Question:

What are the steps needed to make Kits available to ship to clinical sites?

Answer:

Below is the high-level process of loading batches, releasing the kits and approving the release, which are generally managed by the Inventory User (IU). The steps should be followed in the order described below.

NOTE: The sites and planned kit list must be added to the RTSM system prior to beginning this process.

Step 1: Load the Batches

From the Batches page:

1. Load the Blinded Batches.
2. Blinded Batches include the Blinded Batch Number, Country Code, and Expiration Date.
3. The Blinded Batch must be loaded prior to loading the Unblinded Batch.
4. Load the Unblinded Batch.
5. Unblinded Batch includes the Unblinded Batch Number, the Blinded Batch Number the Unblinded Batch will be associated with, and the Clinical Trial Material (CTM )Type.

Note: Child Batches can be added to a Blinded Batch at anytime.

Step 2: Release the Investigational Product (IP)

1. View the available kits for release on the CTM Data page.
2. From the IP release page, enter the IP release data.
3. IP release data includes the start and end sequence for the quantity of kits you plan to release, Kit Quantity, Site the Kits will be released to, and Blinded Batch the Kits will be associated with.

NOTE: An email notification will be sent upon release notifying you that you may now approve the QP release if required for any Sites that need to receive kits.

Step 3: Approval by the Qualified Person/Persons (QP)

From the QP Release page:

1. Select the appropriate countries that will need approval.
2. The kits will now be available to ship to the clinical sites.

Process Flow

NOTE: Your study may have different names associated with the Batches.

Related Documentation:

How to Create a Blinded Batch in RTSM?

How to Create a Child Batch?

How to Create an Unblinded Batch in RTSM?

How to Release an IP in RTSM?

How to Approve the QP Release in RTSM?