Skip Headers
Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide
Release 5.4
E63096-01
  Go To Documentation Library
Library
Go To Product List
Product
Go To Table Of Contents
Contents

Previous
Previous
 
 

5 Plan and Source Field Descriptions

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

Home Page Fields

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

Table 5-1 Home Page Fields

Field Description Notes

Edit menu

Add or edit plans, studies, products, templates, and portfolios.


Report menu

Generate standard reports that are not plan-specific.


Maintain menu

Define, select, and edit:

Templates—A reusable plan that serves as a starting point when planning any study.

Service providers—The service providers to whom you can assign work in a plan.

Resources—Manage system-defined resources and add, edit, and delete user-defined resources.

Billing rates—Define billing rates for service providers to whom you assign work. After you publish the billing rates, the application shares the rates between plans.

Departments and functional areas—Map departments to labor and costs. Choose a mapping mode.

GL codes—Map labor and costs to the general ledger.

Exchange rates—Create and define your organization's standardized rates for each currency to be used in your plans.

Reporting Regions—Group reporting regions for studies based on your global organizational structure and accounting practices.

Custom Fields—Manage custom field models and custom fields.

Select Purge Deleted Items to permanently remove items.

Admin menu

Users shows all users currently defined and allows the system administrator to add, edit, delete, and restore users; reset a selected user's password; clear a session when a user is locked out; and reset a user account. A reset clears the user's security question and answer, unlocks the account, and forces the user to reset the password.


Help menu

Display a Help screen associated with the screen currently displayed.

View version and product information on the About Oracle Health Sciences ClearTrial Cloud Service dialog box.

Contact technical support.


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.


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

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

Plans Screen

Table 5-2 Plans Screen Fields

Field Description Notes

New button

Create a new plan.


Edit button

Edit the selected plan or open it to view details, the summary, or reports.

You can also a open a plan by double-clicking the plan name.

Delete button

Delete the selected plan.

Deleted plans are removed at a later time and can be restored.

Restore button

Restore a deleted plan.

To use this option, adjust the filters so that you can see inactive as well as active items.

Copy button

Make a copy of the selected plan.


Compare button

Compare selected plans. You can specify service provider and location details and change the currency used to generate the costs and comparison reports.


Other Actions... button

Access additional features, such as locking and unlocking plans, freezing, and unfreezing billing rates, copying a plan as a template, and so on.


Plan name column

Unique identifier of plans.


Study Name column

Name of study.


Description column

Short description of the plan.


Status column

Status of the plan:

  • Incomplete—Basic assumptions have not been set for the plan.

  • Draft—All input questions of the selected edit mode have been answered, but the plan owner or creator might still be working on the plan.

  • Final—All input questions have been answered and the plan owner believes the plan will be used to conduct the clinical study. However, the plan has not yet been approved.

  • Approved—The plan has been approved and is ready to go out as part of an RFP or proposal or to be used to conduct the trial.

  • RFP—The plan has been approved and included as part of an RFP.

  • Agreement reached; not started—An agreement has been reached on the plan and it is under contract (if an outsourced study) or ready for study activities to begin (if an internal sponsor-executed study).

  • In progress—The study has begun and is operating according to this plan

  • Study Complete—The study has ended.

  • Archived—The plan is being preserved for historical purposes only.

You cannot choose another plan status until you enter information on all tabs through the Provider tab.

Last Modified column

Date a user last modified this plan.



Plans Screen Dialog Boxes

The following dialog boxes are associated with the Plans screen.

Define Plan Filter Dialog Box

Table 5-3 Define Plan Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes plans last edited and saved the specified number of days.


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 as

Name assigned to the filter.



Configure List Options Dialog Box - Plans Screen

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

Field Description Notes

Configure Columns

Selected columns appear on the Plans screen.


Sort By

Orders the plans based on your selections.

Change the order by clicking a column heading.

Show n plans per page

Number of plans displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Choose Study and Plan Template Dialog Box

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

Field Description Notes

Study Name study column

Unique name given to study by its creator.

Read-only.

Product/Compound study column

The product or compound being studied.

Read-only.

Phase study column

The study phase being planned. The application supports study phases I, II, IIa, IIb, III, IIIb, Phase IV with an IND, and Phase IV without an IND. The application supports Phase I for oncology and vaccine studies, as well as Phase I studies for healthy volunteers. Phase I Oncology or Phase I Vaccine studies more closely resemble Phase IIa trials.

Read-only.

Therapeutic Area study column

The therapeutic area or body system for which this study will be conducted.

The application uses this selection to calculate monitoring time required, time for query resolution, data entry, and to provide other default values.

Read-only. Determines the choices available for the indication.

Indication study column

The reason selected to perform this study. Indications are classified into therapeutic areas.

The application uses this selection to calculate monitoring time required, time for query resolution, data entry, and to provide other default values.

Read-only.

Template Name template column

Name of a plan or partial plan that can be used as a starting point for new plans for a study.

Read-only.

Inactive template statuses (Deleted, Archived, Study Complete) are not available for selection.

Description template column

Information describing the template to help you recognize a particular scenario or purpose for the plan.

Read-only.

Applicable For template column

Study phase(s) for which the template has been defined.

Read-only.


Copy Plan Dialog Box

Table 5-6 Copy Plan Dialog Box Fields

Field Description Notes

Plan Name

Name of the copy.


Use Cost Model from

Cost model to apply to the copy.

The default is the cost model of the plan being copied. The list includes all supported cost models beginning with 5.3.

Custom Field Model

Custom field model to apply to the copy.



Compare Plan Dialog Box

Table 5-7 Compare Plan Dialog Box Fields

Field Description Notes

Available Comparisons

Comparisons to be made and details to include.


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 5-8 Copy Plan as Template Dialog Box Fields

Field Description Notes

Template Name

Name of the new template based on the plan.


Use Cost Model from

Cost model to apply to the template.

The default is the cost model of the plan being copied. The list includes all supported cost models beginning with 5.3.

Custom Field Model

Custom field model to apply to the template.



Change Plan Attributes Dialog Box

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

Table 5-9 Change Plan Attributes Dialog Box Fields

Field Description Notes

Plan Name

Unique name that identifies the plan.

If you select multiple plans, the name field is disabled to prevent you from changing the name of more than one plan to the same name.

Status

Status of the plan:

  • Incomplete—Basic assumptions have not been set for the plan.

  • Draft—All input questions of the selected edit mode have been answered, but the plan owner or creator might still be working on the plan.

  • Final—All input questions have been answered and the plan owner believes the plan will be used to conduct the clinical study. However, the plan has not yet been approved.

  • Approved—The plan has been approved and is ready to go out as part of an RFP or proposal or to be used to conduct the trial.

  • RFP—The plan has been approved and included as part of an RFP.

  • Agreement reached; not started—An agreement has been reached on the plan and it is under contract (if an outsourced study) or ready for study activities to begin (if an internal sponsor-executed study).

  • In progress—The study has begun and is operating according to this plan

  • Study Complete—The study has ended.

  • Archived—The plan is being preserved for historical purposes only.


Cost Model

Cost model to apply to the plan.

The list includes all supported cost models beginning with 5.3.

Custom Field Model

Custom field model to apply to the plan.


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

Field Description Notes

Name column

Portfolios to which you can add the selected plan(s).


Description column

Short description of the portfolio.


# Plans Now column

Number of plans in the portfolio before adding the selected plan(s).


# Plans After column

Number of plans in the portfolio after adding the selected plan(s).


Also create a new portfolio and add the selected plans to it column

Create a 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 5-11 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).


Use Cost Model from

Cost model to apply to the reforecast.

The list includes all supported cost models beginning with 5.3.

Custom Field Model

Custom field model to apply to the reforecast.


Create reforecast based on

Actuals for reforecast based on actual tracked data or Plan for reforecast based on planned data.

Only available to users licensed to the Track module.


Reforecast Exch Rates (Create Reforecast) Dialog Box

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

Field Description Notes

Reforecast Date

Reforecast date for all listed plans.

You can edit the date for each plan individually.

Use Exchange Rates

Exchange rates reforecast method.

  • To reforecast based on exchange rates as of a particular date, choose the first radio button and then specify that date.

  • To reforecast based on exchange rates specified in a predefined published exchange rate table, choose the second option and choose the table by name from the list.


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.


Reforecast Name column

Suggested name for each reforecast. You can either accept this name or type a new name.


Prior Forecast Date column

Date of the last forecast per plan.

The new reforecast date must be later than this date.

Study End Date column

Date by which study is expected to be complete, defined as the date that all activity stops (usually the date the final report <CSR> is finalized).


Reforecast Date column

Date from which to apply the newly chosen exchange rates for each plan.

Recommended option if progress was tracked and actuals are up to date.

Based on column

Base the reforecast on the actual progress, rather than on the predicted progress.

Only available to users licensed to the Track module and for plans whose studies are being tracked.


Create/Edit Plan or Template Screen (Overview Tab)

Table 5-13 Overview Tab fields

Field Description Notes

Plan Name

Unique name that identifies the plan.


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.


Short Description

Short description of the plan that appears on the Plans screen.


Long Description

Detailed plan description.


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.

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.

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 5-14 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 5-15 Locations Tab Fields

Field Description Notes

Add Location(s) button

Add one or more locations on the Choose Locations dialog box.


Remove Location(s) button

Remove selected location(s).

Removing a location from a plan does not delete that location from the application.

Add Language(s) button

Add one or more languages not suggested for the plan by the application.


Remove Language(s) button

Remove a selected user-specified language.


Location column

Name of a location (either the country or the region) where sites will be located and subjects enrolled.


Number of Sites column

Number of sites for the location.


Subjects to Randomize column

Number of subjects to randomize in this location.

Should contain only the number of subjects that will actually be enrolled in the trial.

Must be a value between 1 and 999,999.

Avg Grant Amount column

Average grant amount is paid to each investigator for each subject the investigator enrolls in the study at the location.

Payment for a dropped subject is approximately 75% of the grant.

Must be a value between 0 and 500,000 USD (or the equivalent in another currency).

MOH/FDA Delay column

Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time frame for each location.

Must be a value between 0 and 999.

Total/Avg column

Averages of the total sites, subjects to randomize, grant amount and MOH/FDA time delay.


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 Location Dialog Box

Table 5-16 Choose Locations Dialog Box Fields

Field Description Notes

Regions filter

Include locations by region.


Countries filter

Include locations by country.


Remove Language(s) filter

Remove the selected languages.


Region column

Regions available for selection.


Country column

Countries available for selection.


Primary Language column

Primary language of the selected region or country.


Primary Currency column

Primary currency of the selected region or country.


MOH/FDA Delay column

Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time for each location.



Choose Additional Languages Dialog Box

Table 5-17 Choose Additional Languages Dialog Box Fields

Field Description Notes

Language column

Languages available.


ISO Code column

Internationally recognized country code associated with the language.



Document Translations Required Dialog Box

Table 5-18 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 5-19 Site Tab Fields

Field Description Notes

Location column

Name of a location where sites will be located and subjects enrolled.


Number of Sites column

Number of sites within the selected location.


Site Approval Schedule column

Type of site approval schedule for the location.

  • User Defined Schedule—Site approval schedule has been modified.

  • ClearTrial Default Schedule—Site approval follows the application-defined schedule.


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 of 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.

Task Group column

Assignment group to which outsourcing responsibilities are applied.

For a list of tasks, see the online Help for the Sites tab.

Sponsor column

Assign all of the tasks in that group to the study sponsor.


Vendor column

Assign all of the tasks in that group to the primary vendor assigned on the Provider tab.


Mixed column

Assign some of the tasks to the sponsor and some to the vendor.

Make these assignments on the Assignment tab.

N/A column

None of the tasks in the group will be performed.



Edit Site Approval Schedule Dialog Box

Table 5-20 Edit Site Approval Schedule Dialog Box Fields

Field Description Notes

Site Approval Schedule

Type of site approval schedule for the location.

User Defined Schedule—Site approval schedule has been modified.

ClearTrial Default Schedule—Site approval follows the application-defined schedule.


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.


Week # column

Week number. within the site approval schedule.


Week Of column

Start date of each week of the site approval period.


Sites (Default) column

Number of sites expected to be approved (according to the ClearTrial Default Site Approval Schedule) each week.

Cumulative totals appear inside parentheses.

% (Default) column

Percentage of sites expected to be approved (according to the ClearTrial Default Site Approval Schedule) each week.


Sites (User Defined)

Number of sites expected to be approved (according to the user-defined Site Approval Schedule) each week.


% (User Defined) column

Percentage of sites expected to be approved (according to the user-defined Site Approval Schedule) each week.


Total column

Total for each column.


Restore Defaults button

Restore the default site approval schedule for this location.


Apply button

Add the specified number of weeks to the site approval schedule.


Copy Default Value button

Populate the user-defined site approval schedule with the application defaults.

Use to revise part of the schedule rather than entering a new set of assumptions.


Subject Tab

Table 5-21 Subject Tab Fields

Field Description Notes

Project Activity Start Date

Date the study begins, defined as the date that vendors and the sponsor start identifying sites and vendors start billable activity.

Appears here for easy reference.

First Subject In Date (FSI/FPI)

Date for the first subject visit (FSFV) to occur.


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.


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 5-22 Edit Subject Enrollment Dialog Box Fields

Field Description Notes

Update study level enrollment period to

Study-level enrollment period.


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).


FSI column

First Subject In. Date that the First Subject First Visit (FSFV) is expected to take place.


Enrollment Period column

Number of weeks during which subjects will be enrolled in the trial.


Last Subject In Date column

Location -specific First Subject In date plus the enrollment period.


Enrollment Rate column

Number of subjects expected to be enrolled per site per month.



Edit Subjects Arrival Dates Dialog Box Fields

Table 5-23 Edit Subjects Arrival Dates Dialog Box Fields

Field Description Notes

Enrollment per Location

Defines subjects arrival dates per location.


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.


Apply button

Applies the FSI date shift value to the selected locations.


Location column

Subject arrival region.


FSI column

First Subject In date.

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

Study Level column

Location-specific First Subject In date plus the enrollment period.



Edit Enrollment Distribution Dialog Box

Table 5-24 Edit Enrollment Distribution Dialog Box Fields

Field Description Notes

Location option

Location for which the subject enrollment distribution is managed.


Type of enrollment distribution option

Expected enrollment distribution.

  • Acute—For indications where the subjects must present with the condition and will not be found by searching the medical records. Example: Anti-infective trials might experience an Acute or Acute Short Startup enrollment distribution.

  • Acute Short Startup—For Acute indications AND when you expect that less than 75% of the sites will be approved at the time when the first subject enrolls.

  • Bell Curve—Used only when the enrollment type is unclear to get an estimate of the study using an approach other than an even distribution of subjects across the enrollment period.



  • 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 option

Resolution at which to manage the subject enrollment distribution.


Period column

Period, quartile, or study week, during which subjects are planned to enroll.


Subjects column

Number of subjects expected to enroll during a particular period or quartile.


Percentage column

Percentage of subjects expected to enroll during a particular period or quartile.



Edit Location-specific Screening and Drop Rate Assumptions Dialog Box

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

Field Description Notes

Location

Screening and drops region.


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 5-26 Treatment Tab Fields

Field Description Notes

Trial Design

Parallel or Cross-over study design.

