Table 1

Examples of where the CRN/M can influence overall trial performance

Design phase—specific focus on potential patient research pathways and eligibility criteriaInfluence on trial recruitment and performance
Knowledge of the clinical condition and experience in research delivery enables the CRN/M to contribute at all levels of discussion and decision-making but specifically to:
Influence the proposed patient pathway…
Collaborate with research networks/clinical colleagues/CRN/Ms etc…
Support PPI members to develop skills and confidence…
To facilitate maximum involvement of participating research sites
To ensure trial procedures are acceptable to potential participants
To support the development of inclusionary eligibility criteria
To influence proposed patient research pathways, recruitment strategies and patient facing documents
Delivery Phase—specific focus on the clinical/research delivery aspects of the trial protocol Influence on trial recruitment and performance
Knowledge of the clinical condition, grant designed and experience in research delivery enables the CRN/M to provide clinical/research delivery expertise to all participating research sites in the support of trial performance but specifically to:
The design and content of all patients facing documents prior to
  • Patient and public involvement review/input…

  • Ethical/governance approval…

The design and content of trial database/case report form (CRF/eCRF) and data collection tools…

Deputise for Chief Investigator…

Resolve real-time eligibility issues…

Facilitate accurate reporting of adverse events…
  • Good clinical research practice

  • General trial delivery

  • NHS research teams

  • Strategies to facilitate recruitment

  • Inexperienced CRN/Ms

  • Factors within NHS organisations impacting on recruitment

Ensures documents are acceptable to the population under investigation and relevant governing bodies
To ensure only, the data required for the purposes of analysis will be collected and data collection tools are fit for use in the clinical setting
To support quality of data captured

Provides continuity and leadership

Facilitates recruitment

Promotes quality, accurate data collection and trial integrity
  • CRN/M, clinical research nurse/midwife; NHS, National Health Service.