| Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.4 E63096-01 |
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Home > Plan and Source User Guide > Working with Plans
| Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.4 E63096-01 |
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Home > Plan and Source User Guide > Working with Plans
After you create a plan, you enter assumptions using the tabs on the Edit Plan screen. By working through these tabs, you can specify all the information related to your plan, in the level of detail determined by your edit mode.
Table 2-1 Roadmap: Creating a Plan
| Step | Action | Description |
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1 |
Create a product. |
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2 |
Create a study. |
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3 |
Create a new plan. |
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4 |
Enter your assumptions for the plan. |
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5 |
Save the plan. |
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From the Plans screen, click New.
The Choose Study and Plan Template dialog box appears.
Select the checkbox of the study for which you want to create a plan.
Select the radio button corresponding to the template to use.
Click Ok.
The Create Plan screen appears.
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Select the plan checkbox and click Edit.
The Edit Plan screen appears.
Enter or edit the information on each tab.
Add a note.
To save the plan, click Save.
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To continue defining plan assumptions, click Next.
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Note: If you have created a request for proposal for a plan, you can no longer edit it. The Edit button is replaced with a View button. |
When you create a new plan, the cost model and custom field model applied depends on the template selected. If you use the ClearTrial template, the new plan inherits the cost model for the current release and the most recently published custom field model. If you use a custom template, the new plan inherits the cost model and custom field model from the custom template.
If you determine that your plan should use a different cost model or custom field model, you can select new models through the Change Attributes option. The cost model and custom field model can only be updated for unlocked plans. For more information, see Change Attributes.
If you assigned a custom field model to a plan, the custom fields that are available in the custom field model can be used in the plan. A custom field can be set by your custom field designer to display on one of the following assumption tabs:
Overview
Site
Subject
Treatment
Data
Monitoring
If custom fields exist for a tab, they appear in a separate section, labeled Custom Fields, that appears below the ClearTrial default assumptions. If you do not see an expected assumption, change your edit mode to the highest level of detail available to you. For information about changing your edit mode, see Changing Your Edit Mode Mid-plan. Your custom field designer determines the edit mode in which a custom field appears.
Custom assumptions can be centralized or location-scoped. A location-scoped custom field has a Blue Globe indicator to the right of the field. When you enter a value in the field, that value cascades to each plan location. You can click the Blue Globe to see a list of locations and edit the value for each location separately. If a location-specific value has been entered for any location, the Blue Globe indicator changes from light blue to dark blue.
A centralized custom field will not have a Blue Globe indicator and accepts a single value.
On the Plans screen, select the checkbox of the plan you want to copy. You cannot copy a plan in an Incomplete status.
Click Copy.
The Copy Plan dialog box appears.
In the Plan Name field, enter a name for the new plan.
From the Use Cost Model from drop-down list, select a cost model. The default selection is the cost model of the plan being copied.
From the Custom Field Model drop-down list, select a custom field.
The new plan inherits the custom field model from the source plan. You can change the custom field model, or choose not to attach a custom field model, using Change Attributes. For more information, see Change Attributes.
Click Ok.
The new plan inherits the cost model and custom field model from the source plan. You can change the cost model and the custom field model through the Change Attributes option. For more information, see Change Attributes.
The Overview tab includes basic information about the plan. Enter assumptions in the fields that appear. Your current edit mode determines the fields shown.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Plan or Template Screen (Overview Tab).
In the Plan Name field, enter a name for the plan.
Oracle recommends that a plan name be a combination of the study name and the version of the plan that you are creating. Your team should establish a standard naming convention for your plans and templates.
For example, if you create multiple plans for a study named CLARITY, you might name the first version of the study, Clarity version 1. The second version would be Clarity version 2, and so on.
To select the Project Activity Start Date, click the calendar icon.
For studies that are outsourced (in whole or in part), the Project Activity Start Date is the date on which any service provider on the study will begin billable work on the project. For studies conducted internally by the sponsor, the Project Activity Start Date is the date on which project initiation activities will begin utilizing sponsor personnel.
The value for the Start pre-study planning field defaults to three months prior to the Project Activity Start Date. However, you can override this date to any date prior to the Project Activity Start Date.
If you change the project activity start date after entering other information, a warning icon appears. Clicking the icon displays a message stating all dates will be adjusted according to the new start date.
Select the status of the plan from the Status drop-down list.
The application fills the Status field with the status corresponding to the plan currently. Study statuses for plans include the following. There are additional statuses associated with the RFPs and Bids features.
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.
Select an outsourcing option.
Conducted Internally—The study will be performed internally by the sponsor, with no outside service providers. This sets all responsibility radio buttons to Sponsor throughout the tabs for the plan.
Outsourced—The entire study will be outsourced to an external service provider (excluding oversight of that service provider). This sets all responsibility radio buttons to Vendor.
Combination—Some of the study tasks (in addition to Oversight) will be performed by the sponsor, while others will be done by one or more external service providers that you specify on the Assignments tab.
In the Short Description and Long Description fields, enter meaningful descriptions that might help you recognize a particular scenario or remind you of the purpose of the plan when you view a list of plans.
From the Default Modeling Currency drop-down list, select the currency to use to enter most costs, determine the default value for monetary assumptions, and display on the Labor, Costs, Payments, and Summary tabs.
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Note: You can enter monetary assumptions in the currency of your choice at a later time. |
From the Default Reporting Currency drop-down list, select the default currency for reports.
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Note: When you generate a report, you can choose any supported currency. |
Indicate the option to use for exchanging or converting between currencies:
As of (specified date)—Select a specific date for calculating exchange rates. If the application does not have rates for the specified date, the date defaults to the first prior date with exchange rates.
Defined in (global exchange rates table)—Choose a published and named set of rates that can be shared across plans.
As specified here...—Override one or more exchange rates by clicking the link to launch the Override Currency Exchange Rates dialog box. If you have previously overridden exchange rates, the application removes the overridden values and restores all values to the exchange rates for the newly selected date.
As of plan created date—This is the recommended option for templates. Indicates that, for each plan created from the template, the exchange rates date defaults to the latest available date.
From the Drug Storage drop-down list, define other factors, such as special handling considerations and study difficulty issues.
If the product or compound is radioactive, select the Radio Labeled checkbox.
Specify study difficulty when there are unusual circumstances about the trial that make aspects other than monitoring and data management more difficult than most clinical studies. This is rare.
The difficulty to which the Drug Storage field refers applies to other aspects of the study (site training, multiple locations, unusual monitoring conventions, sponsor micro management, and so on) not covered by the usual assumptions. For example:
Several sites might require more than one location to visit or additional interaction with several clinical investigators or their staff (for example, pharmacy or hospital medical unit or record room).
Sites might be approved and ready to receive a study drug in a very short time, requiring exceptional effort on the part of the vendor. Drug accountability requirements might be atypical.
Use the Locations tab to specify locations for investigation sites and enrolling subjects and to select languages for document translations. The application suggests languages based on the locations specified. You can add or remove languages/dialects as needed. You can translate (and back-translate) all documents, or no documents, or specify which documents are to be translated.
Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Locations Tab.
On the Locations tab, click Add Location(s).
The Choose Locations dialog box appears.
Filter the list by region or country, or show both regions and countries.
When adding locations in which you will conduct a study, Oracle recommends that you select either regions (if you are not sure of the exact countries) or specific countries (if you know which countries in which the study will be conducted). The application allows mixing regions and countries, but this practice is not recommended.
Select the checkboxes of the locations to add.
Click Ok.
The application adds the location to the list of locations.
For each location, in the Number of Sites text box, enter the number of sites.
In the Subjects to Randomize text box, enter the number of subjects to be given the study drug/device or an alternative treatment (for example, a placebo).
This field should contain only the number of subjects that will actually be enrolled in the trial. For example, if the protocol calls for 1000 subjects to be randomized, enter 1000.
In the Avg Grant Amount text box, enter the amount to be paid to each investigator in this location for each subject enrolled in the study. Select the currency from the drop-down list.
Do not include payments made for screen failures, university-related overhead, or other overhead associated with certain sites, or inflation. All of these items are accounted for on the Site tab.
The application includes the total for investigator grant payments as a pass-through cost in the budget.
If you do not know the grant amount for a location, Oracle recommends that you enter your best estimate or zero. If you enter zero for the grant amount for one location, Oracle recommends that you enter zero for all locations, so that the final budget does not include the grant.
The application estimates costs based on completed and partially completed subjects. A completed subject gets 100% of the investigator grant amount. A dropped subject is estimated to require payment to an investigator of 75% of the grant. Oracle expects the average to be closer to 75% of all visits completed since dropped subjects must return for a termination visits (generally a repeat of the last subject visit regardless of where the subject terminates).
You can adjust these pass-through costs if specific knowledge of the prorated grant budget is known. For endpoint studies, be sure to include the grant costs for both the standard treatment and the full extended treatment schedules
For some rare disease trials, grants might run as high as 500,000 USD per subject. However, this is not typical. Check that you have entered a per-subject amount. This field must contain a value between 0 and 500,000 USD (or the equivalent in another currency).
For a MOH/FDA delay, modify the number of days.
This field displays the expected Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time frame for each location.
This value represents the number of elapsed days required in each location to obtain approval to proceed with the study. The application uses this number with other statistical factors to forecast the number of sites that should be approved by any particular date.
The application also uses this forecast to suggest and validate assumptions regarding the first subject enrolled date (FSI/FPI), the enrollment distribution type, and the first quartile enrollment objectives You can override this value if necessary to reflect changes or other knowledge concerning the regulatory delay in any particular location.
You can also override the suggested FSI date, enrollment distribution type, and first quartile objectives, which are based on the site approval forecast derived in part from this value.
If a large number of sites are in countries with very long MOH/FDA approval times, there may not be enough sites approved at the First Subject Enrolled date to meet enrollment targets. This could require extending the enrollment period, reducing the expectation of enrollment by the first quartile, or moving the First Subject Enrolled date to a later date. Alternatively, this could suggest that the study would benefit from the addition of sites in locations with shorter MOH/FDA delays.
Select the checkboxes of the locations to remove.
Click Remove Location(s).
If there is more than one location in the plan, you can quickly select all locations with a single click by using the checkbox that appears to the left of the Location column label.
The application removes the location from the list of locations.
The Locations tab also includes the languages into which it is likely that study documents will be translated and allows you to add or remove languages and dialects as needed. The application suggests languages based on the locations specified. You can translate (and back-translate) all documents, no documents, or specify which documents to translate.
Click Add Language(s).
The Choose Additional Languages dialog box appears.
Select the checkboxes of the languages to add.
Click Ok.
The languages appear in the Languages section.
If you add a language not suggested by the application, the text, <User specified>, appears in the Locations column. For example, a study being conducted in the USA might require translation into French, for portions of Maine, and Spanish, for parts of the Southwest. Or a study conducted in India, where there are over 27 languages, might require additional translations.
In the Dialects/Variations column, increase or decrease the number that appears to indicate the number of study document translations required.
For each language, specify which documents to translate.
If you select Specified Documents, the Document Translations Required dialog box appears.
For each document type:
To translate the document, select the Translate checkbox.
To translate the document back into the original language, select Back Translate. Comparison of a back-translation with the original text is sometimes used as a check on the accuracy of the original translation.
To prevent the translation cost from being automatically calculated, select As Pass-Through Cost. You can then add the translation cost on the Costs tab.
Click Ok.
The application calculates the number of translations required.
Select the checkboxes of the languages to remove.
Click Remove Language(s).
If there is more than one user-specified language in the plan, you can quickly select all user-specific languages with a single click by using the checkbox that appears to the left of the Language column label.
