Key information you should be aware of:
Please note that expressing interest in a study does not commit the practice (site) to participate; nor does it guarantee involvement.
- Some studies may not require the study team to confirm that the practice can be involved (such as a study which simply asks a practice to send patients and/or staff a link to a survey).
- Other studies may require that individual practices be selected to participate by the study team.
- Where a study team selects a practice to participate in a study, a Site Initiation Visit (SIV) is usually arranged.
- The practice is responsible for the ongoing treatment of its patients, and for ensuring that patients and patient data are treated with due care.
- Most studies will require that a Principal Investigators (PI) be appointed at the practice. PIs are responsible for the conduct of a specific study at each research site. Tasks may be delegated but responsibility remains with the PI.
- Many studies require that staff who will be involved in recruiting participants and receiving consent must have completed NIHR Good Clinical Practice (GCP) training. Check the protocol and/or with the study team for clarification.
- The practice is responsible for ensuring that all staff who may be involved in a study have an understanding of what this involves.
- Sponsors are responsible for the initiation, management and financing of a specific study.
- Chief Investigators (CIs) are responsible for the conduct of a specific study within the UK.
Full guide
Site selection:
Some studies may not require the study team to confirm that the practice can be involved (such as a study which simply asks a practice to send patients and/or staff a link to a survey). This will usually be made clear in the Expression of Interest (EoI) email you receive from the Research Delivery Network (RDN), from South West London Research & Development or from the study team. If in doubt, please feel free to ask the question of the sender of the EoI.
Other studies may require that individual practices be selected to participate by the study team. Depending on the complexity of a study, this may be based on one or more of the following:
- Demographics of the practice’s patient population (i.e. sufficient numbers of potential participants meeting the inclusion criteria for the study)
- Previous research experience of the practice
- Previous recruitment figures demonstrated by the practice
- Staff skills, experience and training
- Availability of a PI
- Other factors specific to the study
If site selection is required for a study, do not start any study procedures until this has been confirmed by the study team.
Due to the number of EoIs received by study teams, they may only reply to practices that are selected to participate. Therefore, no reply can usually be assumed to mean that your practice has not been selected for a particular study on that occasion.
Even if your practice is not selected to participate, it would be good to save a copy of the interest expressed. This could be helpful to establish intent and interest, for example when applying for future research infrastructure funding.
Site Initiation Visit (SIV):
- Where a study team selects a practice to participate in a study, a SIV is usually arranged. This could be in the form of a telephone call, video conference, or face-to-face meeting.
- The study team should tell you who will need to be present for the SIV, but you should also make sure all relevant staff are included from the practice point of view.
- The SIV is not only an opportunity for the study team to explain details of the study, provide necessary training and give direction as to completing the delegation log etc., but it is also an opportunity for staff members to ask questions and raise concerns.
- Attendance at a SIV should be documented and could be used in staff appraisals.
Glossary of Acronyms and Terms
- NIHR – National Institute for Health Research
- RDN – Research Delivery Network
- GCP – Good Clinical Practice training
- ISF – Investigator Site File (or Site File)
- OID – Organisational Information Document
- SIV – Site Initiation Visit
- SOPs – Standard Operating Procedures
- AEs – Adverse Events
- PI – Principal Investigator
- CI – Chief Investigator
Site selection:
Some studies may not require the study team to confirm that the practice can be involved (such as a study which simply asks a practice to send patients and/or staff a link to a survey). This will usually be made clear in the Expression of Interest (EoI) email you receive from the Research Delivery Network (RDN), from South West London Research & Development or from the study team. If in doubt, please feel free to ask the question of the sender of the EoI.
Other studies may require that individual practices be selected to participate by the study team. Depending on the complexity of a study, this may be based on one or more of the following:
- Demographics of the practice’s patient population (i.e. sufficient numbers of potential participants meeting the inclusion criteria for the study)
- Previous research experience of the practice
- Previous recruitment figures demonstrated by the practice
- Staff skills, experience and training
- Availability of a PI
- Other factors specific to the study
If site selection is required for a study, do not start any study procedures until this has been confirmed by the study team.
Due to the number of EoIs received by study teams, they may only reply to practices that are selected to participate. Therefore, no reply can usually be assumed to mean that your practice has not been selected for a particular study on that occasion.
Even if your practice is not selected to participate, it would be good to save a copy of the interest expressed. This could be helpful to establish intent and interest, for example when applying for future research infrastructure funding.
Some studies may not require the study team to confirm that the practice can be involved (such as a study which simply asks a practice to send patients and/or staff a link to a survey). This will usually be made clear in the Expression of Interest (EoI) email you receive from the Research Delivery Network (RDN), from South West London Research & Development or from the study team. If in doubt, please feel free to ask the question of the sender of the EoI.
Other studies may require that individual practices be selected to participate by the study team. Depending on the complexity of a study, this may be based on one or more of the following:
- Demographics of the practice’s patient population (i.e. sufficient numbers of potential participants meeting the inclusion criteria for the study)
- Previous research experience of the practice
- Previous recruitment figures demonstrated by the practice
- Staff skills, experience and training
- Availability of a PI
- Other factors specific to the study
If site selection is required for a study, do not start any study procedures until this has been confirmed by the study team.
Due to the number of EoIs received by study teams, they may only reply to practices that are selected to participate. Therefore, no reply can usually be assumed to mean that your practice has not been selected for a particular study on that occasion.
Even if your practice is not selected to participate, it would be good to save a copy of the interest expressed. This could be helpful to establish intent and interest, for example when applying for future research infrastructure funding.
Site Initiation Visit (SIV):
- Where a study team selects a practice to participate in a study, a SIV is usually arranged. This could be in the form of a telephone call, video conference, or face-to-face meeting.
- The study team should tell you who will need to be present for the SIV, but you should also make sure all relevant staff are included from the practice point of view.
- The SIV is not only an opportunity for the study team to explain details of the study, provide necessary training and give direction as to completing the delegation log etc., but it is also an opportunity for staff members to ask questions and raise concerns.
- Attendance at a SIV should be documented and could be used in staff appraisals.
Glossary of Acronyms and Terms
- NIHR – National Institute for Health Research
- RDN – Research Delivery Network
- GCP – Good Clinical Practice training
- ISF – Investigator Site File (or Site File)
- OID – Organisational Information Document
- SIV – Site Initiation Visit
- SOPs – Standard Operating Procedures
- AEs – Adverse Events
- PI – Principal Investigator
- CI – Chief Investigator
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