Research SOPs and associated documents

We are committed to conducting high quality health and social care research that adheres to our standard operating procedures (SOPs). These Research and Development (R&D) SOPs have been designed to comply with relevant regulatory requirements, Good Clinical Practice and reflect the practical application of these frameworks and associated guidance within the trust.

This section provides a list of R&D SOPs that will be relevant to Chief and/or Principal Investigators (CIs and PIs) intending to conduct research within the trust. There are additional SOPs for activities managed directly by the R&D team, such as contract negotiation and study records archiving. Investigators are not expected to read these but may need to comply with the procedures described and will be advised on how to do so.

If you intend either to conduct research at a trust site or lead research sponsored by the trust you must familiarise yourself with the appropriate SOPs before the study opens. All CIs and PIs who have received regulatory approvals for their research whether sponsored or hosted by the trust will automatically be sent an ‘R&D SOP Investigator Training Pack’. This includes PDFs of the SOPs, guidance on which ones will be relevant to your research, and a template to record your training.

Investigators should complete SOP training before they start recruiting participants. You will be asked to confirm this in writing prior to local confirmation of Capacity and Capability from the R&D office. If you need access to the SOP pack now please contact bsuh.rd.approvals@nhs.net. We can provide up to date versions of SOPs, associated guidance and the templates required to manage your project.

Our SOPs are routinely reviewed every three years and whenever there are significant changes to the regulations, guidance or national and local processes. When changes are made, researchers managing open projects will be notified directly by the R&D Office.

March 2021 – Please note that, in line with the trust merger, all R&D SOPs will be reviewed and updated over the next 12 months to reflect the new trust identity, any changes to governance arrangements, new locations where research may take place etc.

SOPs for research at trust sites/ involving trust patients