ICH E6(R3) - Good Clinical Practice 3.15-supply: Supply investigational product only after required approvals, with handling instructions, timely provision, records from shipment to disposition, retrieval and disposition processes, in-date stable stock and retained samples for re-testing

What does 3.15-supply require?

The sponsor supplies investigational product to investigators, or directly to participants where regulation allows, only after IRB/IEC and regulatory approvals, choosing shipping and dispensing approaches suited to the product, route, complexity and safety knowledge, with safeguards for integrity, protocol use and safety. It should give investigators or participants handling and storage instructions covering receipt, storage, dispensing, retrieval of unused product and its return or authorised alternative disposition; provide product on time to avoid interruptions; keep records of identity, shipment, receipt, return and destruction; maintain documented retrieval (for example recalls, end-of-trial returns, expired stock) and disposition processes; keep product stable and used only within shelf life; and retain enough samples to re-confirm specifications, with batch analysis records, until data analysis is complete or as regulation requires, whichever is longer (manufacturers usually keep samples for unmodified authorised products).