Facilitating clinical trials involving medicinal products
KGO supports both investigator-initiated and industry-sponsored clinical trials, including those involving high-risk substances (such as cytostatic agents and advanced therapy medicinal products) and opiates.
KGO holds an exemption for the use of opiates in scientific research. If the required opiate is not yet covered under this exemption, a separate application must be submitted to the Health and Youth Care Inspectorate (in Dutch: Inspectie Gezondheidszorg en Jeugd, IGJ).
For investigator-initiated studies where Amsterdam UMC acts as the sponsor, the institution is responsible for ensuring the quality of the investigational medicinal product. To maintain this quality, a quality agreement is established between KGO and the company responsible for producing the medicinal product. Involving KGO early is crucial, as setting up a quality agreement can be time-consuming.