Hospital pharmacies normally operate as separate public utilities. Contracts regarding hospital pharmacy services are usually made as sub-contracts to the clinical trial agreements. The preparation of the contract and the documents required vary depending on the hospital pharmacy in question similar to the pricing of respective pharmacy services.
All clinical trials with medicinal products conducted in University Hospitals must be notified to hospital pharmacies irrespective of whether hospital pharmacy services are needed or not. Medicinal product manufactures, units manufacturing medicinal products for clinical trials, medicinal product wholesalers and pharmacies may supply the medicinal products necessary for a clinical trial to the physicians or dentists conducting the trial. In this case the Investigator has a responsibility to inform hospital pharmacy received medicinal products. It is highly recommended though that all drug deliveries for clinical trials with medicinal products are processed through hospital pharmacies to ensure drug safety and accurate trial documentation and Investigational Medicinal Product records.
Documentation related to the services provided by the hospital pharmacy is maintained by the hospital pharmacy and at the end of the trial this documentation is transferred and filed in the Investigator’s Study File. All substantial amendments to the study protocol (significant changes in the number of estimated study subjects, study contact changes and amended contact details, and any changes in the duration of the trial) must be notified to the hospital pharmacy contact person for assessing the need for further amending or extending the contract.