As the result of aging population, chronic diseases become serious worldwide health problems. Following the international trend, Taiwan develops her pharmaceutical industry. For the benefit of the public, it is important to learn how to effectively train and integrate the clinical investigators to enhance the country’s competence and to accelerate the launch of new drugs in Taiwan. The phases of clinical trials are the most important parts to develop new pharmaceuticals. Under the phases, the study nurses, the key role of clinical trials, are investigated. The objectives of this study include as below: first, the frequency of study nurses involved in the activities or taking responsibilities of clinical trials; second, the view of study nurses on their professional role; and third, the influence of their professional qualification, organizational and individual characteristics on clinical trial activities. This study was conducted by the cross-sectional method and SPSS 10.0 software. One hundred and twenty three study nurses were enrolled from the nineteen medical centers in Taiwan. The result shows that the most routine clinical trial activities of study nurses in Taiwan are subject enrollment, informed consent process, investigational product management, implementation, evaluation and data management. There are some significant factors about the frequency and importance of clinical trial activities, such as the professional organizational membership, the nursing experience, the availability of job-related standard operation procedures, the policy and opportunity of professional promotion, and the line manager who is a physician or not , the salary of study nurse, and so on.
Study nurses who receive trainings more often would participate in clinical trial activities more frequently.
Study nurses’ opinion on their professional roles would be more significant while they recognize the implementation and importance of clinical trial activities more strongly. There are correlated between the number of trainings of study nurses, their performance as nurses, and their perspectives on the
professional roles of nurses. The experience of conducting phase II or phase III clinical trials, different job positions, different job locations may be the predictors to identify the frequency and importance of conducting clinical study activities. By the study result, it is expected to provide some new ideas of assessment on the trainings of clinical investigators for the clinical trial industry.
