4 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," and Chapter 3, "Maintaining Resource Information and Settings."

Home Page Fields

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

Table 4-1 Home Page Fields

Field	Description	Notes
Menu Bar
Edit	Add or edit plans, studies, products, templates, and portfolios.
Report	Generate standard reports that are not plan-specific.
Maintain	Define, select, and edit: 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 labor and costs to departments and functional areas. 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.	Select Purge Deleted Items to permanently remove items.
Admin	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.
Help	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.
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.
Logout	Sign out of the application.
Filter
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.

Plans Screens, Tabs, and Dialog Boxes

Plans Screen

Table 4-2 Plans Screen Fields

Field	Description	Notes
Buttons
New	Create a new plan.
Edit	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	Delete the selected plan.	Deleted plans are removed at a later time and can be restored.
Restore	Restore a deleted plan.	To use this option, adjust the filters so that you can see inactive as well as active items.
Copy	Make a copy of the selected plan.
Compare	Compare selected plans. You can specify service provider and location details and change the currency used to generate the costs and comparison reports.
Other Actions...	Access additional features, such as locking and unlocking plans, freezing, and unfreezing billing rates, copying a plan as a template, and so on.
Columns
Plan name	Unique identifier of plans.
Study Name	Name of study.
Description	Short description of the plan.
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.	You cannot choose another plan status until you enter information on all tabs through the Provider tab.
Last Modified	Date a user last modified this plan.

Plans Screen Dialog Boxes

Define Plan Filter Dialog Box

Table 4-3 Define Plan Filter Dialog Box Fields

Field	Description	Notes
Plan Filter Criteria
Created or modified in the last n days	Includes plans last edited and saved the specified number of days.
Include deleted plans	Includes plans that have been previously deleted.
Plan name starts with	Includes plans whose names start with the specified text.
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
Save filter as	Name assigned to the filter.
Sorting and Paging
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 4-4 Choose Study and Plan Template Dialog Box Fields

Field	Description	Notes
Study Columns
Study Name	Unique name given to study by its creator.	Read-only.
Product/Compound	The product or compound being studied.	Read-only.
Phase	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	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	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 Columns
Template Name	Name of a plan or partial plan that can be used as a starting point for new plans for a study.	Read-only.
Description	Information describing the template to help you recognize a particular scenario or purpose for the plan.	Read-only.
Applicable For	Study phase(s) for which the template has been defined.	Read-only.

Copy Plan Dialog Box

Table 4-5 Copy Plan Dialog Box Fields

Field	Description	Notes
Plan Name	Name of the new copy plan.

Compare Plan Dialog Box

Table 4-6 Compare Plan Dialog Box Fields

Field	Description	Notes
Available Comparisons	Comparisons to be made and details to include.
Providers To Include	Service providers to include in the comparison.
Reporting Currency	Currency to use for the comparison report.

Copy Plan as Template Dialog Box Fields

Table 4-7 Copy Plan as Template Dialog Box Fields

Field	Description	Notes
Template Name	Name of the new template based on the plan.

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 4-8 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.
Short Description	Short description of the plan that appears on the Plans screen.
Long Description	Detailed plan description.
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.

Add Plans to Portfolio(s) Dialog Box

Table 4-9 Add Plans to Portfolio(s) Dialog Box Fields

Field	Description	Notes
Columns
Name	Portfolios to which you can add the selected plan(s).
Description	Short description of the portfolio.
# Plans Now	Number of plans in the portfolio before adding the selected plan(s).
# Plans After	Number of plans in the portfolio after adding the selected plan(s).
Also create a new portfolio and add the selected plans to it	Create a new portfolio.
Create New Portfolio
Portfolio Name	Name for the new portfolio.
Short Description	Short description of the portfolio. This description appears on the Portfolios screen.
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 4-10 Create Reforecast Dialog Box Fields

Field	Description	Notes
Reforecast Name	Name of the new forecast.
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.
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).
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 4-11 Create Reforecast Dialog Box Fields (Reforecast Exchange Rates)

Field	Description	Notes
Reforecast Details
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.
Use Exchange Rates: as of (date)	Date from which to obtain exchange rates as they were at the close of market on that day.
Use Exchange Rates: defined in (published exchange rates table)	Published set of exchange rates to apply
Columns
Reforecast Name	Suggested name for each reforecast. You can either accept this name or type a new name.
Prior Forecast Date	Date of the last forecast per plan.	The new reforecast date must be later than this date.
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).
Reforecast Date	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	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 Screen (Overview Tab)

Table 4-12 Overview Tab fields

Field	Description	Notes
General Information
Plan Name	Unique name that identifies the plan.
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.
Status	Plan status.
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.
Description
Short Description	Short description of the plan that appears on the Plans screen.
Long Description	Detailed plan description.
Currency Options
Default Modeling Currency	Currency used to enter plan costs.
Default Reporting Currency	Currency the application uses to generate reports.
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.
Other Factors
Drug Storage	Special handling considerations.
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.
History
Created By	Displays the name of the user who created the plan.
Last Modified By	Displays the name of the user who last modified the plan.
Created Date	Displays the date the plan was created.
Last Modified	Displays the date the plan was last modified.
Created as a copy of	Displays the plan that was copied.
Original Template	Displays the template from which the plan was created.

Override Currency Exchange Rates Dialog Box

Table 4-13 Override Currency Exchange Rates Dialog Box Fields

Field	Description	Notes
Currency Exchange Rates
1 US Dollar (USD) equals...	Default exchange rates for 1 US dollar as of the current date.

Locations Tab

Table 4-14 Locations Tab Fields

Field	Description	Notes
Buttons
Add Location(s)	Add one or more locations on the Choose Locations dialog box.
Remove Location(s)	Remove selected location(s).	Removing a location from a plan does not delete that location from the application.
Add Language(s)	Add one or more languages not suggested for the plan by the application.
Remove Language(s)	Remove a selected user-specified language.
Columns
Location	Name of a location (either the country or the region) where sites will be located and subjects enrolled.
Number of Sites	Number of sites for the location.
Subjects to Randomize	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	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 and 500,000 USD (or the equivalent in another currency).
MOH/FDA Delay	Ministry of Health (MOH) or Federal Drug Administration (FDA) approval timeframe for each location.	Must be a value between 0 and 999.
Total/Avg	Averages of the total sites, subjects to randomize, grant amount and MOH/FDA time delay.
Language
Language	Language into which study materials might need to be translated.
Dialects/Variations	Number of dialects or variants of this language into which to translate study documents.
Document Translations	Which documents are to be translated into the languages specified.
Number of Translations/ Dialects	Total number of translations required.

Choose Locations Dialog Box

Table 4-15 Choose Locations Dialog Box Fields

Field	Description	Notes
Filter
Regions	Include locations by region.
Counties	Include locations by country.
Remove Language(s)	Removes the selected language.
Columns
Region	Regions available for selection.
Country	Countries available for selection.
Primary Language	Primary language of the selected region or country.
Primary Currency	Primary currency of the selected region or country.
MOH/FDA Delay	Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time for each location.

Choose Additional Languages Dialog Box

Table 4-16 Choose Additional Languages Dialog Box Fields

Field	Description	Notes
Columns
Language	Languages available for selection.
ISO Code	Internationally recognized country code associated with the language.

Document Translations Required Dialog Box

Table 4-17 Document Translations Required Dialog Box Fields

Field	Description	Notes
Document Type	Type of document.
Translate	Translates the document type to the languages indicated.
Back Translate	Translates the document back into the language of the original text, from the translated version.
As Pass-Through Cost	Translation costs are to be considered pass-through costs, not calculated costs.
Apply these choices for:	Applies selected translation choices to other languages.

Site Tab

Table 4-18 Site Tab Fields

Field	Description	Notes
Site Approval (Columns)
Location	Name of a location where sites will be located and subjects enrolled.
Number of Sites	Number of sites within the selected location.
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.
Site Information
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.
Percent of sites identified by sponsor	Percentage of study sites that the study sponsor identifies. The application calculates the number of sites.
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.
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 o f sites.
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 o f sites.
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.
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.
Percent of sites requiring only phone-based close-outs	Percentage of sites that require only phone-based close-outs. The application calculates the number o f sites.
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 o f sites.
Percent of sites requiring overhead	Percentage of sites requiring overhead above the standard investigator grant. The application calculates the number o f sites.
Average percent overhead	Average overhead percentage for sites requiring overhead.
Number of drug shipments per site	Estimated number of drug shipments for each site.
Percent of sites requiring a QA audit	Percentage of sites requiring a quality assurance audit. The application calculates the number o f sites.
Percent of regulatory documents collected	Enter the percentage of regulatory documents to collect during the investigator approval process.
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.
Responsibilities
Columns
Task Group	Assignment group to which outsourcing responsibilities are applied.	For a list of tasks, see the online Help for the Sites tab.
Sponsor	Assign all of the tasks in that group to the study sponsor.
Vendor	Assign all of the tasks in that group to the primary vendor assigned on the Provider tab.
Mixed	Assign some of the tasks to the sponsor and some to the vendor.	Make these assignments on the Assignment tab.
N/A	None of the tasks in the group will be performed.

