Identifying and contacting sites
As well as carrying out your research at our trust, you may wish to carry out your research at other external sites.
When considering organisations to act as research sites, it is recommended to share the study protocol with them. You will need to have early discussions to understand if they can take part.
External sites can give opportunities for more people to take part in the research. This can speed up how quickly you achieve your sample size. However, there are potential obligations and costs to consider. These can include needing to arrange training on the study, a secure way to transfer data and monitoring visits.
The NIHR (National Institute for Health Research) Study Support Service can help to identify suitable research sites across the UK: NENCStudies@nihr.ac.uk. You can also find NHS research and development contacts nationwide on the RD Forum website.
Organisations that agree they might be able to take part should be added to Part C of the IRAS (Integrated Research Application System) form. If more participating organisations are identified after your initial submission, these can be added by submitting a study amendment. See information in the IRAS website about amendments for projects conducted in NHS/HSC. Our research and development team can guide you through this process too.
Obtaining local research and development sign off (confirm capacity and capability)
The local research and development department at each participating NHS Trust will do a review to confirm they have the capacity and capability (C&C) to go ahead with the study.
This review focuses on the local practical aspects of delivering the study. For example, if suitable staff and resources are in place. The review does not duplicate the national review of the study.
To formally start the local research and development review at a site, documents known as the Local Information Pack (LIP) must be sent to the research and development department by email. The LIP is mainly made up of the application form and documents you submitted for national approval. The local research and development review can take place at the same time as the national review to speed up timescales.
Site initiation and green light
The study sponsor needs to carry out checks to confirm the site is suitably trained and ready to start the study. These sponsor checks are referred to as site initiation or green light checks.
The checks for the site to complete can include:
- Attending a site initiation visit
- Attending training or providing a copy of the delegation log
The specific checks necessary will depend on the study requirements and risk profile. If our trust is acting as sponsor, our research and development team can give advice about the necessary steps and provide checklist templates.
The sponsor can provide a green light email once they receive confirmation that all necessary checks are complete. At that point, the site can begin to recruit participants and start their study activities.
Plan for managing the study
A Trial Master File and Investigator Site File should be created and kept up to date during the study. These files collect essential study documents and provide a record of study conduct.
Usually, a study has one Trial Master File and each site have their own Investigator Site File. However, these requirements can vary and potentially be streamlined. For instance, for a study only taking place at our trust it may be possible to combine both file types into a single record. Also, in some cases an electronic-only site file may be permitted. You can clarify these arrangements through discussion with the sponsor. Also, if you have any research and development delivery staff assigned to your study they can help manage these files.
Where we are sponsor our research and development team will provide:
- Study management guidance
- A draft monitoring plan
These documents will suggest the type of oversight to be carried out, which will depend on the study’s needs and risk profile. For instance, whether there are face-to-face monitoring visits planned and who will record the number of research participants. Our team may liaise with you to clarify certain points.
We will welcome your feedback if you think the plans should be changed in any way or need additional support.
