Systems & Management: Targets & Time – in Acute and PCT settings

1. Systems & Management: Targets & Time – in Acute and PCT settings R&D Forum, 10 May 2006 R&D Teams – University Hospitals of Leicester NHS Trust & West Midlands South Joint PCT RM&G

2. Systems & Management: Targets & Time Team Introductions John Hampton – Assistant Director of R&D, University Hospitals of Leicester Nicky Turner – R&D Office Manager, University Hospitals of Leicester Chris Beyer – R&D Facilitator, R&D Solutions – working primarily within PCTs across the WMS PCT RM&G, and involved at UHL in developing this process Elizabeth Kettle – R&D Manager, R&D Solutions range of work including RM&G manager WMS PCT RM&G and various R&D projects at UHL.

3. Systems & Management: Targets & Time Introduction • From early 2005 we became aware of increasing pressure on R&D Offices to ensure project approval is both thorough and swift. • With proposals for better metrics in R&D based to a degree around timescales it is essential we are able to demonstrate systems to facilitate efficient approval of Research studies. • To reflect the different needs of PCTs and Acute Trusts using different systems we employed different approaches to address this, which we will outline today.

4. Systems & Management: Targets & Time Systems & Management: Targets & Time Chris slide one - UHL R&D Databases – What they can do! EPS • Both EPS and ReDA give us the potential to be able to break down the R&D approval process in order to; • Establish ‘R&D’ time within the process • Establish where the hold-ups are • Managing Workload of staff • Easily check the position of an application in the R&D process

5. Systems & Management: Targets & Time System 1: UHL & EPS • IT System: Research Manager • Trust: Large Teaching Acute Trust, very research active, 11 NHS R&D Programmes • Programme: Project Monitoring Programme allowing stopping / starting of clock • Aims: • Records time in R&D Office • Records total time application has taken to receive R&D approval • Wish to update Researchers as to progress of studies through the process

6. Systems & Management: Targets & Time System 1: UHL & EPS • The two most notable outcomes UHL benefited from using this additional module are: • Significant reduction in complaints relating to timelines for R&D Approval • Monitoring and Management tool for workload of the R&D Programme Board Co-ordinators

7. Systems & Management: Targets & Time System 1: UHL & EPS • Complaints • Reports can be generated to illustrate what happens with an application at each stage of R&D approval Project Approval Process Total Approval Days: 56 Total Days on Hold: 55 Net Approval Time: 1 Approval Process: Date: Notes: HOLDSTOP-EPS 04/01/06 Received amended letter and pharmacy approval - granted trust approval. HOLDSTART-EPS 03/01/06 Put on hold until we receive an amended letter HOLDSTOP-EPS 03/01/06 Full approval response received from ethics although document incorrect HOLDSTART-EPS 22/12/05 Amended documents forwarded to ethics. Awaiting response. HOLDSTOP-EPS 22/12/05 Response received from investigator. HOLDSTART-EPS 20/12/05 Sent letter to researcher to address the points raised. HOLDSTOP-EPS 20/12/05 Conditional approval received from ethics HOLDSTART-EPS 14/11/05 Sent to ethics HOLDSTOP-EPS 14/11/05 Documents received and peer review. HOLDSTART-EPS 10/11/05 Study reviewed and email sent to researcher.

8. Systems & Management: Targets & Time System 1: UHL & EPS • Workload Management • Reports generated weekly and accessed by researchers on-line for: • Ongoing studies still awaiting R&D approval (monitor workload of R&D Programme Board Co-ordinators) • Approved studies (monitor average time it takes for R&D approval)

9. EPS Systems & Management: Targets & Time R&D Databases – Utilising them effectively • Using the ‘Timed’ and ‘On Hold’ function • Using common governance events or free text • Using the query functions to create the external reports • Create a spreadsheet to hold and retrieve EPS data

15. Systems & Management: Targets & Time Systems & Management: Targets & Time Systems & Management: Targets & Time Beth slide one Beth slide five System 2: PCT & ReDA • IT System: ReDA Database - Infonetica • Trusts: RM&G Unit consisting of 7 PCTs, range of research activity, including Lead PCT with 4 NHS R&D Programmes • Programme: Using ReDA system to monitor R&D Approval time lines and compliance with Approval SOP • Aims: • Demonstrate able to work towards & met deadlines for R&D Approval • Linked to whole R&D Approval to show that is NOT the “delay” step • Follow COREC’s lead, e.g. clock does not stop until avalid submission is received

16. Systems & Management: Targets & Time Systems & Management: Targets & Time Systems & Management: Targets & Time Beth slide two Beth slide five System 2: PCT & ReDA • How & What? • Had a team meeting to draft a process of how this system would work effectively for us • Agreed provisional timelines and considered how to use ReDA & clocks within it to record this information • Piloted system in RM&G Office for 3 months to validate • Took to R&D Committee as a proposal for comment and showed results to date (see o/page) • Re-drafted and the worked to the SOP with associated actions for a further 6 months, results presented to committee every quarter

17. 1.Initial Correspondence received from researcher. Project allocated a reference number 2.Researcher contacted for further information 3.Completed submission received. Papers collated and preparedfor review. 4.R&D Office review 5.Prepare papers for PCT R&D Lead review 6. PCTR&D Lead review Approved Rejected 7.R&D Office notify researcher of outcome 8. If Trust is sponsoring project, researcher will be undertake a brief training session on the RGF and good practice in research delivered by the R&D Office. Systems & Management: Targets & Time Systems & Management: Targets & Time Systems & Management: Targets & Time Beth slide five Beth slide three Flowchart with Timescale for PCT R&D Approval TIME ALLOCATION 1 day 2 days 10 days 2 days 25 days 5 days MAXIMUM TIME TO PROCESS: 45 DAYS

18. Systems & Management: Targets & Time Systems & Management: Targets & Time Systems & Management: Targets & Time Beth slide four Beth slide five System 2: PCT & ReDA Results – Q3 (2005) - pilot Projects Registered, Approved & Currently Pending Q3 (July-Sep 2005) % of projects meeting SOP guideline in Q3 (July – Sept 2005)

19. Systems & Management: Targets & Time Systems & Management: Targets & Time Beth slide five System 2: PCT & ReDA • Outcomes: • Assists in identifying problems in individual PCTs, and then provide assistance as required • Shows us “blocks” in the system, able to target resources to those blocks and if necessary provide guidance to other departments • Not a perfect system, but a useful tool

20. Systems & Management: Targets & Time Systems & Management: Targets & Time Chris slide two - UHL R&D Databases – Utilising them effectively • Ensure Database in accurate and kept up-to-date • Using the ‘clock’ function • Choosing appropriate ‘Governance Events’ in the R&D process and programming these into ReDA • Using the ‘Work Area’ & search facility to produce reports on the position of an application

21. Systems & Management: Targets & Time Systems & Management: Targets & Time Chris slide three - PCT

22. Systems & Management: Targets & Time R&D Databases – Utilising them effectively

24. Systems & Management: Targets & Time Contact Details John Hampton – john.hampton@uhl-tr.nhs.uk 07921 545 692 Nicky Turner – nicola.turner@uhl-tr.nhs.uk 0116 258 4109 Chris Beyer – chris.beyer@swarkpct.nhs.uk 01926 493 491 ext 283 Elizabeth Kettle – elizabeth.kettle@uhl-tr.nhs.uk 07909 877 111

25. Systems & Management: Targets & Time – in Acute and PCT settings R&D Forum, 10 May 2006 R&D Teams – University of Leicester NHS Trust & West Midlands South Joint PCT RM&G