The application deletes the language from the list of selected languages.
On the Site tab you specify details regarding how sites are identified, initiated, monitored, and closed out. Your current edit mode determines the choices available.
For more information about a field, click the field name.
For more information about the screen, see Site Tab.
Because these values can differ from location to location, you can specify values both globally and by location. You first specify the values common to all locations. Then you specify values for the locations whose assumptions differ. It is not necessary to save specific values for each location in the study, only those that differ from those specified for All Locations.
In the Site Information section, from the Values apply to drop-down list, select All Locations or a specific location from the list.
For example, if the site-related values for four out of five locations in the study will be the same, select All Locations, specify the values common to the four locations, and click Save. Then select the specific location whose values differ, specify the values, and click Save or Next.
When one or more locations have been overridden, the phrase Other than <location>, <location>, ..., and <location> appears to the right of the Values apply to drop-down list, listing each location whose values are not represented by those currently displayed. Click this phrase to restore one or more of the listed locations to the values used by All Locations.
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Note: All Locations means those locations for which the user has not provided specific values or overridden the values. The application uses these values when calculating effort and costs for any location currently defined or later added to the plan, unless you have defined separate values for that specific location. |
In the Site Approval section, click the Clear Trial Default Schedule link of the selected location.
The Edit Site Approval Schedule dialog box appears.
The Site Approval Schedule section shows the default values on the left. The Sites column in the User Defined section provides the option of specifying the schedule week by week.
Accept the default schedule by clicking Close.
or
Edit the week-by-week schedule in the Sites column in the User Defined section to customize the site approval schedule for the location.
For more information about a field, click the field name.
For more information about the screen, see Edit Site Approval Schedule Dialog Box.
Click Save, and then Close.
The Site tab refreshes. The Site Approval Schedule column for the location edited now contains the User Defined Schedule link, indicating that you have modified the schedule and allowing you to make additional changes to the schedule.
To restore the default schedule, display the Edit Site Approval Schedule dialog box, and click Restore Defaults.
Click Save, and then Close.
When adding locations, Oracle recommends that you select regions if you are not sure of the exact countries. For budgeting purposes, you can map reporting locations to regions with the Reporting Regions feature.
In the Site Information section, from the Values apply to drop-down list, select All Locations or a specific location from the list.
This choice determines whether your entries apply to all locations or only the selected location.
For each field, enter the percentage of sites to which the information applies.
The application calculates and displays the number of sites to which the percentage applies.
For more information about a field, click the field name.
The Percent of sites identified by sponsor field allows you to specify the percentage of study sites (investigators) that were identified by the sponsor. These may be sites that were used in previous studies or that the sponsor has a special relationship with. The cost of identifying these sites is assigned to the sponsor rather than to the vendor responsible for obtaining all of the regulatory documents and approving the sites.
Site visits add a significant cost to your plan and can be performed pre-study, at site initiation, and at study closeout. You can specify the percentage of the sites that require in-person visits versus phone-based visits.
Pre-study visits—If a site was used within the last year by either the sponsor or the monitoring vendor, it usually does not need a pre-study site visit. Refer to your own SOPs regarding pre-study visits.
Site-initiation visits—This is normally equal to or less than the number of sites expected to participate in the study. On rare occasions, the study project manager might allow additional sites to be initiated (as back-ups) but, generally, will not approve the drug to be shipped unless the plan is to activate the sites later in the enrollment period.
Close-out visits—Normally, all sites participating in the study need a close-out visit when all subjects have completed the study. Therefore, the default for the field is 100%. However, there are some studies where this does not apply. For example, in Phase IV trials not done under an IND, it may not be necessary to close out the sites. In that case, the value for onsite close-out visits is 0%.
Clinical sites are paid based on certain milestones, subjects enrolled, data collected, and so on. In the Number of grant payments per site field, determine the number of payments to be made to investigators (average) over the course of the study. The application derives a default value for this field once the study duration can be calculated. This value assumes quarterly payments. If this value is not appropriate, override this application-suggested value. Otherwise, accept the default. The application updates this value as study assumptions change. Your overridden values are maintained.
Local monitoring refers to sites assigned to monitors that work in the same city as the investigators. These sites do not require overnight travel or lengthy travel time to and from the site (generally less than 30 minutes each way).
Many sites require an overhead beyond the standard investigator grant. For example, university sites and other independent sites without university affiliations might require overhead. If you have not included this in the investigator grant amount on the Locations tab, specify the percentage of sites that require this additional overhead. For example, if you entered an investigator grant of $10,000 with 50% overhead at 4 of 10 sites requiring overhead and 25% overhead at the remaining 6 sites, the percentage is 35%.
Use the radio buttons in the Responsibilities section to enter the outsourcing option for each group of assignable tasks.
Sponsor—Assigns all tasks in that group to the study sponsor.
Vendor—Initially assigns all tasks in that group to the primary vendor specified on the Provider tab.
Mixed—Allows you to assign some tasks in that group to a vendor and other tasks in that group to the study sponsor on the Assignment tab.
N/A—None of the tasks in that group will be performed, if they are optional.
To assign a combination of some responsibilities to sponsor and some to vendor, you must change your selection on the Overview tab to Combination.
If you selected Conducted Internally on the Overview tab, you cannot assign any of the responsibilities to Vendor. If you have selected Outsourced, you cannot assign any of the responsibilities to Sponsor.
The Subject tab includes information about the expected enrollment period and subject enrollment rate, the treatment schedule, and the First Subject In Date (FSI/FPI). Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Subject Tab.
In this section, you define the relationship between the Project Activity Start Date and the First Subject In (FSI) date.
For studies that are outsourced (in whole or in part), the Project Activity Start Date is the date on which a service provider begins billable work on the project. You selected this date on the Overview tab. For studies conducted internally by the sponsor, the Project Activity Start Date is the date on which project initiation activities begin.
The First Subject In Date (FSI/FPI) value is the date that the First Subject First Visit (FSFV) is expected to take place. The application estimates this date based on the study site approval schedule. However, you can override the suggested value with any date later than the Project Activity Start Date.
If you change the Project Activity Start Date after this section has been completed and saved, the following might have to be addressed:
If you or another user accepted the default First Subject In (FSI) date, the application updates this date according to the changed Project Activity Start Date.
If you or another user changed the FSI date, any change in the Project Activity Start Date updates the FSI date that was entered. You must revisit and revise any dates that have been overridden.
If you select a start date that is greater than the user-specified FSI date, a warning appears in the FSI date indicating that the date is before the Project Activity Start Date.
You can specify the expected First Subject In (FSI) date for each location globally. The application applies changes you make to the system-suggested FSI date to each location based on the number of days you shifted the date. If you choose to manage the location-specific dates and enrollment periods per location, a dialog box appears for you to enter a specific date and enrollment period for each location.
The Subjects to randomize field displays the number of subjects expected in the selected location or for all locations. You can specify a percentage of the total subjects randomized to be screened as alternate subjects and a stipend to pay to alternate subjects.
In the Screen failure rate field, enter the percentage of screened subjects expected to fail to become study participants.
For example, if 1 out of every 5 potential subjects is expected to fail the screening, the screen failure rate is 20%. If the number of subjects to randomize is 100, the number of subjects to screen is 125. This value cannot be greater than 99.99%. Oracle recommends entering a value between 0% and 50%. The calculation for this field is as follows:
Number Of Screen Failures Expected = Number of Subjects to be Randomized / (100 - Percent of Subjects that Fail Screen).
For example, if the protocol requires 100 subjects to be randomized, and it is expected that for every four subjects screened, one will fail, the screen failure rate is 25%. You would need to screen at least 133 subjects. 33 screen failures = 100 subjects to randomize / 133 * 0.25.
In the Subject drop rate field, indicate the percent of subjects you expect to not complete a full CRF due to early termination. The application uses this percentage as it calculates the data that needs to be monitored and entered into the database. For example, if you expect only three out of four subjects randomized to complete the study, the drop rate is 25%. If 100 subjects are randomized and you expect a 25% drop rate, only 75 subjects are expected to complete the study. Sponsors likely do not have a schedule developed during the bidding or budgeting phase, so the application estimates 75% of the costs will be incurred for dropped subjects. These are pass-through costs and can only be estimated. However, you can easily adjust these costs if more exact amounts are known.
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Note: The actual costs per subject are based on a prorated schedule that is given to the investigator prior to the study start. |
On the Treatment tab, you can add, edit, copy, and delete one or more treatments within a plan. You can model single or multiple treatment arm trials, using either parallel or cross-over designs. For late-stage parallel design trials, you can also model endpoint studies. Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Treatment Tab.
In the Study Characteristics section, you specify whether this study uses a parallel or cross-over design, the cost per overnight stay, or bednight, and whether to use an electronic subject diary.
Parallel designs are those in which some subjects receive one of the defined treatments while other subjects receive one of the other defined treatments, and all subjects receive treatments during the same period. You can add treatments to Phase II through IV studies and Phase I oncology and vaccines studies with a parallel trial design.
Cross-over designs are those in which each subject receives all defined treatments, but in a different order or sequence.
Depending on your selection in the Trial Design field, you can also enter baseline and washout assumptions.
An endpoint study is a study in which all patients conclude their participation in the study on or near the same calendar date. The Endpoint Study field is only available for phase II through IV studies and Phase I oncology and vaccine studies.
Many studies require the subject to keep a daily diary. When these diaries are electronic, the data can be uploaded directly into the study database. Data entry and monitoring review of electronic diaries require less time than for paper-based diaries. Third-party vendors provide the electronic diaries.
You can add, edit, copy, and delete treatments. You can add up to five treatments for a study.
In the Treatment(s) section, click Add.
A Treatment Parameters section appears. You can specify per-location assumptions for the selected treatment, customize the treatment schedule, and record notes relevant to the treatment.
Define the treatment parameters.
Treatment duration—For each subject, enter the treatment length (time-on-trial). For Phase 1 trials, specify the duration in days. For late-stage trials, use weeks.
Visits per subject—Specify the number of visits for each subject during the treatment. For Phase 1 trials, a visit is a day for which one or more CRF pages are generate or collected. For late-stage trials, a visit is a week. For example, if you are modeling a trial in which patients are seen twice a week, add the number of pages collected at each of the two visits into a single visit in the treatment schedule.
For Phase 1 (Healthy Volunteers) trials, in which subjects are confined and procedures are performed throughout the day on most or all days of treatment or washout, each day is a visit for the purposes of the application planning algorithms.
Number of bednights—Specify the number of nights subjects will be confined to the study center during the treatment. The application uses this value to calculate pass-through costs associated with non-procedural services provided (for example, room, meals, and entertainment). If subjects are also confined during the washout period(s), specify the number of bednights during washout separately.
Number of CRF pages per subject—Specify the number of Case Report Form (CRF) pages to be collected for each subject during this treatment. This value should include quality-of-life (QOL), pharmacoeconomic, and subject diary pages collected. The application considers the Number of CRF Pages Per Subject, the treatment period, the enrollment period, subject visits, and other factors to estimate the treatment schedule. Baseline visits and final visits are estimated differently than interim visits. The application calculates interim visits based on the average number of pages remaining and spread evenly throughout the first to last subject visit.
Number of subject diary pages—Specify how many of the pages collected during the treatment period are subject diary pages.
Number of pharmacoeconomic pages—Specify how many of the pages collected during the treatment period are pharmacoeconomic pages. These pages are reviewed to see if they have been filled out by the study subjects, but usually require little /z./; or no monitoring.
