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Supply plan for site

In a clinical trial, sites are locations where the subject receives medication during their treatment. The process of providing subjects with items needed for the treatment is called dispensation. To keep the site inventory sufficient for all upcoming dispensations, the sites follow specific supply plans.

A supply plan represents a set of required parameters—such as item units, minimum and maximum stock values, and so on—that is configured to automate the process of item supply to sites to always maintain a sufficient amount of medications for all subjects registered at this site.

Important

The resupply shipment requests start triggering according to the selected plan only after the initial shipment request is sent manually or autotriggered based on the set conditions.

Note that the supply plan will not account for the dispensation needs of the subjects who are discontinued or inactivated or the inactivated dispensing plans. This precaution is required to avoid oversupplying the sites with items.

In IWRS, you can select and modify a supply plan for a site from the Supply Plan page the elements of which you can find described in the following table.

Supply plan page for site
Figure 1. Supply plan page for site

Element

Details

Supply Plan Name

Select the supply plan for your site. The supply plan displayed here is the currently effective one for the site.

The supply plans available in the list are configured via the Supply Plan functionality of the TREATMENT DESIGN tab.

Item Unit

Represents the product unit that is being supplied for the site according to the selected supply plan.

Buffer (Items)

Configure as follows:

  • Turn on this toggle to use the buffer configurations to automatically trigger a supply shipment request once the inventory is low.

  • Turn off this toggle so as not to trigger a supply shipment request based on the buffer configurations.

Initial Stock

Represents the quantity of an item present at the beginning of a study and is decided by the sponsor keeping in mind a number of factors, including storage capability, estimated consumption rate, and others.

You can configure the Initial Stock value under the TREATMENT DESIGN > Supply Plan subtab.

Trigger Buffer

Represents the quantity of an item that when the item count reaches or falls below, triggers an automatic stock replenishment request. The automated shipment must request a quantity that does not exceed the item's ceiling buffer.

A number of factors must be kept in mind while defining this value, such as the recruitment rate, the rate of item consumption, transportation time, along with other factors that might prevent the timely administration of the item.

You can configure the Trigger Buffer value under the TREATMENT DESIGN > Supply Plan subtab.

Ceiling Buffer

Represents the maximum quantity of an item that can be present on a site.

Usually, when the trigger buffer is surpassed, an automatic shipment request is sent to the supplier depot. The number of items in the request is calculated like this:

Requested quantity = Ceiling Buffer value - (number of items available on site + number of items in transit).

You can configure the Ceiling Buffer value under the TREATMENT DESIGN > Supply Plan subtab.

Predictive Window (Days)

Configure as follows:

  • Turn on this toggle to use the predictive window configurations to automatically trigger a supply shipment request once the inventory is low.

  • Turn off this toggle not to trigger a supply shipment request based on the predictive window configurations.

The Site or Study label appears next the this element depending on the setting of your site:

  • Site: represents that the site follows the country-level configurations of the predictive window to calculate the required supply amount.

  • Study: represents that the site follows the study-level configurations of the predictive window to calculate the required supply amount.

Minimum

Represents the number of days from the current date that outline the time frame for the calculation of the site inventory sufficiency for all dispensations that are supposed to occur during this time frame.

If the Predictive Window (Days) toggle is turned on, the system checks all the subject dispensing schedules during the outlined Minimum time frame and compares the estimated number of items needed for upcoming dispensations to the current site inventory and does the following:

  • If the inventory is not sufficient for all dispensations, the system automatically generates the supply shipment request.

  • If the site inventory is sufficient for all dispensations, the supply shipment request is not created.

Maximum

Represents the number of days from the current date to outline the time frame for the calculation of the number of items to be included in the supply shipment requested based on the Minimum period calculations.

The total quantity of items in the request is calculated for all the subject dispensations that are supposed to occur during the time frame outlined by Maximum.

Auto Trigger Initial Shipment

Indicates if the system is configured to trigger an initial shipment for a site automatically and under which condition:

  • When site has first subject [Subject Phase Name]: indicates that the initial shipment request is automatically created when at least one of the subjects at the site obtains the specified subject phase that is set as dispensing.

  • When site activates the shipping: indicates that the initial shipment request is automatically created when the site is activated and available for shipping activities.

  • N/A: indicates that no initial shipment trigger is configured for a site.

From the Supply Plan page, you can perform the following actions:

In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

Medical care given to a subject to mitigate or cure an illness, injury, or reduced health status. In a clinical trial, treatment may include prescribed drugs, biologics, devices, physical or psychotherapies, and such other procedures.

In eClinical, a unit of a drug that is being tested in a clinical trial is referred to as an item.

An investigational product that is used in a study. In eClinical, it can be viewed as an equivalent to a drug name to distinguish items at all stages of their lifecycle—manufacturing, shipment, dispensation to subjects, or else.

Another name for the product unit in the IWRS system is item unit.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

A specific phase that a subject has to complete in the course of a clinical trial to move further to the next phase. For instance, Screening, Enrolled, Randomized, and others.

subject_phase.png

In eClinical, subject phases are designed individually for each study via the SD application, although they are referenced in others, like IWRS or EDC.