Nurses’ role in clinical trials: a novel challenge in nursing
Section: Featured Articles
How to quote
Montes Ona U, Ocón De Miguel MM, Azanza Perea ME, Vivar G C, Fuertes Ran C. Rol de la enfermera en los ensayos clínicos: un nuevo reto para la Enfermería. Metas Enferm 2014; 17(1): 12-16.
Authors
1Usua Montes Ona, 1Marimar Ocón De Miguel, 2Mª Eugenia Azanza Perea, 3Cristina G. Vivar, 4Carmen Fuertes Ran
Position
1Enfermera. Servicio de Neumología. Clínica Universidad de Navarra. 2Enfermera. Unidad de Ensayos Clínicos. Universidad de Navarra. 3Doctora en Enfermería. Facultad de Enfermería. Universidad de Navarra. 4Enfermera. Servicio de Hepatología. Clínica Universidad de Navarra.
Contact address
Usua Montes Ona. Clínica Universidad de Navarra. Avda. Pío XII, 36. 31008 Pamplona (Navarra)
Contact email: umontes@unav.es
Abstract
Purpose: to describe the role of nurses in clinical trials (CT), to define competences, tasks and responsibilities nurses should have and the way they can improve quality and reliability in any CT.
Methods: a literature search and review was carried out covering the last 20 years; the following databases were used: CINHAL, Medline (Pubmed). Searching keywords were: coordinating nurse, clinical trials nurse, clinical trial and coordinating nurse role.
Results: a review of 30 selected articles showed two main categories reporting nurses’ role in CT: Importance of a CT coordinating nurse (besides data collection, nurse’s role includes data management, and frequently care and treatment in a complex and isolated setting, which requires expertise, along with ethical and professional competences), and Tasks of a CT coordinating nurse (according to Green, the following six tasks: 1- Reference staff member for patients, 2- Reference member and person in charge of contact among research team members, 3- Data management, 4- Biological samples collection, 5- Drugs and medicines administration, and 6- Knowledge of protocols and monitoring).
Conclusions: the role of a coordinating nurse is critical to ensure quality and rigor in any CT, acting as a liaison between patients, sponsor and other members of the research team, minimizing mistakes, and enhancing adherence to therapy.
Keywords:
Coordinating nurse; data managerclinical trial
Versión en Español
Título:
El rol de la enfermera en los ensayos clínicos: un nuevo reto para la Enfermería
