An Investigational Medicinal Product (IMP) is the drug or biologic being tested in a clinical trial, including placebo or comparator products used for control.
IMPs are subject to strict requirements for labeling, storage, dispensing, blinding, and accountability to ensure participant safety and data validity. Study teams must track IMP receipt, use, returns, and destruction to maintain an accurate chain-of-custody. Protocol deviations involving IMP handling can affect both safety and efficacy interpretations, making documentation critical. Proper IMP management supports consistent dosing, reduces error risk, and strengthens regulatory confidence in trial conduct.