El rol de la enfermera en los ensayos clínicosun nuevo reto para la Enfermería

  1. Montes Ona, Usua
  2. Ocón De Miguel, Marimar
  3. Azanza Perea, María Eugenia
  4. García Vivar, Cristina
  5. Fuertes Ran, Carmen
Journal:
Metas de enfermería

ISSN: 1138-7262

Year of publication: 2014

Volume: 17

Issue: 0

Type: Article

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More publications in: Metas de enfermería

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.

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