  • Parallel—Different subjects receive different treatments during the same period.

  • Cross-over—Each subject receives all of the defined treatments, but in a different sequence.


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.


currency drop-down list

Currency of the Cost per bednight.


Number of CRF pages collected in the baseline visit

Total number of CRF pages collected for enrolled subjects during their screening visits and during the baseline visit.

Appears if the Trial Design is Cross-over.

Must be a value between 0 and 99.

If two or more patient visits occur in the same week, treat them as a single visit for calculation purposes.

Baseline visit monitoring time required (in minutes)

Minutes required to monitor pages collected during screening and baseline visits.

Appears if the Trial Design is Cross-over.

Must be a value between 0 and 9,999.99.

Washout period duration

Length of the washout period, specified in weeks for late stage trials and in days for Phase 1 trial.

Appears if the Trial Design is Cross-over.

Time between treatments in a cross-over trial in which subjects are not treated. Done to reduce or avoid residual effects of the prior treatment from skewing the data or compromising the validity of the subsequent treatment(s).

Must be a value between 0 and 999.

Number of bednights during the washout period

Number of nights that a subject is confined to a study center during the washout period.

Appears if the Trial Design is Cross-over.

Add button

Add a new treatment.

You can add up to five treatments to the study.

Edit button

Edit a treatment on the Treatment Details dialog box.


Copy button

Duplicate an existing treatment.


Delete button

Remove a treatment.

Deleting a treatment removes all of its associated assumptions.

ID

Alphabetic identifier for the treatment entry.


Number of subjects

Number of subjects to receive the treatment.

Included for parallel studies.

Not included for cross-over studies because all subjects receive all treatments. Treatment sequence varies).

Must be a value between 1 and 999,999.

Treatment duration

Treatment length, or time-on-trial, for each subject.

For late-stage trials, specified in weeks.

For Phase I trials, specified as days.

Must be a value between 2 and 999.

Visits per subject

Number of visits for each subject during the treatment.

For late-stage trials, a visit is a week.

For Phase I trials, a visit is a day on which one or more CRF pages are collected.

For Phase I (Healthy Volunteers) trials, in which subjects are confined, each day is a visit.

Must be a value between 2 and 999.

Number of bednights

Number of nights subjects are confined to a study center during the treatment period.

Must be a value between 0 and 999.

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 2 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.

Monitoring minutes per CRF page

Number of minutes to monitor one regular CRF page.

This field does not apply to monitoring for pages generated during the baseline visit. The application calculates the default value based on the study phase and therapeutic indication. You can override this value for each treatment. Overridden values do not affect minute per page values for the baseline visit or washout period for a crossover study.

  • If endpoint study, applies to both the standard treatment period and the extended treatment period for the treatment arm.

  • Does not apply to pages collected at baseline visit or during washout period. Those values can be configured through the washout configuration option or on the treatment schedule.

Available in Expert mode only.

Must be a value between 1 and 100.

Precision up to three decimal places appears. If the default value has more than 3 decimal places, the full numeric value appears when you hover the mouse over the field.

Name

Cross-over design that determines the sequences of treatments to which subjects are randomized.

The application supports Latin Square and Balaam's Design. Balaam's design is only applicable to trials with exactly two treatments.


Treatment Sequence

Order in which treatments are administered.



Edit Washout Period Dialog Box

Table 5-27 Edit Washout Period Dialog Box Fields

Field Description Notes

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 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, Notes Tab)

Table 5-28 Details Tab Fields

Field Description Notes

Treatment duration

Treatment length for each subject.

For late-stage trials, specified as weeks.

For Phase I trials, specified as days.

Must be a value between 2 and 999.

Visits per subject

Number of visits for each subject during the treatment.

Must be a value between 2 and 999.

Number of bednights

Number of nights subjects are confined to a study center during the treatment period.

Must be a value between 0 and 999.

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.

Location column

Location to which the treatment cost is applied.


# Subjects column

Number of subjects expected to be randomized to this treatment in each location.


Procedure Cost column

Amount paid to the CPU for each subject to perform the standard/common procedures required by the trial.

Must be a value between 0 and 500,000 USD (or the equivalent in another currency).

Special Procedure Cost column

Amount paid to the CPU for each subject to perform special or uncommon procedures required by this treatment.

Must be a value between 0 and 500,000 USD (or the equivalent in another currency).

Stipend Per Enrolled Subject column

Amount paid to the subjects in this location.

Must be a value between 0 and 500,000 USD (or the equivalent in another currency).


Table 5-29 Schedule Tab Fields

Field Description Notes

Monitoring minutes per CRF page

Number of minutes to monitor one regular CRF page.

This field does not apply to monitoring for pages generated during the baseline visit. The application calculates the default value based on the study phase and therapeutic indication. You can override this value for each treatment. Overridden values do not affect minute per page values for the baseline visit or washout period for a crossover study.

Must be a value between 1 and 100.

Use example grant amount

Select to enter numeric values for each visit. The application converts these into percentage values.

The value is not saved; only the percentage is saved.

Day

Day within the treatment period, represented by an integer.


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.

Change the percentages to control how grants are accrued and payments distributed over the course of the trial.

Total Number of CRF Pages

Total number of CRF pages to be collected for a single subject during the course of this treatment.


Total visits per subject.

Total number of visits for each subject for this treatment.

Must be a value between 2 and 999.

Total Grant Allocation

Total percentage of the grant allocated to the subject treatment schedule.

Must equal 100% for the schedule to be valid.

Clear CRF Defaults link

Overrides the entire calculated schedule.


Restore CRF Defaults link

Restores default values for CRF pages and monitoring time.


Clear Grant Overrides link

Restores default values for grant allocations.



Table 5-30 Notes Tab Fields

Field Description Notes

Notes

Information relevant to the treatment that you want to be available to other people who view this plan or reports.



Data Tab

Table 5-31 Data Tab Fields

Field Description Notes

Data Collection Method

Data collection method for the study.

  • Paper (Traditional Monitoring)—Monitors visit the sites to collect data.

  • Electronic Data Capture (EDC)—Study data is collected electronically. The application calculates associated direct labor fees and indirect costs based on the level of EDC proficiency.

  • EDC-3rd Party—The application does not calculate labor fees related to EDC. Instead, you can create or adjust pass-through costs to account for these expenditures.

  • Faxed CRFs—Case Report Forms (CRFs) are completed at the investigator site and faxed to the data management location.

  • Investigator Site Data Entry—Data is entered into a data capture system or web-based system by someone at the site.

If there is no data monitoring for the study, select Paper (Traditional Monitoring) and set monitoring responsibilities to N/A.

Electronic Data Capture (EDC) is the default data collection method.

EDC Maturity Level

Level of EDC proficiency for the study. Enter if you selected Electronic Data Capture (EDC) or EDC-3rd Party data collection method.

  • Stage 1: Pilot/Single Study—Actively conduct experimental EDC implementations within a single study or within a limited number of trials.

  • Stage 2: Limited Standardization—Use EDC in a limited number of studies.

  • Stage 3: Standardization—Use EDC for all new trials.

  • Stage 4: Enterprise Deployment—EDC is fully integrated for all of your trials.

Default data collection method is EDC Maturity Level 3 for all new plans.

Query Rate

Average percentage of queries expected for every 100 pages of Case Report Form (CRF) data.

Must be a value between 0 and 999.99.

Percent of database data to audit

Percent of database information that is audited.

Default value is 10%.

Minutes for Data Entry per CRF page

Number of minutes required to enter one Case Report Form (CRF) into the database.


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.

Number of Unique Pages

Number of unique pages in the Case Report Form (CRF) that are not duplicates of another CRF page or screen.

Minimum value is 1.

Number of screens per CRF page

Number of screens needed to capture one paper Case Report Form (CRF) page.

Must be a value between 1 and 10.

CRF page NCR ply

Type of paper on which the Case Report Form (CRF) prints.

2, 3, or 4 ply NCR paper.

Cost per page to print CRF

Cost per page for printing the Case Report Form (CRF).

Between 1.00 and 1.60 USD per page, depending on ply. Must be a value between 0.00 and 10.00 USD (or the equivalent in another currency).

Number of Unique Data Tables

Number of unique data tables.

The application calculates a default number based on the Number of Unique Pages field.

Number of Repeat Data Tables

Number of repeat data tables.

The application calculates a default based on the Number of Unique Pages field.

Must be a value between 0 and 99.

Number of Unique Data Listings

Number of unique data listings.

The application calculates a default number based on the Number of Unique Pages field.

Number of Repeat Data Listings

Number of repeat data listings.

The application calculates a default number based on the Number of Unique Pages field.

Number of Unique Figures and Graphs

Number of unique figures and graphs.

The application calculates a default number based on the Number of Unique Pages field.

Number of Repeat Figures and Graphs

Number of repeat figures and graphs.

The application calculates a default number based on the Number of Unique Pages field.

Number of Unique PK/PD Data Tables

Number of unique PK/PD related tables.


Number of Repeat PK/PD Data Tables

Number of repeat PK/PD related tables.


Number of Unique PK/PD Data Listings

Number of unique PK/PD related listings.


Number of Repeat PK/PD Data Listings

Number of repeat PK/PD data listings.


Number of Unique PK/PD Figures and Graphs

Number of unique PK/PD related figures or graphs.


Number of Repeat PK/PD Figures and Graphs

Number of repeat PK/PD figures and graphs.


Number of newsletters per site

Number of newsletters to provide per site.

Indicate how many timed the newsletters will be generated. For example, if the study has 120 sites and there will be 12 newsletters, enter 12.

Will there be an ICF Video/DVD?

Whether there will be an ICF Video/DVD.


Number of years to archive data

Number of years study data must be kept after the study completes.

Default value is 5 years. Must be a value between 0 and 30.

Number of online EDC training sessions

Additional training sessions that occur for EDC. This is not the training at the Investigator meeting or initial CRA training.

Default value is 3.

Required if you selected EDC or EDC-3rd Party as the data collection method.

Number of pages in the Investigator Brochure

Number of pages in the Investigator Brochure.

The Investigator Brochure can be a few pages or more than 250 pages.

Deselect the Write IB task on the Assignment tab if the Investigator Brochure was previously written.

Number of manuscripts

Number of documents, other than the final Clinical Summary Report.

Must be a value between 0 and 99.

Days from LSO/LPO until Database Lock

Number of days from last subject observation (LSP/LPO) until the database lock.

Default values are 30 days for Stage 1, 20 days for Stage 2, 12 days for Stage 3, and 8 days for Stage 4.

The minimum value is 1.

Days from Database until Statistical Report is due

Number of days from the database lock date until the statistical report is delivered.

Default values are 45 days for Stage 1, 38 days for Stage 2, 36 days for Stage 3, and 34 days for Stage 4.

Minimum value is 1.

Days from Database Lock until Draft Report is due

Number of days from the database lock date until the draft clinical report is delivered.

Default values are 73 days for Stage 1, 70 days for Stage 2, 67 days for Stage 3, and 65 days for Stage 4.Minimum value is 1.

Days from Database Lock until Final Report is due

Number of days from the database lock until the final clinical summary report (CSR) is delivered.

Default values are 98 days for Stage 1, 95 days for Stage 2, 90 days for Stage 3, and 85 days for Stage 4.Minimum value is 1.

SAE rate as a percent of randomized subjects

Percentage of anticipated serious adverse events (SAEs) in terms of a percent of the total subject population.

Must be a value between 0 and 9,999.99.

SAEs

Number of serious adverse events (SAEs) calculated by the application.


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 Usage

Tasks for which an Interactive Voice Response System (IVRS) is used.


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.


Task Group column

Assignment groups to which outsourcing responsibilities are applied.

For a list of tasks, see the online Help for the Sites tab.

Sponsor column

Assign all of the tasks in that group to the study sponsor.


Vendor column

Assign all of the tasks in that group to the primary vendor assigned on the Provider tab.


Mixed column

Assign some of the tasks to the sponsor and some to the vendor on the Assignment tab.


N/A column

None of the tasks in the group will be performed.



Monitoring Tab

Table 5-32 Monitoring Tab Fields

Field Description Notes

Monitoring will be performed

Whether monitoring will be done in-person, by phone, or by a combination of these methods.


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.


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.


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.


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.


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.


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 5-33 Edit Per Location Monitoring Schedule Dialog Box Fields

Field Description Notes

Monitoring will be performed

Whether monitoring will be done in-person or by phone or by a combination of these methods.


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.


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 5-34 Edit Per Location Monitoring Approach Dialog Box Fields

Field Description Notes

Restore Defaults

Click to restore the monitoring assumptions to the global values for a specific location.


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 5-35 Provider Tab Fields

Field Description Notes

Add Provider(s) button

Add providers.


Remove Provider(s) button

Remove providers.


Set as Primary Provider button

The primary, or default, provider for tasks.


Replace Provider button

Replace the selected provider with another provider.


Freeze Billing Rates/Unfreeze Billing Rates button

Freeze or unfreeze the rates for the plan.

The application copies the current rates for the current providers and stores them with this plan.

Provider Name column

Provider name.


Provider Type column

Provider type.


Rate Year in Effect column

Rate Year used to look up billing rates for the resources for this service provider for this plan.


Back-Office Billing Rate Location column

Location used to determine the default billing rates for centralized tasks or tasks conducted at a central location.

To change this or other provider-specific values, click the provider name to open the Provider Details dialog.


Choose Service Providers Dialog Box

Table 5-36 Choose Service Providers Dialog Box Fields

Column Description Notes

Name

Name of the service provider.


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 5-37 Specify Provider-Specific Details Dialog Box Fields

Field Description Notes

Rate Year in effect

Rate year, associated with the billing rate, selected from the drop-down list.


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.


Line Item Discount

Negotiated line-item discount established with this particular provider.

Must be a positive value between 0 and 999,999 USD (or equivalent value if non-USD).

Default is 0.

If there is more than one provider for a plan, each could offer a different discount.

Currency

Currency in which line-item discount is calculated.

If provider is replaced, currency selection remains in effect.

Billing Rate Currency

Currency type for billing rate.


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.

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.


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 5-38 Choose Replacement Provider Dialog Box Fields

Column Description Notes

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 5-39 Meetings Tab Fields

Field Description Notes

Edit button

Edit a meeting.


Copy button

Copy a meeting.


Include button

Include a meeting.


Exclude button

Exclude a meeting.


Delete button

Delete a meeting.


Name column

Meeting name.


Type column

Meeting type.


Location column

Meeting location.


Occurs column

Meeting frequency.


Planner column

Meeting organizer.



Define New Meeting Dialog Box

Table 5-40 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 5-41 Meeting Details Tab Fields

Field Description Notes

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.


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.


Provider

Service providers attending the meeting.


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 5-42 Attendees Tab Fields

Field Description Notes

Service Provider

Service provider for which you are editing or viewing meeting attendees.


Add button

Add additional meeting attendees.


Delete button

Delete meeting attendees.

You can only delete user-defined attendees.

Duplicate button

Copy a meeting attendee.


Expand All Billable Hours link

View details about billable hours for each meeting attendee.


Attendees column

Number of meeting attendees for the associated resource type.


Resource Type

The resource type attending the meeting.


