Drug Evaluation Committee 2008-43 Use of Carriers by CROs for Clinical Trial Drug Delivery
Related classification: Clinical trial contract procedures
First published: March 2009
Question
If a CRO is entrusted by a sponsor to store and manage investigational new drugs and ship them to Investigator Site, is it acceptable for the CRO to entrust a carrier to ship the investigational new drugs to Investigator Site and enter into a two-party contract with the CRO and the carrier?
JPMA's Opinion
Article 17 Guidance 5 of the GCP states, "When using a carrier to deliver investigational new drugs to Investigator Site, the sponsor shall take necessary measures such as concluding a contract with the carrier to ensure quality control, transport and delivery of the investigational new drugs. The above is a requirement for the CRO and the sponsor. Therefore, if the sponsor and the CRO have an agreement that the CRO will re-consign the entrusted work to the carrier, and if the sponsor confirms that the work entrusted by the sponsor to the CRO will be reliably performed according to the contract between the CRO and the carrier and the work procedures, etc., then the CRO and the carrier must conclude a contract with the carrier and take other necessary measures to ensure the quality control, transport, and delivery of the investigational drug, A two-party contract between the CRO and the transporter would be acceptable.