Finding the right investigators and sites for your study

As a single point of contact, the NRS Centralised Feasibility Service aims to assist in the identification of appropriate investigators and sites across Scotland for the delivery of clinical research studies.

Confidentiality

The NRS Centralised Feasibility Service has a master Confidential Disclosure Agreement (CDA) available for Sponsors/CROs. This will allow the sharing of confidential information with NHS Scotland Health Boards (separate CDAs are in place between NRS and those NHS organisations).

Use of study-specific CDAs will likely increase timelines.

• Read more and download the master CDA

Study-specific CDAs will only be required with individual NHS Scotland Health Boards once the site selection has been confirmed.

Three levels of service are available

Early Feedback

Identify key opinion leaders for feedback in the development of study protocols.

Site Intelligence

Assessing top-level capability of Scotland to participate in a particular study, including:

• does it match current standard of care?
• is there a sufficient patient population?

Distributed to the appropriate Topic Network or Specialty Group. Feedback will be returned within 3 to 5 working days.

Site Identification

Actively identify interested sites and researchers

• sponsor actively looking for sites to participate in a study
• distributed to NHS Scotland Health Board R&D teams and to the Topic Network and/or Specialty Group

NHS Scotland Health Board R&D offices and Topic Networks/Speciality Groups have established relationships with investigators in each therapy area. Local teams will actively support investigators with the accurate and timely completion of questionnaires. Interim feedback can be returned within 5 working days and full feedback will be returned within 10 working days.

Please highlight key investigators during submission.

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
  • Please limit direct approaches to investigators to informal notification. During the submission process, highlight key individuals and they will be considered a priority for feedback. This will enable the teams to better support the investigator
• We do not have CDAs in place with all Health Boards in Scotland, how can we tackle this?
  • With the master CDA, there is no requirement for CDAs with individual NHS Scotland Health Boards until the site’s participation has been confirmed
    • Please note that site-level CDA requests should be sent to local R&D offices. Scottish investigators should not be approached individually to sign confidentiality agreements
• Do we receive feasibility requests from NIHR?
  • If your feasibility has been submitted to NIHR, and has not been limited to English-only sites, NRS Centralised Feasibility Service will be notified. However, if there are key Scottish investigators you would like to be involved in your study, please contact us
  • Currently, NRS does not share direct feasibility requests with either NIHR or other Devolved Administrations. Contact details for these countries are as follows:
    • England – support@nihr.ac.uk
    • Wales – industry-research@wales.nhs.uk
    • Northern Ireland – NICRNGeneralQuery@nicrn.hscni.net

A joined-up approach delivers efficiency in study set-up

NRS operates a coordinated, managed, proportionate, and streamlined system to facilitate local R&D Permissions. A single point of contact will take you through the study-wide governance review, including negotiation of budget and contract.

The NRS permissions system is designed to remove duplication of effort and standardise approach across Scotland wherever possible:

• central submission – documents circulated to all participating sites
• single point of contact to assess study-wide governance
• single budget and contract template for all sites in Scotland
• study-level Coordinated Pharmacy Review and cost
• NHS Permission letters issued.

Managed via a Central Permissions Team, our clocks work on a rate-limiting basis and start upon submission of a full document set and stop when an action lies with Sponsor.  This ensures that the completion of both study-wide and local reviews is actively driven, which translates into rapid overall start-up times.

Multi-centre research in the UK

Upon completion of the study-wide review, study documentation and the study-wide governance report is distributed to participating nations. The participating nation will accept the study-wide governance review and perform nation specific checks.

Defined systems are in place to ensure that studies led in Scotland proceed smoothly through other UK nation’s start-up processes. The table below outlines the key points and provides contact points:

Studies led in other nations

Processes are in place to facilitate the transfer of study documentation to our team upon the completion of study-wide governance checks from all nations within the UK. However, as our process includes negotiation of study budget and contract, we currently recommend a parallel submission is made to the Permissions Coordinating Centre.

Site permissions in Scotland – best practice

Scottish sites aspire to be the first open and ready to recruit wherever possible and will work closely with Sponsors to achieve this.

To help your team realise the full potential of the streamlined permission process, hints and tips on best practice have been provided.

Submit directly to NRS as early as possible

• Although NRS works within the UK regulatory framework, there is no need to wait for acknowledgements or approvals from any other system ahead of submission
• Please send your documents to the Permissions Coordinating Centre as early as possible

Talk to NRS

• At the start of the process, it is good to speak with the allocated reviewer which will allow any key questions to be raised and timelines to be agreed

Set target dates

• Such as SIV date at the start of the process and work to maintain these dates wherever possible

Maintain momentum of review and budget negotiations

• Work to answer queries on the budget or other study documentation as quickly as possible, which will ensure that the reviewer can process your application quickly without the need to re-visit submissions if significant time has passed since the query was issued

Provide what is needed early

• The document submission checklist can be found here
• Update with changes and send through Ethics and MHRA correspondence as they become available

A ‘single cost for Scotland’ policy enables budgets to be agreed on behalf of all sites

NRS operate a single price model for commercial research. As part of the study-level review, the lead reviewer negotiates the study budget with the Sponsor on behalf of all sites participating in the study - there is no additional requirement for validation of the costing template for studies submitted to Scotland.

The single price scheme is based on the current version of the NIHR costing template.

The full cost of conducting commercial research in NHS Scotland must be covered by the Sponsor. Therefore, it is vital that the draft costing template is completed to accurately reflect all study activities mandated by the protocol and any supporting documents (e.g. imaging, lab, pharmacy and monitoring).

• Find out more about NIHR costing templates and guidance

Frequently Asked Questions

Once agreed, can study budgets be changed at sites?

• Local sites will accept negotiated per patient budgets, but there are some instances where local practice may require revision
• Due to geographical areas covered by some NHS Health Boards, patient travel and sustenance expenses may differ
• NRS reserve the right to reassess study budgets to reflect additional requirements after the study starts
• All changes to the contract are negotiated by the local team following discussion with the lead reviewer

A single contract draft policy for Scotland where wording is agreed once on behalf of all sites

Clinical Trial Agreements

Scotland operates a single contract draft model for commercial research. As part of the study-level review, the lead reviewer will negotiate and agree on contract wording with the Sponsor on behalf of all sites participating in the study.

These template model agreements are applicable to the health services in Scotland, England, Northern Ireland, and Wales.

• Find out more and download the Commercial Model Clinical Trial Agreements (mCTA and CRO-mCTA)

Equipment Indemnity

Equipment loaned to the NHS to facilitate a research project must be fully indemnified.  In Scotland, companies on the Master Indemnity Agreement (MIA) register can provide equipment to support trial activity without the need for additional agreements so long as the loaned equipment is not the subject of the research project.

• Suppliers on the MIA register

Where companies are not listed on the MIA register, an agreed NRS indemnity contract will be required by each Board in addition to the clinical trial agreement.