Billing Rate Location column

The billing rate location for the meeting attendee.


Attendance Method column

Attendee travel method.


Billable Hours column

Number of billable hours for the meeting attendee.


Preparation column

Number of hours of preparation expected by this resource.

Appears if the Expand All Billable Hours or Edit links are selected.

Must contain a value between 0 and 999.99.

Travel column

Number of hours of travel expected by this resource.

Appears if the Expand All Billable Hours or Edit links are selected.

Must contain a value between 0 and 999.99.

Attendance column

Number of hours that this resource is expected to attend the meeting.

Appears if the Expand All Billable Hours or Edit links are selected.

Must contain a value between 0 and 999.99.

Follow Up column

Number of follow up hours expected by this resource.

Appears if the Expand All Billable Hours or Edit links are selected.

Must contain a value between 0 and 999.99.

Indirect Costs column

Indirect costs for the meeting attendee.


Travel column

Total travel indirect costs for each meeting attendee.


Other column

Other indirect costs for each meeting attendee.



Table 5-43 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 5-44 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 5-45 Notes Tab Fields

Field Description Notes

Notes

Description and notes about the meeting.

Any user who has permission to edit the plan can view and edit these notes.


Assignment Tab

Table 5-46 Assignment Tab Fields

Field Description Notes

Values apply to

Assign responsibility for a specific country or region to a specific service provider.

If you select Centralized Tasks/Locations Defaults, your task assignments apply to all locations in the study.

If you select the country or region, the task assignments you make only apply to that country or region.

Default service provider for outsourced tasks

Default service provider for outsourced tasks.


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.


Assignment Group/Task column

Available assignment groups and tasks.


Assign to column

Service provider to which the task is assigned.


Billing Rate Location column

Billing rate location.

The application uses this location to calculate resource costs for the task.

Pinned column

Save your assignments for a specific task or assignment group.

Pinning a task or assignment group ensures your selections are not lost due to other changes in the work breakdown structure.

Pinned settings are lost if the associated locations or service providers are removed from the plan.

If you replace a service provider, your pinned settings are saved.


Resource Overrides Dialog Box

Table 5-47 Resource Overrides Dialog Box Fields

Field Description Notes

Values apply to

Locations affected by the overrides.


Default service provider for outsourced tasks

Service provider whose resources or rates are to be overridden.


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

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

Table 5-48 Labor Tab Fields

Field Description Notes

Show hours and fees for

Service provider for which hours and fees appear.


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.


New Major Task button

Create a major task. Opens the Task Manager dialog box.


Edit Major Task button

Edit the selected major task. Opens the Task Manager dialog box.


Delete Major Task button

Delete the selected user-defined major tasks.

Permanently deletes the major task and its tasks, resources, algorithms, and overrides. You cannot restore deleted major tasks.

Adjust Hours of Fees button

Adjust the labor unit hours and fees for the selected major task and service provider on the Task Manager dialog box.


Pin Labor button

Pin all labor units, costs, hours and distributions.


Unpin Labor button

Unpin all labor units, costs, hours and distributions.


Major Task column

Major task type.

For a description of each major task, see the online Help for the Labor tab.

Unit Hours column

Level of effort (in hours) for the selected service provider to complete one unit of work for the major task.

Displayed values are rounded to the nearest 10th. Hover over the value to see the actual value.

Unit Cost column

Total cost for the selected service provider to complete one unit of work for the major task.

Displayed values are rounded according to the conventions of the currency.

# Units column

Total number of units of work expected (or, in the case of a re-forecast, remaining).

Some major tasks have a single unit of work; for example, Study or Database. Hover over the value to see the number of units.

Ext Hours column

Total level of effort (in hours) for the selected service provider to complete the major task.

The application multiplies the Unit Hours by the # Units.

Displayed values are rounded to the nearest 10th. Hover over the value to see the actual value.

Ext Cost column

Total cost for the selected service provider to complete the major task.

Displayed values are rounded to the nearest whole number. Hover over any value to see the value rounded according to the conventions of the currency.

Total Ext Hours column

Total level of effort in hours for the selected service provider to complete the major task.

Determined by multiplying the Unit Hours by # Units.

Total Ext Cost column

Total cost for the selected service provider to complete the major task.

Determined by multiplying Unit Cost by # Units.


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

Table 5-49 Task Manager: 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.

Custom units of work appear in italicized type followed by an asterisk.

New Task button

Create a new task for the selected major task.


Edit Task button

Edit the selected task.


Delete Task button

Delete the selected task.


Edit Assignments button

Edit service provider assignments for the selected task.



Table 5-50 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.


Location column

Location (countries/regions or centralized) where the service provider is conducting work on the major task.


Planned column

Planned number of units, unit hours, and unit cost for the major task.


Adjusted column

Adjusted number of units, unit hours, and unit cost for the major task.

You can override these fields. Enter the number of unit hours and unit cost or a percentage.

Pinned column

Saves the number of units, unit hours, and unit costs preventing changes from cascading through the plan.


Extended Hours column

Total plan hours for each location.

The application calculates this number based on plan assumptions.

Extended Cost column

Total cost for each location.

The application calculates this number based on plan assumptions.


Table 5-51 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.

Period column

Period during which the number or percentage of units are expected to be completed.


Percentage column

Percentage of units expected to be completed during the associated period.


Total column

Total percentage of work completed during the work periods.



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

Table 5-52 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.

Add Resource button

Add a resource to this task.


Edit Resource button

Change details about the resource effort or rates for this task. resource


Delete Resource button

Remove a resource from this task.


Resource Name column

Resource typically assigned to this task.


Substitutions column

Resource overrides for a resource.



Table 5-53 Task Manager: New Task, Task Assignments Tab Fields

Field Description Notes

Location column

Location in which task is performed.

For centralized tasks, All Locations appears.

Included column

If selected, the task is included in the study, for the location.

Deselect to exclude a task for a specific location.

Service Provider column

Service provider who performs the task for this location.


Billing Rate Location column

Billing rate location for each location.

If you select Local, the application uses the location from where the subject data are collected for the billing rate calculations.

If you select a country, the application uses the billing rate data for that country.

If you select Back Office, the application uses the location specified as the back office billing rate location for the assigned service provider.

You can choose a different billing rate location for each resource for each location.

Pinned column

Saves your task settings so that changes made at general levels do not affect the task.


Add Resource button

Add a resource to this task.


Edit Resource button

Change details about the resource effort or rates for this task. resource


Delete Resource button

Remove a resource from this task.


Resource Name column

Resource typically assigned to this task.


Substitutions column

Resource overrides for a resource.



Task Manager: Select Resources Dialog Box

Table 5-54 Task Manager: Select Resources 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 5-55 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.


Location column

Location in which the resource performs the work.


Service Provider column

Service provider to which the resource belongs.


Department column

Department to which this resource belongs when performing the task.


GL Code column

General Ledger code for fees associated with this resource when performing the task.



Table 5-56 Task Manager: Edit Resource, Algorithm Tab Fields

Column Description Notes

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.

Custom units of work appear in italicized type followed by an asterisk.

# 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 5-57 Task Manager: Edit Resource, Billing Rate Location Tab Fields

Column Description Notes

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 5-58 Task Manager: Edit Resource, Rates & Substitutions Tab Fields

Column Description Notes

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 5-59 Task Manager: Edit Resource, Unit Hours Tab Fields

Column Description Notes

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.


Task Manager: Major Task Descriptions

Table 5-60 Task Manager: Major Task Descriptions

Field Description Notes

Project Initiated

Activities associated with getting the study started for all sites at all locations


Study Setup

Centralized start up activities such as negotiation of the all the central labs, design of study documents, development of Investigator Brochure, ICF, diary and protocol translations, and design of the randomization system.


Study Setup Per-Location

Start up activities that are specific to individual locations, such as printing and distribution of the IB; distribution and collection of training materials and investigator meeting materials; development of country-specific ICF; clinical trial application approvals and negotiation of central IRB/IEC.


A Written Protocol

For a protocol provided by the sponsor or CRO, create, edit, and review the protocol draft.


Unique CRF Page Developed

The development of a single unique CRF page or the electronic equivalent, including creation of the edit specifications.


CRF Book Printed

Activities associated with the printing of the CRF; does not apply to electronic data capture.


Meetings - Kickoff

Activities for kickoff meetings.


Meetings - Investigator

Activities for investigator meetings.


Meetings - Face to Face

Activities for face to face meetings.


Meetings - Teleconference

Activities for teleconference meetings.


Meetings - Internal Team

Activities for internal team meetings.


Meetings - Other

Other tasks related to meetings.


Meetings - End of Study

Activities for end of study meetings.


Site Identified by Sponsor

Sites that have been identified and screened by the sponsor and not by the vendor.


Site Identified by Vendor

Sites that have been identified and screened by the CRF provider and not by the sponsor.


Pre-study Site Visit (PSSV)

The activities that are associated with a pre-qualification visit to an investigator site; includes preparation, follow-up, and travel time.


Pre-study Site Visit (PSSV) by phone

Pre-study site qualification activities conducted by telephone versus in person.


Site Approved

Activities for the identification and approval of an investigative site. Includes regulatory document preparation, collection and approval, site contract negotiation, and drug shipment to site. It does not include the Pre-study or Site Initiation Visits.


Site Initiation Visit

The activities for the initiation of a study investigator site and staff; includes preparation, follow-up and travel time.


Site Initiation Visit by Phone

Site initiation by phone.


Drug Packaging and Supply Audit

Audit activities of the drug packaging and supply facility.


Study Drug Shipment Tracked

Tracking of the drug shipment to all study sites.


Completed Statistics & Analysis Plan (SAP)

Development of the Statistical Analysis plan for the final report and performance of the analysis.


Database Designed

Activities for the design and programming of the clinical data base.


Data Entry Screen Developed

The development of a data entry screen for the internal or external data entry for the CRF pages or EDC equivalent.


IVRS Setup

The set up and management of an interactive voice response system.


Subject/Volunteer Randomized

Tracking the randomization of subjects in any given study.


Project Management Week prior to FSI

The project management activities that are associated with the clinical trial from study start through First Subject Enrolled.


Project Management Week after FSI

The project management activities that are associated with the clinical trial from First Subject Enrolled through the Final Report.


SAE Database Programmed

SAE Database Programmed (an independent activity from SAE management).


SAE Report Completed

All of the tasks for the reporting of Serious Adverse Events, including writing the relevant narratives.


Expedited SAE Report Completed

Preparation of SAEs that are reportable events to health authorities. These are events that are being reported for the first time.


Monitored Clean CRF Page

The on-site Source Document Verification (SDV) and retrieval of paper CRF pages, or the review of electronic equivalents, and related on-site activities.


Onsite Monitoring Visit - Prep, Travel, Reporting, and Follow-up

The non-source document verification tasks associated with monitoring visits, including preparation, travel, and follow-up.


One Hour of Phone-based Monitoring

One hour of phone-based monitoring, in lieu of on-site monitoring. Formal trip reports will be completed.


Separate Drug Accountability Visit

A separate visit to an investigator site to account for drug to keep the CRO vendor monitor blinded to the study drug.


Newsletter Prepared

The preparation and distribution of newsletters to clinical investigators.


CRF Page Entered into Database

The double keyed data entry of a paper CRF into the data base; tracking and logging of CRF pages, coding and data coordination, which does not apply to electronic data capture.


Query Resolution - by Monitor

Resolution of Data Clarifications Forms (DCF) by the study monitor. Can be conducted on-site or remotely. Does not include resolution by the data management group.


Interim Analysis

All activities for the development of an interim analysis of the study data.


Site Audited

All activities for performing a clinical compliance audit of an investigator site.


Annual IND Report Activities

Preparation of the annual IND safety update tables and listings for each active year of the study.


Site Close-out Visit

Activities associated with study close out of an investigator site.


Site Close-out by Phone

Site close out activities completed by phone versus in person.


Third-party Data Import

Import of third party data at a defined frequency throughout the life of the study.


All Data Cleaned and Database Locked

The ongoing data query process and cleaning of the clinical data from first patient enrolled through database lock.


Data Transfer

The transfer of clinical data to the sponsor one or more times.


Final Data Audit

An internal audit of the database, conducted by the provider responsible for data management, defaulted to 10% of the data, but can be edited by you.


Issued Unique PK/PD Summary Table

Activities required to issue a unique summary table.


Issued Unique PK/PD Summary Listing

Activities required to issue a unique data listing.


Issued Unique PK/PD Summary Figure/Graph

Activities required to issue a unique data figure or graph.


Issued Repeat PK/PD Summary Table

Activities required to issue a unique summary table.


Issued Repeat PK/PD Summary Listing

Activities required to issue a unique data listing.


Issued Repeat PK/PD Summary Figure/Graph

Activities required to issue a unique data figure or graph.


Issued Unique Summary Table

Includes activities for specifications, programming, and quality control to issue unique tables.


Issued Unique Summary Listing

Includes activities for specifications, programming, and quality control to issue unique data listings.


Issued Unique Summary Figure/Graph

Includes activities for specifications, programming, and quality control to issue unique data figures/graphs.


Issued Repeat Summary Table

Includes activities for specifications, programming, and quality control to issue repeated tables.

Tasks include:

  • Complete Repeat Summary Table Specification

  • Complete Repeat Summary Table Programming

  • Complete Repeat Summary Table Quality Control

Issued Repeat Summary Listing

Includes activities for specifications, programming, and quality control to issue repeated summary listings.

Tasks include:

  • Complete Repeat Summary Listing Specifications

  • Complete Repeat Summary Listing Programming

  • Complete Repeat Summary Listing Quality Control

Issued Repeat Summary Figure/Graph

Includes activities for specifications, programming, and quality control to issue repeated figures or graphs.

Tasks include:

  • Complete Repeat Summary Figure/Graph Specifications

  • Complete Repeat Summary Figure/Graph Programming

  • Complete Repeat Summary Figure/Graph Quality Control

PK/PD Report

Activities required to issue the PK/PD Report.


Stat Report

The development of the statistical report section of the Clinical Summary Report.


Draft Report

All of the activities associated with one draft of the Clinical Summary Report.


Final Report (CSR)

The activities associated with taking the draft report and finalizing it for publication/submission.


Prepared Publication

Manuscripts or journal articles other than the Clinical Summary Report that are prepared for publication.


EDC Help Desk

Set-up of the software and necessary hardware for the study. Assist the investigator site personnel with access to the on-call clinical expert or medical monitor to address questions related to trial matters.


EDC Training

Responsible for activities related to EDC training management. Includes initial and one round of refresher training.


Sponsor Oversight

All of the management activities associated with oversight of the outsourced tasks. This does not include time that a sponsor spends on any of the project tasks conducted internally.



Costs Tab

Table 5-61 Costs Tab Fields

Field Description Notes

Show: Excluded Cost(s) filter

Displays costs that have been previously excluded.

Excluded costs are not included in the plan budget.

Show: Categories where costs total 0.00 filter

Displays cost categories where the total cost equals 0.00.

Deselect to hide cost categories where the total cost equals 0.00.


New button

Opens the Define New Category dialog box to create a user-defined cost.


Edit button

Opens the Edit or Adjust Cost dialog box to display the breakdown of costs by location and adjust the cost category type, department, and GL code.

