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Quick links: Site selectionSite Initiation Visit (SIV)Delegation of duties log (or delegation log)Site file maintenanceContentsAppointing a Principal Investigator (PI) / Glossary
 

How to guide: Site selection / initiation visit (SIV)

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.

See also

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 Clinical Research Network (CRN), from West Yorkshire Research & Development (WY R&D) 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:

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)

How to guide: Delegation of duties log (or delegation log)

Key information you should be aware of:

The delegation log (stored in the Site File, usually alongside research CVs and GCP certificates) is a list of study-related duties assigned to staff members. This may also be known as an authorised personnel log. It is a live document which must be kept up to date if staff working on the study change roles or leave etc. The Principal Investigator is responsible for duties carried out in connection with the study, but the delegation log enables them to delegate some specified duties to other staff. Staff members must only carry out duties to which they are assigned on the delegation log. Please note that some very simple studies (e.g. surveys) may not have a delegation log. If in doubt, staff should always check with the study team before handling any study-related task.

Full guide

Delegation of duties log (or delegation log)

How to guide: Site file maintenance

Most studies will require that a site file be held and maintained by each recruiting site. Site files are often provided by the study team and may be in paper or electronic format.

Key information you should be aware of:

A site file must contain current versions of all documents being used in the study. Previous versions must be kept in the file but crossed through and marked ‘superseded’.

Highlights

The National Institute for Health Research (NIHR) provides a comprehensive list of suggested site file contents: https://www.nihr.ac.uk/documents/suggested-investigator-site-file-contents/11537

Full guide

Contents

Site files are often provided by the study team and may be in paper or electronic format.

The NIHR has provided a comprehensive list of suggested investigator site file contents, recommending the inclusion of a contents page, and advising that each section should be signed and dated upon completion: https://www.nihr.ac.uk/documents/suggested-investigator-site-file-contents/11537:

Please note, this is a suggested contents list. Please discuss a study’s site file with the study team; they will often provide the site file and request that the site keep this maintained. As per the NIHR website, the suggested list is as follows:

o    by Investigator to co-ordinating research body

o    by co-ordinating research body to Investigator

o    by co-ordinating research body to regulatory authorities (if this will not be supplied place a file note stating this).

o    Laboratory normal reference ranges (including revisions)

o    Laboratory certificate(s)

o       Investigator Commitment Statement/Study Acknowledgement

o       Indemnity

o       Confidentiality

o       Clinical Trial Agreement including financial details.

o       Completed and signed FDA 1572 form (if applicable)

o       Financial disclosure letter (if applicable)

After the completion of the trial, the following must also be filed in the site file:

Section 23 - Clinical study report to document results and interpretation of trial.

Practices should liaise with study teams about the site trial requirements for specific studies.

Where a document is amended with a new version, outdated versions should be marked ‘superseded’ and placed behind the current version in the site file.

It is the responsibility of the PI to ensure the site file is maintained. The physical maintenance of the site file may be done by a staff member delegated by the PI.

Please continue to refer to the NIHR website for current guidance related to site files, and liaise with study teams if you have study specific queries.

How to guide: Appointing a Principal Investigator (PI)

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.

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):

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

 

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