Monitoring minutes per CRF page—Specify the number of minutes to monitor one regular CRF page. If a study is complex, or you want the monitors to spend extra time onsite performing additional activities, increase the monitoring time. This field does not apply to monitoring pages generated during the baseline visit. The application calculates the default value based on the chosen phase and therapeutic indication of the study. You can override this value for each treatment arm. Overridden values do not affect minute-per-page values for the baseline visit or washout period for a crossover study.
The default or custom monitoring minutes per CRF page applies to both the treatment and extended treatment period for the treatment arm.
Number of QOL pages—Specify how many of the pages collected during the treatment period are Quality of Life (QOL) pages, reviewed to see if they have been filled out by the study subjects. These usually require little or no monitoring.
In the Subject Treatment Schedule section, optionally specify how many CRF pages are to be collected each week, the monitoring time in minutes, and how to distribute investigator costs.
You can override the calculated collection of CRF pages created for each week (or day for Phase 1 trials). However, the total number of CRF pages should equal the Number of CRF Pages Per Completed Subject. If the calculations are accurate, and you still want to adjust the monitoring time associated with a specific week, update the Monitoring Time value for any of the visits.
If you know the specific weeks/periods when visits will occur during the treatment period and the number of CRF pages that will be collected at each of those visits, you can enter that information. If you do not know that information, accept the default values.
If there are two or more patient visits that occur in the same week, combine those visits and the respective CRFs into a single visit for calculation purposes.
The application considers the Number of CRF Pages Per Subject, the treatment period, the enrollment period, subject visits and other factors to estimate the treatment schedule. It estimates the Baseline visit and the final visit differently than interim visits. All interim visits are then calculated based on the average number of pages remaining and spread evenly throughout the first to last subject visit.
When treatments vary only in a few specific ways, you can save time by defining the first treatment with the most common values, then duplicating that treatment and changing only the values that differ.
In the Treatment(s) section, select the checkbox of a Treatment Parameters section, and click Copy.
A new Treatment Parameters section appears that is a copy of the selected treatment.
Change the copied treatment as necessary.
Click Save.
On the Data tab, you specify information regarding the collection and management of study data. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Data Tab.
In the Data Collection section, from the Data Collection Method drop-down list, select the data collection method to apply to the plan.
Paper (Traditional Monitoring)—Monitors will visit the sites to collect data. To specify that there will be no monitoring, select this data collection method, but in the Responsibilities section, set monitoring responsibilities to N/A.
Electronic Data Capture—A sponsor, CRO, or other service provider added to this plan is responsible for EDC management. The application calculates associated direct labor fees and indirect costs based on the selected EDC maturity level you select from the EDC Maturity Level drop-down list. This is the default data collection method.
EDC-3rd Party—You do not want the application to calculate labor fees related to EDC, but instead want to create or adjust pass-through costs to account for these expenditures. Use this option if none of the service providers added to this plan are responsible for EDC management. You can include and assign individual tasks that are excluded by default for EDC 3rd Party on the Assignment tab.
Investigator Site Data Entry—Data will be keyed into a data capture system or web-based system by someone at the site. This option is not the same as EDC.
Faxed CRFs—CRFs will be faxed.
In step1, if you selected Electronic Data Capture or EDC-3rd Party from the EDC Maturity Level drop-down list, select the stage to apply to the plan.
Stage 1: Pilot/Single Study—You are actively conducting experimental EDC implementations within a single study or within a very limited number of clinical trials. The primary goal in conducting pilot or single-study EDC implementations is to identify the possible benefits.
Stage 2: Limited Standardization—You have moved past piloting EDC and have recognized its potential value. Stage 2 tests EDC abilities to full scale and assesses reliability. EDC deployment is typically expanded to other trial phases or different therapeutic areas during this stage.
Stage 3: Standardization—You have an established standardization for EDC on all new trials over all phases and therapeutic areas. Most clinical trials using paper are doing so only because they began prior to initial EDC implementation and are grand-fathered until they conclude. There is a high level of integration between EDC and other systems such as CTMS, laboratory systems, project management systems, payment systems, and IVRS. During this stage, companies commit to a preferred EDC solution vendor and entertain discussions about forming long-term partnerships with vendors.
Stage 4: Enterprise Deployment—You have an established enterprise-wide standardization on a single integrated EDC solution and all clinical management systems are fully integrated with the EDC system. EDC solutions found in Stage 4 provide hybrid paper/electronic features that support a limited number of paper records. All note taking is done directly in the system, and all signatures are recorded electronically. A small number of clinical trials, or certain portions of a trial, might still require the use of paper.
In the Query Rate field, specify as a percentage the average number of queries expected per every 100 pages of CRF data.
If you are planning a single treatment arm trial and have estimated in terms of queries per CRF book instead, enter the value obtained by the following conversion:
(Number of Queries per CRF Book / Number of Pages in the CRF Book) * 100
In the Percent of database data to audit field, indicate the percent of the database information that must be audited.
Typically, the vendor required to manage the data is required to audit some percentage of the database. The default for this value is 10%.
In the Minutes for Data Entry per CRF page field, the application displays the number of minutes required to enter one CRF page into the database, assuming double data entry. The application calculates this value based on the phase and therapeutic indication of the study. You can override this value.
In the Minutes for Data Coordination per CRF page field, the application displays the number of minutes required to coordinate CRF data. The application calculates this value based on the phase and therapeutic indication of the study. You can override this value.
From time to time the vendor who manages the data must transfer the data in electronic format to the sponsor. This can be done at the end of the study or periodically throughout the study. In the Total number of data transfers field, enter the number of data transfers to be performed. If the sponsor is performing data management, enter 0.
In the Number of interim analyses to be performed field, specify the number of interim analyses to be performed. The default value is 0 and Oracle recommends that the value should not be greater than 3.
An interim analysis is a preliminary look at the study data to determine if there are large differences between treatment groups. Interim analysis can be planned for specified calendar times (for example, quarterly) or when specific numbers of subjects have enrolled in the study to ensure that a sufficient amount of data is available for review.
Interim analysis typically requires a dedicated monitoring trip at the end of this period to collect data so that the data can be entered into the database and the interim analysis performed. Oracle recommends that you adjust the monitoring schedule if an interim analysis is required for your study.
In the Number of third-party vendors/data sources field, specify the number of third-party vendors or data sources used to capture study-related data. These vendors or sources are those, other than the CRO, whose data need to be imported or otherwise collected.
In the Total number of data imports from third-party vendors field, specify the total number of imports from third-party vendors expected throughout the study. This is the total number of imports, not the number expected per third-party vendor.
In the CRF Design section, specify the number of Case Report Form (CRF) pages that are not duplicates of another CRF page or screen.
For example, the same AE page that is required at each visit counts as one unique page. The minimum field value is 1.
Define the number of screens per CRF page. This is the number of screens needed to capture one paper CRF page.
Enter the number of unique and repeat tables, listings, and figures and graphs for the study.
If your study is a Phase 1, Healthy Volunteers trial, complete the Unique and Repeat PK/PD sections.
The application displays a default setting for these fields based on the number of CRF unique pages specified. You can override the estimates.
Some studies use newsletters to inform the investigators about overall study progress, compare investigators to each other, and provide updates about issues or protocol/CRF interpretation. In the Number of newsletters per site field, indicate how many times you expect to generate newsletters.
For example, if there are 120 sites in a study and you enter 12 newsletters, all 120 sites are expected to receive 12 newsletters each during the enrollment and treatment period of the study.
Specify whether to include an ICF Video/DVD.
After a study is concluded, you must archive the data for some period of time. In the Number of years to archive data field, enter the number of years. Check with your regulatory department for the most current regulations regarding data archiving. The default value is 5 years.
If you selected Electronic Data Capture (EDC) or EDC- 3rd Party as the data collection method, specify the number of online EDC training sessions required. This is not the training that happens at the Investigator Meeting or the initial CRA training. The default value is 3.
In the Number of pages in the Investigator Brochure field, specify the number of pages, which can be a few pages to over 250 pages.
The Investigator Brochure provides a description of the drug substance or device and the formulation, a summary of the pharmacological and toxicological effects, a summary of information relating to safety and effectiveness in humans, and a description of possible risks and adverse reactions to be anticipated and precautions or special monitoring required.
You provide the brochure to investigators and, ultimately, to ethical committees for review. You can use a vendor to help write, edit, print, translate, or distribute the brochure to clinical investigators.
The application uses the approximate size of this brochure to calculate costs for the activities related to the production, translation, and distribution of the brochure.
Oracle recommends that you enter the total number of pages of your full Investigator Brochure to calculate the effort required to print and distribute the brochure.
The default value for this field assumes that the sponsor requires that the full Investigator Brochure be written and edited for each new study.
If the Investigator Brochure:
Has been previously written, you can de-select the Write IB task on the Assignment tab.
If the brochure has been written but needs updating, check Edit IB on the Assignment Tab.
If no updates are required, de-select Edit IB.
In the Number of manuscripts field, enter the number of manuscripts to be created for journal publication. This field must contain a value between 0 and 99.
A manuscript is something other than the final Clinical Summary Report (CSR) and is generally a document that appears in a peer industry journal. It may be written by the sponsor, a CRO, or an independent medical writer.
Set milestones and due dates related to clinical data.
In the Days from LSO/LPO until Database Lock field, enter the number of elapsed days from last subject observation (LSO/LPO) until the expected database lock. This typically occurs at least eight days after LSO (due to the possibility of a late reportable SAE) and must occur before the Statistical Report date.
If you selected Electronic Data Capture (EDC) or EDC- 3rd Party as the data collection method, the application calculates the default value based on the EDC maturity level. The 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 this field can accept is 1.
In the Days from Database Lock until Statistical Report is due field, enter the number of elapsed days from the database lock date until the statistical report is expected to be delivered. This is the time by which the assigned provider is expected to have the statistical report completed, expressed in elapsed days from the database lock date.
If you selected Electronic Data Capture (EDC) or EDC- 3rd Party as the data collection method, the default value is calculated based on the EDC maturity level. The default values are 45 days for Stage 1; 38 days for Stage 2; 36 days for Stage 3; and 34 days for Stage 4.
In the Days from Database Lock until Draft Report is due field, enter the number of elapsed days from the database lock date until the draft clinical report is expected to be delivered. This is the time by which the assigned service provider is expected to have the draft clinical summary report completed, expressed in elapsed days from the database lock date.
If you selected Electronic Data Capture (EDC) or EDC- 3rd Party as the data collection method, the default value is calculated based on the EDC maturity level. The default values are 73 days for Stage 1; 70 days for Stage 2; 67 days for Stage 3; and 65 days for Stage 4.
In the Days from Database Lock until Final Report is due field, enter the number of elapsed days from the database lock date until the final clinical summary report (CSR) is expected to be delivered. This is the time by which the assigned service provider is expected to have the clinical summary report (CSR) completed, expressed in elapsed days from the database lock date
If you selected Electronic Data Capture (EDC) or EDC- 3rd Party as the data collection method, the default value is calculated based on the EDC maturity level. The default values are 98 days for Stage 1; 95 days for Stage 2; 90 days for Stage 3; and 85 days for Stage 4.
In the SAE rate as a percent of randomized subjects field, estimate the number of anticipated Serious Adverse Events (SAEs) as a percent of the total subject population.
This value yields the expected number of Serious Adverse Events (SAEs) across all subjects over the entire duration of the study.
In the Hours medical monitor will spend with each SAE field, specify the number of hours a medical monitor will spend with regard to each Serious Adverse Event (SAE).
In the Expected percent of SAE Reports to be expedited field, enter the percentage of SAE reports to be expedited to regulatory agencies and ethics committees.
From the Provide data to the DSMB drop-down list, select the frequency with which to report data to the Data Safety Monitoring Board (DSMB).
