Measuring CRN HLO 4 for 14/15 Delivering clinical research to make patients, and the NHS, better

The purpose of CRN HLO4 and the NIHR 70 day benchmark The purpose of CRN HLO 4 is to measure the time taken for a study to gain NHS permission at all associated sites. This is especially important to benchmark the UK globally for the life-sciences industry. The target is a median of 40 calendar days (from receipt of a valid complete application for the national study to NHS permission at all sites in a study). The purpose of the NIHR Performance in Initiating and Delivering Clinical Research exercise, relating to the 70-day benchmark, is to determine the time to achieve site NHS permission by the individual provider of NHS Services and achieve first patient recruited. The target is 70 days from valid research application at site)

The problem Currently CCRN asks Trusts to report against HLO 4 KPIs for NHS permission (30 days for study wide and 30 days for local review); some Trusts also report to CCF against the NIHR 70 day benchmark Performance of HLO4 has been split locally and reported on by Trust, which has caused confusion and tension when Trust Boards see conflicting data on site set up times. With the introduction of the LCRN structure, nearly all Trusts will have to report against the NIHR 70 day benchmark from 1st April because they will either hold Host contracts or step down agreements

The solution for 14/15 CRN HLO 4 will be adopted as an indicator of LCRN performance only for studies for which the LCRN is the lead Network (i.e. conducting study wide checks). LCRNs will not report and performance manage individual Trusts against HLO 4, as this is inappropriate and misleading. The targets for local and study wide checks will be amended to 15 days respectively but this will be a process target within CSP and detailed in the CRN Performance & Operating Framework (POF) and the CSP operating manual. This target will not be associated with HLO4. As the 70 day benchmark will come into effect for most Trusts from 1st April, the POF and the annual LCRN planning guidance states that Trusts will need to deliver against the 70 day benchmark for all clinical trials (portfolio and non-portfolio).

The solution for 14/15 continued The starting datapoint for CSP local checks will align the 70 day benchmark, and there will no longer be local clock stops from the 1st April. The responsibility for collecting, managing and acting upon data from the 70 day benchmark will remain with CCF