If the Edit button is disabled, you have selected more than one cost. Deselect the additional costs.

Exclude button

Excluded the selected costs from the plan budget totals.

Excluded costs are not deleted. They appear with a line through them.

Include button

Restores the selected excluded costs.

Set the filter to show excluded costs.

Delete button

Permanently delete the selected user-defined costs.

You cannot delete default application costs. You cannot restore deleted user-defined costs.

Name column

Name referring to a specific cost or cost type.

For a description of each cost, see the online Help for this tab.

Type column

Whether the cost type is a pass-through or another type of indirect cost.


Calculated column

Application-calculated cost based on the assumptions entered on other tabs.


Adjustment column

Total amount of adjustments entered on the Adjustments tab of the Edit or Adjust Dialog box.


Total column

Total calculated cost, including any adjustments.

Must be zero or greater.


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

Table 5-62 Define New Category Dialog Box, Definition Tab Fields

Field Description Notes

Name

Name for the user-defined cost, containing up to 45 characters.

The name must be unique to the plan.

Type

Whether the cost is a pass-through or miscellaneous cost, or associated with a specific department.


Code

User-defined task code.


Mapping Key

System-defined code that is included as part of the mapping key in the bid grid export found in the RFP feature.


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

Additional notes or comments about the cost.

Displayed as help content for user-defined costs.

Created By

Name of the user who created the cost.


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 5-63 Define New Category Dialog Box, Algorithm Tab Fields

Field Description Notes

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.

Custom units of work appear in italicized type followed by an asterisk.

Location

Location with which a cost is associated.

Applies only to costs that are defined to vary by location.

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 5-64 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.



Cost Category Descriptions

Table 5-65 Cost Category Descriptions Fields

Field Description Notes

Advertising (additional)

Advertising costs for finding subjects, not included in the investigator grants.

The application does not calculate this cost.

Call Center

Costs associated with a subject enrollment call center.

The application does not calculate this cost.

Clinical Trial Insurance

Costs based on the location of the sites and the number of sites for a particular clinical trial.

The total clinical trial insurance is the sum of these costs for all sites you select on the Locations tab and are entered as Pass Through Costs.


Consultants

Fees associated with outside consultants that are not part of CRO Vendor fees.

The application does not calculate this cost.

CRF Printing

Costs for printing the CRF books, based on the number of pages per CRF book, the number of subjects in the study, the ply of the NCR paper, and the cost per page that you indicate on the Data tab.

The costs for CRF distribution are the costs to package and ship the CRF books to each site.

The application assumes you print an average of fifteen percent of CRF Books.

The application calculates this cost, however, you can enter adjustments to raise or lower this value.

Drug Distribution - Special Handling

These costs apply to special costs associated with shipping the study drug/test article. Examples include the use of dry ice, custom fees, and central pharmacy shipping fees.

The application does not calculate this cost.

Drug Distribution - Standard Shipping

The application bases these costs on the location of the sites and which company is handling the distribution of the study drug or device being studied.

These are estimated costs for storing and distribution of the study drug (test article) to the sites based on the frequency of shipments of the material being shipped.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Drug Packaging

Costs associated with the actual packaging and storage of the test article prior to routing to the distribution center.

The application bases these costs on the location of the sites and which company is handling the packaging of the study drug. The method of packaging is a significant driver of these costs.

If your study drug or device requires special packaging and labeling, Oracle recommends that you override the estimate the application calculates.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

DSMB Reporting

Costs associated with compiling and reporting information to the Data Safety Monitoring Board (DSMB).

The application calculates these costs based on several factors, including how often you report data to the Data Safety Monitoring Board. This assumption is on the Monitoring Tab.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

EDC - 3rd Party Costs

Costs associated with Electronic Data Capture (EDC) that is managed by a third party.


EDC Hosting

Costs associated with Electronic Data Capture (EDC) Hosting. This is a centralized cost and calculates based on the EDC maturity level you select.

The start date is 28 days prior to the First Subject In (FSI) and the End Date is the date of the Database Lock.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

EDC Licensing

Costs associated with Electronic Data Capture (EDC) Licensing. This is a centralized cost and calculated based on the EDC maturity level selected.

The Start Date is the Project Activity Start Date and the End Date is the Final Report Date.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

EDC Setup

Costs associated with setting-up Electronic Data Capture (EDC) with a Third Party. This is a centralized cost and is calculated based on the EDC maturity level selected.

The start date is 30 days prior to the global First Subject In (FSI) date and the End Date is the FSI date.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Electronic Data Capture (EDC)

Costs associated with Electronic Data Capture (EDC), including hardware costs, configurations costs, training costs, telecommunication fees, and monthly maintenance fees.

This cost category only applies to plans that were created prior to ClearTrial release 4.2.0. As of release 4.2.0, this item is replaced by tasks and costs covering setup, hosting, and licensing.

Event Committee Costs

Costs associated with Event Committee costs, not including Initial and Annual IRB fees estimates.

The application does not calculate this cost.

FDA Audits

Costs associated with FDA audits.

Actual FDA audits are not typically covered in bids from CROs, as these audits are typically conducted by the sponsor. When the FDA requires an audit, the CRO or sponsor handles this as a change order.

If you know or expect a certain number of audits to occur, enter an estimated value here.

The application does not calculate this cost.

Investigator Grants - Grant Payments

All fees paid per subject to the investigator sites for enrollment into the study and in accordance with the study protocol.

The application calculates this value based on the grant amount you enter on the Locations tab, by country, specifically for the numbers of subjects in each country.

The grant amount calculation includes the number of subjects to randomize and the subject drop rate.

The grant calculation for dropped subjects assumes each dropped subject only completes 75% of a completed CRF book.

The grant calculation for a completed subject assumes 100% of the CRF is complete.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Investigator Grants - Overhead

All fees paid to sites requiring overhead and the percentage of overhead allowed per site specified on the Site tab.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Investigator Grants - Screen Failures

Screen failure payments made to the investigator sites.

The application calculates this value based on various user input including the screen failure rate and the payment per screen failure.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Investigator Meetings

Costs associated with the Investigator meetings as specified on the Meetings tab.

The application calculates this cost category based on the number of attendees from each site plus the expected vendor staff and sponsor staff as specified on the Meetings tab for each Investigator Meeting.

This calculated value does not include any meeting planning fees, but does include the travel costs for the meeting planner, in addition to all other meeting attendees.

If you plan to use a third-party meeting planner, the fees associated with the third party vendor should be added as a separate pass through cost.

The pass through costs for investigator meetings include travel costs to and from the meeting venue(s) for the Vendor, Sponsor and Investigator and his or her representatives (study coordinator, sub investigator, etc). They also cover costs for the meals, meeting rooms, and other miscellaneous travel expenses for all parties.

These costs are apportioned by vendor and the bulk of these expenses are apportioned to the planner of the investigator meeting as specified for each Investigator Meeting on the Meetings tab.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

IRB and Annual Renewal Fees

Initial and annual renewal fees for IRB or Ethics Committee Submissions. These are not part of the investigator grant and are paid by the sponsor for each site.

These fees are calculated based on the number of Local and Central IRBs that are required for the study, specified on the Site tab, and the number of sites participating in the study.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

IVRS - Central Randomization

Includes IVRS Fees. If IVRS is not assigned to one of the plan providers, you should enter the costs associated with the IVRS or Central Randomization vendor here. This cost should include the setup, maintenance and close out of the IVRS system.

If IVRS is assigned to a CRO, the application calculates these costs, however, you can enter adjustments to raise or lower this value.

If IVRS is assigned to the sponsor or a third-party vendor, the application does not calculate these costs.

IVRS - Hardware Only

Any costs directly associated with an Interactive Voice Response System (IVRS). This value should not include other costs associated with an IVRS.

The application does not calculate this cost.

Labs - Central Lab

All fees paid to the Central Lab for analysis of safety labs.

The application calculates these costs based on the number of subject visits, factors specific to the locations in which the sites and subjects are being treated, and the number of subjects being treated.

These fees are an estimate for central laboratory analyses for standard safety labs (CBC, chemistry panel and urinalysis) and assumes that safety labs are done on all subjects at least 66.667% of all visits.

These fees do not include costs that some Central Labs may charge for shipment of samples. You should add lab shipment fees either by adjusting this cost line item or entering costs under the Pass-Through Line Item labeled Drug Distribution - Special Handling.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Labs - Core Labs (e.g., Holter monitoring)

These costs are typically different than the central lab costs. They may include PK analysis, Central EKG Lab, Holter monitoring, specialized lab analysis, etc.

The application does not calculate this cost.

Labs - Efficacy Labs (not included in Central lab)

The application calculates and estimates the Central Safety lab costs, however, there may be additional costs that need to be included in the costs of the study. For example, costs related to efficacy.

The application does not calculate this cost.

Labs - Other Lab Costs

Lab fees not covered in core lab fees.

The application does not calculate this cost.

Meeting - Face to Face Meeting (CT Internal Training Sponsor)

All costs associated with face to face meetings for the internal training sponsor.


Meeting - Face to Face Meeting (Major CRO)

All costs associated with face to face meetings for the major CRO.


Meeting - Investigator Meeting (CT Internal Training Sponsor)

All costs associated with investigator meetings for the internal training sponsor.


Meeting - Investigator Meeting (Major CRO)

All costs associated with investigator meetings for the major CRO.


Meeting - Kickoff Meeting (CT Internal Training Sponsor)

All costs associated with kick-off meetings for the internal training sponsor.


Meeting - Kickoff Meeting (Major CRO)

All costs associated with kick-off meetings for the major CRO.


Meeting - Primary Provider Internal Team Meeting (CT Internal Training Sponsor)

All costs associated the primary provider internal team meeting for the internal training sponsor.


Meeting - Primary Provider Internal Team Meeting (Major CRO)

All costs associated the primary provider internal team meeting for the Major CRO.


Meeting - Status Update to Sponsor (Major CRO)

All costs associated with meetings for status updates to sponsor for the major CRO.


Meeting - Status Update to Sponsor (CT Internal Training Sponsor)

All costs associated with meetings for status updates to sponsor for the internal training sponsor.


Meeting - Status Update to Sponsor (Major CRO)

All costs associated with meetings for status updates to sponsor for the major CRO.


Miscellaneous Costs

Costs associated with miscellaneous minor expenses, such as copying, faxing, and sending letters to sites.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Other Costs

Any other known or expected costs that are not part of a pre-defined or user-added category.

The application does not calculate this cost.

Printing (not including CRF Printing)

Applies to any printing costs other than printing the CRF.

This covers the cost of printing Investigator Brochures, newsletters, and other general correspondence.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Protocol Amendment IRB Submissions

Covers costs associated with submissions to Institutional Review Boards or Ethics Committees with respect to changes in the protocol.


Protocol Distribution

Distribution of the protocol. Costs are driven by the number of sites to which each provider is distributing the protocol.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Recruitment Costs (additional)

Subject recruitment costs not included in the investigator grants

The application does not calculate this cost.

Regulatory Approval Outside the USA

Any fees to be paid to other regulatory bodies if required. For instance, if there are fees assessed by a local MOH, then you should adjust this cost by that amount.

The application does not calculate this cost.

Shipping (not including study drug/test article shipping)

Applies to costs associated with shipping for CRFs, Investigator Brochures, and other printed media (both to and from the site).

These costs are separate from shipping related to the study drug/test article.

Note that additional costs are added to this category when a third-party vendor is expected to perform translations. Translated documents must be printed and shipped to all sites.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Shipping - Central Lab Test Kits

Includes costs associated with shipping test kits to the central lab prior to treatment start. Test kits include supplies for use during treatment.


Stability Studies Fees & Expenses

Stability studies are routinely performed throughout the drug development process. If stability studies are a part of the protocol being modeled, those costs should be captured here.

The application does not calculate this cost.

Subject Stipends - Enrolled

Payments made to enrolled subjects to pay for travel and parking.


Subject Stipends - Screen Failures

Accounts for costs associated with subjects who fail the screening to cover travel and parking.


Translation Services - 3rd Party

Applies to translations being done by a third-party Vendor. If you specified any of the document translations as pass-through costs (see the Locations tab), those costs should be entered here.

The application does not calculate this cost.

Travel - Monitoring Travel Expenses

Applies to costs associated with all travel to and from investigator sites for monitoring, including Pre-Study Site Visits (PSSV), Site Initiation Visits, Interim Monitoring, and Site Close-out Visits.

Travel for Site Audits are not included here, but are calculated separately under Travel Fees for Site Audits.

Travel costs are determined in part by the monitoring frequency (more trips require more travel costs, however multiple-day monitoring visits require more overnight accommodations), as well as the monitoring strategy (loop visits tend to decrease travel costs, but increase costs associated with overnight accommodations; spoke visits tend to require more travel).

You should examine the Monitoring Schedule reports to help plan the optimal frequency and strategy.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Travel - Other Travel Expenses

Other travel costs, such as drug accountability travel. The application calculates these costs separately from other travel costs.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.

Travel - Site Audit Travel Expenses

Travel costs specifically for site audits. The application calculates these separately from other travel costs.

The application calculates these costs, however, you can enter adjustments to raise or lower this value.


Payments Tab

Table 5-66 Payments Tab Fields

Field Description Notes

Set Payment Terms button

Open the Payment Terms dialog box to specify the number of days from invoice to payment is expected for each service provider.


Edit Recurring Payments button

Open the Recurring Payments dialog box to define the frequency of payments for any listed unit of work or pass-through cost.

Defining the frequency as <milestone> indicates that the fees associated with that item are included in payments made in response to the occurrence of one or more milestones.

Add Milestone button

Opens the Create Milestone dialog box to add a user-defined milestone to this plan.

Adding milestones allows you to add payments in response to events not currently defined in the application.

Edit Milestone button

Opens the Edit Milestone dialog box to edit a user-defined milestone.

You can edit a previously added milestone to change its name and properties, which determine when it occurs.

Delete Milestone button

Delete a user-defined milestone.

To not make a payment at a system-defined milestone, define the percentage as 0.

Milestone column

The milestone at which payments can be made or received.


Inv. Date column

Displays the date on which the milestone is expected to occur and trigger an invoice.


Service Provider (Payment Percentage and Amount) column

The payment percentages and amounts to be received by the service provider.

For example, Major CRO, Medium CRO, Premium CRO.

Total column

Total amount paid to all service providers at this milestone.

Includes line-item discounts for the providers. The discounted values are allocated to the milestones based on the default or overwritten percentages.

Budget Total column

Total payment percentage and amount for all plan milestones.

Includes line-item discounts for the providers.


Payment Terms Dialog Box

Table 5-67 Payment Terms Dialog Box Fields

Column Description Notes

Provider

Service provider.


Payment Term

Number of days between the invoice date and the date of payment.



Recurring Payments Dialog Box

Table 5-68 Recurring Payments Dialog Box Fields

Column Description Notes

Item Name

Major task or pass-through cost that can be set as a milestone triggering a recurring payment.


Specific Service Provider

For each service provider, the milestone when the recurring payment is to be made.



Create/Edit Milestone Dialog Box

Table 5-69 Create/Edit Milestone Dialog Box Fields

Field Description Notes

Name

Name of user-defined milestone.

The name must be unique to the plan.

