11 Subject Tab

The Subject Tab is used to enter information about the expected enrollment period and subject enrollment rate, the treatment schedule, and the First Subject In Date (FSI/FPI).

11.1 Define the Enrollment Period

The Subject Tab allows you to activities related to the enrollment period.

• Project Activity Start Date: This date is displayed here as an aid for entering or evaluating the First subject enrolled date (FSI/FPI).Click the icon to the right of the First subject enrolled date (FSI/FPI) field for more information about that value.

  For studies which are outsourced (in whole or in part), the Project Activity Start Date is the date on which a service provider 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.

• First subject enrolled date (FSI/FPI): This value represents the date that the first subject first visit (FSFV) is expected to take place. ClearTrial estimates this date based on the expectation of study sites approval, however, you can override the suggested value with any date later than the Project Activity Start Date.

• First Subject In Date Calendar Control: The calendar icon represents a popup calendar which may be used to select a date as an alternative to typing the date into the corresponding field. Click the icon to display the popup calendar.

• Enrollment Period: The value entered in this field represents the number of weeks during which subjects will be enrolled in the trial. This is defined as the time from the first enrolled subject's first visit to the last enrolled subject's first visit.

• Enrollment Rate: This field displays the average rate at which subjects must be enrolled to meet the specified number of subjects randomized during the specified enrollment period.

• Manage Location-specific values: You may choose to specify the expected First Subject In (FSI) date for each location in one of two ways.

  If you choose to manage the location-specific dates and enrollment periods globally, changes you make to the system-suggested FSI date will be applied 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 will be displayed to allow the entry of a specific date and/or enrollment period for each location.

11.2 Define the Enrollment Distribution

The Subject Tab allows you to select an enrollment distribution.

• Type of enrollment distribution: This field allows you to specify the expected enrollment distribution. The enrollment distribution specifies the percentage of subjects expected to enroll in each quartile (fourth) of the enrollment period.

  Select one of the predefined Enrollment Distribution Rates from the drop-down box for a fast way of entering you enrollment expectations.

  The predefined Enrollment Distributions include:

  1. Acute: Use Acute distribution for indications where the subjects must present with the condition and will not be found by searching the medical records (Generally, when investigators can only estimate their ability to enroll by looking at empirical data and projecting potential enrollment numbers based on this empirical data) and if you expect that most of the sites will be approved before the first subject first visit (FSFV/FPFV) is expected to take place.

     For example, Anti-infective trials might experience an Acute or Acute Short Startup enrollment distribution. See Acute Short Startup, below, for the difference between Acute and Acute Short Startup.

  2. Acute Short Startup: Use this for Acute indications and when you expect that less than 75% of the sites will be approved at the time when the first subject will enroll.

  3. Bell Curve: This is used only when you are unsure of the enrollment type and want to get an estimate of the study using something other than an even distribution of subjects across the enrollment period.

  4. Block Enroll: This is used specifically for things like allergy studies where it is expected that patients will be enrolled quickly over the first two quartiles of the enrollment period and stragglers over the last two quartiles.

  5. Chronic: Use a Chronic enrollment for studies where the subjects that meet the criteria are generally known by the investigator and can be readily found by reviewing the patient charts and if you expect all or most of the sites will be approved before the first subject visit takes place.

     For example, Chronic illness like diabetes, Alzheimer's, AIDs are examples of an indications that might experience a Chronic or Chronic Short Startup enrollment distribution, unless the study requirements for these disorders are to be newly diagnosed. In this case, they should be considered acute.

  6. Chronic Short Startup: Use a Chronic Short Startup distribution for chronic indications and when you expect that less than 75% of the sites will be approved at the time when the first subject will enroll.

  7. Even Distribution: Even distribution is rarely used, usually only for general estimations when you have no idea what the enrollment distribution will be.

  8. Custom...: This option allows you to enter the percentage of the total subject population expected to be enrolled during each quartile of the enrollment period. This will depend on the number of sites that are approved at the start of subject enrollment (FSFV), availability of subjects, and the therapeutic indication.

• Manage Location-specific values: This field allows you to choose the expected enrollment distribution for each location, either globally or per location. If you choose to manage location-specific enrollment globally, changes you make will be applied to every location.

  If you choose to manage the enrollment distribution per location, a dialog box will be displayed to allow you to choose a different distribution for each location. Additionally, if you choose to manage enrollment per location, you may choose to create a custom weekly enrollment schedule.

11.3 Screening and Drops

The Subject Tab allows you to specify the number of subjects to be screened and estimate the subject drop rate.

• Subjects to randomize: This field displays the number of subjects expected in the selected location or for All Locations whose values are being displayed.

• Screen failure rate: This field allows you to enter the percentage of screened subjects expected to fail to become study participants.

• Number of subjects to screen: This field displays the number of subjects to screen based on the screen failure rate.

• Investigator payment per screen failure: This field allows you to enter the investigator payment per screen failure.

• Percent of screen failures paid for: This field allows you to enter the percentage of screen failures for which payment will be made.

• Stipend per screen failure: This field allows you to enter the subject stipend for screen failures.

• Number of CRF pages per screen failure: This field allows you to indicate the number of CRF pages that will be collected per screen failure.

• Subject drop rate: This field allows you to enter the percentage of subjects that will not complete a full CRF due to early termination.

• Subjects expected to complete all study visits: This field displays the number of subjects expected to complete the study based on the drop rate.

• Manage location-specific values: This field allows you to edit location-specific values, if needed. You can manage the expected enrollment distribution for each location in one of two ways.

  If you choose to manage location-specific enrollment globally, changes you make will be applied to every location. If you choose to manage the enrollment distribution per location, a dialog box will be displayed to allow you to choose a different distribution for each location.

  Additionally, if you choose to manage enrollment per location, you may choose to create a custom weekly enrollment schedule.