The Clinical Research Network East Midlands (CRN EM) Study Support Service (SSS) meet with Study Teams / Sponsors at the early contact stage, to discuss specific study details, study set-up and CRN support.

The CRN EM Primary Care IT Solutions Lead will also be in contact with the Study Team / Sponsor at this stage to ensure that study eligibility criteria is compatible with clinical coding systems in primary care, to ensure a centralised approach is taken.

Each study is then submitted by the study team / sponsor to the Health Research Authority (HRA) for assessment of governance and legal compliance, in addition to an independent ethical opinion by a Research Ethics Committee (REC).

The study is successfully granted Health Research Authority (HRA) and Research Ethics Committee (REC) approval and is now ready to be sent out to Primary Care sites.

Once a study has received HRA Approval the study is then ready to be sent out to Primary Care sites.

The SSS team create a brief overview of each study and this is then published on the Open Study page of CRN EM Primary Care Website.

The Primary Care Research Team then send a digital link direct to the study on the CRN EM Primary Care Website, along with the HRA Approval Letter and Protocol, to all contactable Primary Care sites in the East Midlands.

Primary Care sites are then able to review each study and where appropriate run a feasibility database search (utilising the pre-developed searches) to identify the number of potential eligible participants. Following this the site may electronically submit an Expression of Interest or Decline Form as deemed appropriate.

Submitted Expressions of Interest are received into a centralised spreadsheet regulated by the SSS and Primary Care Team. Each Expression of Interest is extracted from the sheet and forwarded to the relevant Study Team / Sponsor for review.

The Study Team / Sponsor will then select the sites they wish to proceed with.

The Primary Care Team will communicate this outcome to each site, copying in Study Team / Sponsor contacts as a means of introduction to successfully selected sites.

The Study Team / Sponsor provide the selected sites with all relevant Study Information (See below). It is the Primary Care Sites responsibility to assess Capacity & Capability at their site.

For further information on Governance & Compliance when delivering Research in Primary Care, Click Here.

Patient Identification Centre (PIC) Studies: Information Provided to Primary Care Sites

The Study Team / Sponsor is responsible for providing Primary Care Sites with a ‘PIC Agreement’. This document provides information in relation to the activities to be completed by the Primary Care Site, including the procedure for the processing of personal data. The Primary Care Site should review this document and complete the required sections.

As per the National Integrated Research Application System (IRAS), NHS organisations in England are not permitted to commence study activities until HRA Approval has been received. Primary Care sites should assess, arrange and confirm their own capacity and capability in regards to completing the required study activities outlined in the 'PIC Agreement'. The Research Site (ie. Hospital, where patients will attend research study appointments) are also required to assess, arrange and confirm, their capacity and capability. The Research Site is responsible for ensuring that they have an appropriate agreement in place, with the Primary Care site acting as a PIC.

Recruiting Studies - Information Provided to Primary Care Sites:

It is the Study Teams / Sponsors responsibility to provide Primary Care Sites with the ‘UK Local Study Information Pack’, including the organisation information document. Sites should then work with the Sponsor to assess, arrange and confirm capacity and capability.

The final decision on whether to proceed with a study, based on considerations of capacity and capability, rests with the Primary Care Site.

The Primary Care Sites complete the Research Study activities as dictated by the ‘PIC Agreement’ or the ‘UK Local Study Information Pack’ and in accordance with the Study Protocol and Good Clinical Practical (GCP).

Depending on the type of study you have been successful in Expressing an Interest in the activities associated with each will generally be as follows ;

● PROMOTION ONLY STUDIES - The study team will simply send you an advertisement poster or similar to be displayed in waiting areas/ or added to websites / newsletters etc.

● SURVEY STUDIES - The study team will ask for contact details of those you have identified in the practice to be surveyed or send you a link to take the survey.

● PATIENT IDENTIFICATION CENTRE STUDIES (PIC) - The Study Team / Sponsor is responsible for providing Primary Care Sites with a ‘PIC Agreement’. This document provides information in relation to the activities to be completed by the Primary Care Site, including the procedure for the processing of personal data. The Primary Care Site should review this document and complete the required sections. Primary Care sites should assess, arrange and confirm their own capacity and capability in regards to completing the required study activities outlined in the 'PIC Agreement'. Once the agreement has been signed the site will complete a database search utilising a pre-made downloadable E-Search. These can be found on this website for each study, under E-Searches. The site should then run the database search. A list of potential eligible participants will be generated and these should then be checked again for eligibility by the sites Clinical Research Lead. A mail-out (utilising a 3rd party mailing company) / text-out will then be completed inviting all identified participants to take part in the study. For PIC studies the participants are recruited by a team located in a secondary care site, as detailed in the PIC Agreement. The Primary Care site has no further involvement. More information on the study delivery process can be found Here.

● RECRUITING STUDIES - The study team issues the site with a ‘UK Local Study Information Pack’, this outlines the study activities for completion by the site. Sites should then work with the Sponsor to assess, arrange and confirm capacity and capability. A recruiting study follows the same initial way of identifying patients as a PIC study does, with the difference being that the eligible participants wanting to take part in the study are recruited by staff at the Primary Care site and all study activity and visits are carried out here. More information on the study delivery process can be found Here.

You will be paid for all research activity completed. Some of the payments will be sent directly by the study teams, these are known as Research Costs and relate to things such as clinical screening tests, follow up appointments, data storage etc. Service Support Costs (SSCs) are paid to you via the CRN and this is for activities such as running a data search, screening lists and completion of texts/mail-outs. You do this by going to the SSC page on this website. For more information about the ways in which you will be paid for all research activity completed, Click Here.

