enabled only for the user who checked out the DRAFT model and the system administrator.
Publish button	Publish the DRAFT custom field model.	Enabled only for the user who checked out the DRAFT model and the system administrator.
Change Description button	Change the description associated with a published custom field model.	Maximum of 32 characters.
Version column	Status or rendition number of the custom field model.	Can be DRAFT, PUBLISHED, or a version number from 1 to n.
Description column	Short description associated with a published custom field model.	32 characters maximum.
Published Date column	Date and time that the custom field model was published.	There are no notes.
Published By column	Who published the custom field model.	There are no notes.
Checkout Date column	Date and time that the DRAFT custom field model was last checked out.	There are no notes.
Checkout By column	Who currently has the DRAFT custom field model checked out.	There are no notes.

Custom Field Screen Fields

Table 5-155 Custom Field Screen Fields

Field	Description	Notes
New button	Create a new custom field.	There are no notes.
View button	Display the field definitions, display criteria, and designer notes for the selected custom field.	There are no notes.
Delete button	Delete the selected custom fields.	Deleted custom fields are not removed permanently.
Restore button	Restore the selected deleted custom fields.	There are no notes.
Copy button	Make a copy of the selected custom field.	There are no notes.
Checkout button	Check out the DRAFT custom field model.	Enabled only if no other user has checked out the DRAFT model.
Cancel checkout button	Cancel the checkout of the DRAFT custom field model.	Enabled only for the user who checked out the DRAFT model.
Publish button	Publish the DRAFT custom field model.	Enabled only for the user who checked out the DRAFT model.
Name column	Name of the custom field.	There are no notes.
Label column	How custom field appears on screens and in reports.	There are no notes.
Unit Of Measure column	Unit of Measure for the custom field.	There are no notes.
Tab column	Plan assumption tab on which the custom field appears.	There are no notes.
Last Modified column	Date and time that the custom field was last modified.	There are no notes.
Last Modified By column	Who last modified the custom field.	There are no notes.

Define Custom Field Filter Dialog Box Fields

Table 5-156 Define Custom Field Filter Dialog Box Fields

Field	Description	Notes
Created or modified in the last n days	Includes custom fields modified and saved within the number of days selected from the drop-down list.	There are no notes.
Include deleted custom fields	Includes custom fields that have been previously deleted.	There are no notes.
Custom Field name starts with	Includes only custom fields with names starting with the specified text.	There are no notes.
Created by:	Includes only those custom fields that were created by one of the selected users.	To see custom fields regardless of who created them, select Any User.
Last Modified by:	Includes only those custom fields that were last edited and saved by one of the selected users.	To see custom fields regardless of who last updated them, select Any User.
Save filter as	Name to assign to the filter.

Configure List Options Dialog Box Fields - Custom Fields Screen

Table 5-157 Configure List Options Dialog Box Fields - Custom Fields Screen

Field	Description	Notes
Configure Columns	Selected columns appear on the Custom Fields screen.	There are no notes.
Sort By	Order the custom fields according to your selection, rather than by the first displayed column.	Change the order by clicking a column heading.
Show n custom fields per page	Number of custom fields to be displayed on each page.	Use the paging tool to move to the next or previous page or directly to a page number.

View/Create/Edit Custom Field Screen Field Descriptions

Table 5-158 View /Create/Edit Custom Field Screen Fields

Field	Description	Notes
Name	The programmatic variable name by which the application will refer to this assumption in custom algorithms.	Must start with a letter and contain only letters, numbers, or the underscore (_) character. The value must be unique.
Data Type	The type of data users can enter when populating the custom field.	Currently, custom field values are restricted to positive whole numbers.
Label	The name that appears on a plan's assumption tab to the left of the input element for this custom field.	Should be terse, but meaningful. The name must be unique.
Prompt	Include to provide additional instructions to users populating the field in a plan.	Displayed in the status area of a plan's assumption tab (lower left corner of the screen).
Help Text	Include to provide additional instructions to users populating the custom field in a plan.	Displayed when a user invokes context-sensitive help for this custom field by clicking its label on a plan's assumption tab.
Values vary by location	Defines whether users can provide location-specific or centralized values for this assumption.	Fields that will vary by location display a small icon to the right of their input element. Clicking the icons displays the location-specific values dialog box for the associated field.
Minimum Value	Lowest acceptable value for this assumption.	Must be a value between 0 and 99,999,999.
Maximum Value	Highest acceptable value for this assumption.	Must be a value between 0 and 99,999,999.
Unit of Measure Name, Singular	Name for this assumption to appear in the Unit of Measure drop-down lists in the Task Manager/Major Task panel, Resource Algorithm pane, and the Cost Details Algorithm tab.	Must be a unique value. Custom unit of measures appears in italicized type followed by an asterisk.
Unit of Measure Name, Plural	Plural form for the name for this assumption.	There are no notes.
Sort Order Rank	Order in which custom fields appears on a plan's assumption tab.	There are no notes.
Display on the <tab>	The plan assumption tab on which this custom field will appear.	Only custom fields that are location-scoped can appear on the Site tab.
Edit Mode	Specified the minimum edit mode in which the custom field will be displayed.	To make this field unavailable to novice users or when performing less detailed planning, specify Advanced or Expert mode.
Phase	Specified which phase(s) a plan must be associated to display the custom field.	There are no notes.
Therapeutic Area	Specifies which therapeutic area(s) a plan must be associated to display the custom field.	There are no notes.
Indication	Specifies which indication(s) a plan must be associated with to display the custom field.	There are no notes.
Designer Notes	Use this field to document the purpose of the custom field.	This description does not appear to users in plans. It only displays on the View/Edit/Create Custom Fields screen.

Admin Menu

User Profile Screen Fields

User Profile Screen Fields

Table 5-159 Edit User (Profile Tab, User Preferences) Screen Fields

Field	Description	Notes
Login Name	Name or phrase you use to log in.	There are no notes.
First Name	Your first name.	There are no notes.
Last Name	Your last name.	There are no notes.
Email Address	Your email address.	This email address allows users to use the Forgot Your Password? feature. If users forget their password, they need to supply this email address to reset their password.
Security Question	Security question used for authentication purposes.	There are no notes.
Security Answer	Security answer used for authentication purposes.	There are no notes.
Preferred Edit Mode	Your preferred edit mode, used for creating or editing plans.	Plans automatically open in this mode.
Preferred Home Page	The page that appears when you log in.	If a user requests a specific screen or follows a previously bookmarked URL, that page appears after a successful login, not the Preferred Home Page.
Preferred Locale	Your preferred geographical location.	Determines how dates and numbers are displayed and interpreted.

Change Password Screen Fields

Table 5-160 Change Password Screen Fields

Field	Description	Notes
Current Password	Your currently valid password.	Required to authorize the password change request.
New Password	The password to use for subsequent logins.	Passwords must be at least eight characters and contain at least one letter, one number, and one of the following special characters: !$*+-.=?@^_|~. Passwords must not contain the login name or any of the following words: password, oracle, guest, admin, administrator, or Cleartrial.
Verify New Password	The new password retyped to ensure that you have not mistyped the password.	There are no notes.

Reset Password Screen Fields

Table 5-161 Reset Password Screen Fields

Field	Description	Notes
New Password	Your new password.	Passwords must be at least eight characters, contain at least one letter, one number, and one of the following special characters: !$*+-.=?@^_|~. Passwords must not contain your login name or any of the following words: password, oracle, guest, admin, administrator, or cleartrial. Do not use easily guessed passwords such as a pet's name; your own name, address, or phone number; or any easily identifiable personal information.
Verify New Password	Your new password.	There are no notes.