Edit Site Approval Schedule Dialog Box

Table 4-19 Edit Site Approval Schedule Dialog Box Fields

Field	Description	Notes
Site Approval Schedule for the Selected Location
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.
Default Site Approval Period	Default length of the site approval period.
Additional Site Approval Weeks	Number of weeks added to the application-defined approval period.
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.
Site Approval Schedule (Columns)
Week #	Week number. within the site approval schedule.
Week Of	Start date of each week of the site approval period.
Sites (Default)	Number of sites expected to be approved (according to the ClearTrial Default Site Approval Schedule) each week.	Cumulative totals appear inside parentheses.
% (Default)	Percentage of sites expected to be approved (according to the ClearTrial Default Site Approval Schedule) each week.
Sites (User Defined)	Number of sites expected to be approved (according to the user-defined Site Approval Schedule) each week.
% (User Defined)	Percentage of sites expected to be approved (according to the user-defined Site Approval Schedule) each week.
Total	Total for each column.
Buttons
Restore Defaults	Restore the default site approval schedule for this location.
Apply	Add the specified number of weeks to the site approval schedule.
Copy Default Value	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 4-20 Subject Tab Fields

Field	Description	Notes
Define Treatment Phase Start Date
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.
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.
Screening and Drops
Subjects to randomize	Number of subjects in the selected location or all locations.
Additional percent of randomized subject as alternates	Percentage of the total subjects randomized to be screened as alternate subjects.
Stipend per alternate subjects	Stipend provided each alternate subject.
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.
Investigator payment per screen failure	Amount paid to the investigator for a subject that fails study screening.
Percent of screen failures paid for	Percentage of the expected screen failures for which investigators are paid.
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.
Number of CRF pages per screen failure	Number of CRF pages collected for each screen failure.
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.
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.

Edit Subject Enrollment Dialog Box

Table 4-21 Edit Subject Enrollment Dialog Box Fields

Field	Description	Notes
Study Level Adjustments
Update study level enrollment period to	Study-level enrollment period.
Enrollment per Location
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).
Columns
FSI	First Subject In. Date that the First Subject First Visit (FSFV) is expected to take place.
Enrollment Period	Number of weeks during which subjects will be enrolled in the trial.	If the enrollment period is less than four weeks, contact [e-mail].
Last Subject In Date	Location -specific First Subject In date plus the enrollment period.
Enrollment Rate	Number of subjects expected to be enrolled per site per month.

Edit Subjects Arrival Dates Dialog Box Fields

Table 4-22 Edit Subjects Arrival Dates Dialog Box Fields

Field	Description	Notes
Enrollment per Location	Defines subjects arrival dates per location.
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.
Buttons
Apply	Applies the FSI date shift value to the selected locations.
Columns
Location	Subject arrival region.
FSI	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	Location-specific First Subject In date plus the enrollment period.

Edit Enrollment Distribution Dialog Box

Table 4-23 Edit Enrollment Distribution Dialog Box Fields

Field	Description	Notes
Options
Location	Location for which the subject enrollment distribution is managed.
Type of enrollment distribution	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.
	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.
Distribution resolution	Resolution at which to manage the subject enrollment distribution.
Columns
Period	Period, quartile, or study week, during which subjects are planned to enroll.
Subjects	Number of subjects expected to enroll during a particular period or quartile.
Percentage	Percentage of subjects expected to enroll during a particular period or quartile.

Edit Location-specific Screening and Drop Rate Assumptions Dialog Box

Table 4-24 Edit Location-specific Screening and Drop Rate Assumptions Dialog Box Fields

Field	Description	Notes
Subject Screening and Drops
Location	Screening and drops region.
Subjects to randomize	Number of subjects expected in the selected location or for All Locations.
Additional percent of randomized subjects as alternates	Percentage of the total subjects randomized to be screened as alternate subjects.
Stipend per Alternate subject	Stipend provided each alternate subject.
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.
Stipend per screen failure	Stipend to be paid to each potential subject that fails to pass the screening.
Percent of screen failures paid for	Percentage of the expected screen failures investigators will still be paid.
Number of screen failures allowed	Maximum number of screen failures for which investigators will compensated in this location.
Subject drop rate	Percent of subjects that will not complete a full CRF due to early termination.

Treatment Tab

Table 4-25 Treatment Tab Fields

Field	Description	Notes
Study Characteristics
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.
Will there be an electronic subject diary?	Whether there is an electronic subject diary.
Cost per bednight	Cost per night that a subject is confined to a study center during the treatment period.
Baseline and Washout (Cross-over Trials)
Number of CRF pages collected in the baseline visit	Number of CRF pages collected in baseline visits.	Must be a value between 0 and 99.
Baseline visit monitoring time required (in minutes)	Monitoring time required for baseline visits.	Must be a value between 0 and 9,999.99.
Washout period duration	Length of the washout period.	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).
Number of bednights during the washout period	Number of nights that a subject is confined to a study center during the washout period.
Treatment(s)
Buttons
Add	Add a new treatment.	You can add up to five treatments to the study.
Edit	Edit a treatment on the Treatment Details dialog box.
Copy	Duplicate an existing treatment.
Delete	Remove a treatment.	Deleting a treatment removes all of its associated assumptions.
Treatment Parameters
ID	Alphabetic identifier for the treatment entry.
Number of subjects	Number of subjects that will receive the treatment.	Included for parallel studies. Not included for cross-over studies because all subjects receive all treatments (in a different sequence). Must be a value between 1 and 999,999.
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.
Number of 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.
Number of QOL pages	Number of Quality of Life (QOL) pages collected during the treatment period.	Must be a value between 0 and 9,999.
Number of subject diary pages	Number of subject diary pages collected during the treatment period.	Must be a value between 0 and 9,999.
Number of pharmacoeconomic pages	Number of pharmacoeconomic pages collected during the treatment period.	Must be a value between 0 and 9,999.
Cross-over Design
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.
Treatment Sequence	Order in which treatments are administered.

Edit Washout Period Dialog Box

Table 4-26 Edit Washout Period Dialog Box Fields

Field	Description	Notes
Washout Period
Day	Integer representing day within washout period.
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 amount of 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.

Edit Treatment Dialog Box (Details Tab, Schedule Tab)

Table 4-27 Details Tab Fields

Field	Description	Notes
Details Tab
Treatment Details
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.
Number of 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.
Number of QOL pages	Number of Quality of Life (QOL) pages collected during the treatment period.	Must be a value between 0 and 9,999.
Number of subject diary pages	Number of subject diary pages collected during the treatment period.	Must be a value between 0 and 9,999.
Number of pharmacoeconomic pages	Number of pharmacoeconomic pages collected during the treatment period.	Must be a value between 0 and 9,999.
Columns
Location	Location to which each treatment cost is applied.
# Subjects	Number of subjects expected to be randomized to this treatment in each location.
Procedure Cost	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).
Special Procedure Cost	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).
Stipend Per Enrolled Subject	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 4-28 Schedule Tab Fields

Field	Description	Notes
Schedule Tab
Subject Treatment Schedule
Day	Day within the treatment period, represented by an integer.
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.
Monitoring Time (minutes)	Number of minutes required for this visit.
Percent of Grant	Percentage of the grant amount allocated to each visit.
Total Number of CRF Pages	Total number of CRF pages to be collected for a single subject during the course of this treatment.
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.
Links
Clear CRF Defaults	Overrides the calculated schedule.
Restore CRF Defaults	Restores default values for CRF pages and monitoring time.
Clear Grant Overrides	Restores default values for grant allocations.

