Common use of Returned investigational product Clause in Contracts

Returned investigational product. When used or unused IMPs are being retrieved from the investigational site, an IMP Return/Destruction Form must be completed (GCP026-D), and approved (signed and dated) by both a representative at the investigational site and the monitor before despatching the IMPs. The original must be sent with the returned IMPs, a copy must be sent to the CSC for filing in the TMF and a copy must remain at site. Used and unused IMPs can either be destroyed on the investigational site or returned to the CTSU or Interim Storage Facility as defined in the protocol. Used or unused IMPs returned from investigational sites must be stored at either the Interim Storage Facility or at the original CTSU with labels on the containers to describe the contents. This storage must be maintained until IMP destruction has been agreed between the CSC and storage facility (refer to section 2.6). If IMPs cannot be returned, the monitor should instruct the site that supplies must not be destroyed until the monitor has performed an IMP accountability check and has ensured the accountability is adequate.