In the IVRS (Interactive Voice Response System) section, select the IVRS Usage checkbox that identifies how the Interactive Voice Response System (IVRS) will be used.
Check all choices that apply.
Changes are common in clinical trials. You can add expected changes in the form of protocol amendments to your plan. Planning for these amendments makes the study budget more accurate. Protocol amendments cannot be added to Phase 1, Healthy Volunteer plans.
In the Expected Protocol Amendments section, click the Add an amendment link.
An amendment is expected to occur field appears.
Specify the number of days before or after a milestone the amendment is expected to occur.
In the days field, enter the number of days.
From the first drop-down list, select before or after.
From the second drop-down list, select the milestone nearest to the date the amendment will occur.
The application displays the anticipated amendment date to the right of the milestone drop-down to reflect this offset.
To add additional protocol amendments, click the Add another amendment link.
Click Save.
To delete a protocol amendment, click the x button to the right of the expected date.
In the Responsibilities section, assign each group of outsourcing tasks to sponsors and vendors.
Sponsor—Assigns all of the tasks in that group to the study sponsor.
If you selected Outsourced on the Overview tab, you cannot assign responsibilities to Sponsor.
Vendor—Initially assigns all of the tasks in that group to the Primary Vendor specified on the Provider tab.
If you selected Conducted Internally on the Overview tab, you cannot assign any responsibilities to Vendor.
Mixed—Allows you to assign some of the tasks in that group to a vendor and other tasks in that group to the study sponsor. You do this on the Assignment tab.
If you want to assign a combination of responsibilities to the sponsor and a vendor, you must change your selection on the Overview tab to Combination.
N/A—Indicates that none of the optional tasks in that group will be performed.
On the Monitoring tab, specify information about the monitoring frequency, approach, and which responsibilities are outsourced versus internal. You can also manage monitoring schedules globally or for each location. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Monitoring Tab.
In the Monitoring Methods section, specify the types of monitoring to be performed.
On-site—Monitoring is done in person.
Via phone—Monitoring is done by phone. Phone-based monitoring is typically done only for Phase IV studies or during long follow-up periods.
Combination—Select both the on-site and via phone checkboxes.
In the Manage monitoring schedule values field, specify whether to manage monitoring schedules globally or per location.
If you manage monitoring schedules globally, the application applies all of the assumptions entered on the Monitoring tab to all the plan locations in the study.
If you manage monitoring schedules per location, you can modify schedules for each location within the study.
To select each location and edit the associated monitoring methods and monitoring schedule, click the Per Location link.
The Edit per Location Monitoring Schedule dialog box appears.
Choose the locations from the navigation tree.
For each location, specify the monitoring methods and the associated on-site and phone-based monitoring schedules
Click Ok.
In the On-Site Monitoring Schedule section, you control the monitoring schedule, the number of visits, and the travel strategy.
In the Monitor every field, specify the frequency of monitoring visits to the sites in the study during each period of the monitoring schedule.
For example, if a monitor will visit each site every 4 weeks, enter 4 in this field.
If the monitoring will continue at the specified frequency through the end of the treatment period, select the until LSO/LPO radio button.
If you want to use a variable monitoring frequency, for example, monitoring every 4 weeks in the beginning of the study, every 2 weeks in the middle of the study, and every 6 weeks at the end of the study, in the Monitor every field, enter the frequency for the first period.
Select the until week radio button and enter the week at which this frequency ends and a new monitoring frequency begins.
This value specifies the week at which the specified frequency for monitoring changes. This is the week number corresponding to 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.
In the next Monitor every field, enter the frequency to be used for the next period (or until the end of the treatment period).
Repeat as necessary to define each change in frequency over the course of the monitoring schedule.
Override the total number of monitoring visits in the Total Visits field, if necessary (for example, if the value in the RFP is different from the generated value).
The application derives the default value shown from the total number of sites, monitoring frequency, and subject enrollment rate. You can increase this number to add more monitoring visits. You can also lower the total number of monitoring visits.
If you are working with new sites that have limited research experience or where you know that there is a need to accelerate monitoring for some reason, add monitoring visits. For example, if the application calculates 1068 visits and there are 89 sites in the study o which 35 are inexperienced, you might add one additional monitoring visit for these 35 sites. The new number of monitoring visits is 1103.
Oracle recommends that the total number of visits selected be as close to the value calculated by the application as possible.
From the Monitoring Travel Strategy drop-down list, specify the monitoring visit strategy to use.
Spoke monitoring— The monitors return to their homes or offices after visiting each site. Selecting Spoke roughly doubles the average travel time (in hours) for site monitors.
Loop monitoring— Monitors travel to site 1, then to site 2, then to site 3, and so on, before returning to their homes or offices. Typically, loop visits are more cost efficient. However, monitors often choose not to spend more than five consecutive days in the field without returning home. Therefore, select Spoke if monitoring visits average more than three days per visit.
Use the Monitoring Schedule chart or the Monitoring section of the Assumptions report to verify the schedule.
To select each location and edit the associated monitoring methods and monitoring schedule, click the Per Location link.
The Edit per Location Monitoring Schedule dialog box appears.
Choose the locations from the navigation tree.
For each location, specify the monitoring methods and the associated on-site and phone-based monitoring schedules
Click Ok.
In the Phone-based Monitoring Schedule section, you control the call schedule, number of calls, and average hours per visit.
In the Call every field, specify how frequently a monitor will call the sites during each period of the monitoring schedule.
If the phone-based monitoring will continue at the specified frequency through the end of the treatment period, select the until LSO/LPO radio button.
If you want to use a variable monitoring frequency, for example, calling every four weeks in the beginning of the study, every two weeks in the middle of the study, and every six weeks at the end of the study:
In the Call every field, enter the frequency for the first period.
Select the until week radio button and enter the week at which this frequency ends and a new monitoring frequency begins. This is the week number corresponding to 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.
Repeat as necessary to define each change in frequency over the course of the monitoring schedule.
The application calculates the total number of calls to be made, derived from the phone-based monitoring frequency and the subject enrollment rate, and displays it in the Total calls field.
In the Average hours per visit field, specify the average number of hours required to perform a phone-based monitoring visit, including preparation and follow-up activities.
In the Monitoring Approach section, enter the following details.
Percentage of time monitors spend in the field—The application assumes that monitors spend the remainder of their time on site management activities.
Percentage of monitoring done by CRAs (vs. Senior CRAs)—In complex studies, you might prefer that a Senior CRA perform a larger percentage of the monitoring. If this is the case, decrease the percentage to indicate that less of the monitoring will be done by CRAs.
Percentage of monitoring done by Regional Monitors—Even when 100% of monitoring is done by Regional Monitors, some site management activities are performed by CRAs or SCRAs. When using Regional Monitors, time allocated for travel is assigned to monitored CRF and site management tasks.
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Note: The values in these fields are not related to travel time or distance. The application uses these values to split the effort of monitoring and site management tasks across resources that have different billing rates. |
Avg travel time (in hours) for site monitors—The average number of hours a monitor requires to travel to sites.
Percent of source documentation verification—Specify the percent of key safety and efficacy data to be source verified. For most studies, this is 100%. Some Phase III and Phase IV studies might not require a level of monitoring the study data this rigorous.
Time to review queried from previous visit (minutes)—The application calculates a value representing the number of minutes required to re-review queries and CRF data from a previous monitoring visit, based on the therapeutic area and indication selected for the study. You can override this value.
Manage location-specific value—Enter monitoring approach assumptions per location by clicking the Edit location specific overrides link. In the Edit Per Location Monitoring Approach dialog box, enter the monitoring approach assumptions by location, overriding global default values.
To determine the number of total CRFs for a study, shown in the Monitored Data section, including a correction for dropped subjects, the application does the following:
For the first two weeks of enrollment, the application assumes that no subjects drop (therefore, the retention for weeks 1 and 2 is 100%), and that all scheduled CRFs are completed.
For each week after week 2 of enrollment (for example, the total enrollment period minus the first two weeks), the application starts correcting the total number of CRFs completed by the drop rate.
Total CRF pages generated (without subject drops)—Displays the total number of predicted CRF pages generated, assuming that no subjects drop. It is the sum of all CRF pages entered for each subject visit across all subjects and sites, as defined on the subject treatment schedule.
Total CRF pages monitored (accounting for subject drops)—Displays the predicted CRF pages that will be monitored, accounting for subjects that drop out of the study. The application derives this value from the subject drop rate, which is applied to each week of the study to calculate the subject retention rate.
The drop rate is assumed to be linear, and the weekly reduction rate is calculated as the overall drop rate divided by the number of weeks after week 2.
The application takes the number of CRFs that would have been generated each week if no subjects had dropped out of the study, and multiplies it by the retention rate percentages to calculate the CRFs including drop outs.
You can increase or decrease this value. The percentage change of your adjustment is applied to the CRF pages generated during each week of treatment to produce the total number of CRF pages, including drop outs you have specified.
In the Estimated number of FTE (full-time equivalent) Medical Monitors field, accept or change the time for a Medical Monitor (MD) to serve as the team medical lead and provide support to the CRA monitoring staff and investigators for issues beyond safety reporting. Tasks include the following, and others as appropriate:
Developing protocol entry criteria.
Developing abnormal lab data.
Interpreting the protocol and discussing potential deviations.
Medical discussion with Investigators.
The value in this field is the estimated number of full-time equivalent (FTE) Medical Monitors required for all sites for the period from FSI/FPI to LSI/LPO, not the entire study.
The application supplies a calculated default value based on the study indication, the number of subjects, and the phase of the plan being modeled.
You can override the calculated default value. The application calculates the FTEs required based on 1800 hours per FTE per year. This task appears under the Site Management/Monitoring Task Group on the Assignment tab.
Use the fields in the Separate Drug Accountability section to indicate whether additional drug accountability visits are required, who performs these visits, and how many visits per site to perform.
Separate drug accountability generally applies to oncology and some vaccine studies and is done by someone other than the CRA that monitors the site to assure that all involved in the study are completely blinded to the study drug or test article.
On the Provider tab, you can add one or more vendors to the list of possible service providers for this plan. Adding a provider to this list does not automatically assign that provider to any tasks. This tab also displays and allows you to designate the primary service provider, to whom outsourced tasks are automatically assigned. You can change these assignments on the Assignments tab as well as assign tasks to service providers. Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Provider Tab.
From the Edit menu, select Plans.
The Plans screen appears.
Select the checkbox of the plan.
Click Edit.
The Edit Plan screen appears.
Click Provider.
The Provider tab appears, displaying a list of the service providers.
The application supports two types of service providers: Sponsors and Contract Research Organizations (CROs). There are four types of CROs:
Premium—Provide a global presence in all major regions. You can fully outsource studies to them, but premium CROs are more expensive than other CRO types.
Major—Provide a global presence in all major regions. You can fully outsource studies to them.
Medium—Provide an incomplete global presence. You can fully outsource studies to them, but they may have to sub-contract some of the work.
Niche—Operate in only one country or region and often offer only a subset of services.
Click a service provider listed in the Provider Name column.
The Specify Provider-Specific Details dialog box appears.
In the Billing Rate Information, FTE Utilization Information, and Other sections, accept or override the values shown.
For more information about a field, click the field name.
For more information about the screen, see Specify Provider-Specific Details Dialog Box.
Click Ok.
On the Provider tab, click Add Provider(s).
The Choose Service Providers dialog box appears.
Select one or more service provider checkboxes.
Click Ok.
The application adds the service provider(s) to the plan. A service provider does not become part of this plan until you click Save or Next
Click a provider name.
The Specify Provider-Specific Detail dialog box appears.
