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Introduction

Site groups are groups of sites with common:

• region and

• enrollment group.

A Site Groups Table can be used to define:

• the number of sites per site group

• site activation per site group

• enrollment per site group

• the patient cap per site group

• the site resupply long windows and

• Initial shipment timing

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Region

Defines the region in which a site group is located.

Must match an existing region specified in the Site Network Table. If an invalid entry is made, no error is raised, but the site group is ignored.

Site Group Code

Defines a group of sites with a common region and a common enrollment group.

Site group codes have to be unique within a single scenario specification. If the same site group code is entered more than once, the interpretation is stopped and an error with the following message is shown:

In forecast calculations with RTSM data extract, each site group specified in 4C Supply® must map correctly to the corresponding combination of region and enrollment group in the RTSM. This can be verified in the RTSM data extract mapping report.

If a site group is present in the RTSM extract, but no corresponding site group is defined in the 4C Supply® specification, 4C Supply® will attempt to map to the most appropriate site group which is specified in 4C Supply® (see examples below).

Example

Site group in RTSM data extract is not defined in the 4C Supply® specification

Background

An RTSM data extract has site groups AUT-Low, AUT-Med and AUT-No-Enrollment, but only site group AUT-All is defined for region AUT in the 4C Supply® specification.

Enrollment groups in RTSM extract:

Extract of regions in RTSM extract:

Site groups table in 4C Supply® specification:

Data Extract Mapping Report Extract:

Example

Region with no site group in the 4C Supply® specification

Background

An RTSM extract has 3 site groups in region AUT, but no corresponding site groups are defined in the 4C Supply® specification.

Enrollment groups in RTSM data extract:

Extract of regions in RTSM data extract:

Site groups table in 4C Supply® specification:

Data Extract Mapping Report Extract:

Note: It is good practice to specify site groups using the syntax [region]_[enrollment group].

Site Group Description

Describes a site group.

Note: Description is not interpreted.

Enrollment

Defines the enrollment rate of sites in a site group.

See manual section enrollment definition in the site groups table.

In forecast calculations with RTSM data extract, the enrollment rate specified in 4C Supply® is the enrollment rate used for future enrollment.

If different enrollment rates are forecasted for a site group in different periods, column Enrollment should be removed from the site groups table and an enrollment table should be used.

In forecast calculations with RTSM data extract, any enrollment specified on 4C Supply® to occur before the RTSM data extract date will be ignored in forecast calculation.

Site Count

Defines the number of sites in a site group.

Must be a single integer. If an invalid entry is made, an error is shown:

When a Site Activation table is used, the site count column is optional. The site count values will be inferred from the Site Activation table. If an invalid entry is made, the value in the site activation table is used and the following warning message is shown:

In forecast calculations with RTSM data extract, the site count specified in 4C Supply® is the overall site count in the study.

• If a lower site count is specified in the 4C Supply® specification than in the RTSM data extract, the forecast calculation will assume that only the sites specified in the RTSM data extract exist. This means that existing sites in the RTSM data extract and sites forecasted to be activated by 4C Supply® both contribute to reaching the site count.

• If a higher site count is specified in the 4C Supply® specification than in the RTSM data extract, then the difference between the two counts will be considered in the forecast calculation as forecasted site activations.

Example

An RTSM extract has 6 site groups which are mirrored in the corresponding 4C Supply® scenario with site quantities as follows:

 Scenario specification extract

 Actuals data as shown in Site Activation Report

Forecast Calculation Result

The table below shows different variants of the logic above:

 Combined (Actuals + Forecast) data as shown in Site Activation Report:

In forecast calculations with RTSM data extract, it must be taken into account that site counts are considered by site group in 4C Supply®. If e.g. site group A has a count of 1 site in the 4C Supply® specification and 2 corresponding sites in the RTSM data extract and site group B has a count of 2 sites in the 4C Supply® specification and 1 corresponding sites in the RTSM data extract, then 4C Supply® will forecast one further site in site group B to be activated, resulting in a total site count of 4.

