title: The impact of registration of clinical trials units: the UK experience.
abstract: BACKGROUND
  Over the last decade, the United Kingdom has invested significant resources in its clinical trial infrastructure. Clinical research networks have been formed, and some general oversight functions for clinical research have been centralised. One of the initiatives is a registration programme for Clinical Trials Units involved in the coordination of clinical trials. An international review panel of experts in clinical trials has been convened for three reviews over time, reviewing applications from Clinical Trials Units in the United Kingdom. The process benefited from earlier work by the National Cancer Research Institute that developed accreditation procedures for trials units involved in cancer trials. This article describes the experience with the three reviews of UK Clinical Trials Units which submitted applications.
  
  
  OBJECTIVE
  This article describes the evolution and impact of this registration process from the perspective of the current international review panel members, some of whom have served on all reviews, including two done by the National Cancer Research Institute.
  
  
  METHODS
  Applications for registration were invited from all active, non-commercial Clinical Trials Units in the United Kingdom. The invitations were issued in 2007, 2009 and 2012, and applicants were asked to describe their expertise and staffing levels in specific areas. To ensure that the reviews were as objective as possible, a description of expected core competencies was developed and applicants were asked to document their compliance with meeting these. The review panel assessed each Clinical Trials Unit against the competencies. The Clinical Trials Unit registration process has evolved over time with each successive review benefiting from what was learned in earlier ones.
  
  
  RESULTS
  The review panel has seen positive changes over time, including an increase in the number of units applying, a greater awareness on the part of host institutions about the trials activity within their organisations, more widespread development of Standard Operating Procedures in key areas and improvements in information technology systems used to host clinical trials databases. Key funders are awarding funds only to registered units, and host institutions are implementing procedures and structures to ensure improved communication between all parties involved in trials within their organisation.
  
  
  CONCLUSIONS
  The registration process developed in the United Kingdom has helped to ensure that trials units in the United Kingdom are compliant with regulatory standards and can meet acceptable standards of quality in their conduct of clinical trials. There is an increased awareness among funders, host institutions and Clinical Trials Units themselves of the required competencies, and communication between all those involved in trials has increased. The registration process is an effective and financially viable way of ensuring that objective standards are met at a national level.
authors.affiliation: Frontier Science (Scotland) Ltd, Kincraig, UK eleanor.mcfadden@frontier-science.co.uk.
authors.forename: Eleanor
authors.initials: E
authors.lastname: McFadden
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Saeeda
authors.initials: S
authors.lastname: Bashir
authors.affiliation: Canham Information Systems, Surrey, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Canham
authors.affiliation: University College London, London, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Darbyshire
authors.affiliation: NIHR Evaluation, Trials and Studies Coordinating Centre, University of Southampton, Southampton, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Davidson
authors.affiliation: Clinical Trials Consulting & Training Limited, Buckinghamshire, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Day
authors.affiliation: Kirby Institute, University of New South Wales Australia, Sydney, NSW, Australia.
authors.forename: Sean
authors.initials: S
authors.lastname: Emery
authors.affiliation: Queen's University, Kingston, ON, Canada.
authors.forename: Joseph
authors.initials: J
authors.lastname: Pater
authors.affiliation: Arthritis Research UK, Chesterfield, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Rudkin
authors.affiliation: Alexandra House, Huddersfield, UK.
authors.forename: Maxine
authors.initials: M
authors.lastname: Stead
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Brown
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D003406:Credentialing / Q000331:legislation & jurisprudence / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D006113:United Kingdom
keywords: Clinical trials unit; coordinating centre; core competencies; registration