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Feasibility

Finding the right investigators and sites for your study

A Central Feasibility Service aims to increase the volume of commercial research placed across Scotland by helping sponsor companies identify appropriate investigators and sites in Scotland to deliver research studies.

Our Feasibility service only covers NHS sites in Scotland. Separate submissions to other UK administrations are required for a UK-wide feasibility.

Two levels of service are available with feedback provided within 14 days.

Capability/feasibility

Requests assessing the top-level feasibility of a study in Scotland:

  • does it match with the current standard of care?
  • is there a sufficient patient population?
  • top-level feedback on study design.

Distributed to the appropriate Topic Network or Specialty Group clinical lead.

Site identification

  • Sponsor actively looking for sites to participate in a study
  • Distributed to R&D teams across Scotland and to the Topic Network/Specialty Groups across Scotland.

Health Board R&D offices and Topic Networks/Speciality groups understand current study capability and have established relationships with investigators in each therapy area.  Following receipt of a request, local teams will actively support investigators with the accurate and timely completion of questionnaires.

Process

1. Submission

Feasibility or Site ID requests and supporting documentation (protocol, protocol synopsis and questionnaire) should be submitted via email to feasibility@nrs.org.uk.

Sponsors should submit as much information as possible to allow investigators to fully understand the study and specific delivery requirements. This can include a protocol, protocol synopsis and site feasibility questionnaires.

2. Circulation

Once confidentiality arrangements have been confirmed, the request will be circulated to either Health Board R&D departments and/or Topic Network/Speciality group leads where appropriate.

3. Feedback

Completed questionnaires or expressions of interest will be returned to the sponsor directly from the Health Board or via our Central Feasibility team as they are made available.  A collated summary of responses will be returned to sponsor within 14 days or by the agreed deadline.

Confidentiality

Each Health Board in Scotland is a separate legal entity; therefore, confidential disclosure agreements (CDAs) are required for each site.  CDAs are signed by the delegated R&D representative at Health Board level. There is no requirement for the proposed investigator to sign.

The Central Feasibility service is operated by the NRS Central Management Team based at the Golden Jubilee National Hospital; a CDA will be required to cover the Feasibility team.

Standard study-specific and master CDAs that can be accepted at all sites automatically without changes have been provided.

Use of Sponsor-specific CDAs will likely require negotiation at each Health Board and increase timelines.

If you need a CDA in place before sharing information on your study, please send blinded information to assess which sites are interested. CDAs can then be put in place at interested Boards.

Frequently Asked Questions

What information should I submit?

Please provide as much information as possible, clearly outlining the protocol requirements and the target population for your research, including key inclusion/exclusion criteria. Ideally, a draft protocol or a protocol synopsis will allow the investigators to assess the study. In addition, a clinically focused site evaluation questionnaire should be submitted. Please consider the following points when submitting your request:

  • Do you have an idea of the sites you want to approach?
    • Are there specific sites or investigators you would like to target
  • Have you made individual approaches to some key investigators already?
    • Include if you have made individual approaches to investigators. This will ensure that an approach is not duplicated and will enable the teams to better support the investigator
  • Do you have a deadline date for expressions of interest?
    • It is the aim to turn around requests in 14 calendar days; if you have an urgent request please make that clear in your submission email and this can be facilitated where possible

We do not have CDAs in place with all Health Boards in Scotland, how can we tackle this?

If you do not have confidentiality arrangements in place with Health Boards in Scotland it is recommended that you provide blinded protocol and/or top-line study information that can be circulated to identify investigators who want to know more about the study. Confidentiality agreements can then be put in place with interested institutions.

It is recommended that all CDA requests are sent to the Board R&D offices; investigators in Scotland should not be approached individually to sign confidentiality agreements.

Do we receive site ID or feasibility requests from the NIHR?

No, these services currently work outside of the NIHR system. If you are looking for study sites it is strongly recommended that you make a separate submission to feasibility@nrs.org.uk. Similarly, NRS do not share requests with either the NIHR or other Devolved Administrations. Contact details for these countries are as follows: