Management of experimental medications
EVENT
It is recommended that a medication manager be appointed within the study team, responsible for the receipt, storage, maintenance, distribution, and retrieval of medications. The medications should be stored in opaque medicine cabinets. Prior to prescribing, the treatment investigator must obtain a randomization number and drug number from the central randomization system, following which the study nurse is instructed to retrieve the medication from the medication manager. During this process, the medication manager should ensure neither the blinded study personnel nor patients are present. The study nurse collects the medication and directly transfers it to the treatment investigator, taking care to avoid the presence of blinded center-reading investigators. If for any reason the medication cannot be immediately utilized following collection, it should be temporarily stored in areas inaccessible to blinded personnel. In the event a participant withdraws from the trial, the study nurse should promptly return the unused medication to the medication manager.