Occurs

The number of days before or after the application-defined milestone that this milestone occurs.

The application calculates user-defined milestones in relation to application-defined milestones.

Before or After

Whether to calculate the estimated date for this milestone as a number of days prior to an application-defined milestone or following an application-defined milestone.


Milestone

The application-defined milestone before or after which this user-defined milestone occurs.


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 5-70 Summary Tab Fields

Field Description Notes

Included Providers

Selected service provider checkboxes identify which service providers' fees. hours, and costs appear on the Summary Tab.

Dates and metrics are not affected.

Startup Fees

All fees, hours, and FTEs associated with the start up of the study from Project Activity Start Date to the First subject enrolled date (FSFV).


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

Which line item appears depends on the criteria met.

Possible line items:

  • Total Fees without inflation and discount

  • Inflation (Fees)

  • Line-Item Discounts

  • Total fees before discount

  • Total fees before inflation

Total Fees

All fees associated with the study.


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, sponsor internal costs, and any applicable inflation and line-item discount.


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).


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 5-71 Clinical Indicator Reports Descriptions

Field Description Notes

Assumptions

Assumptions based on data entry.

Includes custom assumptions.

Currency Exchange Rates

Currency exchange rates based on data entry.


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.

The following metrics include line-item discount and inflation, if report parameters are selected for inclusion:

  • Direct fees per Enrolled Subject

  • Cost per subject per site per week

  • Total study cost per on-site monitoring day

  • Total study cost per CRF page

Milestone Dates

Critical dates in the study.


Milestones Timeline Chart

Graphical view of key milestones.



Costs Reports

Table 5-72 Costs Reports Descriptions

Field Description Notes

Plan Summary

Printable view of the Plans Summary Tab.

Includes line-item discount and inflation.

Fees by Major Task

Fees by major task.

Includes inflation (when selected for inclusion) and line-item discount.

Fixed Unit Prices

Fixed unit prices.

Includes inflation (when selected for inclusion) and line-item discount.

Pass-Through and 3rd Party Costs

Pass-through and 3rd party costs.


Monthly Budget

Monthly budget.

Includes inflation (when selected for inclusion) and line-item discount.

Monthly Budget By Reporting Region

Monthly budget by reporting region.

Includes inflation (when selected for inclusion) and line-item discount.

Labor Adjustments

Breakdown of unit level adjustments by major task.

Includes inflation (when selected for inclusion) and line-item discount.

Cash Flow

Planned value (PV) versus payments.

Includes inflation and line-item discount.

Milestone Payment Schedule

Schedule of payments at each milestone.

Includes inflation and line-item discount.

Meetings Report

Meeting costs and assumptions.


Summary Grid by Major Task

Plan/Provider-specific report showing selected values by major task.

Includes line-item discount.

Inflation Rates

Inflation rates by location and year.



FTE/Resources Reports

Table 5-73 FTE/Resources Reports Descriptions

Field Description Notes

Resource/FTE Demand Summary

Summary of the plan resources and FTE demands.

Includes inflation (when selected for inclusion) and line-item discount.

Resources By Major Task

Resources by major task.

Includes inflation (when selected for inclusion) and line-item discount.

Resources By Department

Resources by department.

Includes inflation (when selected for inclusion).

Resources By GL Code

Resources by GL code.

Includes inflation (when selected for inclusion).

Resource Demand by Date

Resources by demand date.

Cost view includes inflation (when selected for inclusion) and line-item discount.

Resource Demand Chart

Graphical view of resource demand by date.


Billing Rates by Resource Name

Billing rates by resource name.



Studies Screen Fields

The following screens and dialog boxes are associated with studies.

Studies Screen Fields

Table 5-74 Studies Screen Fields

Field Description Notes

New button

New study.


Edit button

Edit a study.


Delete button

Delete a study.


Restore button

Restore a deleted study.


Create Plan button

Create a plan based on a study.


Study Name column

Studies in the application.


Product/Compound column

Product or compound the associated study is based on.


Phase column

Study phase of the associated study.


Therapeutic Area column

Therapeutic area the associated study is based on.


Indication column

Indication the associated study is based on.


Status column

Study status.



Create/Edit Study Screen Fields

Table 5-75 Create/Edit Study Screen Fields

Field Description Notes

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

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

Study description



Define Study Filter Dialog Box Fields

Table 5-76 Define Study Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes studies created or modified within the number of days selected from the drop-down list.


Include deleted studies

Includes studies that have been previously deleted.


Study name starts with

Includes studies whose names begin with the text entered. Filters out all other studies.


Created by

Includes studies created by the selected users.

To display all studies regardless of who created them, select Any User.

To display more users to choose from, click the Expand list... link.

Last Modified by

Includes studies last edited and saved by the selected users.

To display studies regardless of who last updated them, select Any User.

To display more users to choose from, click the Expand list... link.

Status

Includes studies with the selected statuses.

To display studies regardless of their status, select Any Status.

Phases

Includes studies pertaining to the selected phases.

To display studies regardless of the phase, select Any Phase.

Therapeutic Areas

Includes studies pertaining to the selected Therapeutic Areas

To display studies regardless of the Therapeutic Area, select Any Therapeutic Area.

Sponsors

Includes studies for the selected sponsors.

To display studies regardless of the sponsor, select Any Sponsor.

Save filter as

Name to assign to the filter.



Configure List Options Dialog Box Fields - Studies Screen

Table 5-77 Configure List Options Dialog Box Fields - Studies Screen

Field Description Notes

Configure Columns

Selected columns appear on the Plans screen.


Sort By

The list of studies can be ordered according to your selection, rather than by the first displayed column.

Change the order by clicking a column heading.

Show n studies per page

Number of studies to be displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Create Product Dialog Box Fields

Table 5-78 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

The following screens and dialog boxes are associated with products.

Product Screen Fields

Table 5-79 Product Screen Fields

Field Description Notes

New button

Add a product.


Edit button

Edit a product.


Delete button

Delete a product.


Restore button

Restore a deleted product.


Product Name column

Products in the application.


Description column

Product description.


Last Updated column

Date and time the product was lasted modified.


Updated By column

User who modified the product.



Create/Edit Product Screen Fields

Table 5-80 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 5-81 Define Product Table Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes products created or modified within the number of days selected from the drop-down list..


Include deleted products

Includes products that have been previously deleted.


Product name starts with

Includes products whose names begin with the text entered. Filters out all other products.


Created by

Includes products created by the selected users.

To display all products regardless of who created them, select Any User.

To display more users to choose from, click the Expand list... link.

Last Modified by

Includes products last edited and saved by the selected users.

To display products regardless of who last updated them, select Any User.

To display more users to choose from, click the Expand list... link.

Save filter as

Name to assign to the filter.



Configure List Options Dialog Box Fields - Products Screen

Table 5-82 Configure List Options Dialog Box Fields - Products Screen

Field Description Notes

Configure Columns

Selected columns appear on the Plans screen.


Sort By

The list of products can be ordered according to your selection, rather than by the first displayed column.

Change the order by clicking a column heading.

Show n products per page

Number of products to be displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Portfolios Screens, Tabs, and Dialog Boxes

The following screens and dialog boxes are associated with portfolios.

Portfolio Screen

Table 5-83 Portfolio Screen Fields

Field Description Notes

Show filter

Show or hide portfolios based on selected criteria:

  • All Portfolios—No filter is applied. All portfolios appear.�

  • Active Portfolios Only—Portfolios that are not deleted or marked as Study Complete or Archived appear.

  • Portfolios matching filter—Only portfolios that match the criteria you selected from the custom filter drop-down list appear.


Modify link

Define a custom filter on the Define Portfolio Filter dialog box.


New button

Create a new portfolio on the Create Portfolio screen (Overview tab).


Edit button

Edit the selected portfolio or open it to view details, the summary, or reports.


Delete button

Delete the selected portfolio.

Deleted portfolios are permanently removed at a later time.

Restore button

Restore a deleted portfolio.

To use this option, adjust the filters so that you can see inactive as well as active items.

Copy button

Make a copy of the selected portfolio.


Portfolio Name column

Name of the portfolio.


Description column

Description of the portfolio.


Number of plans column

Number of plans included in the portfolio.


Last Modified column

Date a user last modified this portfolio.



Portfolio Screen Dialog Boxes

Define Portfolio Filter Dialog Box

Table 5-84 Define Portfolio Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes portfolios created or modified within the number of days selected from the drop-down list.


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 as

Name to assign to the filter.



Configure List Options Dialog Box Fields - Portfolio Screen

Table 5-85 Configure List Options Dialog Box Fields - Portfolio Screen

Field Description Notes

Configure Columns

Selected columns appear on the Plans screen.


Sort By

Sort order for the Portfolios screen. Sort according to this selection, rather than by the first displayed column. Up to three levels of sorting are permitted.

Change the order by clicking a column heading.

Show n portfolios per page

Number of portfolios to be displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Create/Edit Portfolio Screen (Overview Tab)

Table 5-86 Create/Edit Portfolio Screen (Overview Tab) Fields

Field Description Notes

Portfolio Name

Unique name for the portfolio.


Short Description

Details that appear on the Portfolios screen to help you recognize the portfolio.


Long Description

Detailed description of the portfolio.


Default Reporting Currency

Default reporting currency that is used to generate portfolio reports.

Each plan in the portfolio uses its own exchange rate rules to convert from the plan values to the reporting currency.

Created By

Name of the user who created the portfolio.

Edit Portfolio screen only.

Created Date

Date the portfolio was created.

Edit Portfolio screen only.

Last Modified By

Name of the user who last modified the portfolio.

Edit Portfolio screen only.

Last Modified

Date the portfolio was last modified.

Edit Portfolio screen only.


Create/Edit Portfolio Screen (Plans Tab) Fields

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

Field Description Notes

Add Plans button

Add plans to the Portfolio on the Choose Plans dialog box.

You cannot add more than 200 plans.

Remove Plans button

Remove plans from a portfolio.


Include Plans button

Restores an excluded plan to a portfolio.


Exclude Plans button

Excludes a plan from the portfolio.

Excluded plans have a line through them on the Plans tab.

Plan Information column

Plan name and description.


Start Date column

Plan project activity start date.


Start Offset column

Effects of beginning a plan, or plans, earlier or later than originally scheduled.

To move the start date earlier, enter a negative number of days. To postpone the start date, enter a positive number of days.

No adjustments are made for inflation. Must contain a value between -999 and 9,999.

Probability column

Likelihood that the plan is going to occur on schedule, expressed as a percentage.



Create/Edit Portfolio Screen (Summary Tab)

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

Field Description Notes

Start

By default, start date of the earliest plan in the portfolio, including any offset dates.


End

By default, end date of the final plan in the portfolio.


Cost Distribution Graph

Graphical view of when costs occur over the time range specified.

Costs inclusive of line-item discount and inflation.

The blue shaded area represents the time frame selected in the Summary Portfolio dialog box.

Reset button

Resets Start and End values to portfolio defaults.


Plan Name column

Displays the plan name.


Study Name column

Displays the study for the plan.


Plan Cost column

Displays the total plan cost inclusive of inflation and line-item discount.


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 5-89 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 5-90 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.

Includes inflation (when selected for inclusion) and line-item discount.

Monthly Budget

Displays monthly budget.

Includes inflation (when selected for inclusion) and line-item discount.


FTE/Resources Reports Descriptions

Table 5-91 FTE/Resources Reports Descriptions

Field Description Notes

Resource Demand Summary

Displays a summary of the portfolio resources demands.

Includes inflation (when selected for inclusion) and line-item discount.

Resource Demand by Date

Displays a summary of the portfolio date demands.

Includes inflation (when selected for inclusion) and line-item discount.

Resource Demand Chart

Displays resources demand chart.



Portfolio Reports Descriptions

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

Portfolio Clinical Indicator Reports Descriptions

Table 5-92 Clinical Indicator Reports Descriptions

Field Description Notes

Portfolio Milestones Timeline Chart

Graphical view of key milestones in the portfolio.



Portfolio Costs Reports Descriptions

Table 5-93 Costs Reports Descriptions

Field Description Notes

Portfolio Summary

Printable view of the Portfolio Summary Tab.


Fees by Major Task

Fees by major task.

Includes inflation (when selected for inclusion) and line-item discount.

Monthly Budget

Monthly budget.

Includes inflation (when selected for inclusion) and line-item discount.


Portfolio FTE/Resources Reports Descriptions

Table 5-94 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.

Includes inflation (when selected for inclusion) and line-item discount.

Resource Demand Chart

Resources demand chart.

Includes inflation (when selected for inclusion) and line-item discount.


RFPs and Bids Screens, Tabs, and Dialog Boxes

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

RFPs Screen

Table 5-95 RFPs Screen Fields

Field Description Notes

New button

Create a new request for proposal.


Edit button

Edit the selected RFP or open it to view details, the summary, or reports.

You can also a open an RFP by double-clicking the plan name.

Delete button

Delete the selected RFP(s).

Deleted RFPs are removed at a later time and can be restored.

Restore button

Restore a deleted RFP.

To use this option, adjust the filters so that you can see inactive as well as active items.

Import Bid button

Upload a bid received from a vendor.


Compare Bids button

Compare the bids associated with the selected RFPS.


Download Bid Grid button

Generate and download the Bid Grid for the selected RFP.


Plan name column

Unique identifier of plans.


Scope/Provider column

Provider representing the scope of work on which the RFP is based.


Description column

Short description of the RFP.


Number of Bids column

The number of bids associated with the RFP.

.


RFPs Screen Dialog Boxes

The following dialog boxes are associated with RFPs.

Define RFP Filter Dialog Box

Table 5-96 Define RFP Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes RFPs last edited and saved the specified number of days.


Include deleted RFPs

Includes RFPs that have been previously deleted.

When you delete an RFP, the application does not permanently delete and purge it until 30 days later.

Created by

Includes only RFPs created by one of the selected users.

To include all RFPs, select Any User.

Last Modified by

Includes only RFPs last edited and saved by the selected user.

To include all RFPs, select Any User.

Save filter as

Name assigned to the filter.



Configure List Options Dialog Box - RFPs Screen

Table 5-97 Configure List Options Dialog Box Fields - RFPs Screen

Field Description Notes

Configure Columns

Selected columns appear on the Plans screen.


Sort By

Orders the RFPs based on your selections.

Change the order by clicking a column heading.

Show n RFPs per page

Number of RFPs displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Choose Plan for RFP Dialog Box

Table 5-98 Choose Plan for RFP Dialog Box Fields

Field Description Notes

Plan Name column

Unique name given to the plan by its creator.

Read-only.

Study Name column

Name of the study with which the plan is associated.

Read-only.

Phase column

The study phase being planned. The application supports study phases I, II, IIa, IIb, III, IIIb, Phase IV with an IND, and Phase IV without an IND. The application supports Phase I for oncology and vaccine studies, as well as Phase I studies for healthy volunteers. Phase I Oncology or Phase I Vaccine studies more closely resemble Phase IIa trials.

Read-only.

Indication column

The reason selected to perform this study. Indications are classified into therapeutic areas.

The application uses this selection to calculate monitoring time required, time for query resolution, data entry, and to provide other default values.

Read-only.

Status column

The status of the plan:

  • Incomplete—Basic assumptions have not been set for the plan.

