Study Nurse
The study nurse is the interface between patients, investigators, CROs, and monitors the pharmaceutical industry and the university hospitals or study groups as a customer (sponsor) of the study. The activity of the study nurse on the basis of Good Clinical Practice (GCP, Good Clinical Practice) and the German Drug Law (AMG). Although the title Study of the Nurse in any of these documents mentions the term “study nurse” has prevailed in the directly involved in the study.
Study Nurse is not a protected professional title, there is no uniform rule for the training. Basic medical training e.g. Physician assistants or nurse and regular training are helpful, English and computer skills are required. The job descriptions medical documentaries and medical documentation assistants meet these criteria, the training is also taught to plan and conduct of clinical trials. The presentation of new research protocols and participation in national and international study meeting is required.
— Nurse
Several organizations offer training on the study nurse, for example Founded in May 1999 working group study nurse with members of the pharmaceutical industry, CROs, hospitals and universities under the auspices of the Association for Applied Human Pharmacology (AGAH), the continuing education courses for study nurses developed and carried out [1]. Prerequisite for participation in the AGAH-certified courses, a completed training as a nurse, technician or equivalent medical training, the total duration of about six months [2] or the KKS Network (Coordination Center for Clinical Studies), whose training for study assistance 120 hours provides on-site courses and a bi-weekly internship in an external study by leading department.
