Safety Hub practice will engage spoke practices regarding feasibility via The hub practice will need to spoke contacts. Spoke ensure there is a robust system in contacts will respond within a place for out of hours if they are reasonable timeframe to be agreed hosting a blinded Clinical Trial of with the Hub practice. an Investigational Medicinal Product (CTIMP). If any of the spoke practice contacts are on leave/away, the hub can send in their own and any other spoke The hub practice will need to practice numbers to express interest ensure there is a robust system in in a study. place for reporting Serious Adverse Events (SAEs) between Spoke practices can decide on a the spoke practices, the hub study by study basis whether it is practice and all required agencies. feasible for the practice to participate although spoke practices are encouraged to take part in all studies Pharmacy offered through the hub and spoke The hub practice will need to model. ensure robust arrangements for storage, monitoring, prescribing and issuing of study drug or Hub practice will complete Expression intervention are in place. of Interest for study and based on the feasibility obtained from spoke practices by the required deadline. Monitoring If requested/appropriate, the hub Any issues about placement of study practice will have a responsibility in Primary care will be fed back from to allow space and access for the hub practice to the NIHR CRN Sponsor monitors or local NHS Clinical Studies Development Officer. R&D audit teams at the hub site. Training Expressions of Interest to participate in research studies Hub practices will have a nominated Principal Investigator Hub practice will receive notifications (PI), and lead nurse for each study. of new studies from Clinical Research Some studies may also require a sub-investigator for holiday/ Network. Hub practice will make an initial decision of interest based on additional cover. Some studies may also provide an opportunity for criteria e.g. population group being sought, viability for study to run in Healthcare Assistants or other staff primary care, equipment, capacity. to be involved. Hub practice will run feasibility at their The hub practice Lead Research GP and other Hub practice staff own practice in 1st instance. involved in research, will have undertaken the National Institute for
Safety The hub practice will need to ensure there is a robust system in place for out of hours if they are hosting a blinded Clinical Trial of an Investigational Medicinal Product (CTIMP). The hub practice will need to ensure there is a robust system in place for reporting Serious Adverse Events (SAEs) between the spoke practices, the hub practice and all required agencies. Pharmacy The hub practice will need to ensure robust arrangements for storage, monitoring, prescribing and issuing of study drug or intervention are in place. Monitoring If requested/appropriate, the hub practice will have a responsibility to allow space and access for Sponsor monitors or local NHS R&D audit teams at the hub site. Expressions of Interest to participate in research studies Hub practice will receive notifications of new studies from Clinical Research Network. Hub practice will make an initial decision of interest based on criteria e.g. population group being sought, viability for study to run in primary care, equipment, capacity. Hub practice will run feasibility at their own practice in 1st instance. Hub practice will engage spoke practices regarding feasibility via spoke contacts. Spoke contacts will respond within a reasonable timeframe to be agreed with the Hub practice. If any of the spoke practice contacts are on leave/away, the hub can send in their own and any other spoke practice numbers to express interest in a study. Spoke practices can decide on a study by study basis whether it is feasible for the practice to participate although spoke practices are encouraged to take part in all studies offered through the hub and spoke model. Hub practice will complete Expression of Interest for study and based on the feasibility obtained from spoke practices by the required deadline. Any issues about placement of study in Primary care will be fed back from the hub practice to the NIHR CRN Clinical Studies Development Officer. Training Hub practices will have a nominated Principal Investigator (PI), and lead nurse for each study. Some studies may also require a sub-investigator for holiday/ additional cover. Some studies may also provide an opportunity for Healthcare Assistants or other staff to be involved. The hub practice Lead Research GP and other Hub practice staff involved in research, will have undertaken the National Institute for
Hub-and-Spoke-Research-Framework-Agreement-final.docx