Trigger weeks (TW)

Supplies

Resupply Setting

Predictive Resupply

The minimum number of weeks of supply required to be available at the site at all times.

• Used to determine the Projected Need (PN).
• Based on the patient visit schedule.
• Must be less than or equal to the Resupply Weeks value.
• The result of projecting the quantity of drug units required to support all expected visits for active, randomized subjects between the current date and the last day of the trigger weeks.

Resupply weeks (RW)

Supplies

Resupply Setting

Predictive Resupply

The maximum weeks of supply at a site as a result of a resupply order.

• Required to determine the Total Quantity Needed (TQN).
• Based on the patient visit schedule.
• Must be greater than or equal to the Trigger Weeks value.
• The result of projecting the quantity of drug units required to support all expected visits for active, randomized subjects between the current date and the last day of the resupply weeks.
• If sufficient drug units are available for Trigger Weeks, the Resupply Weeks is not used.

Initial quantity

Supplies

Resupply Setting

Buffer or Predictive Resupply

The quantity of each type of drug unit that is shipped to a site when the initial trigger is reached.

• The initial quantity does not apply to reactivated sites.
• During study design, the initial shipment trigger can be when a site is activated for the first time or when the first subject is screened.

Minimum buffer (MinB)

Supplies

Resupply Setting

Buffer or Predictive Resupply

The minimum number of drug units needed to account for unpredictable events, such as new subjects who need to be randomized and lost or damaged supplies.

Note: MinB is not a predictive value.

• Added to the quantity of drug units required for trigger weeks to calculate Projected Need (PN).
• Must be less than or equal to the Max Buffer.

Maximum buffer (MaxB)

Supplies

Resupply Setting

Buffer or Predictive Resupply

The maximum number of drug units needed to account for unpredictable events, such as new subjects who need to be randomized and lost or damaged supplies.

Note: MaxB is not a predictive value.

• Required to determine the total quantity needed (TQN).
• Added to the quantity of drug units required for resupply weeks to calculate Total Quantity Needed (TQN).
• Must be greater than or equal to the Min Buffer.

Projected Need (PN)

Calculated.

Determines whether a resupply order is made.

• The sum of:
  • The quantity of drug required for subject visits within the trigger weeks.
  • The minimum buffer for each drug type.
• Drug units are reordered if the site available inventory quantity of drug units is less than or equal to the projected need.

Site Availability Inventory (SAI)

Calculated.

The quantity of drug units available at the site.

• Sum of:
  • The total amount of drug units at this site with these statuses applied: Available, Quarantined, or Temporarily Available.
  • The quantity of drug units in transit (included in any drug order on its way to the site).
• Minus:
  • The total amount of drug that has reached the Do Not Count day (for expiry management).

Note: The DNC value is applied at the lot level.

Total Quantity Needed (TQN)

Calculated.

The quantity of drug units needed to be ordered for this site.

• Sum of:
  • The amount of drug required for subject visits within the Resupply Weeks.
  • The maximum buffer for each drug type.
• Minus:
  • Site availability inventory.