Key information you should be aware of:
Most studies (except some very simple studies such as questionnaires) will require that a PI be appointed at the practice. PIs are responsible for the conduct of a specific study at each research site (e.g. the GP practice). Tasks may be delegated but responsibility remains with the PI.
Full guide
Appointing a Principal Investigator (PI):
The study team will be able to advise whether a PI needs to be appointed for the study being delivered at a practice (a PI will generally need to be appointed for all but the simplest of studies). IRAS guidance notes: ‘Principal Investigators are expected to be in place at participating NHS / HSC organisations where locally employed staff take responsibility for research procedures’.
If a PI is required for the study, there will be a need to ensure the potential PI has the appropriate skills/training to carry out the role, as well as the time and subject interest.
- Most studies (except for very simple ones not involving consenting of participants) require the PI to hold an up to date GCP certificate. While there is no official expiry for GCP certificates, most studies require these to be within the past 2 years.
- The study team may also provide some study specific training which they require the PI to attend.
- The study team may require a copy of a simple research CV for the PI. This should be signed and dated. A template for this CV can be downloaded here.
- While not a requirement, there may be some additional PI training available. Please check with WY R&D to see what might be available locally.
A PI is responsible for oversight of the study at the local site (in this case, the GP practice). Therefore, it is important that they have an understanding of what will be required and have the capacity to handle these responsibilities. This may include the following (this is not an exhaustive list, and depending on the type of study, the responsibilities may be much less):
- Setting up and maintaining the site file
- Carrying out the study in line with the protocol and any SOPs supplied by the study team
- Delegating responsibilities at the practice relating to the study (completion of the delegation log)
- Ensuring all practice staff involved in the study are aware of the site file and that those with delegated responsibilities are properly trained to do so
- Providing data to the study team where applicable
- Reporting Adverse Events
In some cases, a local collaborator rather than a PI is required. The guidance states that “the role of the Local Collaborator is to facilitate the presence of Sponsor / CRO [contract research organisation] research staff.” [IRAS guidance]
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
Appointing a Principal Investigator (PI):
The study team will be able to advise whether a PI needs to be appointed for the study being delivered at a practice (a PI will generally need to be appointed for all but the simplest of studies). IRAS guidance notes: ‘Principal Investigators are expected to be in place at participating NHS / HSC organisations where locally employed staff take responsibility for research procedures’.
If a PI is required for the study, there will be a need to ensure the potential PI has the appropriate skills/training to carry out the role, as well as the time and subject interest.
- Most studies (except for very simple ones not involving consenting of participants) require the PI to hold an up to date GCP certificate. While there is no official expiry for GCP certificates, most studies require these to be within the past 2 years.
- The study team may also provide some study specific training which they require the PI to attend.
- The study team may require a copy of a simple research CV for the PI. This should be signed and dated. A template for this CV can be downloaded here.
- While not a requirement, there may be some additional PI training available. Please check with WY R&D to see what might be available locally.
A PI is responsible for oversight of the study at the local site (in this case, the GP practice). Therefore, it is important that they have an understanding of what will be required and have the capacity to handle these responsibilities. This may include the following (this is not an exhaustive list, and depending on the type of study, the responsibilities may be much less):
- Setting up and maintaining the site file
- Carrying out the study in line with the protocol and any SOPs supplied by the study team
- Delegating responsibilities at the practice relating to the study (completion of the delegation log)
- Ensuring all practice staff involved in the study are aware of the site file and that those with delegated responsibilities are properly trained to do so
- Providing data to the study team where applicable
- Reporting Adverse Events
In some cases, a local collaborator rather than a PI is required. The guidance states that “the role of the Local Collaborator is to facilitate the presence of Sponsor / CRO [contract research organisation] research staff.” [IRAS guidance]
The study team will be able to advise whether a PI needs to be appointed for the study being delivered at a practice (a PI will generally need to be appointed for all but the simplest of studies). IRAS guidance notes: ‘Principal Investigators are expected to be in place at participating NHS / HSC organisations where locally employed staff take responsibility for research procedures’.
If a PI is required for the study, there will be a need to ensure the potential PI has the appropriate skills/training to carry out the role, as well as the time and subject interest.
- Most studies (except for very simple ones not involving consenting of participants) require the PI to hold an up to date GCP certificate. While there is no official expiry for GCP certificates, most studies require these to be within the past 2 years.
- The study team may also provide some study specific training which they require the PI to attend.
- The study team may require a copy of a simple research CV for the PI. This should be signed and dated. A template for this CV can be downloaded here.
- While not a requirement, there may be some additional PI training available. Please check with WY R&D to see what might be available locally.
A PI is responsible for oversight of the study at the local site (in this case, the GP practice). Therefore, it is important that they have an understanding of what will be required and have the capacity to handle these responsibilities. This may include the following (this is not an exhaustive list, and depending on the type of study, the responsibilities may be much less):
- Setting up and maintaining the site file
- Carrying out the study in line with the protocol and any SOPs supplied by the study team
- Delegating responsibilities at the practice relating to the study (completion of the delegation log)
- Ensuring all practice staff involved in the study are aware of the site file and that those with delegated responsibilities are properly trained to do so
- Providing data to the study team where applicable
- Reporting Adverse Events
In some cases, a local collaborator rather than a PI is required. The guidance states that “the role of the Local Collaborator is to facilitate the presence of Sponsor / CRO [contract research organisation] research staff.” [IRAS guidance]
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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