In the Billing Rate Information section, override the default billing rate settings for the provider:
Rate Year in effect—Specify which set of billing rats to use to calculate the provider's fees. The application uses the hourly rates published for this provider for the rate chosen as the base rate, plus or minus any discount indicated here, then applies the specified inflation percentages over the course of the study.
Discount rate to apply to this study—Specify any negotiated percentage discount established with this provider.
Back-Office Billing Rate Location—Specify the location where centralized or regionalized tasks or functions are performed. The application uses this location to calculate fees based on the billing rates associated with resources in this location. When you edit the detailed assignments on the Assignment tab, you can choose another location for one or more centralized tasks if necessary.
Line-item Discount—Specify any negotiated monetary discount established with this provider for the plan. This discount is only applied to the provider's labor fees. Select the currency in which to calculate the discount from the drop-down list. If there is more than one provider for a plan, each could offer a different discount.
Currency Exchange Rates—Choose an option to indicate which exchange rates the application uses to convert between currencies:
Use rates defined on the Plan Overview tab—Do not override any exchange rates specified on the Overview tab.
Use rates defined below—Open a new section on the screen to override exchange rates for this provider. If you have overridden exchange rates on the Overview tab, those values appear. To override these rates, type the exchange rate that is equal to one unit of the provider's billing rate currency. Overridden values appear with a shaded background. To restore the default value, delete the value in the field.
In the FTE Utilization Information section, override the percentages in the Project Manager utilization before/after FSI/FPI.
The application suggests percentages of project manager resources prior to and after a first-subject-in date. These values are not calculated until after all study tasks have been assigned on the Assignment tab.
These values change whenever certain assumptions are modified, including the number of sites or locations.
Oracle recommends that you review the values if the number of sites or locations change or if tasks are reassigned.
For example, if you know that one full-time project manager will be allocated to the project before the date the first subject is enrolled, then you should enter 100% in the utilization prior field. If two full-time project managers are needed during this period, enter 200%. If a project manager will spend only half time on this study during the period, enter 50%.
Enter a Resource Allocation Factor percentage, if desired.
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Note: Do not modify this factor without a full understanding of how it will affect the plan |
Use this field only to allow comparison of the cost and time for a sponsor to conduct a study (or subset of study tasks) versus a CRO to conduct a study or perform certain tasks.
This field indicates the percentage of time, on average, that this service provider or sponsor team is working on the project, as a percentage of their overall workday.
For CROs, the recommended value is 80%.
For sponsors, the recommended values are between 50 and 70%.
If you decrease this percentage, you are indicating that this service provider requires more hours to complete a task than a service provider with a higher allocation. For example, if a sponsor's employees are dedicated to the project 70% of the time and spend only 30% of their time on other company activities, including meetings, conferences, vacation, sick, time, or other duties, then enter 70% in this field for the sponsor.
Generally, the larger the organization, the more time is spent on non-project-related activities.
Enter values in the fields in the Other section.
Number of sponsor affiliates—Enter the number of your affiliates with which this vendor will be working.
Type of reporting to affiliates—Select those items you want the vendor to do.
Additional type of vendor with which this service provider will work—From the drop-down list, select the type of provider with which this provider will work. This indicates the relationship that this vendor has with these other third parties. Do not include relationships where there is little or no daily interaction. For example, if the vendor only collects data from the central lab and does not interact with the central laboratory on a daily basis, do not include this interaction. If the vendor is managing the activities of another vendor, however, include this relationship.
Will this provider manage the CTMS—Indicate whether or not this provider will enter data into the sponsor's Clinical Trial Management System (CTMS).
Built-in service providers have default inflation profiles associated with them. You can also set default inflation profiles per custom provider from the Maintain menu. When using a ClearTrial built-in provider, or a custom provider with an established profile, you can use the default inflation rates, plan-specific inflation rates, or no inflation at all. Access the inflation table in the plan and make your updates as needed.
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Note: To use your plan-specific inflation rates only for specific locations, overwrite the default ClearTrial values with your values for those specific locations. Leave the ClearTrial defaults in the remaining locations in the event one of those remaining locations is later included in a plan. |
Click a provider name.
The Specify Provider-Specific Details dialog box appears.
Click the Inflation tab.
The application renders the Inflation Rates table for the selected provider.
In the Compound inflation annually field, select Yes or No.
To change inflation rates for the provider, enter the new rate for each location for each year.
To remove your overrides, click Clear Overrides.
To reset the inflation rate to zero, click Set Inflation to 0%.
Click Ok.
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Note: To quickly update the inflation table to your desired rates, overwrite only the default inflation values for the locations you have included in your plan. Oracle recommends that you leave the ClearTrial default values in the unused locations in the event a user adds new locations later and does not revisit the inflation table. If you prefer to model your plan without inflation, click Set Inflation to 0%. |
On the Provider tab, select one or more service provider checkboxes and click Remove Provider(s).
The application immediately removes the service providers from the list. However, they are not removed from the plan until you click Save or Next.
If there is more than one service provider in the plan, you can quickly select all service providers with a single click by using the checkbox that appears to the left of the Provider Name column label.
Tasks that have been assigned to a removed service provider are reassigned according to the following rule:
If the task assignment is for subject data from a location whose assignments have been overridden, the task is reassigned to the default service provider for that location.
Otherwise, the task is reassigned to the service provider specified as the primary provider.
The primary service provider is automatically assigned to tasks indicated as outsourced to Vendor. The primary service provider also becomes assigned to tasks assigned to a vendor who is later removed from the plan.
On the Provider tab, select a service provider checkbox, and click Set as Primary Provider.
Two asterisks appear to the right of the provider name indicating that this is the primary service provider for the plan.
Click Save.
Select a service provider checkbox and click Replace Provider.
The Choose Replacement Provider dialog box appears, listing eligible service providers.
Choose the radio button of the service provider to replace the currently selected service provider.
Click Ok.
The application saves all of your current service provider-level assumptions and replaces the selected service provider with your new choice.
If you replace a provider who has a line-item discount, the new provider inherits the same line-item discount value and currency.
If there is an Unfreeze Rates, button, billing and inflation rates have been frozen for this plan. If there is a Freeze Rates button, no rates have been frozen. The Rate Year in Effect column shows the Rate Year used to look up billing and inflation rates for the resources for this service provider for this plan. If no billing or inflation rates have been published for a provider, an information icon appears to the right of the rate year. When you click the icon, a message appears stating that neither billing rates nor inflation rates have been published for the provider for the year the study is expected to start.
When you freeze billing rates for a service provider, changes to the service provider's billing rates no longer impact the plan. The application copies the current rates for the current service providers and stores them with the plan. If you add service providers, the application also copies their current rates to this plan.
If you click Unfreeze Rates, the application deletes the copied rates and uses the current rates for the service providers to calculate costs for this plan. The plan reflects the changes to the billing rates of service providers.
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Note: You cannot freeze billing rates for templates. |
On the Meetings tab, you can add and edit meetings; specify meeting details, attendees, and notes for each meeting; and track meeting costs.
Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Meetings Tab.
From the Edit menu, select Plans.
The Plans screen appears.
Select the checkbox of the plan.
Click Edit.
The Edit Plan screen appears.
Click Meetings.
The Meetings tab appears, displaying a list of the planned meetings. Meetings with a line through them have been excluded from the plan.
To add a meeting, click Add.
The Define New Meeting dialog box appears.
In the Name field, enter a name for the new meeting.
From the Type drop-down list, select the meeting type.
Click Continue.
The Meeting Details dialog box appears.
On the Meeting Details tab, in the Meeting Definition section, specify basic information about the meeting.
The application uses the code you enter as a prefix for tasks associated with this meeting type.
Non-travel costs include audio-visual equipment rental, meeting space, and so on.
In the Schedule section, enter the frequency, start and stop times, and duration of the meeting.
The calculated distribution start date cannot be earlier than the pre-study planning date.
To create a recurring meeting, you select the frequency from the Occurs drop-down list, the start date, and use the Until field to specify the range of time over which the meeting recurs.
In the Providers Attending section, select the checkbox of each service provider type to participate in the meeting.
Click Save.
Click the Attendees tab.
From the Service Provider drop-down list, select a service provider type.
Click Add.
The Resource Name dialog box appears.
Select the checkboxes of the resources to include.
Click Ok.
The application adds the service providers to the Provider Attendees list associated with the meeting.
For each resource type, specify the number of attendees, the back office billing rate location, how the attendee will attend the meeting, the billable hours expected for meeting attendance, and indirect costs.
To divide the billable hours into preparation, travel, attendance, and follow-up costs, click the Expand All Billable Hours link and enter a value into each field.
Click Save.
Repeat steps 2 through 8 for each service provider type.
On the Attendees tab, select the checkbox of an attendee resource type, and click Duplicate.
The application duplicates the settings for the selected attendee and adds it to the bottom of the list.
Click Save.
Click the Site Attendees tab.
If the meeting type involves on-site attendees, meeting details appear and include the number of attendees per site, percentage of sites represented, location, attendance method, and indirect costs associated with the meeting.
To change site attendee settings, modify the values in the fields.
To delete a site attendee, select the Attendee/Site checkbox and click Delete.
To duplicate a site attendee, select the checkbox of the site attendee to duplicate and click Duplicate. The application adds the duplicated site attendee to the bottom of the page. You can modify the duplicated values.
To add a site attendee, click Add. The application adds another site attendee to the bottom of the page. You can modify the default values used.
Click Save.
Select a meeting checkbox, and click Edit.
The Meeting Details dialog box appears.
Make changes to the meeting on the Meetings Details, Attendees, Site Attendees, and Notes tabs.
Click Save.
Select a meeting checkbox, and click Copy.
The Meeting Details dialog box appears. The application populates the fields on the tabs with the copied meeting values.
Accept or change the details from the meeting you copied on the Meetings Details, Attendees, Site Attendees, and Notes tabs.
Click Save.
To exclude a meeting, select a meeting checkbox, and click Exclude.
The application does not delete the meeting. The excluded meeting appears with a line through it. The application excludes the associated costs from the totals.
Click Save.
To include an excluded meeting, select the checkbox of an excluded meeting, and click Include.
The application removes the line crossing out the meeting and includes the associated costs in the totals.
Click Save.
Select one or more meeting checkboxes, and click Delete. You can delete both application-defined and user-defined meetings.
If there is more than one meeting in the plan, you can quickly select all meetings with a single click by using the checkbox that appears to the left of the Name column label.
The application prompts you to confirm that you want to permanently delete the meeting.
To delete the meeting, click OK. To retain the meeting, click Cancel.
Use this tab to assign the service provider and billing rate location to tasks.
Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Assignment Tab.
From the Values apply to drop-down list, select the location.
Select Centralized Tasks/Location Defaults if you want assignments to pertain to every location in the study.
Select a specific location to assign it to a different service provider.
If all outsourced tasks in your plan are performed by a single service provider, from the Default service provider for outsourced tasks drop-down list, select that service provider.
or
If outsourced tasks in your plan are performed by various service providers, from the Default service provider for outsourced tasks drop-down list, select the service provider who performs most of the outsourced work.
Example 1: Values apply to is set to Centralized Tasks/Location Defaults. To assign all outsourced tasks for all locations to Major CRO, select Major CRO.
Example 2: Values apply to is set to Chile. To assign all outsourced tasks in Chile to Medium CRO, select Medium CRO.
If a service provider is not available for selection, return to the Provider tab and add the service provider.
Click Save.
Click the Show Tasks link.
For the selected location, the associated assignment groups/tasks appear.
To see and assign individual tasks, click the blue triangle to the left of the assignment group.
