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P-194 Exploring the scope, value and contribution of the clinical research nurse to trial design, conduct and overall trial performance
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  1. Clare Pye1,2,3,
  2. Jon Painter3,
  3. Tony Smith3 and
  4. Mostafa Metwally2
  1. 1St Luke’s Hospice, Sheffield, UK
  2. 2Sheffield Teaching Hospitals NHS FT, Sheffield, UK
  3. 3Sheffield Hallam University, Sheffield, UK

Abstract

Background Clinical Research Nurses and Midwives (CRNs/Ms) make significant contributions to the clinical research process, quality of research outcomes and most importantly the safe expert care of research participants (McNiven, Boulton, Locock, et al. Health Res Policy Syst. 2021;19(1):74). However, there is limited evidence in relation to the scope, value and contribution of the CRN/M to trial design, conduct and overall trial performance when they are included and funded as a co-applicant and member of the Trial Management Group (TMG).

Aim This study examined the role of CRNs performing an extended role during the performance of three case studies with the aim of discovering their value, scope, and contribution in the context of this specific research delivery role.

Methods A qualitative instrumental case study was performed to describe, compare, and evaluate the perspectives of the Trial Management Group members interviewed. Eight semi-structured qualitative interviews were performed to explore the perspectives and experiences of working with a CRN in this extended research delivery role. The method of recruitment was purposeful, and individual interviews were audio recorded, transcribed and analysed to identify themes.

Results Inductive thematic analysis (Braun, Clarke. Qual Res Psychol. 2006;3(2):77–101) identified four themes - specialist operational/organisational knowledge and experience; organisational and operational practical perspective; advocacy and attributes. All Trial Management Group members unanimously recognised the value and positive influence of this extended role.

Conclusions Trial membership must include the right multidisciplinary team members with the most appropriate skills, knowledge, and experience from the conception of a trial question by embedding representation from a wide team of clinical and academic colleagues including the CRN/M workforce. The author considers this evidence is (i) relevant and transferable to all clinical areas including palliative care and (ii) this was the first qualitative evaluation that assessed the effectiveness of CRNs/Ms in this role providing an important contribution to the lack of literature on the topic.

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