Data Tab

Table 4-29 Data Tab fields

Field	Description	Notes
Data Collection
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.
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.
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.
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.	This is the total number of imports, not the number expected per vendor.
CRF Design
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).
Biostatistics
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 Unique PK/PD Data Tables	Number of unique PK/PD related tables.
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 Unique PK/PD Data Listings	Number of unique PK/PD related listings.
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 Unique PK/PD Figures and Graphs	Number of unique PK/PD related figures or graphs.
Project Management
Number of newsletters per site	Number of newsletters to provide per site.
Will there be an ICF Video/DVD?	Whether there will be an ICF Video/DVD.
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	Number of online EDC training sessions.	Default value is 3.
Medical Writing / Timelines
Number of pages in the Investigator Brochure	Number of pages in the Investigator Brochure.
Number of manuscripts	Number of manuscripts.	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 Management
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.
Hours medical monitor will spend with each SAE	Number of hours a medical monitor spends with each serious adverse event (SAE).
Expected percent of SAE Reports to be expedited	Percentage of serious adverse event (SAE) reports to be expedited to regulatory agencies and ethics committees.
Expedited SAEs	Number of expedited serious adverse events (SAEs) calculated by the application.
Provide data to the DSMB	How often data is reported to the Data Safety Monitoring Board (DSMB).
IVRS (Interactive Voice Response System)
IVRS Usage	Tasks for which an Interactive Voice Response System (IVRS) is used.
Amendments
Expected Protocol Amendments	Add one or more protocol amendments.
An amendment is expected to occur	The number of days before or after a specific milestone this amendment is expected to occur
Milestone nearest to the protocol amendment	The selected milestone from which the application calculates the approximate date of the amendment.
Add another amendment	Add additional protocol amendments to the study.
Responsibilities
Columns
Task Group	Assignment groups to which outsourcing responsibilities are applied.	For a list of tasks, see the online Help for the Sites tab.
Sponsor	Assign all of the tasks in that group to the study sponsor.
Vendor	Assign all of the tasks in that group to the primary vendor assigned on the Provider tab.
Mixed	Assign some of the tasks to the sponsor and some to the vendor on the Assignment tab.
N/A	None of the tasks in the group will be performed.

Monitoring Tab

Table 4-30 Monitoring Tab fields

Field	Description	Notes
Monitoring Methods
Monitoring will be performed	Whether monitoring will be done in-person, by phone, or by a combination of these methods.
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.
On-Site Monitoring Schedule
Monitor every	Frequency, in weeks that a monitor visits the study sites during each period of the monitoring schedule.
Until LSO/LPO	Site monitoring continues at the entered frequency until the end of the treatment period.
Until Week	The week during the study the monitoring frequency changes.
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.
Monitoring Approach
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.
Percentage of monitoring done by Regional Monitors	Percentage of monitoring regional monitors complete.
Avg travel time (in hours) for site monitors	Average travel time, in hours, for site monitors.
Percent of source document verification	Percentage of safety and efficacy data to be source verified while monitoring the data.
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 Approach dialog box.
Monitored Data
Total CRF pages generated (without subject drops)	Number of predicted Case Report Form (CRF) pages generated, assuming no subjects drop out of the study.
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.
Medical Monitoring
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.
Separate Drug Accountability
Will there be additional drug accountability visits?	Whether additional drug accountability visits are required.
Additional drug accountability visits performed by	Who will perform additional drug accountability visits, if applicable.
Additional drug accountability visits per site	Number of additional drug accountability visits to be made per site.

Edit Per Location Monitoring Schedule Dialog Box

Table 4-31 Edit Per Location Monitoring Schedule Dialog Box Fields

Field	Description	Notes
Monitoring Methods
Monitoring will be performed	Whether monitoring will be done in-person or by phone or by a combination of these methods.
On-Site Monitoring Schedule
Monitor every	Frequency, in weeks that a monitor visits the study sites during each period of the monitoring schedule.
until LSO/LPO	Indicates that site monitoring will continue at the specified frequency throughout the end of the treatment period.
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.
Monitoring Travel Strategy	Travel strategy to be used for most of the monitoring trips.
Phone-Based Monitoring Schedule
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.
Total Visits	Total number of visits across all locations.
Total Calls	Total number of calls across all locations.
Manage location-specific values	Monitoring approach assumptions for each location.

Edit Per Location Monitoring Approach Dialog Box

Table 4-32 Edit Per Location Monitoring Approach Dialog Box Fields

Field	Description	Notes
Monitoring Approach (Location)
Restore Defaults	Click to restore the monitoring assumptions to the global values for a specific location.
Restore All Defaults	Click to restore the monitoring assumptions to the global values for all locations.
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.
Percent of source document verification	Specify the percent of key safety and efficacy data to be source verified while monitoring the data.
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).
Percentage of monitoring done by Regional Monitors	Indicates the percentage of monitoring that will be done by Regional Monitors.
Avg travel time (in hours) for site monitors	The average number of hours a monitor will need to travel to sites

Provider Tab

Table 4-33 Provider Tab Fields

Field	Description	Notes
Buttons
Add Provider(s)	Add providers.
Remove Provider(s)	Remove providers.
Set as Primary Provider	The primary, or default, provider for tasks.
Replace Provider	Replace the selected provider with another provider.
Freeze Billing Rates/Unfreeze Billing Rates	Freeze or unfreeze the rates for the plan.	The application copies the current rates for the current providers and stores them with this plan.
Columns
Provider Name	Provider name.
Provider Type	Provider type.
Rate Year in Effect	Rate Year used to look up billing rates for the resources for this service provider for this plan.
Back-Office Billing Rate Location	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 4-34 Choose Service Providers Dialog Box Fields

Field	Description	Notes
Columns
Name	Name of the service provider.
Type	Provider type.
Last Updated	Date and time when service provider was last updated.
Updated By	User who last updated the service provider.

Specify Provider-Specific Details Dialog Box

Table 4-35 Specify Provider-Specific Details Dialog Box Fields

Field	Description	Notes
Billing Rate Information
Rate Year in effect	Rate year, associated with the billing rate, selected from the drop-down list.
Discount rate to apply to this study	Discount rate negotiated for the study, as a percentage.
Inflation rate to apply to year 2 of study	Percentage to be added to billing rates in year 2 to offset inflation.
Inflation rate to apply to subsequent years of study	Percentage to be added to billing rates after year 2 to offset inflation.
Compound inflation annually	Whether or not to calculate inflation by compounding it annually.
Back-Office Billing Rate Location	Location used to determine the default billing rates for centralized tasks or tasks conducted at a central location.
Billing Rate Currency	Currency type for billing rate.
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.
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.
FTE Utilization Information
Project Manager utilization prior to FSI/FPI	Percentage of project manager resources required before the first patient has enrolled.
Project Manager utilization after FSI/FPI	Percentage of project manager resources required after the first patient has enrolled.
Resource Allocation Factor	Percentage of each full workday that the service provider's team works on the project.
Other
Number of sponsor affiliates	The number of affiliates that the provider is to work with.
Type of reporting to affiliates	The types of reporting to sponsor affiliates by the provider.
Additional type of vendor with which this service provider will work	Relationship this service provider has with another provider.
Will this provider manage the CTMS	Whether or not this service provider will enter data into the sponsor's Clinical Trial Management System.

Choose Replacement Provider Dialog Box

Table 4-36 Choose Replacement Provider Dialog Box Fields

Field	Description	Notes
Columns
Name	Name of the service provider.
Type	Provider type.
Last Updated	Date and time when service provider was last updated.
Updated By	User who last updated the service provider.

Meetings Tab

Table 4-37 Meetings Tab Fields

Field	Description	Notes
Buttons
Add	New meeting.
Edit	Edit a meeting.
Copy	Copy a meeting.
Include	Include a meeting.
Exclude	Exclude a meeting.
Delete	Delete a meeting.
Columns
Name	Meeting name.
Type	Meeting type.
Location	Meeting location.
Occurs	Meeting frequency.
Planner	Meeting organizer.

Define New Meeting Dialog Box

Table 4-38 Define New Meeting Dialog Box Fields

Field	Description	Notes
Name	Meeting name.
Type	Meeting type.

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

Table 4-39 Meeting Details Tab Fields

Field	Description	Notes
Meeting Definition
Name	Meeting name.
Type	Meeting type.
Code	Meeting code.	The application uses the code as a prefix for the task associated with the meeting type.
Organizer/Planner	Meeting planner.
Location	Meeting location.
City	Name of the city where the meeting takes place.
Non-travel event costs	Non-travel meeting costs.
Schedule
Occurs	Meeting frequency.
Starts	Meeting start date.
Until	Meeting end date.
# Meetings	Displays the number of meetings.
Meeting Duration	Enter the number of hours each meeting lasts.
Providers Attending
Provider	Service providers attending the meeting.
Locations Attending
Location	Personnel from sites in the chosen location attending the meeting.
% Sites Attending	Percentage of sites in this location sending participants to the meeting.
# Sites Attending	Number of sites attending the meeting from this location.

