Preliminary tasks

1

Set up the study.

Study ()

Work with your Oracle representative to perform these tasks in IRT before the study goes live.

Examples: set up countries, approve the drug list.

2

Decide on the depot architecture.

N/A

This architecture organizes the hierarchy of the study facilities, such as central depots, local depots, and countries supplied by each depot.

Setup and release

(roadmap)

3

Create and associate depots.

Supplies

Depots

Depot Association

Create the depots to match the architecture, set the properties of the depots (such as the countries supplied by each depot), and link drug units to the depots.

4

Create and associate lots.

Supplies

Lots & Expiry

Lot Association

Before a lot is released, it must be created in IRT and associated with the appropriate drug units.

You must set up the expiration dates, Do Not Ship (DNS) dates, and Do Not Count (DNC) dates.

5

Create and associate labels.

Supplies

Label Groups

Label Group Association

If the study requires different label groups (for example, by country or group of countries), the label group must be set up in IRT and linked to the countries receiving drug units with that label group.

Drug units can then be associated with the label groups.

If required

7

Manually transfer drug orders from the central depot to the local depot.

Supplies

Request Manual

If required by your study.