How to Become a Research Active Site

Providing the opportunity for your patients to take part in research is Exciting, Interesting & Rewarding & is not as complicated or as time consuming as you think!

There Are Many Ways You Can Get Involved....

Primary Care sites can support the delivery of Clinical Research by;

● PROMOTION ONLY STUDIES - Advertising a research study through posters or digital resources.

● SURVEY STUDIES - Staff at the practice complete short online research surveys- normally collecting their views / experiences on a certain topic. In these cases its the staff at the practice who count as the recruits!

● PATIENT IDENTIFICATION CENTRE STUDIES (PIC) - Identifying potential participants, via a database search & mail-out/ text-out, who will then be seen/ recruited in secondary care.

● RECRUITING STUDIES - Identifying potential participants, via a database search & mail-out/ text-out and conducting the research/ recruitment of participants at your site.

Get Started....

GET IN TOUCH - Contact your Local RDN Primary Care Research Team. Each county in the East Midlands has its own dedicated RDN Primary Care Research Team, who are equipped with the knowledge, experience and expertise required to provide personalised support to your site to assist you with everything research related. We also have a collective of both 'one off' and 'continuous' infrastructure support available , in the form of both financial funding and clinical support staff. To find out more in regards to the infrastructure support we can provide for your site, Click Here.

IDENTIFY PERSONNEL - You will need to determine who will be the sites main Research Contact/ Coordinator (for the majority of sites this will be the Practice Manager or Admin Staff) and Clinical Research Lead (GP or ANP). For more information in regards to the responsibilities of these roles, Click Here.

TRAINING - Any staff wanting to be involved with research will need to complete Good Clinical Practice (GCP) training. GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. This can be accessed online via our training platform on NIHR Learn. The course is Free and takes approximately 4 hours to complete. A refresher should then be completed every 2-3 years.

SELECT A STUDY - Studies requiring Expressions of Interest (EOI) will be sent to you via email, via your local CRN Primary Care Research Team. In addition studies can also be found on our Studies Open to Expressions of Interest Page on this website. This can be accessed at any time, and all available studies and their related information can be found here.

EXPRESS YOUR INTEREST IN A STUDY - Once you have decided you would like to submit an EOI for a study, this process is also completed online by following the link provided on the studies information page. You will be asked to input information in regards to your sites details such as ODS code, list size, contact details etc. On submitting an EOI, your response will be sent to the CRN who then pass this onto the study team. Study teams review the EOIs and select which sites they wish to work with. You will hear back in regards to this decision within a couple of weeks.

ASSESS, ARRANGE & CONFIRM - Research taking place on NHS premises (in this case general practice) and/or involves NHS patients, patient data or staff, will usually require the general practice to formally confirm they have the capacity and capability to undertake the study. The HRA Approval letter will state what is expected of the site in relation to this. The general practice also needs to ensure adequate contracts are in place and that any cost implications are covered. The NHS Health Research Authority (HRA) refers to this process as "Assess, Arrange and Confirm". The protocol should be reviewed by the Clinical Research Lead, and consideration given to, where required, whether there are the right facilities and staff on site, and that patient/participant types are available. For further information on the Compliance and Governance for research delivery in Primary Care, Click Here.

RUN THE STUDY - 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 STUDY - 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 STUDY (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 STUDY - 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.

CLAIM SERVICE SUPPORT COSTS - 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.

We Are Ready To Support You....

NIHR East Midlands RDN has its own dedicated Primary Care Research Team, who are equipped with the knowledge, experience and expertise required to provide personalised support to your site to assist you with everything research related. We also have a collective of both 'one off' and 'continuous' infrastructure support available , in the form of both financial funding and clinical support staff.

Click Here to contact your Local RDN Primary Care Team

Click Here to Find Out About Our Research Site Initiative Scheme and How Your Site Can Access This Funding

Click here for further information on the Health Research Authority (HRA) Processes and Legislation in relation to the delivery of Clinical Research in Primary Care.

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