Summary

This article covers the Manage Inventory function.

Table of Contents

Refer to the list of deprecated features for information on the properties no longer used in the latest versions of the Randomization & Trial Supply Management product.

Requirements

For studies with randomization, you must indicate whether or not you will use the Manage Inventory function and define the drug types and treatment types.

Indicate Whether the Study Will Use the Manage Inventory Function

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Manage Inventory: Enter ‘yes’ if the study uses Inventory Management. Enter ‘no’ if the study does not use Inventory Management.
  3. Drug Assignment Upon Treatment: Enter ‘yes’ if the drug assignment should be performed immediately after the subject is activated. Enter ‘no’ otherwise.
  4. Use Alternative Treatment: Enter ‘no’ as this parameter has been deprecated.
  5. Use Sub-container: Enter ‘no’ as this parameter has been deprecated.
  6. Initial Shipment Requisition ID: If the study uses Inventory Management, enter the tracking number of the first shipment. Enter ‘none’ if the study does not use Inventory Management.

Complete Manage Inventory Information

If the study does not use Inventory Management, leave this section blank.

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Automatic Drug Supply: Enter ‘yes’ if you want new shipments of drugs to be sent automatically when the number of drug units hits a specified threshold. Enter ‘no’ otherwise.
  3. Order of Drug Supply: Enter one of the following order types which will be used when creating new shipments
    • This order type will indicate the sequence in which drug kits/bottles are requested for shipment to the sites.
    • random – select the drug with random order
    • sequential – select the drug using sequential order
  4. Order of Drug Assignment: Enter one of the following order types which will be used when assigning drugs.
    • This order type indicates the sequence in which drugs will be assigned to the subjects at the site.
    • random – select the drug with random order
    • sequential – select the drug using sequential order
  5. Packaging Company ID: Enter the Packaging Company’s ID. These IDs are usually assigned sequentially starting with the number, 1.
  6. Packaging Company Name: Enter the Packaging Company’s name.
  7. Contact Information (Address, Phone, Fax, Email): Enter the Packaging Company’s contact information.
  8. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  9. ID of Packaging Company: Enter the ID of the packaging company that should be assigned to the configuration you just created.
  10. Repeat these steps for each additional packaging company.

Define Drug Types

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Drug Type ID: Enter a unique number for the Drug Type ID. These are usually assigned sequentially starting with the number, 1.
  3. Drug Type Name: Enter the name of the compound identified in the study protocol.
  4. Description: Enter a description of the drug in relation to the study. This is usually the same as the Drug Type Name.
  5. Blinded Name: Enter the name for the drug that should be used for blinded study participants. Using ‘Study Drug’ for all drug types is recommended.
  6. Blinded Description: Enter the description of the blinded drug. This is usually the same as the Blinded Name.
  7. Threshold: If the study is not using automatic resupply or threshold notifications, leave this field blank. If you want the site’s packaging company to prepare a resupply shipment, enter the number of drug units (bottles, kits, blister packs, etc.) that will trigger a resupply shipment.
    • When the site’s inventory is depleted to this Threshold, the packaging company will be notified.
  8. Restock Level: If the study is not using automatic resupply or threshold notification, leave this field blank. Otherwise, enter the maximum desired inventory for the site.
    • When a resupply shipment is requested, the amount of drug units requested will be the difference between the site’s current inventory level and the Restock Level.
Note: Scripting can also be used for more dynamic requirements when defining the Threshold and Restock Levels. For example, to have the Threshold be defined by a script called countPatient, enter: CALLSCRIPT{countPatient}


  1. Is Managed: Enter ‘no’ if the study is not using automatic resupply or threshold notification. Enter ‘yes’ if the study is using automatic resupply.
  2. Other Drug Types to Restock: Enter a comma separated list of the Drug Type IDs corresponding to other drugs that should be replenished when the drug reaches its Threshold.
    • Example: When the inventory of Drug Type ID 1 is depleted to the Threshold, a resupply shipment will be made for all drugs with Drug Type IDs in this list.
  3. Assignment Expression: Enter ‘true’ for drugs that should be included as an option when assigning a drug to a subject unless the drug is related to randomization. Enter ‘false’ for drugs that should not be included and for drugs related to randomization. If drugs should only be included under certain circumstances, use the eClinical expression language to enter a logic expression that can enforce the data requirement.
    • Example: If the drug should only be listed for drug assignment when the subject is female, enter #screening.demog.sex == 2
Note: Randomized drugs will appear in the list automatically based on the treatment type assigned to the subject during randomization, so they should be set to ‘false.’


  1. Expiration Date Delta for Shipment: If you want to prevent a drug container from being shipped when it is within so many days of expiration, enter the number of days here. Otherwise, leave this property blank.
    • Example: If the expiration date of a drug is December 31 and the Expiration Date Delta for Shipment is set to 30, the container would not be requested for shipment from the packaging company after December 1.
  2. Expiration Date Delta for Assignment: If  you want to prevent a drug container from being assigned to a subject when it is within so many days of expiration, enter the number of days here. Otherwise, leave this property blank.
    • Example: The expiration date of a drug container is December 31 and the Expiration Date Delta for Assignment is set to 30. In this case, the container would not be assigned to a subject after December 1, because then it would be within 30 days of expiring. If the Expiration Date Delta for Assignment is set to 15, the container would not be assigned to a subject after December 16, because it would be within 15 days of expiring.
  3. Unit Label: Enter a label that specifies how the drug is packaged for the study. This label appears in Drug Assignment Screen.
    • Example: If the drug is dispensed as kits, the Unit Label would be ‘kit.’ Other possible Unit Labels include ‘bottle,’ ‘dose’ and ‘vial.’

Define Treatment Types

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Treatment Type ID: Enter a unique number for the ID. These are usually assigned sequentially starting with the number, 1.
    • If there is only one treatment type per drug type, it is best to use the same number for the Treatment Type ID and the Drug Type ID to reduce confusion when managing the study.
  3. Treatment Type Name: Enter the name of the treatment level. This is generally the dose level.
  4. Drug Type ID: Enter the Drug Type ID that corresponds to the Drug Type ID entered in the Drug Types section.
  5. Allocation Ratio: Enter an integer or decimal number for the treatment type ratio.
Note: The Allocation Ratio must be greater than 0 for all treatment types that will be allocated by randomization.


The Allocation Ratios should match the desired activation ratios defined in the study’s protocol.


Define Additional Treatment Properties

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Treatment Table Row ID: Enter a unique number for the ID. These are usually assigned sequentially starting with the number, 1.
  3. Row Condition: If the amount of drug unit will be the same in all cases, enter ‘true.’ Otherwise, use the eClinical expression language to enter the logic expression that will be used to enforce the drug assignment.
    • If multiple Treatment Table Rows are defined, as in the example above, the row conditions can be used to assign different amounts of the drug. In the example above, if the subject’s age is less than or equal to 30, one dose is assigned. If the subject’s age is greater than 30, two doses are assigned.
  4. Configuration ID: Enter the Configuration ID.
  5. Treatment Type ID:Enter the Treatment Type ID.
    • This Treatment Type ID corresponds to the Treatment Type IDs included in the previous section. A row for each treatment type should be added to this section.
  6. Assigned Amount: Enter the amount of drug that should be assigned. (Please note: the assigned amount applies to the drug assigned automatically at randomization only.)


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