Clinical trials are performed to identify the efficacy and/or safety of investigational products, new treatment combinations or routes of administration. In order to arrange formal protection of patients participating in clinical trials, governmental regulations have been designed and implemented. It is obligatory that trials are performed according to the Declaration of Helsinki, and that patients give written or oral informed consent. In July 1991 the guidelines of Good Clinical Practice (GCP) were issued in Europe. The authorities of the European Union now require that trials are conducted in accordance with GCP defining standards so that the rights, safety, integrity of participants are protected and the data are valid and credible. Patients are in this way protected from unnecessary exposure to new modalities. The current guidelines cover the ethical committee, responsibilities of sponsor, monitor and investigator, data handling, statistics and quality assurance. To implement GCP in our hospital setting related to new drug development, clinical trial standard operating procedures (SOPs) were written translating the guidelines into practical applications for the team involved. During this process we found that although the role of the nurse in clinical trials has been well established the GCP guidelines do not include this expertise. Clearly implications on nursing practice can be derived and in the SOPs the responsibilities of all team members, including the research nurses and the ward nurses are detailed. As for the nursing practice several adaptations were made and emphasized on patient safety procedures and data documentation. Major changes were: achieving the nursing records and keeping them for 15 years, limiting the admission of clinical trial patients to prevent workload interference with quality and starting a GCP training for phycisians and nurses. Of additional benefit: the SOPs clarified already existing procedures not known in detail by all team members. An overview of this process; the SOPs and the adaptations made to put the recommendations into practice will be presented. Clinical trials are performed to identify the efficacy and/or safety of investigational products, new treatment combinations or routes of administration. In order to arrange formal protection of patients participating in clinical trials, governmental regulations have been designed and implemented. It is obligatory that trials are performed according to the Declaration of Helsinki, and that patients give written or oral informed consent. In July 1991 the guidelines of Good Clinical Practice (GCP) were issued in Europe. The authorities of the European Union now require that trials are conducted in accordance with GCP defining standards so that the rights, safety, integrity of participants are protected and the data are valid and credible. Patients are in this way protected from unnecessary exposure to new modalities. The current guidelines cover the ethical committee, responsibilities of sponsor, monitor and investigator, data handling, statistics and quality assurance. To implement GCP in our hospital setting related to new drug development, clinical trial standard operating procedures (SOPs) were written translating the guidelines into practical applications for the team involved. During this process we found that although the role of the nurse in clinical trials has been well established the GCP guidelines do not include this expertise. Clearly implications on nursing practice can be derived and in the SOPs the responsibilities of all team members, including the research nurses and the ward nurses are detailed. As for the nursing practice several adaptations were made and emphasized on patient safety procedures and data documentation. Major changes were: achieving the nursing records and keeping them for 15 years, limiting the admission of clinical trial patients to prevent workload interference with quality and starting a GCP training for phycisians and nurses. Of additional benefit: the SOPs clarified already existing procedures not known in detail by all team members. An overview of this process; the SOPs and the adaptations made to put the recommendations into practice will be presented.