Step 1:

By default the Inventory Management pages are disabled and need to be made available through the Role Security. This can be done by anyone, such as a study administrator with access to do so. The applications to enable are Inventory Administration and Inventory Management.

Step 2:

Enable the inventory system functionality in the study configuration.

Step 3:

Import the Inventory Configuration forms into your Form Builder from the Public Form Library titled "Inventory Forms."

  1. From study form builder, click on Import Form
  2. Select Inventory Forms from the library drop down field.
  3. Select Inventory Configuration form. Note, this is a study level form which will be filled out under study forms by the Inventory Administrator.
  4. Click on Import Checked Forms to bring them into your form study form builder.

Step 4:

Open Study Related forms and fill out the details of the first inventory you will be using. A new form can be filled out for independent inventory lists used in the same study. 

See the annotation descriptions below the image for more detail.

1. Name of the inventory list

2. Possible reasons for rejection (field name IC_REJECTION_REASON in the form builder). IMPORTANT: The choices here must be in the format "X. Reason" - where X is any coded number value, period, single space, reason text. This is how the system will know which choices to display when a site is rejecting an item they received.

3. A floor level can be set (Field name = ic_ceiling) and a ceiling level can be set (field name = ic_floor). This is how the system will be able to track when (floor level) to notify the appropriate email regarding a needed re-order of a specific type of product, and how many need to be ordered (ceiling level).

Note, the floor and the ceiling levels are for each Type of product as defined in column two of the main source file mapped in step 4.2 above. If randomization is not tied to inventory, then all items are considered a single type.

4. Add a row for each column in the inventory source file. This file will be uploaded in step 5. 

If Randomization will be tied to the inventory function, as defined during the inventory import process, its important that the second column of the import file is named "Type" and the values in that column follow that of the randomization schedule. This is how the system will know which items from the inventory list are applicable to certain randomization-based allocations. For example, if the randomization schedule has a "2" for subjects getting the placebo drug, the placebo items in the inventory list should also have a "2" in the Type column of the inventory file.

Its suggested to also deny view/edit rights to this form for all roles except the user who is managing inventory.

Step 5: 

If sites will be manually assigning items to subjects in a CRF, configure a subject form for assigning inventory items to subjects. This is done in the Form Builder by using a dropdown field with no choices entered, and changing the 'special type' property to the specific inventory configuration named in step 4. Do not add any choices to the dropdown field. The system will do that automatically on the subject record based on what is available at the corresponding site during time of data entry.

Alternatively, items can be auto-assigned by randomization allocation (IWRS). In that case, add a TEXT type field to the form. Its perferable to do that on the same form where randomization allocation is getting triggered from. Nothing needs to be done with that text field. It will be defined in a later step so the system knows which field in the study to populate with an inventory item based on the subject's allocation and items available at the site.