NIHR Research Support Services
For the current version of the Trust's R&D Operational Capability Statement click here
The Trust uses the Study Planning Framework developed by the NIHR RSS project.
The R&D Unit will use the RSS Study Planning Tool to give potential sponsors, clinical research organisations or chief investigators speedy assessment of particular studies they wish to introduce in the Trust. These assessments identify any operational risks or potential causes of delay in opening a specific study in the specific NHS organisation at the required time.
The R&D Unit will use the RSS planning approach for all studies where we think this will enhance speed and efficiency. We will not use it for very simple studies, but are likely to apply it to studies of any complexity – not just clinical trials. In all cases, the decision on whether or not to apply the RSS approach will rest with the R&D Unit.
Use of the RSS Study Planning Tool may begin when the R&D Unit receives a valid application for NHS Permission, whether directly or via CSP (for NIHR Portfolio Studies). However we are also willing to consider requests for earlier assessments. Indeed we recommend this. Our minimum requirement is a finalised protocol – i.e. one that has been signed off by the sponsor; it may not yet have ethical or other regulatory approvals. We will consult within the organisation, and share our assessment with sponsors or other applicants as quickly as possible. The completed Study Plan may indicate that the study would be ‘business as usual’ for the organisation, that support systems are in place and there is no reason to anticipate delay. Alternatively it may show that there are operational barriers that would have to be overcome, with an estimated timeframe so that applicants could decide whether to proceed. In some cases this process might result in early agreement that the proposed site is unable to accommodate the study within an acceptable timescale – thus at least saving time and trouble for those who might otherwise make formal applications.
In addition to the protocol, other documentation may be provided if wished. If greater detail about the study is provided this will facilitate a more complete assessment; protocol-only assessments are likely to be more limited because they will identify areas where more information is required.
To request an RSS assessment in advance of making a formal application for NHS Permission, please email a copy of the protocol to email@example.com with “RSS Study Planning Request” in the subject line. If a confidentiality agreement is needed before the protocol can be provided, please use the same email address to explain the position, with “RSS Study Planning – Confidentiality Agreement Request” in the subject line.