An Investigational Product (IP) is any drug, biologic, placebo, or device being tested or used as a reference in a clinical trial.
IP management includes controlled storage, labeling, dispensing, accountability, and documentation to ensure proper use according to the protocol. Accurate IP handling supports participant safety by preventing dosing errors and maintaining blinding where required. Regulatory inspections frequently assess IP records to confirm chain-of-custody and reconciliation accuracy. Strong IP controls protect data validity by ensuring participants receive the intended treatment assignment under controlled conditions.