Configuring the global allocation list

  • Published by Viedoc System 2023-10-09
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Introduction

The allocation list setup can be performed only by users assigned to the Unblinded Statistician role.

When randomization is used within a study (see Configuring a static randomization / Configuring a dynamic randomization), the allocation list can be defined in two different ways:

Important! The randomization feature must be included in your study license in order for the randomization configuration and the global allocation list to be available in production mode. You can still configure a randomization in demo mode without a license.
  • Individual allocation list - separate allocation lists are used for each defined randomization. In this case, the allocation list is configured and uploaded in the randomization settings page in Viedoc Admin as described in Configuring a static randomization / Configuring a dynamic randomization.
  • Global allocation list - one global allocation list is used for all the defined randomizations. This is available only if advanced allocation is enabled in Viedoc Designer (for details on advanced allocation settings in Viedoc Designer, see Setting up the randomization lesson)..
  • To be able to use Logistics, a global allocation list must be used.
    If the allocation list is not uploaded, or, in case of using Logistics, if no kits are available at the current defined scope (Study / Country / Study Site), when trying to perform the allocation in Viedoc Clinic, the system will respond with "No slots found for allocation.".

Configuring the global allocation list

The global allocation list is set up under the RTSM settings in Viedoc Admin:

If the global allocation list is selected to be used for all the randomizations defined in the study, the Global allocation list setup is displayed at the bottom of the Randomizations pop-up, as well as the option to Enable logistics, as below:

Enable Logistics - if checked, this allows you to use the Logistics functionality in Viedoc. For more information about the logistics functionality see Overview of Viedoc Logistics.

Important!

  • The Enable Logistics option cannot be selected/deselected after the global allocation list settings have been approved.
  • A valid license that includes the Logistics feature is required to be able to run Logistics in production. You can however still run Logistics in demo mode without a license.

Configuring the global allocation list

To configure the global allocation list:

1 Click Open next to the Global Allocation list setup. The Definition page will be displayed:
2

Under the Definition tab, set the following:

  • the Scope of the allocation - defines the scope from which an Investigational Product (IP) (kit) should be allocated. One of the following scopes can be chosen:
    • Study
    • Country
    • Study Site

If Logistics is enabled, this impacts the way the kits can be managed, as described in Managing kits.

  • Allocation input properties - make sure to add the input properties for all IPs that need to be allocated for all randomizations defined in the study. Enter the Property ID, and the Property label.
    For the code list items (for example radio buttons), add the Property values to define the codes and the matching labels:
    Note! The codes must be defined for all the code list items to be able to upload the allocation list. If any codes that were not defined here with Code and Label are included in the allocation list, this will not be uploaded. You must use the same codes as defined in the study design.
    If the Property values are not set for code list items, only the codes will be displayed in Logistics.
  • Allocation output properties - make sure to add the output properties for all IPs that need to be allocated for all randomizations defined in the study. Enter the Property ID, Property label and, for the code list items, add the Property values to define the codes and the labels.
  • If Logistics is enabled, set the following for all the input and output properties defined:
    • Property type - this defines which column in the allocation list contains the Kit type, Kit number and Expiry date.
    • Blinded - select this option if the item should be blinded to the users accessing the Logistics in Viedoc Clinic.
      Important!
      This setting will only affect the display of blinded properties in Logistics. Whether the property is visible or not in Clinic (the forms) is configured separately in Designer by specifying the item either as output or blinded output.
      Even if the item is set as blinded output in the randomization settings, this will be visible on the Logistics page(s) if it is not set as blinded here.

See an example below:
3

Important!
Make sure that all the needed input and output properties are defined, as it will not be possible to add or change these after approving the settings.

Note that enabling/disabling Logistics will not be possible after approving the settings.

Click Approve settings & generate list. The Mapping tab becomes available.
4 Under the Mapping tab, map each input and output properties defined in step 1 to the respective input and output properties defined for each advanced allocation in the study design. For the properties that do not apply to one or more of the randomizations in the list, select Not mapped.
Note that multiple rows and thus multiple mappings will only be needed when different definitions has been used.
Click Save changes.
5

Under the Upload & View tab, download the template of the allocation list:

Note! If your study does not have a license key (Reference ID), or has a license key that does not include the randomization feature, on the Global allocation list setup, under the Upload and view tab:

  • A message is shown informing you that the randomization feature is not included in the license:
  • The Download template and Upload links are not available.

A template excel file is downloaded:
6 Use the downloaded template file to fill in the allocation list and save the file:

Note! The cell format for the dates (for example EXPIRYDATE) must be set to Text. Make sure that Excel does not format this to Date. If the format of the dates is not set to text, the upload of the allocation list will fail and an error message will be displayed.
7 Click Upload, select the file containing the allocation list and click Open. The file will be uploaded.

Viewing an allocation list

To view the allocation list, under Upload & View tab, click the view icon:
An Excel file is downloaded that has the following sheets:

  • Configuration - summarizes the factors and outcomes and their code lists configured for the allocation.
  • Current distribution - displays the distribution of randomized patients over the different factors and groups.
  • Slots - lists all the slots, the factors and outcomes (kit number in this case), and whether the slot is still available. If the slot has been taken, the subject details, the user details (email address) of the clinic user who allocated the subject, and date and time of allocation are also displayed.

Note! The above Excel file reflects the kit status according to the randomization and allocation forms in Viedoc Clinic. All changes to kit status made in the Logistics interface can be seen in the Logistics stock list Excel file (see Stock list and Kit details view).

If the Logistics functionality is enabled, the Slots and Current distribution always reflects only the list of kits currently at Central depot. The kits that are on site are not included in the list, these can be tracked only from the Logistics interface (see Viedoc Logistics User Guide).

Editing an allocation list

To add new kits to the allocation list, click the tools icon and select Add to list:
Upload the Excel file with the new kits. This has to be in the same format as the originally uploaded list, see step 6 in Configuring the global allocation list above.