Streamlining R&D permission for substantial amendments to oncology clinical trials at an NHS site: a case study
نویسندگان
چکیده
Methods Observation and mapping of Trust wide processes to identify shortfalls and barriers to timely approval. Evident that capacity within service support departments, R&D and local research teams was limited when dealing with amendments from all areas of research. Cases were identified in which not all parties were aware of amendments. It was decided to divide the SOP guided facilitation of service support department sign off (pharmacy, radiology, costing, contracts etc.) between the relevant research units, building capacity for timely reviews and approvals.
منابع مشابه
One stop or full stop? The continuing challenges for researchers despite the new streamlined NHS research governance process
BACKGROUND Obtaining the necessary approvals and permission for clinical research requires successful negotiation of the ethical and R&D layers of the NHS. Differences in structure and governance frameworks feature between the constituent nations of the UK (England, Scotland, Wales and Northern Ireland), which adds complexity to cross-national studies. Difficulties in carrying out research in t...
متن کاملA practical solution to ‘Continuing Care Site’ issues in neonatal clinical trials – a pragmatic approach to regulatory and research governance review
I2S2 is a randomised controlled trial of iodine supplementation in preterm infants examining whether iodine supplementation can improve neurodevelopmental outcome at two years of age. 20 Neonatal Units in the UK will recruit around 1400 infants <31 weeks of gestation into the trial; infants will receive a daily dose of sodium iodide or sodium chloride placebo until 34 week’s corrected age. Due ...
متن کاملStreamlining the planning approval process for a sustainable urban development: A case study for unwinding man-made complexities
The urban development process displays regressive tacit-dominant knowledge areas and their tacit level would impede their movements during multi-level knowledge transfers among stakeholders. The accuracy of a knowledge may be distorted when recipient stakeholders fail to understand a specific knowledge for its purpose. Earlier studies by the authors had highlighted complex yet dynamic environme...
متن کاملSuperior Capsule Reconstruction: What Do We Know?
The management of irreparable rotator cuff tears remains challenging. Since its introduction by Mihata in 2012, superiorcapsule reconstruction (SCR) has grown in popularity at an astonishingly rapid rate. The aim of this article is to providea comprehensive review of the available literature, in order to highlight what has so far been published on SCR,covering all aspects including biomechanica...
متن کاملThe Economic Impact of Clinical Research in an Italian Public Hospital: The Malignant Pleural Mesothelioma Case Study
Background The current economic constraints cause hospital management to use the available public resources as rationally as possible. At the same time, there is the necessity to improve current scientific knowledge. This is even more relevant in the case of patients with malignant pleural mesothelioma (MPM), given the severity of the disease, its dismal prognosis, and the cost of chemotherapy ...
متن کامل