Background: The National Institute for Health Research (NIHR) describes clinical research nurses as vital to delivering research with one of their strategic goals being “improve awareness and understanding of the speciality of clinical research nursing and its contribution and impact”. Advanced therapy investigational medicinal product (ATIMP) clinical trials are high risk requiring additional considerations.
Methods: I used a model of reflection, literature searches and learning from wider teams who participate in gene therapy trials alongside maximising opportunities to speak to gene therapy research nurses in other global leading centres.
Results: I have divided the research nurse (RN) role into four sections. Education; an RN must be a clinical expert in ATIMP clinical trials, regulatory standards, monitoring and good clinical practice (GCP) audits. Part of the specialised role is to educate others including patients, families and the wider multidisciplinary team. Documentation; an RN must understand and sufficiently document the consent process ensuring the added risks of ATIMP clinical trials are understood and reflected in source data. They must thoroughly document the delivery of each ATIMP in the source data. Organisation; an RN must ensure that traceability is transparent and robust, and ensure the patient journey is according to the clinical trial protocol. Timely reporting of adverse events is critical. Challenges; frequent changes to clinical trial protocols means an RN must be adaptable and skilled at troubleshooting.
Conclusions: An RN in ATIMP clinical trials needs a willingness to learn and teach, strong organisational and documentation skills and an ability to rapidly overcome challenges.