Study Nurse

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A study nurse or study assistant is a job that also supervises clinical studies in test centers in hospitals, medical practices or the pharmaceutical industry. The Study Nurse is jointly responsible for carrying out the study in accordance with the study plan .

description

The Study Nurse is the interface between patients, investigators, monitors of the CROs and the pharmaceutical industry as well as the university clinics or study groups as sponsors of the study. The activities of the study nurse on the basis of Good Clinical Practice (GCP, Good Clinical Practice ) and the German Medicines Act (AMG). Although the job title of study nurse is not mentioned in any of these documents, the term “study nurse” has gained acceptance among those directly involved in studies.

Study Nurse is not a protected job title ; there are no uniform rules for further education. Basic medical training such as B. Medical assistant (until 2006 medical assistant ) or nurse as well as regular further training are helpful, English and IT skills are required. The occupational profiles of medical documentary and medical documentation assistant meet these criteria, the training also teaches the planning and implementation of clinical studies. Participation in national and international study meetings is required to present new study protocols.

Various organizations offer further training for Study Nurse , e. For example, the Study Nurse working group founded in May 1999 with members of the pharmaceutical industry, CROs, hospitals and universities under the auspices of the Working Group for Applied Human Pharmacology (AGAH), which develops and conducts further training courses for Study Nurses . The prerequisite for participating in the AGAH-certified courses is a completed training as a nurse , MTA or comparable medical training, the total duration is approximately six months or the KKS network ( Coordination Center for Clinical Studies ), whose further training as a study assistant 120 hours Provides on-site courses and a two-week internship in an external department that conducts studies.

activities

Since the job description of the Study Nurse is not clearly defined, the field of activity can be very different depending on the employer and area of ​​responsibility.

Activities before the start of studies

The contractual matters between the sponsor and the trial center (hospital / practice) are processed. All forms required for submission to the responsible authorities and institutions, such as B. Description of the trial center, résumés of all persons involved in the trial center, confidentiality declaration are collected. The responsible higher federal authorities are the BfArM and the Paul Ehrlich Institute , the responsible institution is the lead ethics committee . There are standard procedures created to study conduct transparent for all persons involved in the clinical site and is uniform.

Activities while conducting the study

Patients are selected for the study together with the investigator by comparing the inclusion and exclusion criteria specified by the sponsor in the protocol (study plan). The Study Nurse checks whether the examinations prescribed in the study plan are carried out on time and takes care of the appointment management. The data collected are documented manually or electronically in the Case Report Form (CRF) specified by the sponsor , and the study and investigator folders are managed. A clinical monitor visits the trial center at regular intervals. These visits (monitoring visits) are prepared and accompanied, i. H. the collected and anonymized data are submitted for review. After the monitored data has been forwarded to data management , ambiguities are sent back to the test center by means of a query. These open questions are dealt with by the Study Nurse and the investigator. Proper storage and dispensing of the study medication is ensured. The Study Nurse is the contact person for questions from patients.

One important aspect is the timely reporting of a serious adverse event (SAE). An SAE is any event that leads to the death of a patient, permanent impairment or hospitalization or the extension of an inpatient stay. These events must be reported to the CRO or the sponsor within 24 hours of becoming known. The preparation and support of inspections by the authorities or audits by the sponsor is also part of the activities of a study nurse.

Post-study activities

After the end of your studies, all study documents are archived for 15 years .

Individual evidence

  1. ↑ Information brochure of the Study Nurse working group (PDF; 361 kB)
  2. ↑ Further training to study assistants on kks-netzwerk.de ( Memento of the original from September 28, 2010 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / kks-netzwerk.de

bibliography

  • Manfred Stapff: Drug Studies: A Manual for Conducting Clinical Trials for Doctors and Medical Assistants. Zuckschwerdt, Germering 2007, ISBN 978-3-88603-912-8 .
  • Joachim A. Schwarz: Guidelines for clinical trials of pharmaceuticals and medical devices: good clinical practice, planning, organization, implementation and documentation. 3rd edition 2005, editio Cantor Verlag, Aulendorf 2005, ISBN 3-87193-254-X .
  • J. Sehouli, D. Könsgen, G. Oskay: Manual Clinical Studies: A Guide for Doctors and Study Nurses (Study Nurses). Akademos Wissenschaftsverlag, 2nd edition 2005, ISBN 978-3-934410-66-4 .
  • C. Hinze, CH Gleiter, P. Meng: Clinical drug testing: Applied GCP for investigators and study teams with SOPs and checklists Editio Cantor; 2nd edition 2012, ISBN 978-3-87193-331-8 .
  • T. Sudhop: Study Nurse - the need for standardized and qualified training. Geelen & Geelen GmbH, German Journal for Clinical Research, Issue 2, Volume 4, April 2000.
  • B. Fisk, J. Beier: Study Nurses in Germany - An examination of their activities in conducting clinical studies. Hans Huber publishing house, Hogrefe AG, Bern 2007, “Pflege 2007”; 20; Pp. 293-299.

Web links