Information for researchers
Study Approval and issuing of NHS permission in LTHT
LTHT is one of the most research active Trust in the UK, we have been a top 5 site nationally for both the number of studies opened and the number of patients recruited in NIHR adopted studies in 2010/11 and 2011/212. We conduct research because we know it is good for patients.
Going forward we aim to build on this success. The Government's "Plan for Growth", published in March 2011, announced the transformation of incentives at local level for efficiency in initiation and delivery of ALL research. In future, NIHR funding to providers of NHS services will become conditional on meeting benchmarks, including a 70-day benchmark to recruit first patients for ALL trials from when the study is first "validated" locally. The NIHR has made this a condition of new contracts from autumn 2011 and performance will affect funding from 2013.
This means in LTHT we aim to approve (issue NHS permission) for ALL studies within 30 days of receiving valid application (start date) and then aim to recruit the first patient into the study within 70 days of this date.
To achieve this target the R&I team will be working in much more co-ordinated fashion with research teams, sponsors and the key service support departments (KSS) in Leeds.
What you can expect from R&I
- To have one nominated individual from the R&I team as a point of contact for your study approval
- *To agree with you how to manage the approval process in Leeds*
- To receive regular updates on your study's progress.
- To be assured that R&I will engage actively with Key Service Support (KSS) teams to drive through these approvals.
- To let you know immediately of any problems or delays in your application.
What we need from you
- Early engagement with R&I to discuss the approval process
- A draft contract as early as possible
- A draft of the costing template or other financial plan for the study
- All regulatory approvals and study documentation "or" conformation of their presence on CSP.
*Your study approval plan*
Working with R&I to plan how your study will gain R&I approval is the key step to this process
Example 1 - local team drive KSS approvals
R&I agrees with departmental that local team (trial co-ordinator) will use established contacts to drive through Key service support approvals (eg. pharmacy, radiology and pathology).
- R&I process the contract and all regulatory approval from CSP.
- You will receive regular updates from R&I on the progress of your study.
Example 2 - local team and R&I drive KSS
R&I agrees to help complete some of the KSS (eg the pharmacy application) and local team to submit the rest. R&I process the contract and all regulatory approval from CSP.
Example 3 - R&I drive all the KSS applications
The local team have no trial co-ordination resource available. R&I will liaise with the sponsor and the lead investigator to complete all relevant KSS applications. R&I process the contract and all regulatory approval from CSP.
In all these cases the R&I point of contact for the study will be chasing you and the KSS departments for and with updates. These updates will detail how far into the 30 day approval timeline we are.
The earlier we receive confirmation that a study will be active in Leeds the sooner we can start to work on it. Please contact firstname.lastname@example.org as early as possible with information about your study, alternatively call the team on 0113 392 2878.
Please note there are some things R&I CAN'T do!
- We can't represent your study at KSS meetings – we don't know the study well enough or have the clinical knowledge to do this.
- We can't complete study feasibility questionnaires.
- We can't complete your IRAS application form.
- We can't do everything for every study – we are a limited resource and need to work with you to drive the study through.