The Included column indicates whether this task is included in the study and, in some cases, allows you to exclude a task from the study. If this checkbox is grayed out, the task must be included (or excluded) from the plan based on other input assumptions you have made or other study characteristics.
You can exclude selected tasks from the plan, which eliminates the effort and costs associated with these tasks. Tasks that cannot be excluded or specifically assigned, or whose billing rate location cannot be different from the location of subject data, are presented with the associated option(s) disabled.
If, on the Overview tab, you selected Outsourced, you can only assign tasks to vendors. If you selected Conducted Internally, you can only assign tasks to the sponsor. To assign some tasks to service providers and others to the sponsor, you must select Combination on the Overview tab.
For each Assignment Group/Task, from the Assign to drop-down list, select the service provider.
The value displayed might indicate additional information when showing the assigned provider(s) for an entire group of tasks, as follows:
Service provider name appears with no additional markers—All tasks in the group are performed by a single service provider.
Service provider name appears with an asterisk (*)—The service provider is the default service provider selected to perform tasks in the group.
From the Billing Rate Location drop-down list, select the billing rate location to use to calculate resource costs for this task or group of tasks.
You can specify a different billing rate location for each group or task. For example, if data management tasks for all European sites are performed in Germany, change this field to Germany for each of the locations in Europe.
You can select any location where this activity or activities are conducted. The location does not need to have active sites participating in the study. For example, you might have study sites in France, Germany, and Italy, but perform all data management in the UK or India.
To choose a location that does not have sites or subjects, from the drop-down list, choose Other.... The Choose Location dialog box appears. Choose the location where the work is performed and click Ok.
By default, centralized tasks are calculated using the back office billing rate selected on the Provider tab.
To prevent cascading changes, pin the service provider and billing rate location assignments by clicking the Pushpin icon in the Pinned column to highlight it.
If an assigned provider has been deleted from the plan, the task assignment changes to the primary provider in the plan. Any changes to tasks are pinned by default.
For example, if assignments made for individual tasks included in the group are not pinned, changes made to the assignment group or to the location defaults override these assignments.
Pinned settings are lost if you remove the associated locations or service providers from the plan. However, if you replace a provider, your pinned settings are maintained.
Task overrides migrated from plans created in earlier versions of the application are pinned by default.
Click Save.
Repeat as necessary for multiple locations where the service provider is different or the billing rate is different from the local rate for that location.
You can override the billing rate location and rate for a specific location or all locations and for tasks assigned to a specific service provider. You can save the overrides by clicking the Push Pin icon to ensure that they are not lost due to other cascading changes.
Save the entries you have already made.
Click the Override Resources or Rates link.
The Resource Overrides dialog box appears.
For more information about a field, click the field name.
For more information about the screen, see Resource Overrides Dialog Box.
In the Scope of Overrides section, from the For tasks assigned to drop-down list, select a service provider.
In the Resources/Overrides section, specify your override for each default resource specification and pin your changes if desired.
Click Save.
To clear the overrides, click the Clear Overrides link.
On the Labor tab, view and adjust the calculated labor unit costs and unit hours for each major task for each service provider. You can also edit tasks and resources, assign project tasks to specific service providers and billing rate locations, and override unit hours and the billing rate of a specific resource.
Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Labor Tab.
From the Edit menu, select Plans.
The Plans screen appears.
Select the checkbox of the plan.
Click Edit.
The Edit Plan screen appears.
Click Labor.
The Labor tab appears, displaying a list of the major tasks and their unit hours, unit cost, number of units, extended hours, and extended costs.
To see the major tasks associated with a specific service provider, in the Filter section, from the Show hours and fees for drop-down list, select the service provider.
To view all major tasks, even if the selected service provider is not assigned to any of the tasks, select the Show major tasks with no planned effort for the selected provider checkbox.
To view only those major tasks that are assigned to the selected service provider, clear the Show major tasks with no planned effort for the selected provider checkbox.
Displayed values for hours are in the thousandths. Displayed values for costs are in the hundredths.
Some major tasks have a single unit of work (for example, Study or Database) and others have multiple units of work (for example, Sites, Subjects, or CRF Pages). The unit of measure is displayed when you hover over the number of units displayed.
A major task is a collection of related tasks that share the same unit of measure, labor scope, and expected distribution of units completed.
The major tasks you add appear below the ClearTrial system-defined major tasks in the order you create them. The application applies inflation to all major tasks, whether user-defined or system-defined, based on inflation settings on the Provider tab.
On the Labor tab, click New Major Task.
The Task Manager dialog box appears.
On the Major Task Details tab, define the basic attributes of the new major task.
Name—Oracle recommends naming the major task with the explicit deliverable or unit of work expected. Major task names must be unique within a plan.
Description—Oracle recommends providing a description to help others understand the purpose of the major task.
Labor—Specify whether associated tasks are location-scoped or study-scoped.
Tasks that are performed locally, such as monitoring or other site visits, are location-scoped and are usually measured in terms of the number of sites or visits in each location. Location-scoped tasks can be assigned to different service providers in different locations. For a location-scoped task, you can create different algorithms to determine the level of effort required to complete the task in that location.
Study-scoped tasks can be assigned to only one service provider. Tasks that are performed as part of project initiation or as part of back-office operations are usually study-scoped and the only relevant unit of measure is the study itself.
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Note: Labor scope cannot be changed for major tasks defined in the prior forecast when creating a reforecast. |
Unit of Measure—From the drop-down list, select the unit of work this major task represents. Both ClearTrial default and custom units of work are available to be selected. The application calculates all effort for associated tasks in terms of hours to complete one such unit.
For example, a major task whose unit of measure is Sites Approved is composed of tasks whose resources level of effort are calculated as the number of hours required to approve one site. This level of effort (or LOE) represents the unit hours for the resource for the task.
The application-calculated unit hours are multiplied by the number of units expected (for example, number of sites approved) to produce the Extended Unit Hours.
Custom Units of work appear in the drop-down list in italicized type followed by an asterisk.
When creating a reforecast, you cannot change the unit of measurement, labor scope, and distribution of a custom major task defined in the prior forecast.
Click Save.
On the Task Manager dialog box, click New Task.
A dialog box with Task Details and Task Assignments tabs appears.
On the Task Details tab, specify the name of the task, a code to use as a prefix to the task name, the assignment group to which the task belongs, and the summary category under which to include the associated hours and fees on the Summary tab.
All tasks inherit major characteristics, such as unit of measure, labor scope, and work units distribution, from their major task.
The application uses the code as a prefix to the selected task name.
The text you enter for the description appears as the help text for this task as it appears on the Assignment tab.
The assignment groups are represented by radio-button choices in the Responsibilities section of various tabs throughout the plan and in drop-down lists on the Assignment tab. You can determine whether a task is performed by the sponsor or CRO, or is not performed at all for this trial, by choosing the appropriate radio-button for its assignment group. You can also manage the assignments of each task on the Task Assignments tab on the Task Manager dialog box or on the Assignment tab.
The summary category determines how the application summarizes the hours and purposes of display and report fees or the resources on the Summary tab.
Click Save.
The application assigns the new task a mapping key. Mapping keys are included in the Bid Grid export to allow vendors to programmatically map their costs to the Bid Grid format.
Click the Task Assignments tab.
For each location, select the service provider and billing rate location.
To include the service provider, select the Included checkbox.
To prevent cascading changes, pin the service provider and billing rate location assignments by clicking the Pushpin icon in the Pinned column to highlight it.
Click Save.
Click Add Resource.
The Select Resources dialog box appears.
Select the checkbox of one or more resources.
Click Ok.
The application adds the resources to the resource list on the Task Assignments tab.
The Resource Name column displays the name of the resource normally expected to perform this task.
If you or another user has used the resource overrides feature to substitute another resource, you can see those substitutions by clicking the value in the Substitutions column or by editing the resource and navigating to the Rates & Substitutions tab. You can override resources at the plan level, the plan-location level, or for a specific task.
Click Save.
To change details about a resource effort or rates for this task, select the Resource Name checkbox, and click Edit Resource.
The application displays information about the resource on five tabs, including Resource Details, Algorithm, Billing Rate Location, Rates & Substitutions, and Unit Hours.
For more information about a field, click the field name.
For more information about the screen, see Task Manager: Select Resources Dialog Box.
You can specify or change the algorithms to calculate this resource's level-of-effort only for resources that are not part of the ClearTrial default model. You can adjust billing rate locations, billing rates, and unit hours for any resource.
On the Resource Details tab, specify the department to which this resource belongs when performing this task.
If you overwrote the resource with another resource on the Billing Rates tab, or at the plan- or plan-location-level, the name of the original resource appears.
Different providers can use different names for the resources that perform tasks. Review and change the description to make sure it identifies the appropriate resource.
On the Algorithm tab, specify the cost driver and the level of effort in hours for the selected resource to produce one unit of the particular work product. You can define algorithms only for resources that are not part of the ClearTrial default model.
You can only define algorithms for resources that are not part of the ClearTrial default model.
While defining an algorithm, review the extended hours column to ensure that you have chosen the correct cost driver. An incorrect cost driver can greatly skew the effort estimated to complete a task.
Custom units of work appear in the drop-down list in italicized type followed by an asterisk.
On the Billing Rate Location tab, assign the billing rate location for the selected resource when working on this task.
Select any location where this activity to activities will be conducted. It is not necessary for the location to have active sites participating in the study. For example, you might have study sites in France, Germany, and Italy but perform all data management in the UK or India.
By default, the application calculates centralized tasks using the back office billing rate of the assigned provider.
On the Rates & Substitutions tab, override the billing rates for the selected resource when performing a specified task.
If the task is location scoped, you can override the rate for each location.
Each row displays the hourly billing rate for the selected resource based on the applicable billing rate location, which may differ from the location listed.
If you have overridden the billing rate location, the rate displayed reflects that choice rather than the local rate.
When selecting a resource to substitute, by default the bill rate used is the effective billing rate, which can be overridden at the plan level or plan-location level, of the selected resource.
If resource substitutions have also been made at the plan level or plan-location level for the assigned service provider, the default effective billing rate is defined as the rate for the selected resource when performing the work of the original resource.
You can override the standard billing rate on a case-by-case basis. For example, a Medical Director might have a billing rate of $300.00 per hour. For a specific task, he or she bills at $500.00 per hour. If you enter $500.00 in the rate field for this task, the application uses the $500.00 per hour rate. All other tasks are calculated at $300.00 per hour.
You can also apply a percentage adjustment to the rate for a selected resource on a case-by-case basis.
On the Unit Hours tab, override system-calculated unit hours for the selected resource. For location-scoped tasks, you can override the unit hours expected for each location.
You can override the default unit hours and the unit hours percentage adjustment for the selected resource for all unpinned locations.
Use the Unit Hours field to specify a specific number of hours. Oracle recommends using this option if you want the hours to remain the same even if the study assumptions change.
If you want hours to change as study assumptions change, use the % Adjust field for the selected resource to specify a percentage adjustment to be applied to calculated hours.
If you added the resource to the task, from the Department drop-down list, select the department to which this resource belongs when performing this task.
From the GL Code drop-down list, select the GL code for the fees associated with this resource when performing this task.
Click Save.
Click Close.
On the Task Details or Task Assignments tab, select the Resource Name checkbox, and click Delete Resource.
Click Save.
The application removes the resources from the task.
Only resources you have added to the task can be removed. To exclude a resource expected by the application, edit the resource and override the unit hours to 0.00%.
On the Labor tab, select a Major Task radio button, and click Adjust Hours or Fees.
The Adjustments tab on the Task Manager dialog box appears.
From the Show hours and fees for drop-down list, select the service provider whose unit hours or fees are to be adjusted.
