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How the JRO is dealing with the disruption to NIHR approvals

14 December 2011

In October of this year, a new online database was launched by the NIHR for the approval and adoption of studies onto the National Institute for Health Research (NIHR) Portfolio of Research.

This new database is referred to as RDMIS CSP. RDMIS is managed by the NIHR and the central RDMIS CSP Unit in Leeds. Since October, several technical issues have arisen which have caused disruption to the management and approval processes for studies pending adoption onto the NIHR portfolio.

The notification of studies, receipt of documents, updates on the status of adoption and approval of amendments have all been affected by the disruption to these NIHR processes

This disruption has had a significant impact on the ability of the NIHR CSP Unit and CLRNs' to approve and accept studies through RDMIS.

Local R&D offices across England have all consequently been affected.

In an attempt to keep the approvals process for NIHR portfolio studies moving at UCL, UCLH and Royal Free Hampstead, the Joint Research Office (JRO), has put in place several measures including:

  • Approval of studies outside of RDMIS,
  • Working closely with the Central and East London CLRN in an attempt to ensure that studies are adopted onto the portfolio promptly, and that communications between sponsors, NIHR and the site continue outside of the RDMIS system,
  • Stepping up our process of continual review of studies, which are pending approval through RDMIS.

In some cases, the CLRN and JRO are unable to view documents, which have been sent to the NIHR as part of an RDMIS submission. In such cases, Investigators maybe contacted by either JRO or CLRN to resubmit documents in order to try to ensure that the studies are not further delayed.

The significance of the disruption for CLRNs and R&D Offices has been acknowledged by the NIHR Clinical Research Network.

The JRO will continue to monitor the disruption, and ensure that action is taken to minimise any potential delay to investigators at UCL, UCLH and the Royal Free.