Unit for Study nurses

Nina B. Langberg
Leader

"A nurse who is well informed on the issues concerning Clinical Trials, is an asset to the successful completion of any clinical study" Jane Cassidy

In order to run high quality clinical trials it is important to have a collaborative team in which the study nurse plays an important role. The study nurse is responsible for coordinating the practical and logistical aspects of the clinical trial, and is an essential contributor in order to maintain quality and continuity in the research process. The study nurse ensures that patients are recruited according to the protocol and international regulations, such as GCP (Good Clinical Practice). The study nurse keeps CRFs (Case Report Forms) and Investigators File continuosly updated. Currently 24 study nurses are employed in the unit.

The Study Nurse - Areas of Responsibility

• In collaboration with the Principal Investigator (PI), the study nurse is responsible for the planning and implementation of a clinical trial and for the follow up of patients
• Responsible for coordinating the logistics before, during and after a clinical trial
• Ensures that the clinical trials are executed according to protocol and that the Guidelines for Good Clinical Practice (GCP) are followed
• Information to the patients about the clinical trial, in cooperation with the PI, and ensure that the patient understands all of the information
• The patient's primary nurse and acts as a liason between the patient and other hospital departments. The patient has direct access to his/her study nurse at all times
• Perform independent consultations with the patients and their families
• Administration of treatment
• Educate other staff (ward staff, newly employed staff, and other hospital staff) about clinical trials and ongoing clinical trials
• Responsible for establishing contacts and building collaborative networks among other participants in clinical trials
• Acts as a liason between the hospital and the pharmaceutical industry

Contact Information
Unit for Study Nurses
Oslo University Hospital
Ullernchausséen 70
NO-0310 Oslo
Tel: +47 91502770

Headed by Nina B. Langberg