To make adjustments, click the Expand All link.
The Extended Hours section expands to show the # Units, Unit Hours, and Unit Cost.
Edit the # Units field and the Unit Hours field to align your plan with the study's contract, bid, and internal tasks and costs.
The application recalculates the unit cost.
Click Save.
To restore the values calculated by the application, click the Clear Overrides link.
On the Labor tab, select a Major Task checkbox, and click Adjust Hours or Fees.
The Adjustments tab on the Task Manager dialog box appears.
Click the Distribution tab.
The application shows the date each service provider is expected to begin and complete work related to the major task in the selected location.
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Note: This tab lists only service providers assigned to work on the selected major task. |
In the Distribute completed units of work according to field, specify the distribution approach.
The distribution of units over time determines how the related fees are incurred, how value is accrued, and what units are expected to be completed as of the reforecast date when reforecasting according to planned values.
If your company has licensed ClearTrial TRACK®, the distribution determines the planned values against which EVA is calculated. When reforecasting against a tracked plan, you can generate the reforecast based on actual values to determine units remaining.
Changes to the assumptions in this plan that revise the predicted milestone date automatically revise the distribution of this work.
If you select System Calculated Distribution or CRF Data Distribution, the application calculates the start and end dates and the periods comprising the task. You can spread units according to one of the pre-defined schedules.
If you select An Even Distribution, you can spread units evenly between two dates, based on available milestones and optional off-set in days prior to or past the occurrence of that milestone. When assumptions in the plan change, the application modifies the predicted date of these milestones, and the distribution of the units accordingly.
If you select A Custom Distribution, you can specify the number of days before or after a selected milestone to start the distribution of units of work.
You can enter an absolute value per period between available milestones and an optional off-set. You can start the work when this milestone occurs or any number of days before or after this milestone occurs.
Example 1: Work is expected to begin 30 days prior to FSI. You enter 30, choose before from the first drop-down list, and First Subject/Patient In (FSI/FPI) from the next drop-down list.
Example 2: Work is expected to complete 15 days after LSI. You enter 15 in this field, choose after in the first drop-down list, and Last Subject/Patient In (LSI/LPI) in the next drop-down list.
You can distribute work from the pre-study planning date up to 10 years after the Final Report Date.
Click Save.
On the Labor tab, click a Major Task radio button, and click Edit Major Task.
The Task Manager appears.
In the Task Search box above the navigation panel, type one of more characters, and click the Magnifying Glass icon.
The application displays the total number of matches found for the search term and highlights the matches.
Click a task or navigate through the list of matches by clicking the Previous and Next links.
The selected task appears on the Task Details tab to the right of the navigation tree.
On the Labor tab, click a Major Task radio button, and click Edit Major Task.
The Task Manager appears.
You can edit the description, add tasks to the selected major task, add resources to the tasks associated with this major task, adjust hours or fees on the Adjustments tab, change the distribution of work units on the Distribution tab, define algorithms to calculate the unit hours for additional resources, and override resources, rates, or unit hours for resources.
Click Save.
On the Labor tab, click a Major Task radio button, and click Delete Major Task.
To confirm the deletion, click OK.
The application permanently deletes the major task and its tasks, resources, algorithms, and overrides. You cannot restore deleted major tasks.
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Note: You cannot delete system-defined major tasks. |
The Cost tab displays the pass-through and miscellaneous cost categories that have been or can be applied to the plan. Some of these costs are pre-calculated. Other costs appear because many studies require costs of these types, but the application cannot derive these amounts from study characteristics or user-provided assumptions. You can increase or decrease each cost listed by editing the cost details.
Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Costs Tab.
From the Edit menu, select Plans.
The Plans screen appears.
Select the checkbox of the plan.
Click Edit.
The Edit Plan screen appears.
Click Costs.
The Costs tab appears, displaying a list of the calculated costs and adjustments. Items with a line through them have been excluded from the plan.
If none of the predefined cost categories adequately captures the nature of a cost that should be included in the estimate for the plan, you can add a new cost.
On the Costs tab, click New.
The Define New Category dialog box appears.
Enter information about the new category on the Definition, Algorithm, and Distribution tabs.
For more information about a field, click the field name.
For more information about the screen, see Define New Category Dialog Box (Definition Tab, Algorithm Tab, Distribution Tab).
On the Definition tab, in the Name field, define a name for the cost.
For any user-defined cost, specify a name of up to 45 characters that is unique for this plan.
You cannot change the name of a system-defined cost.
From the Type drop-down list, select the cost type.
Pass Through—The cost is incurred by an outsourced partner and will be passed through to the sponsor for reimbursement.
Miscellaneous—Costs are incurred by the sponsor as part of the overall study budget.
You can associate the cost with a specific department for cost allocation and can specify a GL code for reconciliation against the General Ledger.
To make this cost part of the recurring payments plotted on the Cash Flow Chart, select the Include in Payment Schedule checkbox. The application assumes the cost is paid out monthly between the specified start and end dates. You can change the frequency of the payment for each cost on the Payments tab by clicking Edit Recurring Payments.
To treat indirect costs as billable items or to allocate one or more resources to manage the costs, select the Include in Resources by Department/GL Code report checkbox. To include inflation for this cost in resulting calculations, select the Include inflation in results checkbox. This selection clears the Treat as credit checkbox, if selected.
or
To treat the cost as a credit item, select the Treat as Credit checkbox. This selection disables the Include inflation in results checkbox. This option is not available to all users.
In the Notes section, enter details or comments about the new cost category. The application displays these notes as the help content for this cost.
Click Save.
The application assigns the new cost a mapping key. Mapping keys are included in the Bid Grid export to allow vendors to programmatically map their costs to the Bid Grid format.
Click the Algorithm tab.
If you selected the Treat as Credit checkbox on the Definition tab, the Credit Algorithm section and Credits/Adjustments section appear on the Algorithm tab. Otherwise, the Cost Algorithm and Costs/Adjustments sections appear.
In the Costs or Credits field, choose whether to vary the cost or credit by location or treat as a study-level cost or credit.
If you choose vary by location, you can specify a different per-unit amount for one or more locations, assign the responsibility to a different service provider for each location, override the start and end dates over which to distribute the costs or credits, and express the per-unit cost or credit in a different currency for one or more locations.
In the Calculate as field, specify the currency in which you have expressed a per unit amount.
If you have chosen to vary this cost or credit by location, this value is the default for each location.
The application calculates the total value for each location, or the study-level cost, as this value multiplied by the number of units expected for the chosen assumption.
Editing this field does not convert a previously entered value. The application assumes that the value you entered was expressed in the chosen currency.
When the currency is edited, the application applies the change to the location-specific costs or credits, unless they have been overridden to vary from the amount and currency entered in this section.
From the per drop-down list, select a unit-based assumption by which to drive the calculation of this cost or credit.
The application multiplies the number of units derived for the chosen assumption by the amount entered to produce the total cost or credit. Changes to assumptions that result in an increase or decrease in the number of units for the chosen assumption automatically adjust this cost or credit.
Custom cost drivers appear in the drop-down list in italicized type followed by an asterisk.
In the Costs/Adjustments section or Credits/Adjustments section, show the details for the cost or credit. System-calculated values are either location-scoped or study-scoped and cannot be changed.
Assign the responsible provider, if applicable.
Map the cost or credit to a specific department.
Map the cost or credit to a GL code.
Apply costs or credits.
In the Total field, the application displays the total calculated costs or credits, including any adjustments made by you or another user.
Click the Distribution tab.
From the Distribute according to drop-down list, select how to distribute the cost for each location in your plan.
You can spread costs according to one of the pre-defined schedules, including site approval distribution, subject enrollment distribution, or CRF data distribution. In the and shift field, specify an offset for a system-defined distribution curve. You can shift a distribution to occur up to 999 days earlier or later than originally defined.
You can spread costs evenly between two dates, based on available milestones and optional off-set in days prior to or past the occurrence of that milestone. When assumptions in the plan change, the predicted date of these milestones and the distribution of the costs, are modified accordingly.
You can spread costs according to a custom distribution, where you can enter an absolute value per period between available milestones and an optional off-set timeline period or interval. From the by drop-down list, select Week, Month, or Quarter.
In the Default range field, define a Start and End milestone for the cost distribution. These are used as the default start and end date for each location.
For example, you can indicate that a cost is expected to spread from 30 days prior to FSI to 15 days after LSO.
Use the Start and End offset drop-down lists to specify whether the offset is before or after the selected milestone occurs.
From the Start and End milestone drop-down lists, select a milestone to which to anchor the start and end of the cost distribution. You can start the cost on this milestone or some number of days before or after this milestone. Changes to the assumptions in this plan that revise the predicted milestone date automatically revise the distribution of this cost. However, the calculated distribution start date cannot be earlier than the pre-study planning date.
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Note: 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. |
Click Save.
On the Costs tab, select a cost checkbox, and click Edit.
The Edit or Adjust dialog box appears.
Change the settings on the Definition, Adjustments, and Distribution tabs.
Click Save.
On the Costs tab, exclude a cost by selecting the checkbox to the left of the cost, and clicking Exclude.
The application does not delete the cost, but it no longer includes the amount in the plan and its totals and the cost appear with a line drawn through them.
Click Save.
On the Payments tab, configure the payment schedule for each service provider performing work. You can use the payment schedule with the Cash Flow Chart report to determine the cash flow characteristics of the payment plan.
Enter assumptions in the fields that appear. Your current edit mode determines the fields available.
For more information about a field, click the field name.
For more information about the screen, see Payments Tab.
Payments are defined as percentage values representing the portion of the total fees paid or received at the completion of each milestone. You can also define the payment terms to specify the number of days from the invoice that payment is expected.
On the Payments tab, click Set Payment Terms.
The Payment Terms dialog box appears.
From the Payment Term drop-down list, select the payment term for a service provider.
Click Ok.
Any line-item discount will be allocated to the payment amounts based on the percentage values specified for each milestone payment.
Fees that will be paid on a repeating schedule (for example, monthly) are recurring payments.
On the Payments tab, click Edit Recurring Payments.
The Recurring Payments dialog box appears.
For each unit of work or pass-through cost, from the service provider drop-down list, select the payment frequency.
or
To indicate that the fees associated with that item are included in payments made in response to the occurrence of one or more milestones, select Milestone.
Click Ok.
If payments are paid in response to events or conditions not currently defined, you can add milestones.
On the Payments tab, click Add Milestone.
The Create Milestone dialog box appears.
Enter the Milestone Definition.
You can name the milestone anything appropriate as long as the milestone name is unique for this plan.
In the Occurs field, enter the number of days before or after the system-defined milestone that this milestone normally occurs. Select before or after to choose whether to calculate the estimated date for this milestone as a number of days prior to a system-defined milestone or subsequent to a system-defined milestone. From the milestone drop-down list, select the system-defined milestone before or after which this milestone is expected to occur. The calculated date for this milestone is the number of days specified prior or subsequent to the system-defined milestone selected.
Add a Description.
In the Code field, specify a 3-6 character abbreviation for this milestone. The code appears on reports where the full name does not fit or display properly.
In the Description field, enter additional information to describe this milestone or its purpose for this plan.
Click Ok.
You can edit a previously added milestone to change its name and the properties that determine when it is expected to occur.
On the Payments tab, select a Milestone checkbox, and click Edit Milestone.
The Edit Milestone dialog box appears.
Edit the Milestone Definition.
Edit the Description.
Click Ok.
Use the Summary tab to view the study costs and perform what-if scenario testing.
These values are calculated by converting from each service provider's billing rate currency to the modeling currency, using the exchange rates specified on the Overview tab (or any overrides specified at the service provider level).