Table 4-40 Attendees Tab Fields

Field	Description	Notes
Service Provider	Service provider for which you are editing or viewing meeting attendees.
Provider Attendees (Buttons)
Add	Add additional meeting attendees.
Delete	Delete meeting attendees.	You can only delete user-defined attendees.
Duplicate	Copy a meeting attendee.
Expand All Billable Hours link	View details about billable hours for each meeting attendee.
Provider Attendees (Columns)
Attendees	Number of meeting attendees for the associated resource type.
Resource Type	The resource type attending the meeting.
Billing Rate Location	The billing rate location for the meeting attendee.
Attendance Method	Attendee travel method.
Billable Hours	Number of billable hours for the meeting attendee.
Preparation	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	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	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	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	Indirect costs for the meeting attendee.
Travel	Total travel indirect costs for each meeting attendee.
Other	Other indirect costs for each meeting attendee.

Table 4-41 Add Provider Attendees Dialog Box Fields

Field	Description	Notes
Resource Name	Resource you can add to the task.
Code	Code for a resource you can add to the meeting.

Table 4-42 Site Attendees Tab Fields

Field	Description	Notes
Attendees/Site	Number of attendees attending from each site for the selected location.
% Sites	Percentage of sites attending that send this number of attendees by this attendance method.
# Sites	Number of sites attending that send this number of attendees by this attendance method.
Source Location	Location from which each meeting attendee is coming.
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.
Other Cost	Miscellaneous other costs expected by the site attendees for this location.
Total Costs	Total indirect costs for each meeting attendee.

Table 4-43 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 4-44 Assignment Tab Fields

Field	Description	Notes
Task Assignments
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.
Show Tasks link	List of assignment groups and tasks.
Hide Tasks link	List of assignment groups and tasks.
Override Resources or Rates	Override Resources or rates.
Columns
Assignment Group/Task	Available assignment groups and tasks.
Assign to	Service provider to which the task is assigned.
Billing Rate Location	Billing rate location.	The application uses this location to calculate resource costs for the task.
Pinned	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 4-45 Resource Overrides Dialog Box Fields

Field	Description	Notes
Scope of Overrides
Values apply to	Locations affected by the overrides.
Default service provider for outsourced tasks	Service provider whose resources or rates are to be overridden.
Resources/ Overrides
Resource Name	Resource name.
Billing Rate Location	Billing Rate Location.
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.
Clear Overrides link	Restore the default resources and rates for the associated service provider.

Labor Tab

Table 4-46 Labor Tab Fields

Field	Description	Notes
Filter
Show hours and fees for	Service provider for which hours and fees appear.
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.
Buttons
New Major Task	Create a major task. Opens the Task Manager dialog box.
Edit Major Task	Edit the selected major task. Opens the Task Manager dialog box.
Delete Major Task	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	Adjust the labor unit hours and fees for the selected major task and service provider on the Task Manager dialog box.
Pin Labor	Pin all labor units, costs, hours and distributions.
Unpin Labor	Unpin all labor units, costs, hours and distributions.
Columns
Major Task	Major task type.	For a description of each major task, see the online Help for the Labor tab.
Unit Hours	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	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	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	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	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	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	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 4-47 Task Manager: 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.
Labor	Whether associated tasks vary by location or centralized. If you select varies by location, the associated tasks are completed at the study sites.
Unit of Measure	Unit of work this major task represents.
Buttons
New Task	Create a new task for the selected major task.
Edit Task	Edit the selected task.
Delete Task	Delete the selected task.
Edit Assignments	Edit service provider assignments for the selected task.

Table 4-48 Task Manager: Adjustments Tab Fields

Field	Description	Notes
Show hours and fees for	Service provider, whose unit hours or fees are to be adjusted.
Expand All	View all hours and fees in each location for the selected service provider.
Collapse All	Close the expanded view of hours and fees and display only planned and adjusted extended hours and extended cost.
Clear Overrides	Restore all fields to the application default values.
Columns
Location	Location (countries/regions or centralized) where the service provider is conducting work on the major task.
Planned	Planned number of units, unit hours, and unit cost for the major task.
Adjusted	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	Saves the number of units, unit hours, and unit costs preventing changes from cascading through the plan.
Extended Hours	Total plan hours for each location.	The application calculates this number based on plan assumptions.
Extended Cost	Total cost for each location.	The application calculates this number based on plan assumptions.

Table 4-49 Distribution Tab fields

Field	Description	Notes
Distribute completed units of work according to	How to distribute completed units of work across time.
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.
End	Number of days before or after a selected milestone to end the distribution.
Service Provider	Service provider to which these assumptions apply.
Location	Location to which to apply these distribution assumptions.
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.
Columns
Period	Period during which the number or percentage of units are expected to be completed.
Percentage	Percentage of units expected to be completed during the associated period.
Total	Total percentage of work completed during the work periods.

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

Table 4-50 Task Manager: New Task, Task Details Tab Fields

Field	Description	Notes
Name	Name for the task.
Code	Code for the task that the application will use as a prefix to the selected task name.
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.
Buttons
Add Resource	Add a resource to this task.
Edit Resource	Change details about the resource effort or rates for this task. resource
Delete Resource	Remove a resource from this task.
Columns
Resource Name	Resource typically assigned to this task.
Substitutions	Resource overrides for a resource.

Table 4-51 Task Manager: New Task, Task Assignments Tab Fields

Field	Description	Notes
Columns
Location	Location in which task is performed.	For centralized tasks, All Locations appears.
Included	If selected, the task is included in the study, for the location.	Deselect to exclude a task for a specific location.
Service Provider	Service provider who performs the task for this location.
Billing Rate Location	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	Saves your task settings so that changes made at general levels do not affect the task.
Buttons
Add Resource	Add a resource to this task.
Edit Resource	Change details about the resource effort or rates for this task. resource
Delete Resource	Remove a resource from this task.
Columns
Resource Name	Resource typically assigned to this task.
Substitutions	Resource overrides for a resource.

Task Manager: Add Resource Dialog Box

Table 4-52 Task Manager: Add Resource Details Tab Fields

Field	Description	Notes
Columns
Resource Name	Resource you can add to the task.
Code	Code for a resource you can add to the task.

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

Table 4-53 Task Manager: Edit Resource, 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.
Columns
Location	Location in which the resource performs the work.
Service Provider	Service provider to which the resource belongs.
Department	Department to which this resource belongs when performing the task.
GL Code	General Ledger code for fees associated with this resource when performing the task.

Table 4-54 Task Manager: Edit Resource, Algorithm Tab Fields

Field	Description	Notes
Columns
Location	Location to which the algorithm applies.
Calculate unit hours as	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.
Unit Hours	Number of unit hours (per cost driver) the selected resource must spend performing this task to complete one unit-of-measure for this location.
Cost Driver	Work unit to use for this Level of Effort (LOE) algorithm.
# Units	Number of units per the unit of measure defined by the major task.
Ext. Hours	Total hours for the selected resource to complete the task for this location.

Table 4-55 Task Manager: Edit Resource, Billing Rate Location Tab Fields

Field	Description	Notes
Columns
Location	Name of the location where sites and subjects are located.
Service Provider	Service provider assigned to handle this task for sites and subjects in the listed location.
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 4-56 Task Manager: Edit Resource, Rates & Substitutions Tab Fields

Field	Description	Notes
Columns
Location	Location where sites and subjects are located.
Service Provider	Name of the service provider assigned to this task for the listed location.
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, you can enter a	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 4-57 Task Manager: Edit Resource, Unit Hours Tab Fields

Field	Description	Notes
Columns
Location	Location where sites and subjects are located.
Service Provider	Service provider assigned to this task for the listed location.
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.
Ext. Hours	Extended hours for this location.	The application calculates this number by multiplying the unit hours by the number of units expected.