The Primary Care Sites have completed the Research Study activities as dictated by the ‘PIC Agreement’ or the ‘UK Local Study Information Pack’ and in accordance with the Study Protocol and Good Clinical Practical (GCP).

The CRN East Midlands provide expert guidance, during the stages of the commercial research study protocol development and set-up and will provide insight into the NHS landscape including current UK practice.

This stage enables commercial research teams to check the viability of a study in the NHS in England, including Primary Care.

This service engages 2-3 anonymous clinical experts who will look at study complexity, patient populations, timelines and recruitment strategy, offering suggestions and adjustments that can aid delivery.

The web-based interactive Costing Tool (iCT) provides a framework for transparent cost display and calculation to support swift local site budget negotiations when planning commercial trials in the NHS.

Following a review of the commercial costing tool by a working group, comprising colleagues across primary care and different regions, a number of recommended changes have now been made. As a result, primary care costs are more accurately reflected in the tool - improving the accuracy of the tool for use in primary care.

The changes below were implemented in April 2022:

1. Indirect Costs have been standardised at 70% for all settings (this was previously only the case for secondary care)

2. Medical out-of-hours costs are now included specifically for primary care (previously only available for pharmacy)

For more Information on the iCT, including a helpful explanatory video, click here.

The study is successfully granted Health Research Authority (HRA) and Research Ethics Committee (REC) approval and is now ready to be sent out to Primary Care sites.

When eligibility for a commercial research study to receive CRN support is confirmed, and the study is adopted to the NIHR CRN Portfolio, Primary Care Sites can then be identified.

In some situations, a Commercial / Industry Funded Research Study Team may identify the sites at which to deliver their study, without support from the CRN East Midlands Primary Care Team.

Site intelligence is an opportunity to check the sites that the Commercial / Industry Funded Study Team has already identified. In this case, the CRN East Midlands, with their local site intelligence, will confirm that the pre- selected sites, will be supported by them to deliver the study.

If the CRN East Midlands has concerns about any Primary Care Research Site, they may indicate they are not prepared to support the site with the Commercial / Industry Funded Research Studies.

Our Site Identification service enables Commercial / Industry Funded Research Study Teams to rapidly receive Expressions of Interest from Primary Care Research Sites.

Our approach to site identification is a unique mechanism through which all Primary Care Research Sites across the region, can be notified of the latest Commercial / Industry Funded Research Study opportunities and express an interest in participating.

The CRN provide Commercial / Industry Funded Research Study Teams with up-to-date insight into the most suitable sites to deliver their study.

The Primary Care Research Team sends out commercial studies to Primary Care Sites, as a 'Site Identification' request. Primary Care Sites are provided with limited, non confidential study information. This includes, the section B (detailed description of the study), a Schedule of Events (detailed procedures of the study), and a Site Identification Form.

Interested Primary Care Research Sites are required to respond within 15 working days by completing the Site Identification Form, which are collated and passed to the commercial research team.

Submitted Expressions of Interest are received into a centralised spreadsheet regulated by the SSS and Primary Care Team. Each Expression of Interest is extracted from the sheet and forwarded to the relevant Study Team / Sponsor for review.

Interested Primary Care Research Sites are required to respond within 15 working days by completing the Site Identification Form, which are collated and passed to the commercial research team.

The sponsor will contact successful sites directly to inform them they have been chosen to progress with the study..

The CRN East Midlands will endeavor to obtain feedback from Commercial / Industry Funded Research Study Teams, as to the outcome of the Primary Care Sites Identification Form submission, whenever possible.

The Study Team / Sponsor provide the selected sites with all relevant Study Information (See below). It is the Primary Care Sites responsibility to assess Capacity & Capability at their site.

For further information on Governance & Compliance when delivering Research in Primary Care, Click Here.

Patient Identification Centre (PIC) Studies: Information Provided to Primary Care Sites

The Study Team / Sponsor is responsible for providing Primary Care Sites with a ‘PIC Agreement’. This document provides information in relation to the activities to be completed by the Primary Care Site, including the procedure for the processing of personal data. The Primary Care Site should review this document and complete the required sections.

As per the National Integrated Research Application System (IRAS), NHS organisations in England are not permitted to commence study activities until HRA Approval has been received. Primary Care sites should assess, arrange and confirm their own capacity and capability in regards to completing the required study activities outlined in the 'PIC Agreement'. The Research Site (ie. Hospital, where patients will attend research study appointments) are also required to assess, arrange and confirm, their capacity and capability. The Research Site is responsible for ensuring that they have an appropriate agreement in place, with the Primary Care site acting as a PIC.

Recruiting Studies - Information Provided to Primary Care Sites:

It is the Study Teams / Sponsors responsibility to provide Primary Care Sites with the ‘UK Local Study Information Pack’, including the organisation information document. Sites should then work with the Sponsor to assess, arrange and confirm capacity and capability.

The final decision on whether to proceed with a study, based on considerations of capacity and capability, rests with the Primary Care Site.

The Primary Care Sites complete the Research Study activities as dictated by the ‘PIC Agreement’ or the ‘UK Local Study Information Pack’ and in accordance with the Study Protocol and Good Clinical Practical (GCP).

The Primary Care Sites have completed the Research Study activities as dictated by the ‘PIC Agreement’ or the ‘UK Local Study Information Pack’ and in accordance with the Study Protocol and Good Clinical Practical (GCP).