Setting up a study not sponsored by St Georges
There are arrangements you need to keep in mind when setting up studies at St George’s (University or NHS Foundation Trust) which are not sponsored by the us.
Site (JRES) approval
Research site approval (or ‘confirmation of capacity and capability’) is required at St George’s (university or NHS Foundation Trust) where there is research activity being conducted on our premises, with our staff and or patients. This is in line with national HRA approvals. Starting any research without this is a breach of national and organisational research governance policy
What is Research Activity?
Research activity is defined as any activity required under/driven by an approved research protocol. This may include activity that the patient/participant would routinely receive as part of their routine care. However, if they are enrolled in a clinical research project, prior approval will be required.
Types of research sites
- Participant identification centre (PIC)
- Recruiting site
- Shared care site
- Follow-up site
it is the responsibility of the study sponsor to interact with potential sites to initiate set up. This is often delegated to the study’s chief investigator (CI) and/or their research teams.
The study sponsor/CI/lead research team should ensure potential investigators and the JRES at St George’s are approached to discuss study feasibility before formally setting us up as a site. Please ensure email@example.com is copied in to all requests for study set up.
St Georges will only take on studies which have been deemed feasible by the site research team and JRES. The stages of feasibility and set up are outlined below.
Stages of feasibility and Study Set Up
Stage 1: Identify
Identification of potential study of interest by the principal investigator (PI) to then initiate discussions with sponsor, or identification of potential site by sponsor. Start of site-level feasibility, which can be supported by NIHR CRN expression of interest (EOI) and/or site intelligence (SI) processes if applicable. Supported by final/draft protocol and/or protocol synopsis.
Stage 2: Assess
Assessment of the feasibility of a study and whether or not the organisation has the capacity, capability and resources to undertake the study successfully. This is supported by final/draft protocol and or protocol synopsis and information on funding available. St Georges will prioritise projects providing funding and or NIHR CRN adopted projects over un-funded projects.
Please note stage 1 and 2 may:
- occur simultaneously (to avoid duplication)
- not be required/be minimal in certain types of studies where it is expected that the site will participate – for example, urgent public health research and/or studies involving minimal local activity such as distributing questionnaires online. In these instances, the HRA assessment/approval letter(s) will detail the status and nature of the local review requirement.
Stage 3: Arrange
Placing and approving (internally) all practical arrangements required to support effective and timely study delivery. This is based on the nature of the study, its timelines and target population and will require interactions with internal service support departments such as imaging, pharmacy, pathology and the Clinical Research Facility (CRF). This stage is initiated formally by the submission of the local submission package/addition of site, marking the start of the formal setup timeline.
If the study is un-funded, the department where the activity is taking place will be asked to accept all/any costs associated with the study. If unable the study will not may not be approved.
Stage 4: Confirm
Final confirmation notification marking that the organisation has the capacity and capability in place to deliver the study and that all practical arrangements are in place. This confirmation is given through the agreement of the contents of the statement of activities (for non-commercial studies) and sign-off on relevant site agreement where applicable.
- NIHR CRN projects: >40 days from the point of formal submission of local package (step 3)
- Commercial project: >40 days from the point of formal submission of local package (step 3)
- Non Funded and or non-NIHR CRN studies: 40> days from the point of formal submission of local package (step 3)