Costs Tab

Table 4-58 Costs Tab Fields

Field	Description	Notes
Filter
Show: Excluded Cost(s)	Displays costs that have been previously excluded.	Excluded costs are not included in the plan budget.
Show: Categories where costs total 0.00	Displays cost categories where the total cost equals 0.00. Deselect to hide cost categories where the total cost equals 0.00.
Buttons
New	Opens the Define New Category dialog box to create a user-defined cost.
Edit	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	Excluded the selected costs from the plan budget totals.	Excluded costs are not deleted. They appear with a line through them.
Include	Restores the selected excluded costs.	Set the filter to show excluded costs.
Delete	Permanently delete the selected user-defined costs.	You cannot delete default application costs. You cannot restore deleted user-defined costs.
Columns
Name	Name referring to a specific cost or cost type.	For a description of each cost, see the online Help for this tab.
Type	Whether the cost type is a pass-through or another type of indirect cost.
Calculated	Application-calculated cost based on the assumptions entered on other tabs.
Adjustment	Total amount of adjustments entered on the Adjustments tab of the Edit or Adjust Dialog box.
Total	Total calculated cost, including any adjustments.	Must be zero or greater.

Define New Category Dialog Box (Definition Tab, Algorithm Tab, Distribution Tab)

Table 4-59 Define New Category Dialog Box, Definition Tab Fields

Field	Description	Notes
Category Information
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.
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.
Include inflation in results	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 Include inflation in results checkbox.
Notes
Notes	Additional notes or comments about the cost.	Displayed as help content for user-defined costs.
History
Created By	Name of the user who created the cost.
Created Date	Date the cost was created.
Last Modified By	Name of the user who last modified the cost.
Last Modified	Date the cost was last modified.

Table 4-60 Define New Category Dialog Box, Algorithm Tab Fields

Field	Description	Notes
Cost/Credit Algorithm
Costs/Credits	Whether the cost or credit varies by location or is calculated at study-level.	Application-calculated costs and credits are either location-scoped or study-scoped and cannot be changed.
Calculate as:	Per unit cost.	Becomes the default for each location. The application calculates the study-level cost as this value multiplied by the number of units.
Currency	Currency of the per unit cost.	Must contain a value between 0 and 99,999,999 USD (or the equivalent in another currency).
per	Unit-based assumptions that drive this cost calculation.	The application multiplies the number of units derived for the chosen assumption is the amount entered to produce the total cost.
Study-Wide or Location-specific Costs/Credits and Adjustments
Location	Location with which a cost is associated.	Applies only to costs that are defined to vary by location.
Provider	Service provider associated with a cost.
Department	Department associated with the cost.
GL Code	Association of a cost or set of costs with a particular entry in the General Ledger.
Costs	Amount and currency override the per unit cost for a specific location.	Must contain a value between 0 and 99,999,999 USD (or the equivalent in another currency).
Credits	Amount and currency override the per unit cost for a specific location.
Total	Total calculated cost, including any adjustments.	Must be zero or greater.

Table 4-61 Define New 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.
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.
Percentage	Percentage of the total cost paid during the associated period.
Total	Displays the total of the cost distribution.

Payments Tab

Table 4-62 Payment Tab Fields

Field	Description	Notes
Buttons
Set Payment Terms	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	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	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	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	Delete a user-defined milestone.	To not make a payment at a system-defined milestone, define the percentage as 0.
Columns
Milestone	The milestone at which payments can be made or received.
Inv. Date	Displays the date on which the milestone is expected to occur and trigger an invoice.
Service Provider (Payment Percentage and Amount)	The payment percentages and amounts to be received by the service provider.	For example, Major CRO, Medium CRO, Premium CRO.
Total	Total amount paid to all service providers at this milestone.
Budget Total	Total payment percentage and amount for all plan milestones.

Payment Terms Dialog Box

Table 4-63 Payment Terms Dialog Box Fields

Field	Description	Notes
Payment Terms (Columns)
Provider	Service provider.
Payment Term	Number of days between the invoice date and the date of payment.

Recurring Payments Dialog Box

Table 4-64 Recurring Payments Dialog Box Fields

Field	Description	Notes
Columns
Item Name	Major task or pass-through cost that can be set as a milestone triggering a recurring payment.
Specific Service Provider	For each service provider, the milestone when the recurring payment is to be made.

Create/Edit Milestone Dialog Box

Table 4-65 Create/Edit Milestone Dialog Box Fields

Field	Description	Notes
Milestone Definition
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.
Milestone	The application-defined milestone before or after which this user-defined milestone occurs.
Description
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.

Summary Tab

Table 4-66 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.
Fees, Hours, and FTEs
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).
Clinical Monitoring Closeout and Site Audit Fees	All fees, hours, and FTEs associated with site monitoring, site management, telephone monitoring, query resolution, SAE management, site closeouts, and clinical compliance audits.
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.
Biostatistics	All fees, hours, and FTEs associated with table listings and graphs, randomization procedures, statistical and analysis plans, and interim analysis.
Project Management/ Study Oversight	All fees, hours, and FTEs associated with project management of the study from beginning to end.
Medical Writing/ Final Report	All fees, hours, and FTEs associated with delivering the statistical report, draft report, and final report (CSR).
Other	All fees, hours, and FTEs associated with other tasks not included in any other line item.
Total Fees	All fees associated with the study.
Total Hours	Total hourly effort associated with the study.
Total FTEs	Total of all FTEs associated with this study, by functional area.
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.
Total Pass-Through Costs	All third-party, pass-through, and miscellaneous costs in the study.
Inflation (Pass-Through Costs)	Costs incurred due to inflation applied to pass-through costs.
Total Study Costs	Total study costs, including vendor fees, pass-through costs, and sponsor internal costs.
Dates / Duration
Pre-Study Activity Start Date	Date on which the earliest activity or cost occurs.
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.
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).
Total Study Duration	The total study duration (in elapsed days), defined as the end date minus the start date.
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).
Metrics
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.

Reports Tab

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

Clinical Indicators Reports

Table 4-67 Clinical Indicator Reports Descriptions

Field	Description	Notes
Assumptions	Assumptions based on data entry.
Currency Exchange Rates	Currency exchange rates based on data entry.
Responsibilities	Responsibilities based on data entry.
Site Approval Schedule - Cumulative	Cumulative site approval curve for the entire study by week.
Site Approval Schedule By Location	Site approval curve by week for each location in the study.
On-Site Monitoring Schedule - Total Hours	Total hours for all on-site monitoring visits for the entire study.
On-Site Monitoring Schedule By Location	Average hours per on-site monitoring visit for each location in the study.
CRF Pages - Cumulative	Cumulative CRF pages generated per week.
CRF Pages By Location	CRF pages generated per week for each location in the study.
Subject Enrollment - Cumulative	Cumulative subject enrollment per week.
Subject Enrollment by Location	Subject enrollment per week by location.
Metrics	Various performance and cost metrics.
Milestone Dates	Critical dates in the study.
Milestones Timeline Chart	Graphical view of key milestones.

Costs Reports

Table 4-68 Costs Reports Descriptions

Field	Description	Notes
Plan Summary	Printable view of the Plans Summary Tab.
Fees by Major Task	Fees by major task.
Fixed Unit Prices	Fixed unit prices.
Pass-Through and 3rd Party Costs	Pass-through and 3rd party costs.
Monthly Budget	Monthly budget.
Monthly Budget By Reporting Region	Monthly budget by reporting region.
Labor Adjustments	Breakdown of unit level adjustments by major task.
Cash Flow	Planned value (PV) versus payments.
Milestone Payment Schedule	Schedule of payments at each milestone.
Meetings Report	Meeting costs and assumptions.
Bid Grid	Bid grid for the plan.

FTE/Resources Reports

Table 4-69 FTE/Resources Reports Descriptions

Field	Description	Notes
Resource/FTE Demand Summary	Summary of the plan resources and FTE demands.
Resources By Major Task	Resources by major task.
Resources By Department	Resources by department.
Resources By GL Code	Resources by GL code.
Resource Demand by Date	Resources by demand date.
Resource Demand Chart	Graphical view of resource demand by date.
Billing Rates by Resource Name	Billing rates by resource name.

Studies Screen Fields

Studies Screen Fields

Table 4-70 Studies Screen Fields

Field	Description	Notes
Buttons
New	New study.
Edit	Edit a study.
Delete	Delete a study.
Restore	Restore a deleted study.
Create Plan	Create a plan based on a study.
Columns
Study Name	Studies in the application.
Product/Compound	Product or compound the associated study is based on.
Phase	Study phase of the associated study.
Therapeutic Area	Therapeutic area the associated study is based on.
Indication	Indication the associated study is based on.
Status	Study status.

