title: [Study nurses in Germany--a survey of job-related activities in clinical trials as a basis for a job description and for training curricula].
abstract: Until now, the conducting of clinical trials by nurses has scarcely come under scientific examination. Particularly in Germany, the field of activity has only been treated marginally in the health-care and nursing sciences. In Germany, the term 'Study Nurse' is used not only for members of the nursing profession but across disciplines; it is one of the most widely used terms. An explorative, descriptive study has been conducted employing a modified version of the Work Sampling Method. 79 Study Nurses were anonymously surveyed using a self-administered workload catalogue. 85 participated in the survey that focused on demographics, qualifications, and salary. In every workload catalogue, contact with other colleagues as well as job activities and the time spent on each activity were documented over twenty days. Study Nurses are mostly members of the nursing profession. They work mostly at university clinics and are responsible for conducting clinical trials. This applies to all trials that license medicinal products but also for trials initiated by investigators. While trial-specific documentation is their most time-intensive task, the overall role of Study Nurses encompasses a very broad range of activities. For the most part, they work alone and independently but have various contacts mainly to patients and the investigator. Future research should take into consideration the motivation for opting for the job of Study Nurse and the question of whether through their training and experience nurses are better qualified than other healthcare professionals.
authors.affiliation: Klinikum der Johann-Wolfgang-Goethe-Universität, Theodor-Stern Kai 7, D-60590 Frankfurt a.M.
authors.forename: Bettina
authors.initials: B
authors.lastname: Fisk
authors.forename: Jutta
authors.initials: J
authors.lastname: Beier
mesh_terms: D002986:Clinical Trials as Topic / Q000451:nursing*; D003299:Cooperative Behavior; D003479:Curriculum; D003625:Data Collection; D004506:Education, Nursing; D005858:Germany; D006801:Humans; D007587:Job Description; D009737:Nursing Records; D012108:Research Personnel / Q000193:education*; D016526:Workload