All fees and costs, including any applicable inflation and line-item discounts, appear in the modeling currency.
The application calculates the FTE (Full Time Equivalents) values shown based on resource needs. Each FTE is assumed to work 1800 hours over 365.25 days.
To print a copy of the summary, click Print.
For more information, see Summary Tab.
This section allows you to include (or exclude) fees, hours, and costs from the calculated or displayed summary values for specific providers. Dates and metrics are not affected.
Select the service provider checkboxes to include.
Deselect the service provider checkboxes to exclude.
The fees, hours, and FTEs displayed change according to your selections.
The Fees, Hours, and FTEs section shows the fees and indirect costs by functional area, the total fees and hours associated with the study and pass-through costs, as well as any application inflation and line-item discounts.
Startup Fees—All fees associated with the startup of the study, from Project Activity Start Date to the First subject enrolled (FSFV).
Clinical Monitoring Closeout and Site Audit Fees—All fees associated with site monitoring, site management, telephone monitoring, query resolution, SAE management, site close outs, and clinical compliance audits.
Data Management—All fees associated with the database design, data entry data coordination, data cleanup, database audits, and annual IND update.
Biostatistics—All fees associated with table listings and graphs, randomization procedures, statistical and analysis plans, and interim analysis.
Project Management / Study Oversight—All fees associated with the project management of the study from beginning to end.
Medical Writing/Final Report—All fees associated with delivering the statistical report, draft report, and final report (CSR).
Other—All fees associated with other tasks not included in any other line item.
The application calculates the FTE for a functional area based on the total resource hours, total study duration (in days), and number of full-time hours for one year required to complete the work.
For example, if service providers in a functional area (such as Data Management) work 109,887 hours through a study duration of 2,490 days, the FTE equivalent is 0.9 FTEs or [109,887/(2,490 days/365.25)]/1,800 = 0.9.
The application also calculates the FTE for resources. For example, if a resource works 6,998 hours over a study duration of 568 days, the FTE equivalent is 2.5 FTEs or [(6,998 total hours)/(568/365.25)]/1,800 = 2.5.
To obtain an accurate monthly FTE count, use the Resource Demand Chart report with the Show FTEs option.
The total applicable inflation and line-item discount aggregated for all providers are included as separate line-items. Inflation adds to the overall fees, while any line-item discount reduces the overall fees.
All pass-through costs are included in the Total Study Costs including:
CPU Pass-Through Costs—Total costs associated with the Clinical Pharmacology Unit. This line item appears only for Phase 1 (Healthy Volunteers) trials.
Other Pass-Through Costs—Total indirect costs not associated with the CPU.
Total Pass-Through Costs—All third-party, pass-through, and miscellaneous costs in the study.
Inflation (Pass-Through Costs)—Costs incurred due to inflation as applied to pass-through costs.
The Dates/Duration section summarizes study-related dates and durations.
Pre-Study Activity Start Date—The date at which the earliest activity on a task or cost is expected to occur.
Project Activity Start Date—The date that the study is expected to begin, defined as the date that vendors or the sponsor start identifying sites and vendors start billable activity on the study.
Post-Study Activity End Date—The date at which the latest activity on a task or cost is expected to occur.
Study End Date—The date the study is expected to be complete, defined as the date that all activity stops. This is usually the date the final report (CSR) is finalized. It does not include any post study follow-up by the sponsor.
Total Study Duration—Represents the total expected study duration in elapsed days defined as the end date minus the start date.
Duration of Active Treatment Phase—Represents the total expected duration of the active treatment phase (in days), defined as the Last Subject observation (LSLV) minus the First Subject observation (FSFV).
The Metrics section includes the cost per completed subject and the average number of subjects per site per month.
The application calculates Cost per Completed Subject as total study costs divided by the number of subjects expected to complete all scheduled subject visits.
The Number of Subjects/Site/Month value represents the average expected number of subjects monitored at each site per month, defined as the total number of subjects divided by the number of months of enrollment divided by the number of investigator sites.
For example, 1000 subjects/12 months/10 sites = 8.33 subjects per month per site.
The Reports tab provides links to reports based on data entered into or calculated from the current plan. You can view each report in a separate window, print it, export it to Microsoft Excel, or convert it to PDF. You c an use reports to:
Check plan assumptions.
Verify the plan budget.
Manage resources.
Monitor the budget.
Compare fees and prices.
For more information, see Reports Tab.
The application groups the reports into the following categories:
Clinical Indicators reports
Costs reports
FTE/Resources reports
Click a report name.
If the application prompts you to select report-related options, make your selections and click Ok.
The application generates the report and displays it in a separate window.
Select report printing and viewing options.
View as PDF
Export to Excel
Export to CSV
When you are finished working with the report, click Close.
On the Plans screen, select the checkboxes of the plans to compare. Do not include incomplete plans.
Click Compare.
The Compare Plans dialog box appears.
From the Available Comparisons list, select a comparison type.
Assumptions—Comparison of assumptions for two or more plans.
Fees and Costs—Differences in fees, line-item discounts, and pass-through costs for the selected plans.
Fixed Unit Prices—Comparison of fixed unit prices for two or more plans.
Resources—Difference in effort and costs (including line-item discounts) per resource for the selected plans.
Milestone Dates—Differences in milestone dates.
Depending on your selection, other options and sections appear.
Select the checkboxes of the providers to include. To include all the providers, select the All Providers checkbox.
Select the currency to be used in the comparison report.
Click Ok.
The application generates a Fee and Cost Comparison of the selected plans.
You can print the report, view it as a PDF file, export it to a Microsoft Excel spreadsheet, or export it to CSV.
Click Close.
On the Plans screen, the Other Actions... button provides access to a number of additional features. Features that you can perform on the selected plan(s) or based on your edit mode or permissions are highlighted in the list. You cannot select grayed-out features.
When you lock a plan, changes made to the application do not affect that plan.
On the Plans screen, select one or more plan checkboxes.
Click Other Actions..., and then click Lock Plans.
A lock icon appears to the right of the checkbox. You cannot edit a locked plan.
To unlock a plan, select a plan checkbox with a lock to its right.
Click Other Actions..., and then click Unlock Plans.
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Note: If the plan being unlocked has a cost model version earlier than the 5.3 cost model, the plan will be automatically upgraded to use the 5.3 cost model when the application unlocks it. Even though you are able to change the cost model used by an unlocked plan (see Change Attributes), you will not be able to reassign the plan back to a cost model that is older than 5.3. |
When you freeze the billing and inflation rates in a plan, changes made to the rates do not affect that plan.
On the Plans screen, select the plan checkbox.
Click Other Actions..., and then click Freeze Rates.
Subsequent changes to billing and inflation rates no longer affect the plan.
To unfreeze the rates, select the frozen plan checkbox.
Click Other Actions..., and then click Unfreeze Rates.
The Unfreeze menu item will be active.
On the Plans screen, select a plan checkbox.
Click Other Actions..., and then click Copy as Template.
In the Copy Plan as Template dialog box, enter a template name.
From the Use Cost Model from field, select the cost model version.
From the Custom Field Model field, select a custom field.
Click Ok.
The Edit Template screen appears.
Work through the tabs to make any changes to the template.
For more information about a field, click the field name.
For more information about the screen, see Template Screen Fields.
Click Save.
If you have made a plan and want to associate your plan with a different study, copy the plan as a template, then create a new plan for the other study based on this template.
You can change the name, status, cost model, custom field model, and descriptions of the selected plan.
On the Plans screen, select a plan checkbox.
Click Other Actions..., and then click Change Attributes.
In the Change Plan Attributes dialog box, change the attributes shown.
If you select multiple plans:
The Plan Name field is disabled to prevent you from assigning the same name to multiple plans.
The Status field is empty. You can choose any status to apply to the selected plans. The description fields are disabled.
The Cost Model and Custom Field Model fields are disabled.
You cannot change the status of a deleted plan, a plan that is incomplete, or a plan that has been set as a baseline for tracking.
You cannot change the status of plans you did not create unless you are assigned a role that grants you permission to edit other users' plans.
You can only change the cost model and custom field model for an unlocked plans.
Oracle recommends that you select the Update last modified date and user (plan history) checkbox. However, if you often filter by the last modified date deselect the checkbox to prevent bulk updates from changing your view.
Click Save & Close.
Changes are made without opening or unlocking the plans.
What you can change depends on the number of plans selected and the status of the plans.
On the Plans screen, select one or more plan checkboxes.
Click Other Actions..., and then click Add to Portfolio(s).
In the Add Plans to Portfolio(s) dialog box, create a portfolio or select one or more portfolios. For more information, see Creating or Editing a Portfolio.
Enter or modify the portfolio information.
For more information about a field, click the field name.
For more information about the screen, see Add Plans to Portfolio(s) Dialog Box.
Click Ok.
Use reforecasting to update your plan once your study has started, or to model scenarios in which study assumptions change over the course of the trial.
For example, the study has been in progress for six months and you have been tracking actuals since the Study Start Date. Today, you receive a change order to estimate the impact of adding 15 new sites and 150 new subjects. You can use reforecasting to update the plan to reflect these new assumptions. The reforecasted plan knows the history of the study, based both on the actuals you have entered and the previous and new assumptions. The reforecast provides new estimates for unit hours, labor fees, and costs by combining the actual progress, captured using the ClearTrial Track application, with the changes to the assumptions you provide.
You can also reforecast without tracking or considering actuals. In these cases, the ClearTrial application generates new estimates as if the study is continuing exactly as previously planned.
A plan with a cost model earlier than 5.3 cannot be reforecasted with the same cost model. When creating the reforecast, you will choose a new cost model to use for your reforecast that is a supported cost model.
On the Plans screen, select one or more plan checkboxes.
Click Other Actions..., and then click Create Reforecast.
In the Create Reforecast dialog box, specify a name and date for the reforecast.
For more information about a field, click the field name.
For more information about the screen, see Create Reforecast Dialog Box.
Oracle recommends naming each reforecast after its prior forecast.
In the Use Cost Model from field, select a cost model version.
In the Custom Field Model field, select a custom field model.
In the Create reforecast based on field, select Actual Values to base the reforecast on actual tracked data. Select Planned Values to reforecast based on planned date.
You must be licensed to use the ClearTrial Track application to use actual values.
Click Ok.
You can create multiple reforecasts in a single operation to apply different sets of exchange rates for different periods of time. The application handles all assumptions that vary over time using the reforecasting feature.
You can specify rates for a period of time beginning with the plan start date and ending with the reforecast date. You can specify a new set of exchange rates to take effect as of the reforecast date until either the end of the study or another reforecast changes these assumptions. You can also select an exchange rate date or a user-defined Exchange Rate table to apply to the reforecasted plans.
On the Plans screen, select one or more plan checkboxes.
Click Other Actions..., and then click Reforecast Exch Rates.
In the Create Reforecast dialog box, specify reforecast details.
For more information about a field, click the field name.
For more information about the screen, see Reforecast Exch Rates (Create Reforecast) Dialog Box.
Oracle recommends naming each reforecast after its prior forecast.
If you base the reforecast on the planned values, the application calculates the work remaining as though the study is progressing exactly as was originally forecast.
When you reforecast exchange rates on a plan with a cost model that is earlier than 5.3, the application applies the 5.3 cost model to the reforecast. If the cost model of the plan being reforecast is 5.3 or above, the reforecast inherits the cost model from the source plan.
You do not have the ability to manually apply a different cost model or custom field model when using this feature.
If you have licensed ClearTrial Track and are tracking the actual progress of this study against a baseline plan, you can base the reforecast on the actual progress (recommended) rather than on the predicted progress.
Click Ok.