Create/Edit Study Screen Fields

Table 4-71 Create/Edit Study Screen Fields

Field	Description	Notes
General Information
Study Name	Study name.
Protocol	Protocol ID.	The protocol ID number identifies the protocol for this study.
Product/Compound	Product or compound the associated study is based on.
Phase	Study phase.
Sponsor	Study sponsor.
Status	Study status.
Billing Code	Study billing code.
Therapeutic Area & Indication
Therapeutic Area	Therapeutic area the study is based on.
Indication	Indication the study is based on.
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/Notes
Description	Study description

Define Study Filter Dialog Box Fields

Table 4-72 Define Study Filter Dialog Box Fields

Field	Description	Notes
Study Filter Criteria
Created or modified in the last n days	When this option is selected, the criteria applied include the number of days since the study was last edited and saved.
Include deleted studies	Selecting this option includes studies that have been previously deleted.
Study name starts with	When this option is selected, the criteria applied include the text entered in the Study name starts with <text> field.
Created by	Only studies created by one of the selected users are listed.	If you want to display all studies regardless of who created them, select the Any User option. To display more users to choose from, click the Expand list... link.
Last Modified by	Only studies last edited and saved by one of the selected users are listed.	If you want to display studies regardless of who last updated them, choose the Any User option. To display more users to choose from, click the Expand list... link.
Status	Only studies with that status are listed.	If you want to see studies regardless of their status, select the Any Status option.
Phases	Only studies pertaining to the selected Phase(s) are listed.	If you want to see studies regardless of the Phase, select the Any Phase option.
Therapeutic Areas	Only studies pertaining to the selected Therapeutic Area(s) are listed.	If you want to display studies regardless of the Therapeutic Area, select the Any Therapeutic Area option.
Sponsors	Only studies for the selected sponsor(s) will be listed.	If you want to display studies regardless of the sponsor, select the Any Sponsor option.
Save Filter
Save filter as	Name to assign to the filter.
Sorting and Paging
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 4-73 Create Product Dialog Box Fields

Field	Description	Notes
Product ID	Unique product identifier, typically and alphanumeric code used to identify the product/compound.
Name	Name used to refer to the product.
Description	Description of the product.

Products Screen Fields

Product Screen Fields

Table 4-74 Product Screen Fields

Field	Description	Notes
Buttons
New	Add a product.
Edit	Edit a product.
Delete	Delete a product.
Restore	Restore a deleted product.
Columns
Product Name	Products in the application.
Description	Product description.
Last Updated	Date and time the product was lasted modified.
Updated By	User who modified the product.

Create/Edit Product Screen Fields

Table 4-75 Create/Edit Product Screen Fields

Field	Description	Notes
Product ID	Product ID.
Name	Product name.
Description	Product description.

Define Product Filter Dialog Box Fields

Table 4-76 Define Product Table Filter Dialog Box Fields

Field	Description	Notes
Exchange Filter Criteria
Created or modified in the last n days	When this option is selected, the criteria applied include the number of days since the product was last edited and saved.
Include deleted products	Selecting this option includes products that have been previously deleted.
Product name starts with	When this option is selected, the criteria applied include the text entered in the Product name starts with <text> field.
Created by	Only exchange rate table by one of the selected users are listed.	If you want to display all products regardless of who created them, select the Any User option. To display more users to choose from, click the Expand list... link.
Last Modified by	Only products last edited and saved by one of the selected users are listed.	If you want to display products regardless of who last updated them, choose the Any User option. To display more users to choose from, click the Expand list... link.
Save Filter
Save filter as	Name to assign to the filter.
Sorting and Paging
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.

Templates Screen Fields

Template Screen Fields

Table 4-77 Template Screen Fields

Field	Description	Notes
Buttons
New	Add template.
Edit	Edit a template.
Delete	Delete a template.
Restore	Restore a deleted template.
Copy	Copy a template.
Lock Templates	Lock templates.
Unlock Templates	Unlock templates.
Columns
Template Name	Template name.
Phase	Study phase.
Therapeutic Area	Therapeutic area of the associated template.
Indication	Indication of the associated template.

Define Template Filter Dialog Box Fields

Table 4-78 Define Template Filter Dialog Box Fields

Field	Description	Notes
Template Filter Criteria
Created or modified in the last n days	When this option is selected, the criteria applied include the number of days since the template was last edited and saved.
Include deleted templates	Selecting this option includes templates that have been previously deleted.
Template name starts with	When this option is selected, the criteria applied include the text entered in the Template name starts with <text> field.
Created by	Only templates created by one of the selected users are listed.	To display all templates regardless of who created them, select the Any User option. To display more users to choose from, click the Expand list... link.
Last Modified by	Only templates last edited and saved by one of the selected users are listed.	If you want to display templates regardless of who last updated them, choose the Any User option. To display more users to choose from, click the Expand list... link.
Status	Only templates with that status are listed.	If you want to see templates regardless of their status, select the Any Status option.
Phases	Only templates pertaining to the selected Phase(s) are listed.	If you want to see templates regardless of the Phase, select the Any Phase option.
Therapeutic Areas	Only templates pertaining to the selected Therapeutic Area(s) are listed.	If you want to display templates regardless of the Therapeutic Area, select the Any Therapeutic Area option.
Sponsors	Only templates for the selected sponsor(s) will be listed.	If you want to display templates regardless of the sponsor, select the Any Sponsor option.
Save Filter
Save filter as	Name to assign to the filter.
Sorting and Paging
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 4-79 Select Template Defaults Dialog Box Fields

Field	Description	Notes
Sponsor	Default sponsor for the template.
Phase	Phase 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 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.

Copy Template Defaults Dialog Box Fields

Table 4-80 Copy Template Defaults Dialog Box Fields

Field	Description	Notes
Template Name	Name of the new copy template.

Portfolios Screens, Tabs, and Dialog Boxes

Portfolio Screen

Table 4-81 Portfolio Screen Fields

Field	Description	Notes
Filter Section
Show	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.
Modify link	Define a custom filter on the Define Portfolio Filter dialog box.
Buttons
New	Create a new portfolio on the Create Portfolio screen (Overview tab).
Edit	Edit the selected portfolio or open it to view details, the summary, or reports.
Delete	Delete the selected portfolio.	Deleted portfolios are permanently removed at a later time.
Restore	Restore a deleted portfolio.	To use this option, adjust the filters so that you can see inactive as well as active items.
Copy	Make a copy of the selected portfolio.
Columns
Portfolio Name	Name of the portfolio.
Description	Description of the portfolio.
Number of plans	Number of plans included in the portfolio.
Last Modified	Date a user last modified this portfolio.

Portfolio Screen Dialog Boxes

Define Portfolio Filter Dialog Box

Table 4-82 Define Portfolio Filter Dialog Box Fields

Field	Description	Notes
Portfolio Filter Criteria
Created or modified in the last n days	Includes in the criteria applied the number of days since the portfolio was last edited and saved.
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.
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
Save filter as	Name to assign to the filter.
Sorting and Paging
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 4-83 Create/Edit Portfolio Screen (Overview Tab) Fields

Field	Description	Notes
Portfolio Overview
Portfolio Name	Unique name for the portfolio.
Description
Short Description	Details that appear on the Portfolios screen to help you recognize the portfolio.
Long Description	Detailed description of the portfolio.
Currency Options
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.
History (Edit Portfolio Screen only)
Created By	Name of the user who created the portfolio.
Created Date	Date the portfolio was created.
Last Modified By	Name of the user who last modified the portfolio.
Last Modified	Date the portfolio was last modified.

Create/Edit Portfolio Screen (Plans Tab) Fields

Table 4-84 Create/Edit Portfolio Screen (Plans Tab) Fields

Field	Description	Notes
Buttons
Add Plans	Add plans to the Portfolio on the Choose Plans dialog box.	You cannot add more than 200 plans.
Remove Plans	Remove plans from a portfolio.
Include Plans	Restores an excluded plan to a portfolio.
Exclude Plans	Excludes a plan from the portfolio.	Excluded plans have a line through them on the Plans tab.
Columns
Plan Information	Plan name and description.
Start Date	Plan project activity start date.
Start Offset	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	Likelihood that the plan is going to occur on schedule, expressed as a percentage.

