Introduction

This page provides examples of the tables that can be used in 4C Supply®. These tables can be copied directly into the SMART Editor but it is faster and easier to use the template table insert feature.

Example data is included in the tables so users can see how the information should be entered and formatted.

• Some headers include links that will take you to a detailed description within the user manual.

• Columns identified as mandatory must be included when the table is used in a specification.

• These tables can be inserted directly into the specification by using the Template Table Insert feature. Please see the SMART Editor Basics section for more details.

• In order to create a successful specification, the following tables will be required:

  • Visit Schedule

  • Visit Actions

  • Site Groups

  • Network

  • Depot

  • Dispensing Units

 

Scenario Information

Table Caption: Scenario Information

Mandatory Columns: Study Start Date, Number of Patients, Enrollment Type, Cap Type

 

Forecast Configuration

Demand Configuration

Table Caption: Demand Configuration

Mandatory Columns: N/A

Supply Configuration

Table Caption: Supply Configuration

Mandatory Columns: N/A

 

Study Phases

Table Caption: Study Phases

Mandatory Columns: Phase Code, Start Date

 

Visit Schedule

Table Caption: Visit Schedule

Mandatory Columns: Visit Code, Timing

 

Visit Actions

Table Caption: Visit Actions or Event Actions

Mandatory Columns: Visit Code, Action, Argument

Site Groups

Table Caption: Site Groups table

Mandatory Columns: Region, Site Group

• Site Activation (Sites per Month), Site Count, and Start Date columns are mandatory unless a Site Activation or Fixed Site Activation table is defined.

• An Enrollment in Patients/Site/Month column is mandatory unless a Patient Enrollment table is defined.

Cohorts table

Table Caption: Cohorts Table

Mandatory Columns: Cohort Code, Cohort Start Date, Cohort Patient Cap

Enrollment Table

Table Caption: Enrollment Table

Mandatory Columns: Period Start Date

Note: All other column headers should capture Regions/Site Groups/Cohorts.

• Depending on the Enrollment Level defined in the Demand Configuration the other column headers should be either Regions or Site Groups.

• If Cohorts are defined, the enrollment for Site Groups or Regions may also capture cohorts within those Regions/Site Groups, as in the example below.

Example Enrollment Table (rates in patients/site/month)

Example Enrollment Table (rates in patients/region/month)

Example Enrollment Table (rates in patients/region/cohort/month)

Site Activation / Fixed Site Activation

Table Caption: Site Activation Table (or Fixed Site Activation Table)

Mandatory Columns: Period Start Date, Site Group Columns (example below)

Dispensing Units

Table Caption: Dispensing Units

Mandatory Columns: Dispensing Unit Code (Kit Type), Shelf Life

 

Drug Products

Table Caption: Drug Products

Mandatory Columns: Code, Description

Label Groups

Table Caption: Label Groups

Mandatory Columns: Label Group Code, Region

Planned Lots

Table Caption: Planned Lots or Existing and Planned Releases

Mandatory Columns: Lot Number, Dispensing Unit Code (Kit Type), Release Date, Expiry, Available Quantity

Production Settings

Table Caption: Production Settings

Mandatory Columns: Dispensing Unit Code (Kit Type)

Note: This table can be set up to include either a single, static Production Interval or a dynamic Production Interval that has different values before LPI and after LPI.

 

Network

Table Caption: Network

Mandatory Columns: Depot Code, Region Code, Lead Time

Depot

Table Caption: Depots

Mandatory Columns: Depot Code, Supplier, Lead Time

Note: For the root node depot a supplier does not need to be defined.

Initial Shipment Settings

Table Caption: Initial Shipment Settings

Mandatory Columns: Site Group Code, Dispensing Unit, Initial Shipment Quantity

Note: This table is still accepted but the RTSM Parameters table is now the recommended table for defining Initial Shipment Quantities as it allows for dynamic values that change by period (see below).

RTSM Parameters

Table Caption: RTSM Parameters

Mandatory Columns: Period Start Date, Site Group Code, Dispensing Unit

 

Minimal and Additional Safety Stock at Site

Table Caption: Minimal and Additional Safety Stock at Site

Mandatory Columns: Dispensing Unit Code (Kit Type)

Minimal and Additional Safety Stock at Site per Site Group

Table Caption: Minimal and Additional Safety Stock at Site per Site Group

Mandatory Columns: Dispensing Unit Code (Kit Type), Site Group

Minimal and Additional Depot Safety Stock at Depot

Table Caption: Minimal and Additional Depot Safety Stock at Depot

Mandatory Columns: Dispensing Unit Code (Kit Type), Depot Code

 

Shipment Types

Table Caption: Shipment Types

Mandatory Columns: Shipment Type Code

 

Shipping and Storage Costs per Kit at Region and Depot Level

Table Caption: Shipping and Storage Costs per Kit at Region and Depot Level

Mandatory Columns: Dispensing Unit Code

 

Storage Units

Table Caption: Storage Units

Mandatory Columns: Storage Unit Code, Storage Cost