Start Date

Defines when the first site in a site group is activated for patient enrollment. Must be a valid date.

When a Site Activation table is used, the start date column is optional. The start date values will be inferred from the Site Activation table. If an invalid entry is made, the value in the site activation table is used and the following warning message is shown:

In forecast calculations with RTSM data extract, the start date specified in 4C Supply® is the forecasted start of further site activations.

• If the start date in the 4C Supply® specification is earlier than the extract date or empty, then 4C Supply® will assume that new site activations occur starting from the extract date.

• If the start date in the 4C Supply® specification is later than the extract date, then 4C Supply® will assume that new site activations occur starting from the specified start date.

Site Activation Rate

Defines the number of sites activated in each month from the start date.

Must be a single integer. If an invalid entry is made, an error is shown:

In forecast calculations with RTSM data extract, the site activation rate specified in 4C Supply® is the forecasted rate of further site activations.

Site activation rates are always interpreted as activated sites per site group per month; even if the periods are days and exact dates are specified as start dates.

Site activations are forecasted to occur distributed across months rather than at the start of months. E.g., if 1 site is specified to be activated in a month, then 4C Supply® assumes that 0.03 sites are activated in each day of that month:

When a Site Activation table is used, if the site activation (sites per month) defined in the Site Groups table does not match the total sites for a given site group in the Site Activation table the value in the site activation table is used and the following warning message is shown:

Patient Cap

Defines the maximum number of patients allowed to enroll at the sites in a site group.

Must be a single integer. If an invalid entry is made, an error is shown:

In forecast calculations with RTSM data extract, the patient cap specified for a site group in 4C Supply® is the overall patient enrollment cap of the corresponding site group. This means that existing patients in the RTSM data extract and patients forecasted by 4C Supply® to be enrolled both contribute to reaching the patient cap for a site group.

If there are more patients in the RTSM data extract associated with a site group than the patient cap specified for that site group in 4C Supply®, the forecast calculation will assume that no further patients are enrolled at sites in this site group.

Site Group Prediction Window before Last Patient in

Defines the forecast configuration for the site group prediction window before last patient in for a specific site group.

See forecast configuration in the scenario specification.

Site Group Prediction Window after Last Patient in

Defines the forecast configuration for the site group prediction window after last patient in for a specific site group.

See forecast configuration in the scenario specification.

Initial Shipment Timing

Defines when the initial shipment is sent to a site. The Initial Shipment options are Site Activation, First Patient Screened, or Just in Time. If Initial Shipment Timing is undefined, the default is Just In Time.

 

If Initial shipment timing = Site activation, the shipment will arrive at the site x Lead Days (defined in the Network Table) after the Site Activation Date.

For example, if the Lead Time from the Depot to the Site is 5 days and the Initial Shipment Timing is set to Site Activation, the Initial Shipment will arrive at the site 5 days after the site activation date.

If Initial shipment timing = First Patient Screened, the shipment will arrive at the site x Lead Days (defined in the Network Table) after the first patient is screened at the site.

For example, if the Lead Time from the Depot to the Site is 5 days and the Initial Shipment Timing is set to First Patient Screened, the Initial Shipment will arrive at the site 5 days after the first patient is screened.

If Initial shipment timing = Just in time, then the initial shipment is sent just in time to cover the earliest dispensation at the site. Using the corresponding region's Lead Time value defined in the Network Table, 4C Supply automatically calculates the departure date for the shipment so that it arrives in time for the patient's first dose.

For example, if the Lead Time from the Depot to the Site is 5 days, the earliest occurrence of demand is 08Sep, and the Initial Shipment Timing is set to Just in Time, the Initial Shipment will trigger from the Depot 5 days before on 03Sep.

 

Example Site Groups Table

Site Groups Table

In RED are Mandatory Attributes

Note: When a Site Activation table is used, the site count, start date, and site activation rate (sites per month) columns are optional.