SOP for Handling Study Drug

Purpose:
To ensure that all Investigational Medications/Products are inventoried and kept secured per GCP Guidelines.

Scope:
To maintain clinical blind, separation of Study Drug/Product per protocol and to eliminate errors.

Responsibility:
This SOP applies to all staff employed by Drug Study Institute. The inventory and dispensing of Study Drug is the responsibility of the lead coordinator assigned to the study.

Procedures:
Upon receipt of Study Drug the lead coordinator is responsible for the following:

1. Log-in Study Drug/Product shipment on the “Shipment Received Log.”
2. Two research personnel will confirm Study Drug shipment by:
1. Lot number; if applicable.
2. Quantity received.
3. Drug name/number.
3. Complete Drug Receipt Form per instruction received from Sponsor.
4. Study Drug to be kept in a sturdy secure double locked cabinet with limited access in a locked room with Melody being the sole person with the keys.
5. When Study Drug arrives at DSI, acknowledge receipt by all applicable:
1. IVRS (Interactive Voice Response System)
2. Clinphone
3. Teletrial
4. Sponsor/CRO/Shipper
5. All other Study Drug dispensation to be done by CRC (Clinical Research Coordinator) per the protocol.

Notify the RA (Research Assistant) to have Temperature Logs along with a thermometer to be placed on the corresponding locked cabinet door as per protocol.