  • Draft—All input questions of the selected edit mode have been answered, but the plan owner or creator might still be working on the plan.

  • Final—All input questions have been answered and the plan owner believes the plan will be used to conduct the clinical study. However, the plan has not yet been approved.

  • Approved—The plan has been approved and is ready to go out as part of an RFP or proposal or to be used to conduct the trial.

  • RFP—The plan has been approved and included as part of an RFP.

  • Agreement reached; not started—An agreement has been reached on the plan and it is under contract (if an outsourced study) or ready for study activities to begin (if an internal sponsor-executed study).

  • In progress—The study has begun and is operating according to this plan

  • Study Complete—The study has ended.

  • Archived—The plan is being preserved for historical purposes only.

Read-only.

Template Name column

Name of a plan or partial plan that can be used as a starting point for new plans for a study.

Read-only.

Description column

Information describing the template to help you recognize a particular scenario or purpose for the plan.

Read-only.

Applicable For column

Study phase(s) for which the template has been defined.

Read-only.


Create RFP Dialog Box

Table 5-99 Create RFP Dialog Box Fields

Field Description Notes

Scope of Work/Assigned to Provider

Name of the service provider assigned to the desired scope of work in the plan associated with this RFP.


Short Description

Label by which you will recognize this RFP on the RFPs screen.

Must be between 8 and 40 characters.

Not included on the bid grid.

Bid Grid Title

Header that will appear on every page of the bid grid.


Comments

Notes relevant to this RFP.



Edit RFP Screen (Details Tab)

Table 5-100 Edit RFP Screen (Details Tab fields)

Field Description Notes

Short Description

Label by which you will recognize this RFP on the RFPs screen.

Must be between 8 and 40 characters.

Not included on the bid grid.

Bid Grid Title

Header that will appear on every page of the bid grid.


Comments

Notes relevant to this RFP.


History section

Date a sponsor begins pre-planning activities. The default date is three months prior to the Project Activity Start Date.

Not used to calculate effort or costs for the study.

Created By

User who created this RFP.


Created Date

Date and time the RFP was created.


Last Modified By

Name of the user who last changed this RFP..


Last Modified

Date and time this RFP was last changed.


Download Bid Grid link

Regenerate the bid grid with the most recently saved Bid Grid Title.



Edit RFP Screen (Labor Tab)

Table 5-101 Edit RFP Screen (Labor Tab Fields)

Field Description Notes

Include Inflation Checkbox

Include the impact of inflation in the values displayed


Major Task column

Major task type.

For a description of each major task, see the online Help for the Labor tab.

Unit Hours column

Level of effort (in hours) for the selected service provider to complete one unit of work for the major task.

Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.

Unit Cost column

Total cost for the selected service provider to complete one unit of work for the major task.

Displayed values are rounded to the hundredths or according to the conventions of the currency.

# Units column

Total number of units of work expected (or, in the case of a re-forecast, remaining).

Some major tasks have a single unit of work; for example, Study or Database. Hover over the value to see the number of units.

Ext Hours column

Total level of effort (in hours) for the selected service provider to complete the major task.

The application multiplies the Unit Hours by the # Units.

Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.

Ext Cost column

Total cost for the selected service provider to complete the major task.

Displayed values are rounded to the hundredths or according to the conventions of the currency.

Total Ext Hours column

Total level of effort in hours for the selected service provider to complete the major task.


Total Ext Cost column

Total cost for the selected service provider to complete the major task.



Edit RFP Screen (Costs Tab)

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

Column Description Notes

Name

Name referring to a specific cost or cost type.

For a description of each cost, see the online Help for this tab.

Total

Total calculated cost, including any adjustments.


Inflated Total

Total calculated cost, including applicable inflation.



Edit RFP Screen (Bids Tab)

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

Field Description Notes

Compare button

Compare the selected bids.


Delete button

Delete the selected RFPs.


Restore button

Restore the selected deleted RFPs.


Download button

Download the bid grid file received from the vendor.


Update Status button

Display a dialog box from which to choose a new status for the selected bid(s).


Version column

The version of the bid, if you imported more than one bid for the same RFP from the same vendor.


Created Date column

The date the bid was imported.


Status column

The current status of the bid.

Active statuses include:

  • Pending Review

  • Proposal - Under Review

  • Proposal - Pending vendor action

  • Proposal - Selected

  • Contract - Under Review

  • Contract - Pending vendor action

  • Change Order - Under Review

  • Change Order - Pending vendor action

  • Change Order - Accepted Final

Inactive statuses include:

  • Proposal - Rejected

  • Proposal - On Hold

  • Proposal - Canceled

  • Contract - Rejected

  • Contract - Complete

  • Change Order - Rejected

  • Change Order - Complete

Upon vendor bid upload, the default status is Pending Review.

Total Fees column

The total fees for each bid inclusive of line-item discounts.


Total PTC column

The total pass-through costs for each bid.



Import Bids Screen and Dialog Boxes

Edit RFP Screen (Labor Tab)

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

Field Description Notes

Include Inflation Checkbox

Include the impact of inflation in the values displayed


Major Task column

Major task type.

For a description of each major task, see the online Help for the Labor tab.

Unit Hours column

Level of effort (in hours) for the selected service provider to complete one unit of work for the major task.

Displayed values are rounded to the nearest 10th. Hover over the value to see the actual value.

Unit Cost column

Total cost for the selected service provider to complete one unit of work for the major task.

Displayed values are rounded according to the conventions of the currency.

# Units column

Total number of units of work expected (or, in the case of a re-forecast, remaining).

Some major tasks have a single unit of work; for example, Study or Database. Hover over the value to see the number of units.

Ext Hours column

Total level of effort (in hours) for the selected service provider to complete the major task.

The application multiplies the Unit Hours by the # Units.

Displayed values are rounded to the nearest 100th. Hover over the value to see the actual value.

Ext Cost column

Total cost for the selected service provider to complete the major task.

Displayed values are rounded to the nearest whole number. Hover over any value to see the value rounded according to the conventions of the currency.

Total Ext Hours column

Total level of effort in hours for the selected service provider to complete the major task.

Determined by multiplying the Unit Hours by # Units.

Total Ext Cost column

Total cost for the selected service provider to complete the major task.

Determined by multiplying Unit Cost by # Units.


Import Bid Dialog Box

Table 5-105 Import Bid Dialog Box Fields

Field Description Notes

Vendor Name

Vendor who submitted the bid.


Bid Grid File to Upload

Name of bid file to upload. Browse for file on your PC.


Short Description

Label by which you will recognize this bid on the RFPs screen.

Must be between 8 and 40 characters.

Not included on the bid grid.

CRO Bid Number

Number by which the vendor can identify this bid.

Optional

Comments / CRO Information

Notes relevant to this RFP.

Up to 4000 characters.


Import Bid Issues Dialog Box

Table 5-106 Import Bid Issues Dialog Box Fields

Field Description Notes

Severity column

Status of the issue.: Warning, Serious, Fatal.

Fatal errors will prevent the file from successfully importing. Warnings or Serious issues will not prevent a successful import.

Message column

Type of issue and how it will be handled by the application.


Sheet column

Sheet within bid grid workbook on which error appears.


Row column

Number of row on sheet that error appears.


Download Issues link

Saves the list of issues in a spreadsheet.


Cancel button

Abort the loading of the bid.


Continue button

Load the bid with the issues uncorrected.

The bid will fail to load if any of the issues have a severity level of Fatal.


Vendor Bid Comparison Options Dialog Box

Table 5-107 Vendor Bid Comparison Options Dialog Box Fields

Field Description Notes

Major Task and Cost Summary

Compare values aggregated by major task and cost.

Includes line-item discount comparison.

Detailed Fees and Costs by Location, Task, Resource

Compare values by resource per task per location.

Includes line-item discount comparison.

Include RFP i n comparison

Include the RFP values in the comparison.

Selected by default.

Show variances relative to RFP

Compare the selected bids to the RFP values.

Selected by default when the user uses the RFP as the baseline. If selected, turns off Show variances relative to a selected bid.

Show variances relative to a selected bid

Compare bids to the bid selected. The following data is displayed:

  • Service Provider

  • Version

  • Short Description

  • Created Date

Enabled when user selects a bid as baseline. You can select a single bid to compare other bids to. Turns off Show variances relative to RFP.

Variance Analysis Section


Assumptions displayed depend on which comparison is selected.

Include Variance Analysis

For Major Task and Cost Summary comparison, includes:

  • Highlight total cost variances above (user-defined %). Default is 10%.

  • Highlight total hours variances above (user-defined %). Default is 10%.

When turned off, all options below it are disabled and all % fields contain either the default or overridden value as read-only.

For Detailed Fees and Costs by Location, Task, Resource comparison, includes:

  • Highlight unit cost variances above (user-defined %). Default is 10%.

  • Highlight unit hours variances above (user-defined %). Default is 10%.

  • Highlight base billing rate variances above (user-defined %). Default will be 10%.

  • Highlight inflated billing rate variances above (user-defined %). Default will be 10%.

  • Highlight total cost variances above (user-defined %). Default is 10%.

  • Highlight total hours variances above (user-defined %). Default is 10%.

When turned off, all options below it are disabled and all % fields contain either the default or overridden value as read-only.


Highlight total cost variances above

Highlights the unit cost variances outside the specified range.

Highlight total hours variances above

Highlights the unit hours variances outside the specified range.

Highlight base billing rate variances above

Highlights the billing rates variances outside the specified range.


Highlight inflated billing rate variances above

Highlights the inflated billing rates variances outside the specified range.


Report Format

Formats include HTML, PDF, XLS, and CSV.



Bids Screens and Dialog Boxes -new

Bids Screen

Table 5-108 Bids Screen Fields

Field Description Notes

Edit button

Edit the selected bid.

You can also a open a bid by double-clicking the plan name.

Delete button

Delete the selected bid(s).

Deleted bids are removed at a later time and can be restored.

Restore button

Restore a deleted bid.

To use this option, adjust the filters so that you can see inactive as well as active items.

Update Status button

Display a dialog box in which to choose a new status for the selected bids.


Compare button

Compare the selected bids or a single bid with the RFP.


Download button

Download the original bid grid (Excel file) that was uploaded.


Plan name column

Unique identifier of plans.


Scope column

Provider representing the scope of work on which the bid is based.


Vendor column

The name of the vendor from which each bid was received.


Version column

The version of the bid, if you imported more than one bid for the same RFP from the same vendor.

.

Description column

Label by which you will recognize this bid on the RFPs screen.


Status column

The current status of the bid.

Active statuses include:

  • Pending Review

  • Proposal - Under Review

  • Proposal - Pending vendor action

  • Proposal - Selected

  • Contract - Under Review

  • Contract - Pending vendor action

  • Change Order - Under Review

  • Change Order - Pending vendor action

  • Change Order - Accepted Final

Inactive statuses include:

  • Proposal - Rejected

  • Proposal - On Hold

  • Proposal - Canceled

  • Contract - Rejected

  • Contract - Complete

  • Change Order - Rejected

  • Change Order - Complete

Upon vendor bid upload, the default status is Pending Review.

Created Date column

The date the bid was imported.



Edit Bid Screen (Details Tab)

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

Field Description Notes

Short Description

Label by which you will recognize this bid on the Bids screen.

Must be between 8 and 40 characters.

Not included on the bid grid.

CRO Bid Number

A vendor-defined value to identify this bid.


Status

Status to assign to the bid.


Comments

Notes relevant to this bid.


Created By

User who created this bid.


Created Date

Date and time the bid was created.


Last Modified By

Name of the user who last changed this bid.


Last Modified

Date and time this bid was last changed.


Download Imported Bid link

Download the file that was imported to create this bid.



Edit Bid Screen (Labor Tab)

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

Field Description Notes

Include Inflation Checkbox

Include the impact of inflation in the values displayed.


Major Task column

Group of tasks related to a specific unit of work.

For a description of each major task, see the online Help for the Labor tab on the Edit Plans screen.

Unit Hours column

Level of effort (in hours) the vendor requires to complete one unit of work for the major task.

Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.

Unit Cost column

Total fees the vendor requires to complete one unit of work for the major task.

Displayed values are rounded to the nearest hundredths or according to the conventions of the currency.

# Units column

Total number of units of work expected (or, in the case of a re-forecast, remaining).

Some major tasks have a single unit of work; for example, Study or Database. Hover over the value to see the number of units.

Ext Hours column

Total level of effort (in hours) the vendor requires to complete the major task.

The application multiplies the Unit Hours by the # Units.

Displayed values are rounded to the nearest thousandth. Hover over the value to see the actual value.

Ext Cost column

Total fees the vendor requires to complete the major task.

Displayed values are rounded to the nearest hundredth or the conventions of the currency.

Total Ext Hours column

Total level of effort in hours the vendor requires to complete the major task.


Total Ext Cost column

Total fees the vendor requires to complete the major task.



Edit Bid Screen (Costs Tab)

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

Column Description Notes

Name

Name referring to a specific cost or cost type.

For a description of each cost, see the online Help for this tab on the Edit Plans screen.

Total

Total calculated cost, the vendor expects to incur.

If line-item discounts have been entered in the bid by the service provider, the Total Fees and Total columns include the applicable line-item discount value.

The Bid Labor tab footer will include any line-item discount imported from the bid grid.


Edit Bid Screen (Issues Tab)

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

Field Description Notes

Download link

Download the file that was imported to create this bid.


Severity column

Level of concern for the issue encountered.

  • WARNING—Identifies missing information or data entry that differs from expected format.

  • SERIOUS—Warrants inspection of the bid to ensure it accurately reflects the file that was uploaded.

  • FATAL—Prevents the bid from being imported. Must be fixed for the import to proceed.


Message column

Description of the issue.


Sheet column

Name of the worksheet on which the issue was encountered.


Row column

The row number where the issue was encountered.


Change Bid Status Dialog Box

Table 5-113 Change Bid Status Dialog Box Fields

Field Description Notes

Status

Status of the bid.


Update Bid History

Add to the history section included on the Edit Bid screen.



Maintain Menu Screens and Dialog Boxes

Template Screen Fields and Dialog Boxes

Template Screen Fields

Table 5-114 Template Screen Fields

Field Description Notes

New button

Add template.


Edit button

Edit a template.


Delete button

Delete a template.


Restore button

Restore a deleted template.


Copy button

Copy a template.


Lock Templates button

Lock templates.


Unlock Templates button

Unlock templates.


Template Name column

Template name.


Phase column

Study phase.


Therapeutic Area column

Therapeutic area of the associated template.


Indication column

Indication of the associated template.



Define Template Filter Dialog Box Fields

Table 5-115 Define Template Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes templates created or modified within the number of days selected from the drop-down list.


Include deleted templates

Includes templates that have been previously deleted.


Template name starts with

Includes templates created or modified within the number of days selected from the drop-down list.


Created by

Includes templates created by the selected users.

To display all templates regardless of who created them, select Any User.

To display more users to choose from, click the Expand list... link.

Last Modified by

Include templates last edited and saved by the selected users.

To display templates regardless of who last updated them, select Any User.

To display more users to choose from, click the Expand list... link.

Status

Include templates with the selected statuses.

To display templates regardless of their status, select Any Status.

Phases

Include templates pertaining to the selected phases.

