A new Site Selected Email Template is being introduced to serve as official notification of site selection in a commercial contract clinical trial or clinical investigation, confirmation that the site has the capability to deliver the study and that the study set-up plan should start being delivered.
The Health Research Authority (HRA) have published a new Site Selected Email Template for sponsors (or their delegated agents) to use when confirming site selection with HSC and NHS organisations in commercial contract clinical trials or clinical investigations.
The template has been developed to promote a consistent and standardised approach to communication following site selection, providing clarity for both HSC and NHS sites.
How does it work?
The Site Selected Email Template should be used by sponsors (or their delegated agents) to formally confirm that an HSC or NHS organisation has been selected to participate in a study.
It can be used instead of the Site Selected Letter of Intent.
The email serves as the official notification of site selection. It confirms that based on the information provided during the site selection process, that the sponsor and site are aligned in their assessment that the site and proposed Principal Investigator have the capability to deliver the study.
Receipt of the email means that the set-up should now progress in accordance with the agreed study set-up plan.
Is use of the template mandatory?
Use of the template is not mandated. However, the template has been co-developed alongside sponsors and sites to help give the clarity to everyone involved in site set-up when set-up should formally begin.
We hope that the template helps make things clearer for everyone involved in study set-up and would encourage its use.
Guidance
Alongside the template, we have also published user guidance to support sponsors and HSC and NHS organisations in understanding when and how the template should be used.
The guidance outlines the purpose of the Site Selected Email Template, the expectations for its use, and the actions required by recipients, helping to ensure a consistent understanding and application of the process.
This template represents an abbreviated version of the Site Selected Letter of Intent. However, we will continue to explore whether this shorter format provides a sufficient level of information, or whether the more comprehensive information contained within the full letter adds greater value.
Share your feedback
We will continue to engage with sponsors who wish to use either the Site Selected Email Template or the Site Selected Letter of Intent, as well as any future iterations, and will use the feedback received to further refine and improve the approach over time.
Any feedback on the email or letter template should be provided to research.agreements@hra.nhs.uk
Assistance
For assistance with queries relating to model template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact ResearchContracts@innovations.hscni.net