Common use of Despatch request Clause in Contracts

Despatch request. IMPs can be despatched either directly from the CTSU to an investigational site or to an Interim Storage Facility, or from an Interim Storage Facility to an investigational site. The CSC or designee must request all transfers of IMPs on the IMP Despatch Form (GCP026-A). The CSC must provide the CTSU with a list of designees, with their signatures, who are authorised to sign the IMP Despatch Form. A copy of this form must also be filed in the Trial Master File (TMF). The CTSU out source, manufacture and pack the IMP in accordance with current GMP. The CTSU must also provide the CSC or designee with Certificate of Analysis (CofA) and the Pack Batch Release Certificate for each batch of an IMP supplied which is considered the technical green light. The IMP Despatch Form must be sent by the CSC or designee to the despatch office (CTSU or Interim Storage Facility). Additional supporting documentation can be attached to the IMP Despatch Form where appropriate (e.g., a letter of approval from the doctor for compassionate/named patient supplies, import licence). IMP Despatch Forms must be filed in the TMF.