Study setup support

Study set-up is used interchangeably with other terminology such as Capacity & Capability (C&C) and Assess, Arrange and Confirm (AAC).  All of these describe the process followed by NHS R&D departments when completing a comprehensive review of resources and costs to ensure they can deliver a study at their Trust. 

The study set-up support service has existed since June 2018.  It was originally called the Capacity and Capability Pilot, and later was renamed the Capacity and Capability Service. The C&C service offers remote study setup support for R&D teams from an experienced WM RRDN Research Facilitator. 

• All C&C Processes

  • Assess, Arrange and Confirm Process

• EDGE Inputting / Data Completeness

  • Review of monthly Trust reports to identify missing/incomplete data

• Amendment Support

  • Review and approval of amendments

• Training  / Mentoring of New Staff

  • How to set up studies

  • How  to enter data into EDGE and manage data quality

  • General governance queries

  • Acting as a mentor to new staff

• Audit and Monitoring Support

• Review of SOPs or support with process mapping exercises

If the support you require is not listed here you can still make a request and specify the support you need. We will review and assess on a case by case basis.

Before you begin, it’s worth considering the requesting conditions below:

• The majority of the support will be provided remotely; RRDN staff will not be based in the Organisation (we hope you will agree that some valuable time will be saved here, no travel means more hours to dedicate)

• RRDN staff to work only on NIHR Portfolio research

• RRDN staff will need full access to all appropriate SOPs and IT systems to fulfil the role effectively; this together with a letter of access will need to be in place before staff can begin working with your organisation

• Single point of contact within your Organisation must be nominated with whom RRDN staff can liaise directly

WHT: "Many thanks for such a detailed handover.  Thanks for your help within the governance team. You’ve been a great support and so please to hear that you’ve learnt a lot from us, and we’ve supported you.  The SOP spreadsheet it’s most helpful and what was needed.  Hope to speak to you soon re ‘Summary of Findings’ workflow in Edge.  Looking forward to continuing working with you within our team

I just want to say a very big thank you for all your support over the past couple of months in supporting the Walsall governance team with the set-up of studies.  You had become a very valued member of our small team."

Catherine Dexter, R&D Manager, Walsall Healthcare Trust

BWCH: "Velma has been great with helping with set up and has been working really closely with Daisy.  She has adapted to the way we work quickly and is adept at setting up studies and amendments and following the Trust SOP`s.  We have had a really positive experience working with Velma and hope we get the chance to work with her again in the future as she has been a great support.  Thanks you for all the help and support and I am always happy to share my experiences if this helps at all in the future."

Sarah Hadfield, Research Delivery and Compliance Manager, Birmingham Women’s and Children's NHS Foundation Trust

"We have been very pleased to receive support from the C&C Pilot to help us during a period of prolonged staff absence. The initial application was very straightforward, and having discussed our needs with the Pilot team, we have had Facilitator support for processing amendments, staff training, and study set up. A contract has been used to clearly articulate arrangements between CRNWM and the Trust so that everyone knows what the expectation is.

The Facilitators have a point of contact within the Trust to co-ordinate activities, and our experience has been that communication is excellent. The Facilitators are very experienced, and have provided a seamless and timely service. I had some initial concerns about support being provided remotely, but I am pleased to say that these have been proved to be completely unfounded. I would have no hesitation in recommending the service to other Trusts who might be thinking about using it."

Anna Walker, Assistant Research Manager, Worcestershire Acute Hospitals NHS Trust

“CRN (C&C) support from Shelley Grant – R&D Russells Hall have had assistance on a few occasions from the CRN with amendments processing and setting up of studies – we have found the help invaluable as we had staff shortages within the department so until we were up to full staff compliment we handed this task to Shelley. On this most recent occasion it ran really smoothly although Shelley worked remotely she kept in constant contact with the team and we shared a spreadsheet that we could both update and add to so we were all up to date with the amendments being processed. We would encourage other trusts to be a part of this project and to utilise the help being offered from the CRN”

Claire Phillips, Research & Development Manager and Lesley Jones, Research Support Officer, The Dudley Group NHS Foundation Trust

The report below provides an insight into the impact of the team's work across our local Trusts.