To display templates regardless of the phase, select Any Phase.

Therapeutic Areas

Include templates pertaining to the selected Therapeutic Areas.

To display templates regardless of the Therapeutic Area, select Any Therapeutic Area.

Sponsors

Includes templates for the selected sponsors.

To display templates regardless of the sponsor, select Any Sponsor.

Save filter as

Name to assign to the filter.



Configure Lists Options Dialog Box Fields - Templates Screen

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

Field Description Notes

Sort By

Orders the plans based on your selections.

Change the order by clicking a column heading.

Show n templates per page

Number of plans displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Select Template Defaults Dialog Box Fields

Table 5-117 Select Template Defaults Dialog Box Fields

Field Description Notes

Sponsor

Default sponsor for the template.


Phase

Phase from which to derive values when creating the template.

The plan you create uses the values and assignments stored in the template, but calculates according to the study phase.

Therapeutic Area

Therapeutic Area from which to derive values when creating the plan template.

The plan you create uses the values and assignments stored in the template, but calculates according to the study therapeutic area and indication.

Indication

Indication from which to derive values when creating the plan template.



Copy Template Dialog Box Fields

Table 5-118 Copy Template Dialog Box Fields

Field Description Notes

Template Name

Name of the copied template.


Use Cost Model from

Cost model to apply to the templates.

The default is the cost model of the template being copied.

Custom Field Model

Custom field models to apply to the plan.



Change Template Attributes Dialog Box Fields

Table 5-119 Change Template Attributes Dialog Box Fields

Field Description Notes

Template Name

Unique name that identifies the template.

Disabled if multiple templates are selected.

Status

State of the template:

  • Incomplete—Not all input questions have been addressed and the results are not expected to be accurate.

  • Draft—All input questions have been answered, but the template owner or creator is still working on the template.

  • Final—All input questions have been answered; however, the template is waiting approval by a person authorized to approve study templates.

  • Approved—The template is approved and ready to go out as part of an RFP or proposal, or to be used to conduct the trial.

  • RFP—The template has been approved and has been included as part of an RFP.

  • Agreement reached; not started—An agreement has been reach on the template and it is under contract (if an outsourced study) or ready for study activities to begin (if an internal sponsor-executed study).

  • In progress—The study has begin and is operating according to this template.

  • Study Complete—The study has completed execution.

  • Archived—This template is being preserved for historical purposes only.


Cost Model

Cost model to apply to the template.


Custom Field Model

Custom field model to apply to the template.


Short Description

Information displayed when viewing a list of templates.

If multiple templates are selected, this field is disabled.

Long Description

Detailed explanation of the assumptions upon which this template is based.

If multiple templates are selected, this field is disabled.

Update last modified date and user (template history)

If checkbox is selected, updates the selected templates' last modified date and last modifier (user) when you apply changes to the name, status, cost model, custom field model, or descriptions.

Oracle recommends that you select this option. However, if you or other users often filter by the last modified date or user and do not want bulk changes to status, clear the checkbox before saving.


Service Providers Screen Fields

Service Providers Screen Fields

Table 5-120 Service Providers Screen Fields

Field Description Notes

Show filter

Service providers that appear on the Service Providers screen.

You can select sponsors, vendors, and deleted service providers.

New button

Create a service provider.


Edit button

Edit a service provider.


Delete button

Delete a service provider.


Restore button

Restore a service provider.


Billing Rates Report button

Display the Billing Rates report for a service provider.


Name column

Service provider name.


Type column

Service provider type.


Last Modified column

Date and time the service provider was last edited.


Last Modified By column

User who last edited the service provider.



Create/Edit Service Provider Screen Fields

Table 5-121 Create Service Provider Screen Fields

Field Description Notes

Provider Name

Name that will appear in reports and on screens when you assign work to this provider.


Provider Type

Type of service provider: Sponsor or Contract Research Organization (CRS).


Description

Description to differentiate this provider.

Oracle recommends that you not particular specialties or limitations of this provider.

Billing Rates Currency

Currency of the hourly billing rates associated with the service provider.

All billing rates defined for this service provider must be expressed in this currency.

Back-Office Billing Rate Location

Determines the default billing rates for tasks that are typically centralized or conducted at a central location, such as Protocol Preparation and Data Management.

You can override the billing rate location in a plan for any specific task in the Task Manager or on the Assignment tab.

Created By

User who created the service provider.


Created Date

Date and time this service provider was created.


Last Modified By

User who last edited the service provider information.


Last Modified

Date the service provider information was last modified.


Update Billing Rates link

Enter and publish billing rates for this service provider.



Resources Screen Fields

Define Resource Filter Dialog Box Fields

Table 5-122 Define Resource Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes resources created or modified within the number of days selected from the drop-down list.


Include deleted resources

Includes previously deleted resources.

You can restore resources that have been deleted until they are permanently purged.

Resource name starts with

Includes resources with names starting with the specified text.


Save filter as

Name assigned to the filter.



Configure List Options Dialog Box Fields - Resources Screen

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

Field Description Notes

Configure Columns

Selected columns appear on the Plans screen.


Sort By

The list of resources can be ordered according to your selection, rather than by the first displayed column.

Change the order by clicking a column heading.

Show n resources per page

Number of resources to be displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Resources Screen Fields

Table 5-124 Resources Screen Fields

Field Description Notes

Show filter

Resources that appear on the Resources screen.

You can include All Resources, Active Resources Only, or resources matching a filter.

New button

Add a resource.


Edit button

Edit a resource.


Delete button

Delete a resource.


Restore button

Restore a resource.


Name button

Resources in the application.


Name column

Resource name.


Last Updated column

Date and time the resource was last updated.


Updated By column

User who last modified the resource.



Create/Edit Resource Screen

Table 5-125 Create/Edit Resource Screen Fields

Field Description Notes

Code

Alphanumeric code representing this resource.

Example: CRO1.

Name

Job title or classification. Not the name of an individual resource.

Example: Medical Monitor.

Two resources cannot have the same name.

Description

List of job responsibilities.

For system-defined resources, the list is read-only.

Rate Year

Rate year for each service provider.

Applies only to the Create Resource screen.

Auto Fill

Billing rates for each service provider.

Applies only to the Create Resource screen.


Billing Rates Screen Fields

Billing Rates Screen Fields

Table 5-126 Billing Rates Screen Fields

Field Description Notes

Show rates for

Service provider for which billing rates appear on the Billing Rates screen.


For Rate Year

Year for which billing rates appear on the Billing Rates screen.


Include Deleted Rates

Include deleted rates.


New button

Add billing rates.


Edit button

Edit billing rates.


Delete button

Delete billing rates.


Restore button

Restore deleted billing rates.


Copy button

Copy billing rates.


Publish button

Publish billing rates.


Show Revision History button

Revision history of the selected billing rates.


Rates for column

Service provider who charges the billing rates.

Service providers can charge different rates to different sponsors.

When performing work for column

Organization for whom the service provider is performing the work when these rates apply.


Rate Year column

Billing rate year.


Status column

Billing rate status.

Billing rates can be published or drafts.

Last Modified column

Date and time the billing rates were last edited.


Last Modified By column

User who edited the billing rates.



Create/Edit Billing Rates Screen

Table 5-127 Create/Edit Billing Rates Screen Fields

Field Description Notes

When

Service provider who charges these billing rates.

Required when creating a new set of billing rates.

Performs work for

Sponsor that will be charged these rates.


For Rate Year

Year for which these billing rates apply.


Base Rate Location

Location chosen by the user for initial data entry of billing rates by resource. The ClearTrial application suggests values for all other locations based on the rate variance percentages. You can accept these suggested values or override either the rate variance percentages or the resource billing rates for one or more locations.

The country or region whose RATE VARIANCE % is 100.00% is the base rate location. The application derives all other locations' rates as a variance of the base rate.

Currency

Currency in which the billing rates are expressed.


RATE VARIANCE %

The application calculates the country-specific rates per the variance value that appears in this row.

You can change the variance for any country or override a specific rate for a particular resource in any location.

REGION

Country or region for which the base rate applies.


Resource

Each row represents a job title or type of employee who performs work during a study.

The application multiples the hourly rate by the number of hours calculated to be required for the resource to complete the work.

See the online Help for a list of responsibilities associated with each resource.

Country/Region columns

Enter the hourly rate for each resource for each country and region.

Regional rates represent the average billing rates for all locations within a defined region.

Export rates to Excel link

Export the billing rates you defined to a Microsoft Excel spreadsheet.


Save button

Preserves the values in a draft state.


Publish button

Publish the currently displayed set of billing rates and makes them available as the active rated used by the application to calculate fees and costs associated with tasks assigned to the chosen vendor.



Copy Billing Rates Dialog Box Fields

Table 5-128 Copy Billing Rates Dialog Box Fields

Field Description Notes

Copy from

The version of billing rates to copy.

If there is only one version, this field is ready-only.

Apply percentage adjustment

Percentage adjustment, positive or negative, to apply to the copied billing rates.

Must contain a value between -999 and 999.


Show Revision History Dialog Box Fields

Table 5-129 Show Revision History Dialog Box Fields

Field Description Notes

Status

Status of the billing rates.

Billing rates are drafts or published.

Last Modified

Date and time the billing rates were last edited.


Last Modified By

User who last edited the billing rates.


Show Rates

Billing rates of the prior versions.



Inflation Profiles Screen Fields

Inflation Profiles Screen Fields

Table 5-130 Inflation Profiles Screen Fields

Field Description Notes

Show Profile for filter

Include only those inflation profiles associated with the selected provider.

To display inflation profiles for all providers, select Any Provider.

for Rate Year filter

Include rates associated with the selected year.

To display inflation profiles for all years, select Any Year.

Include Deleted Rates filter

Select to include inflation profiles that have been deleted.


New button

Define a new inflation profile.


Edit button

Edit the selected inflation profile.


Delete button

Delete the selected inflation profiles.


Restore button

Restore the selected deleted inflation profile.


Copy button

Copy the selected inflation profile.


Publish button

Make the currently selected draft inflation profile active and available to all plans using the associated vendor and effective rate year.


Show Revision History button

View a history of the revisions made to the selected inflation profile.


Profile for column

Provider with whom the inflation profile is associated

Multiple profiles can be associated with a service provider.

When performing work for column

Organization for whom the service provider is performing the work when this inflation profile applies.


Rate Year column

Billing rate year associated with the inflation profile.


Status column

Status of the inflation profile: Published or Draft.


Last Modified column

Date and time the inflation profile was last edited.


Last Modified By column

User who edited the inflation profiles.



New Inflation Profile Dialog Box Fields

Table 5-131 New Inflation Profile Dialog Box Fields

Field Description Notes

When

The vendor for which this inflation profile applies.


Performs work for

The sponsor that will be charged these rates.


For Rate Year

The year for which these rates apply



Create/Edit Inflation Profile Screen Fields

Table 5-132 Create/Edit Inflation Profile Screen Fields

Field Description Notes

When

The vendor for which this inflation profile applies.


Performs work for

The sponsor that will be charged these rates.


For Rate Year

The year for which these rates apply


Base Rate Location

The country or region for the rates in the Base Rate column.

The country or region whose RATE VARIANCE % is 100.00% is the base rate location. The application derives all other locations' rates as a variance of the base rate.

Add Year button

Copy the contents of the last row to a row added to the bottom of the grid.


Delete Year button

Delete the selected year row.


Publish button

Publish the currently displayed inflation profile.


Export rates to Excel button

Export the data to a Microsoft Excel spreadsheet.



Copy Inflation Profile Dialog Box Fields

Table 5-133 Copy Inflation Profile Dialog Box Fields

Field Description Notes

Copy from

The version of billing rates to copy.

If there is only one version, this field is ready-only.

Apply percentage adjustment

Percentage adjustment to apply to the copied billing rates.



Show Revision History Dialog Box Fields

Table 5-134 Show Revision History Dialog Box Fields

Field Description Notes

Status

Status of the billing rates.

Billing rates are drafts or published.

Last Modified

Date and time the billing rates were last edited.


Last Modified By

User who last edited the billing rates.


Show Rates

Billing rates of the prior versions.



Departments Screen Fields

Departments Screen Fields

Table 5-135 Departments Screen Fields

Field Description Notes

Show filter

Departments that appear on the Departments screen.

You can show all departments, active departments only, or select a department filter.

New button

Add a department.


Edit button

Edit a department.


Delete button

Delete a department.


Restore button

Restore a deleted department.


Map Labor and Costs button

Edit department mappings.


Name column

Department name.


Code column

Department code.


Description column

Department description.


Last Updated column

Date and time the department was last edited.


Updated By column

User who last edited the department.



Define Department Filter Dialog Box Fields

Table 5-136 Define Department Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes departments created or modified within the number of days selected from the drop-down list.


Include deleted departments

Include departments that have been previously deleted.


Department name starts with

Includes departments with names starting with the specified text.


Save filter as

Name to assign to the filter.



Configure List Options Dialog Box Fields - Departments Screen

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

Field Description Notes

Configure Columns

Selected columns appear on the Departments screen.


Sort By

The list of departments can be ordered according to your selection, rather than by the first displayed column.

Change the order by clicking a column heading.

Show n departments per page

Number of departments to be displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Create/Edit Department Screen Fields

Table 5-138 Create Department Screen Fields

Field Description Notes

Code

Alphanumeric code representing the department.


Name

Department name.

Two departments cannot have the same name.

Description

Description of the department.



Edit Department Mapping Screen Fields

Table 5-139 Edit Department Mapping Screen Fields

Field Description Notes

Mapping by <> Change

Displays the currently active mapping mode: resource, location, task, or rule.

To change modes, click the change link.

Restore ClearTrial Defaults

Restore department mappings to the application default mappings.

Discards any mappings you created.

Resource

Resources to which departments can be mapped.

Includes ClearTrial-defined and user-defined resources.

Internal

Department to apply when the resource performs work for an internal provider.

Includes ClearTrial-defined and user-defined departments

Outsourced

Department to apply when the resource performs work for an outsourced provider.

Includes ClearTrial-defined and user-defined departments

Location

Locations to which departments can be mapped.


Internal

Department to apply when an internal provider is assigned to the location.

Includes ClearTrial-defined and user-defined departments.

Outsourced

Department to apply when an outsourced provider is assigned to the location.

Includes ClearTrial-defined and user-defined departments.

Task Group

Task groups to which departments can be mapped.

The application applies the department selected for a task group as the default for all tasks in that group.

Task

Tasks to which departments can be mapped.

Includes only ClearTrial-defined tasks.

Internal

Department to apply when an internal provider is assigned to the task or task group.

Includes ClearTrial-defined and user-defined departments.

Outsourced

Department to apply when an outsourced provider is assigned to the task or task group.

Includes ClearTrial-defined and user-defined departments.

Add Rule button

Add a rule for mapping labor to departments.


Edit Rule button

Edit a selected rule.


Delete Rule button

Delete a selected rule.


Criteria column

Criteria that determine which department is applied.


Department column

The department associated with the rule.


Drag to Order column

Use the mouse to reorder the rules by your own priority.

Rules at the top of the list take priority over the bottom.


Create Department Mapping Rule Dialog Box

Table 5-140 Create Department Mapping Rule Dialog Box Fields

Field Description Notes

Department

The department to be assigned when the rule matches the criteria.


