levels of INVOLVEMENT
Identify the best way your practice can get involved based on your current capacity and capability
Identify the best way your practice can get involved based on your current capacity and capability
There is an array of studies requiring differing levels of engagement and involvement from displaying posters, taking part in surveys, acting as a patient identification centre (PIC) to working on more involved observation or intervention studies (site based).
A practice who identifies and invites eligible patients to participate in a research study where all the procedures are carried out by the research team; usually a hospital trust.
PIC activity is often limited to:
Database search and screening of search list (pre-built search files provided)
Send SMS invites or mail out of an invitation letter using DOCMAIL.
In some cases the study team will ask you to invite patients opportunistically during routine consultations
The practice retains responsibility for patient healthcare outside the research study. Good Clinical Practice (GCP) training is not usually required for this level of involvement.
Research sites are responsible for delivery of research protocol procedures:
Screening patients for eligibility (normally face to face)
Receiving informed consent
Conducting trial intervention(s) & / or conducting assessments with participants
Passing research data to the trial management team
Patient follow-ups
A designated clinician would normally be required to act as a Principle Investigator/GP Lead and is responsible for the day-to-day running of a study at the practice. The GP Lead must have a valid GCP training certificate as a minimum. Practices are responsible for patient care both inside and outside the research study.
Activity is conducted in practice by appropriately skilled health care professionals as noted on a delegation log, some of which may be required to have completed GCP training and/or study training. The term 'health care professionals' doesn't just refer to GPs, research studies can involve nurses, HCAs, practice managers, pharmacists, paramedics depending the focus of the study.
GP trainees: Allocating site based studies to trainee GPs reduces the burden on practice GPs and provides trainees with research experience early on in their careers. Studies are often a good source of Quality Improvement Projects (QIPs) and audit ideas.
Some site-based studies may qualify for additional support from the Regional Research Delivery Network Nurse Team and/or delivered by clinical trials unit nurses.
For academic studies, both of the above study types are eligible for additional funding through our Research Site Initiative scheme.
To find out more on the current studies available please visit our studies page.
All studies have regulatory body approvals such as Ethical approval and the Department of Health and Social Care’s Health Research Authority (HRA) & Medicines and Healthcare products Regulatory Agency (MHRA) approval
Essentially, the only difference between an Academic and a Commercial study is with regard to the process of delivering the study in practice
All study teams endeavor to to run their studies as efficiently and effectively as possible, however research is a learning process and sometimes amendments to the protocol may be required. All changes must be updated in the protocol and re-submitted for relevant approvals. Please be aware that these amendments can be identified at any time during the study pathway and may consequently have an impact on the timing of delivery in practice!