Create/Edit Portfolio Screen (Summary Tab)

Table 4-85 Create/Edit Portfolio Screen (Summary Tab) Fields

Field	Description	Notes
Portfolio Plan Summary
Start	By default, start date of the earliest plan in the portfolio, including any offset dates.
End	By default, end date of the final plan in the portfolio.
Cost Distribution
Cost Distribution Graph	Graphical view of when costs occur over the time range specified.	The blue shaded area represents the time frame selected in the Summary Portfolio dialog box.
Buttons
Reset	Resets Start and End values to portfolio defaults.
Columns
Plan Name	Displays the plan name.
Study Name	Displays the study for the plan.
Plan Cost	Displays the total plan cost.
Fees, Hours, and Pass Through Costs
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).
Clinical Monitoring Closeout and Site Audit Fees	All fees, hours, and FTEs associated with site monitoring, site management, telephone monitoring, query resolution, SAE management, site closeouts, and clinical compliance audits.
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.
Biostatistics	All fees, hours, and FTEs associated with table listings and graphs, randomization procedures, statistical and analysis plans, and interim analysis.
Project Management / Study Oversight	All fees, hours, and FTEs associated with project management of the study from beginning to end.
Medical Writing / Final Report	All fees, hours, and FTEs associated with delivering the statistical report, draft report, and final report (CSR).
Other	All fees, hours, and FTEs associated with other tasks not included in any other line item.
Total Fees	All fees associated with the study.
Total Hours	Total hourly effort associated with the study.
Total Pass-Through Costs	All third-party, pass-through, and miscellaneous costs in the study.
Total Portfolio Costs	Total portfolio costs, including vendor fees, pass-through costs, and sponsor internal costs.

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 4-86 Clinical Indicator Reports Descriptions

Field	Description	Notes
Portfolio Milestones Timeline Chart	Displays a graphical view of key milestones in the portfolio.

Costs Reports Descriptions

Table 4-87 Costs Reports Descriptions

Field	Description	Notes
Portfolio Summary	Displays a printable view of the Portfolio Summary Tab.
Fees by Major Task	Displays fees by major task.
Monthly Budget	Displays monthly budget.

FTE/Resources Reports Descriptions

Table 4-88 FTE/Resources Reports Descriptions

Field	Description	Notes
Resource Demand Summary	Displays a summary of the portfolio resources demands.
Resource Demand by Date	Displays a summary of the portfolio date demands.
Resource Demand Chart	Displays resources demand chart.

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 4-89 Clinical Indicator Reports Descriptions

Field	Description	Notes
Portfolio Milestones Timeline Chart	Graphical view of key milestones in the portfolio.

Portfolio Costs Reports Descriptions

Table 4-90 Costs Reports Descriptions

Field	Description	Notes
Portfolio Summary	Printable view of the Portfolio Summary Tab.
Fees by Major Task	Fees by major task.
Monthly Budget	Monthly budget.

Portfolio FTE/Resources Reports Descriptions

Table 4-91 FTE/Resources Reports Descriptions

Field	Description	Notes
Resource Demand Summary	Summary of the portfolio resources demands.
Resource Demand by Date	Summary of the portfolio date demands.
Resource Demand Chart	Resources demand chart.

Report Menu

The reports listed in this section apply to all data in the application.

• For plans-specific reports, see Report Types.

• For portfolios-specific reports, see Portfolio Costs Reports Descriptions.

Reports Descriptions

Table 4-92 Reports Descriptions

Field	Description	Notes
Bid Grid (Late Stage)	Global bid grid report.
Bid Grid (Phase 1 - Healthy Volunteers)	Bid grid report for Phase I studies with healthy volunteers.
Therapeutic Area / Indications Mapping	Indication mapping for all therapeutic areas.
Study Performance Summary	Overall schedule and budget performance per study.
User Report	Details for all users in the application.
Inactive Users Report	Users who have not logged within a number of specified days.
Plan Inventory Report	Complete list of plans, and their study and product attributes.
Planned Trials	Planned trials.
Tracked Trials	Tracked trials.

Reports Options

Table 4-93 Study Performance Summary Report Options

Field	Description	Notes
Date Range Options
Tracked in the last	Filters the report by studies' last tracked date.
Study Attributes
Status	Filters the report by study status. Studies with one or more statuses can be included in the report.	By default, all study statuses are included.
Phases	Filters the report by study phase. One or more study phases can be included in the report.	By default, all study phases are included.
Therapeutic Areas	Filters the report by therapeutic area. One or more therapeutic areas can be included in the report.	By default, all therapeutic areas are included.
Budget Performance Threshold	Filters the report by the Budget Performance Threshold of tracked studies. One or more of the following can be selected: Ok, Warning, Error, and Extreme.	By default, all Budget Performance Thresholds are included.
Schedule Performance Threshold	Filters the report by the Schedule Performance Threshold of tracked studies. One or more of the following can be selected: Ok, Warning, Error, and Extreme.	By default, all Schedule Performance Thresholds are included.
Overall Performance Threshold	Filters the report by the Overall Performance Threshold of tracked studies. One or more of the following can be selected: Ok, Warning, Error, and Extreme.	By default, all Overall Performance Thresholds are included.

Table 4-94 User Report Options

Field	Description	Notes
Options
Include user roles	Includes the user's primary and additional Roles.

Table 4-95 Inactive Users Report Options

Field	Description	Notes
Options
Days Since Last Login	Includes users who have not logged in the number of days specified.

Maintain Menu

Service Providers Screen Fields

Service Providers Screen Fields

Table 4-96 Service Providers Screen Fields

Field	Description	Notes
Show	Service providers that appear on the Service Providers screen.	You can select sponsors, vendors, and deleted service providers to be included.
New	Add a service provider.
Edit	Edit a service provider.
Delete	Delete a service provider.
Restore	Restore a service provider.
Billing Rates Report	Billing rates report for a service provider.
Columns
Name	Service provider name.
Type	Service provider type.
Last Updated	Date and time the service provider was last edited.
Updated By	User who last edited the service provider.

Create/Edit Service Provider Screen Fields

Table 4-97 Create Service Provider Screen Fields

Field	Description	Notes
Provider Name	Service provider name.
Provider Type	Type of service provider.
Description	Service provider description.
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.
Created By	User who created the service provider.
Created Date	Date and time this service provider was created.
Last Modified By	User who last edited the service provider.
Last Modified	Date the service provider was last modified.
Update Billing Rates	Billing rates for this service provider.

Resources Screen Fields

Define Resource Filter Dialog Box Fields

Table 4-98 Define Resource Filter Dialog Box Fields

Field	Description	Notes
Resource Filter Criteria
Created or modified in the last n days	When this option is selected, the criteria applied include the number of days since the resource was last edited and saved.
Include deleted resources	Selecting this option includes resources that have been previously deleted.
Resource name starts with	When this option is selected, the criteria applied include the text entered in the Resource name starts with <text> field.
Save Filter
Save filter as	Name to assign to the filter.
Sorting and Paging
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 4-99 Resources Screen Fields

Field	Description	Notes
Show	Resources that appear on the Resources screen.	You can include All Resources, Active Resources Only, or resources matching a filter.
New	Add a resource.
Edit	Edit a resource.
Delete	Delete a resource.
Restore	Restore a resource.
Name	Resources in the application.
Columns
Name	Resource name.
Last Updated	Date and time the resource was last updated.
Updated By	User who last modified the resource.

Create Resource Screen

Table 4-100 Create Resource Screen Fields

Field	Description	Notes
Code	Resource code.
Name	Resource name.
Description	Resource description.
Default Billing Rates
Rate Year	Rate year for each service provider.
Auto Fill	Billing rates for each service provider.

Billing Rates Screen Fields

Billing Rates Screen Fields

Table 4-101 Billing Rates Screen Fields

Field	Description	Notes
Show rates for	Service provider for which billing rates appear on the Billing Rates screen.
For Rate Year	Year for which billing rates appear on the Billing Rates screen.
Include Deleted Rates	Include deleted rates.
Buttons
New	Add billing rates.
Edit	Edit billing rates.
Delete	Delete billing rates.
Restore	Restore deleted billing rates.
Copy	Copy billing rates.
Publish	Publish billing rates.
Show Revision History	Revision history of the selected billing rates.
Columns
Rates for	Service provider who charges the billing rates.	Service providers can charge different rates to different sponsors.
When performing work for	Organization for whom the service provider is performing the work when these rates apply.
Rate Year	Billing rate year.
Status	Billing rate status.	Billing rates can be published or drafts.
Last Modified	Date and time the billing rates were last edited.
Last Modified By	User who edited the billing rates.

Create Billing Rates Screen

Table 4-102 Create Billing Rates Screen Fields

Field	Description	Notes
When	Service provider who charges these billing rates.
Performs work for	Organization the service provider is charging these billing rates.
For Rate Year	Billing rate year.
Base Rate Location	The country or region for the rates in the base rate column.
Currency	Billing rates currency.