Providers (Any) tab

Select providers to be matched according to this rule.

Selecting the Internal and Outsource checkboxes include all the service providers in that group.

Selecting Any Provider includes all providers.

Locations (Any) tab

Select locations to be matched according to this rule.

Select Any Location to include study-scoped locations as part of the match.

Tasks (Any) tab

Select tasks to be matched according to this rule.

Select Any Task to include all tasks and task groups. Include ClearTrial-defined and user-defined tasks by selecting their associated task or task group.

Resources (Any) tab

Select resources to be matched according to this rule.

Select Any Resource to include all resources.


GL Codes Screen Fields

GL Codes Screen Fields

Table 5-141 GL Codes Screen Fields

Field Description Notes

Show filter

GL codes that appear on the GL Codes screen.

You can show all GL codes, active GL codes only, or select a GL code filter.

New button

Create a new GL code.


Edit tab

Edit the selected GL code.


Delete tab

Delete the selected GL code.


Restore tab

Restore the selected deleted GL code.


Map Labor and Costs tab

Edit GL code mappings.


Name column

GL code name.


Code column

Code associated with the GL code.


Description column

GL code description.


Last Modified column

Date and time the GL code was last edited.


Modified By column

User who last edited the GL code.



Define GL Code Filter Dialog Box Fields

Table 5-142 Define GL Code Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes GL codes created or modified within the number of days selected from the drop-down list.


Include deleted GL Codes

Includes GL Codes that have been previously deleted.


GL Code name starts with

Includes GL codes with names starting with the specified text.


Save filter as

Name to assign to the filter.



Configure List Options Dialog Box Fields - GL Codes Screen

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

Field Description Notes

Configure Columns

Selected columns appear on the GL Codes screen.


Sort By

Order the list of GL codes according to your selection, rather than by the first displayed column.

Change the order by clicking a column heading.

Show n GL codes per page

Number of GL codes to be displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


Create/Edit GL Code Screen Fields

Table 5-144 Create GL Code Screen Fields

Field Description Notes

Code

Alphanumeric code representing the General Ledger code.


Name

GL code name.

You cannot create two GL codes with the same name.

Description

GL code description.



Edit GL Code Mapping Screen Fields

Table 5-145 GL Code Mapping Screen Fields

Field Description Notes

Mapping by <>Change

Displays the currently active mapping mode: resource, location, task, or rule.

To change modes, click the change link.

Restore ClearTrial Defaults

Restore GL code mappings to the application default mappings.

Discards any mappings you created.

Mapping by Resource

Displays the mapping mode currently being used.

To change modes, click the change link.

Resource

Resources to which GL codes can be mapped.

Includes ClearTrial-defined and user-defined resources.

Internal

GL code to apply when the resource performs work for an internal provider.

Includes ClearTrial-defined and user-defined resources.

Outsourced

GL code to apply when the resource performs work for an outsourced provider.

Includes ClearTrial-defined and user-defined resources.

Location

Locations to which GL codes can be mapped.


Internal

GL code to apply when an internal provider is assigned to the location.

Includes ClearTrial-defined and user-defined GL codes.

Outsourced

GL code to apply when an outsourced provider is assigned to the location.

Includes ClearTrial-defined and user-defined GL codes.

Task Group

Task groups to which GL codes can be mapped.

The application applies the GL code selected for a task group as the default for all tasks in that group.

Task

Tasks to which departments can be mapped.

Includes only ClearTrial-defined tasks.

Internal

GL code to apply when an internal provider is assigned to the task or task group.

Includes only ClearTrial-defined GL codes.

Outsourced

GL code to apply when an outsourced provider is assigned to the task or task group.

Includes ClearTrial-defined and user-defined GL codes.

Map by Rule Advanced Mode

Map labor to GL codes by user-defined criteria.


Add Rule button

Add a rule for mapping labor to GL codes.


Edit Rule button

Edit a selected rule for mapping labor to GL codes.


Delete Rule button

Delete a selected rule for mapping labor to GL codes.


Criteria column

Criteria that determine which GL code is applied.


GL Code column

The GL code associated with the rule.


Drag to Order column

Use the mouse to reorder the rules by your own priority.

Rules at the top of the list take priority over the bottom.


Create GL Code Mapping Rule Dialog Box

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

Field Description Notes

GL Code

The GL code to be assigned when the rule matches the criteria.


Providers (Any) tab

Select providers to be matched according to this rule.

Selecting the Internal and Outsource checkboxes include all the service providers in that group.

Selecting Any Provider includes all providers.

Locations (Any) tab

Select locations to be matched according to this rule.

Select Any Location to include study-scoped locations as part of the match.

Tasks (Any) tab

Select tasks to be matched according to this rule.

Select Any Task to include all tasks and task groups. Include ClearTrial-defined and user-defined and user-defined tasks by selecting their associated task or task group.

Resources (Any) tab

Select resources to be matched according to this rule.

Select Any Resource to include all resources.


Exchange Rate Tables Screen Fields

Exchange Rate Tables Screen Fields

Table 5-147 Exchange Rate Table Screen Fields

Field Description Notes

Show filter

Exchange rate tables that appear on the Exchange Rate Tables screen.

You can show all exchange rate tables, only active ones, or tables matching a filter.

New button

Add an exchange rate table.


Edit button

Edit an exchange rate table.


Delete button

Delete an exchange rate table.


Restore button

Restore a deleted exchange rate table.


Publish button

Publish an exchange rate table.


Set Default button

Set the default exchange rate table.


Description column

Exchange rate table description.


Status column

Exchange rate table status.

Exchange rate tables can be published or drafts.

Last Updated column

Date and time the exchange rate table was last edited.


Updated By column

User who last edited the exchange rate table.



Define Exchange Rate Table Filter Dialog Box Fields

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

Field Description Notes

Created or modified in the last n days

Includes exchange rates created or modified within the number of days selected from the drop-down list.


Include deleted exchange rate tables

Includes exchange rate tables that have been previously deleted.


Exchange Rate Table name starts with

Includes exchange rates with names starting with the specified text.


Created by

Includes exchange rate tables created by he selected users.

To display all exchange rate tables regardless of who created them, select Any User.

To display more users to choose from, click the Expand list... link.

Last Modified by

Includes exchange rate tables last edited and saved by the selected users.

To display exchange rate tables regardless of who last updated them, select Any User.

To display more users to choose from, click the Expand list... link.

Save filter as

Name to assign to the filter.



Configure List Options Dialog Box Fields - Exchange Rate Tables Screen

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

Field Description Notes

Configure Columns

Selected columns appear on the Exchange Rate Tables screen.


Sort By

The list of exchange rate tables can be ordered according to your selection, rather than by the first displayed column.

Change the order by clicking the column heading on which to sort the list.

Show n exchange rate tables per page

Number of exchange rate tables to be displayed on each page.

A paging tool appears at the lower right, allowing you to move to the next page.


Create/Edit Exchange Rate Table Screen Fields

Table 5-150 Create Exchange Rate Table Screen Fields

Field Description Notes

Name

Name for this set of exchange rates.

This name appears as a choice in the defined in drop-down list on the Overview tab.

If you change the name and save the changes as a draft table, the draft name does not appear on the Exchange Rate Tables screen. Only published tables appear.

Status

Status of the exchange rate table:

  • Draft—Visible only on the Exchange Rate Tables screen and not available when you create a plan.

  • Published—Available for use when planning studies and represents the currently active conversion rates.

  • Published with Draft—Has pending draft version associated with it that is not yet available for plans, while the previously published version remains active, available, and it use.

    When editing an exchange rate table in this state, the currently published values appear in a column to the right of the pending changes.


Description

Short description that identifies the exchange rate table.

The description appears only on the Exchange Rate Tables screen.

Use rates as of

Populates the exchange rates as of the chosen date.

This might be a starting point for specifying custom exchange rates.

Apply button

Apply the specified date to establish the values in the exchange rate fields.


1 <currency> equals...

Fields for specify the conversion rate from the source currency rate to each destination currency.

The source currency is the currency used for the exchange rate table.


Reporting Regions Screens and Dialog Boxes

Edit Reporting Regions screen

Table 5-151 Reporting Regions Screen Fields

Field Description Notes

New Reporting Region button

Add a reporting region.


Map Countries to Reporting Regions button

Select a reporting region for a country.


Reporting Region Name column

Reporting regions.


# of Countries Mapped column

Number of countries that are mapped to the associated reporting regions.


Total Number of Countries Mapped to Reporting Regions column

Total number of countries mapped to reporting regions.



Map Countries to Reporting Regions Dialog Box

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

Field Description Notes

Country button

Country to be mapped.


Reporting Region button

User-defined reporting regions that you can map the country to.



Purge Deleted... Screen

Table 5-153 Purge Deleted... Screen Fields

Field Description Notes

Purge Selected Items button

Perform the purge.


Items to delete column

Item type to be purged.


deleted at least n days ago column

Number of days since an item of the selected type was deleted and will be purged when you select the Purge Selected Items button.

To purge all deleted items of the selected type, enter 0.


Custom Field Models Screen Fields

Custom Field Models Screen Fields

Table 5-154 Custom Field Models Screen Fields

Field Description Notes

Open button

Display the custom fields defined for the selected model on the Custom Fields screen.


Checkout button

Check out the DRAFT custom field model for editing.

Enabled only if no other user has checked out the draft model.

Check-In button

Save any changes made to the DRAFT custom field mode.

Enabled only for the user who checked out the DRAFT model and the system administrator.

Cancel Checkout button

Cancel the checkout of the DRAFT custom field model.

Enabled only for the user who checked out the DRAFT model and the system administrator.

Publish button

Publish the DRAFT custom field model.

Enabled only for the user who checked out the DRAFT model and the system administrator.

Change Description button

Change the description associated with a published custom field model.

Maximum of 32 characters.

Version column

Status or rendition number of the custom field model.

Can be DRAFT, PUBLISHED, or a version number from 1 to n.

Description column

Short description associated with a published custom field model.

32 characters maximum.

Published Date column

Date and time that the custom field model was published.


Published By column

Who published the custom field model.


Checkout Date column

Date and time that the DRAFT custom field model was last checked out.


Checkout By column

Who currently has the DRAFT custom field model checked out.



Custom Field Screen Fields

Table 5-155 Custom Field Screen Fields

Field Description Notes

New button

Create a new custom field.


View button

Display the field definitions, display criteria, and designer notes for the selected custom field.


Delete button

Delete the selected custom fields.

Deleted custom fields are not removed permanently.

Restore button

Restore the selected deleted custom fields.


Copy button

Make a copy of the selected custom field.


Checkout button

Check out the DRAFT custom field model.

Enabled only if no other user has checked out the DRAFT model.

Cancel checkout button

Cancel the checkout of the DRAFT custom field model.

Enabled only for the user who checked out the DRAFT model.

Publish button

Publish the DRAFT custom field model.

Enabled only for the user who checked out the DRAFT model.

Name column

Name of the custom field.


Label column

How custom field appears on screens and in reports.


Unit Of Measure column

Unit of Measure for the custom field.


Tab column

Plan assumption tab on which the custom field appears.


Last Modified column

Date and time that the custom field was last modified.


Last Modified By column

Who last modified the custom field.



Define Custom Field Filter Dialog Box Fields

Table 5-156 Define Custom Field Filter Dialog Box Fields

Field Description Notes

Created or modified in the last n days

Includes custom fields modified and saved within the number of days selected from the drop-down list.


Include deleted custom fields

Includes custom fields that have been previously deleted.


Custom Field name starts with

Includes only custom fields with names starting with the specified text.


Created by:

Includes only those custom fields that were created by one of the selected users.

To see custom fields regardless of who created them, select Any User.

Last Modified by:

Includes only those custom fields that were last edited and saved by one of the selected users.

To see custom fields regardless of who last updated them, select Any User.

Save filter as

Name to assign to the filter.



Configure List Options Dialog Box Fields - Custom Fields Screen

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

Field Description Notes

Configure Columns

Selected columns appear on the Custom Fields screen.


Sort By

Order the custom fields according to your selection, rather than by the first displayed column.

Change the order by clicking a column heading.

Show n custom fields per page

Number of custom fields to be displayed on each page.

Use the paging tool to move to the next or previous page or directly to a page number.


View/Create/Edit Custom Field Screen Field Descriptions

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

Field Description Notes

Name

The programmatic variable name by which the application will refer to this assumption in custom algorithms.

Must start with a letter and contain only letters, numbers, or the underscore (_) character.

The value must be unique.

Data Type

The type of data users can enter when populating the custom field.

Currently, custom field values are restricted to positive whole numbers.

Label

The name that appears on a plan's assumption tab to the left of the input element for this custom field.

Should be terse, but meaningful.

The name must be unique.

Prompt

Include to provide additional instructions to users populating the field in a plan.

Displayed in the status area of a plan's assumption tab (lower left corner of the screen).

Help Text

Include to provide additional instructions to users populating the custom field in a plan.

Displayed when a user invokes context-sensitive help for this custom field by clicking its label on a plan's assumption tab.

Values vary by location

Defines whether users can provide location-specific or centralized values for this assumption.

Fields that will vary by location display a small icon to the right of their input element. Clicking the icons displays the location-specific values dialog box for the associated field.

Minimum Value

Lowest acceptable value for this assumption.

Must be a value between 0 and 99,999,999.

Maximum Value

Highest acceptable value for this assumption.

Must be a value between 0 and 99,999,999.

Unit of Measure Name, Singular

Name for this assumption to appear in the Unit of Measure drop-down lists in the Task Manager/Major Task panel, Resource Algorithm pane, and the Cost Details Algorithm tab.

Must be a unique value.

Custom unit of measures appears in italicized type followed by an asterisk.

Unit of Measure Name, Plural

Plural form for the name for this assumption.


Sort Order Rank

Order in which custom fields appears on a plan's assumption tab.


Display on the <tab>

The plan assumption tab on which this custom field will appear.

Only custom fields that are location-scoped can appear on the Site tab.

Edit Mode

Specified the minimum edit mode in which the custom field will be displayed.

To make this field unavailable to novice users or when performing less detailed planning, specify Advanced or Expert mode.

Phase

Specified which phase(s) a plan must be associated to display the custom field.


Therapeutic Area

Specifies which therapeutic area(s) a plan must be associated to display the custom field.


Indication

Specifies which indication(s) a plan must be associated with to display the custom field.


Designer Notes

Use this field to document the purpose of the custom field.

This description does not appear to users in plans. It only displays on the View/Edit/Create Custom Fields screen.


Admin Menu

User Profile Screen Fields

User Profile Screen Fields

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

Field Description Notes

Login Name

Name or phrase you use to log in.


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.


Change Password Screen Fields

Table 5-160 Change Password Screen Fields

Field Description Notes

Current Password

Your currently valid password.

Required to authorize the password change request.

New Password

The password to use for subsequent logins.

Passwords must be at least eight characters and contain at least one letter, one number, and one of the following special characters: !$*+-.=?@^_|~.

Passwords must not contain the login name or any of the following words: password, oracle, guest, admin, administrator, or Cleartrial.

Verify New Password

The new password retyped to ensure that you have not mistyped the password.



Reset Password Page Fields

Table 5-161 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.