S2924
RTT- RTT operational practice and workflow innovations
ESTRO 2026
2373 Trial Coordinator-Led Informed Consent (TC-LIC) in radiotherapy clinical research: three-centre implementation, GCP audit & time-release outcomes. Jackie McCann 1 , Ciaran Malone 1,2 , Roisin O'Maolalai 1,3 , Rebecca O'Donovan 1 , Margaret Looby 1 , Christina Skourou 1 , Elizabeth Forde 4,5 , Ruth Woods 1 , Samantha Ryan 1 , Jill Nicholson 1,4 , Vitor Oliveira 1 , Vijayashree Hegde 1 , Alexander Yavorskyy 1 , Joanne O'Connell 1 , Sarah Murphy 1 , Dymphna McGettigan 1 , Sinead Brennan 1 1 Radiation Oncology, St Luke's Radiation Oncology Network, St Luke's Hospital, Dublin, Ireland. 2 Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands. 3 Radiation Therapy, Irish Research Radiation Oncology Network, Dublin, Ireland. 4 Applied Radiation Therapy Trinity, Discipline of Radiation Therapy, Trinity College, Dublin, Ireland. 5 Trinity St James’s Cancer Institute, Trinity St James, Dublin, Ireland Purpose/Objective: Traditionally, informed consent for radiotherapy clinical research is obtained by the Principal Investigator (PI) or a medically qualified sub- investigator. In response to increasing study and consent workload, an initiative to delegate Radiation Therapists (RTTs) and Research Nurses (RNs) to lead consent for selected radiotherapy research studies was introduced under Irish Research and Radiation Oncology Group (IRROG) governance - the first such initiative since IRROG's establishment. During rollout of a rapidly recruiting, investigator-initiated study, a trial-coordinator-led informed-consent (TC-LIC) pathway was introduced to manage anticipated demand. Good Clinical Practice (GCP-certified) RTTs and RNs received study-specific training and were delegated to obtain consent within a network-wide, GCP-compliant framework. Although internationally accepted, this model is not widely implemented in Ireland, supporting advancement of RTT practice and staff development and retention (1). Material/Methods: Trial coordinator–led informed consent (TC-LIC) was piloted within the OPEN (Optimising Patient Experience in Head & Neck Radiotherapy) Phase III study, a low-intervention, minimal-risk, radiotherapy- specific study (2). Governance was formalised by the clinical trials unit and site PIs, with delegation criteria and a GCP-compliant work instruction specifying procedures and competencies. Seven PI-delegated TCs screened patients. Eligibility confirmation by the
Radiation Oncologist (RO) constituted the start check, after which delegated RTTs and RNs conducted independent consent. Compliance was reinforced by an end check: an independent audit of consent documentation, with 20% undergoing second review check. Evaluation comprised of an audit, staff survey (experience and confidence), and quantification of clinician hours released, used as the key performance indicator (KPI) for feasibility and efficiency. Results: RTTs/RNs completed 230 consents, releasing ~75 clinician hours. All six consenting TCs responded to the survey (primary author not included); responses indicated positive professional development (Fig. 1). The median [IQR] self-reported time per consent was 24.5 [14.5–24.5] minutes. The pathway supported research study throughput and optimized TC skills. Audit identified consent notes in 221/230 (96%) cases, with no major GCP deviations in consent documentation. Minor documentation issues (e.g., absent consent-form version) prompted a Corrective and Preventive Action (CAPA) which included the introduction of a standardised consent note template and adding missing confirmatory-consent documentation to patient records retrospectively.
Figure 1 Conclusion: An RTT/RN-led consent pathway proved feasible, releasing ~75 clinician-hours across the network while maintaining GCP compliance and supporting advanced RTT practice. It fostered staff development, standardized documentation, and scaled to two additional low-intervention/observational trials across the network. TC-LIC sets a benchmark for efficiency and RTT leadership in clinical research. References: 1. Orr M, Rosbottom K. Departmental practice on informed consent in radiotherapy departments: a UK evaluation. J Radiother Pract. 2025;24:e1–e62. Malone C., et al., Intrafraction motion stability of open vs.
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