Copy Billing Rates Dialog Box Fields

Table 4-103 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 to apply to the copied billing rates.

Show Revision History Dialog Box Fields

Table 4-104 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.
Last Modified By	User who last edited the billing rates.
Show Rates	Billing rates of the prior versions.

Departments Screen Fields

Define Department Filter Dialog Box Fields

Table 4-105 Define Department Filter Dialog Box Fields

Field	Description	Notes
Department Filter Criteria
Created or modified in the last n days	When this option is selected, the criteria applied include the number of days since the department was last edited and saved.
Include deleted departments	Selecting this option includes departments that have been previously deleted.
Department name starts with	When this option is selected, the criteria applied include the text entered in the Department name starts with <text> field.
Save Filter
Save filter as	Name to assign to the filter.
Sorting and Paging
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.

Departments Screen Fields

Table 4-106 Departments Screen Fields

Field	Description	Notes
Show	Departments that appear on the Departments screen.	You can show all departments, active departments only, or select a department filter.
New	Add a department.
Edit	Edit a department.
Delete	Delete a department.
Restore	Restore a deleted department.
Map Labor and Costs	Edit department mappings.
Columns
Name	Department name.
Code	Department code.
Description	Department description.
Last Updated	Date and time the department was last edited.
Updated By	User who last edited the department.

Create/Edit Department Screen Fields

Table 4-107 Create Department Screen Fields

Field	Description	Notes
Code	Department code.
Name	Department name.
Description	Department description.

Edit Department Mapping Screen Fields

Table 4-108 Edit Department Mapping Screen Fields

Field	Description	Notes
Change	Method of mapping departments.	You can map by resource, location, task, or Rule (Advanced Mode).
Restore ClearTrial Defaults	Restore department mappings to the application default mappings.	Any mappings you created are discarded.
Mapping by Resource
Resource	Resources to which departments can be mapped.
Internal	Department to apply when the resource performs work for an internal provider.
Outsourced	Department to apply when the resource performs work for an outsourced provider.
Mapping by Location
Location	Locations to which departments can be mapped.
Internal	Department to apply when an internal provider is assigned to the location.
Outsourced	Department to apply when an outsourced provider is assigned to the location.
Mapping by Task
Task Group	Task groups to which departments can be mapped.
Internal	Department to apply when an internal provider is assigned to the task or task group.
Outsourced	Department to apply when an outsourced provider is assigned to the task or task group.
Map by Rule (Advanced Mode)
Add Rule	Add a rule for mapping labor to departments.
Edit Rule	Edit a rule for mapping labor to departments.
Delete Rule	Delete a rule for mapping labor to departments.
Criteria	Rule criteria, which applies when the rule is used to map labor to departments.
Department	The department associated with the rule.
Drag to Order	Prioritize mapping rules.	Rules at the top of the list take priority over the bottom.

GL Codes Screen Fields

Define GL Code Filter Dialog Box Fields

Table 4-109 Define GL Code Filter Dialog Box Fields

Field	Description	Notes
GL Code Filter Criteria
Created or modified in the last n days	When this option is selected, the criteria applied include the number of days since the GL Code was last edited and saved.
Include deleted GL Codes	Selecting this option includes GL Codes that have been previously deleted.
GL Code name starts with	When this option is selected, the criteria applied include the text entered in the GL Code name starts with <text> field.
Save Filter
Save filter as	Name to assign to the filter.
Sorting and Paging
Sort By	The list of GL Codes can be ordered 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.

GL Codes Screen Fields

Table 4-110 GL Codes Screen Fields

Field	Description	Notes
Show	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	Add a GL code.
Edit	Edit a GL code.
Delete	Delete a GL code.
Restore	Restore a deleted GL code.
Map Labor and Costs	Edit GL code mappings.
Columns
Name	GL code name.
Code	Code for the GL code.
Description	GL code description.
Last Updated	Date and time the GL code was last edited.
Updated By	User who last edited the GL code.

Create/Edit GL Code Screen Fields

Table 4-111 Create GL Code Screen Fields

Field	Description	Notes
Code	General Ledger code.
Name	GL code name.
Description	GL code description.

Edit GL Code Mapping Screen Fields

Table 4-112 GL Code Mapping Screen Fields

Field	Description	Notes
Change	Method of mapping GL codes.	You can map by resource, location, task, or Rule.
Restore ClearTrial Defaults	Restore GL code mappings to the application default mappings.	Any mappings you created are discarded.
Mapping by Resource
Resource	Resources to which GL codes can be mapped.
Internal	GL code to apply when the resource performs work for an internal provider.
Outsourced	GL code to apply when the resource performs work for an outsourced provider.
Mapping by Location
Location	Locations to which GL codes can be mapped.
Internal	GL code to apply when an internal provider is assigned to the location.
Outsourced	GL code to apply when an outsourced provider is assigned to the location.
Mapping by Task
Task Group	Task groups to which GL codes can be mapped.
Internal	GL code to apply when an internal provider is assigned to the task or task group.
Outsourced	GL code to apply when an outsourced provider is assigned to the task or task group.
Map by Rule (Advanced Mode)
Add Rule	Add a rule for mapping labor to GL codes.
Edit Rule	Edit a rule for mapping labor to GL codes.
Delete Rule	Delete a rule for mapping labor to GL codes.
Criteria	Rule criteria, which applies when the rule is used to map labor to GL codes.
GL Code	The GL code associated with the rule.
Drag to Order	Prioritize mapping rules.	Rules at the top of the list take priority over the bottom.

Exchange Rate Tables Screen Fields

Define Exchange Rate Table Filter Dialog Box Fields

Table 4-113 Define Exchange Rate Table Filter Dialog Box Fields

Field	Description	Notes
Exchange Filter Criteria
Created or modified in the last n days	When this option is selected, the criteria applied include the number of days since the exchange rate table was last edited and saved.
Include deleted exchange rate tables	Selecting this option includes exchange rate tables that have been previously deleted.
Exchange Rate Table name starts with	When this option is selected, the criteria applied include the text entered in the Exchange rate table name starts with <text> field.
Created by	Only exchange rate tables by one of the selected users are listed.	If you want to display all exchange rate tables regardless of who created them, select the Any User option. To display more users to choose from, click the Expand list... link.
Last Modified by	Only exchange rate tables last edited and saved by one of the selected users are listed.	If you want to display exchange rate tables regardless of who last updated them, choose the Any User option. To display more users to choose from, click the Expand list... link.
Save Filter
Save filter as	Name to assign to the filter.
Sorting and Paging
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.

Exchange Rate Tables Screen Fields

Table 4-114 Exchange Rate Table Screen Fields

Field	Description	Notes
Show	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	Add an exchange rate table.
Edit	Edit an exchange rate table.
Delete	Delete an exchange rate table.
Restore	Restore a deleted exchange rate table.
Publish	Publish an exchange rate table.
Set Default	Set the default exchange rate table.
Columns
Name	Exchange rate table name.
Description	Exchange rate table description.
Status	Exchange rate table status.	Exchange rate tables can be published or drafts.
Last Updated	Date and time the exchange rate table was last edited.
Updated By	User who last edited the exchange rate table.

Create/Edit Exchange Rate Table Screen Fields

Table 4-115 Create Exchange Rate Table Screen Fields

Field	Description	Notes
Details
Name	Exchange rate table name.
Status	Status of the exchange rate table.	Exchange rate tables can be drafts, published, or published with a draft.
Description	Exchange rate table description.
Currency Exchange Rates
Use rates as of	Date from which to populate the exchange rates.
Apply	Populate the exchange rate fields with the values from the Use rates as of field.

Reporting Regions Screen Fields

Table 4-116 Reporting Regions Screen Fields

Field	Description	Notes
Buttons
New Reporting Region	Add a reporting region.
Map Countries to Reporting Regions	Select a reporting region for a country.
Columns
Reporting Region Name	Reporting regions.
# of Countries Mapped	Number of countries that are mapped to the associated reporting regions.
Total Number of Countries Mapped to Reporting Regions	Total number of countries mapped to reporting regions.

Admin Menu

User Profile Screen Fields

User Profile Screen Fields

Table 4-117 User Profile Screen Fields

Field	Description	Notes
Login Name	Name or phrase you use to log in.
First Name	Your first name.
Last Name	Your last name.
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.
Security Answer	Security answer used for authentication purposes.
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.

Reset Password Page Fields

Table 4-118 Create Product Dialog Box 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.