At University Hospitals Sussex we are committed to conducting high quality research. To ensure that all research conducted involving our patients (or their cells or tissues), staff and premises complies with the relevant regulatory requirements and Good Clinical Practice we have developed a set of standard operating procedures (SOPs). These SOPs reflect the practical application of these frameworks and associated guidance within the Trust, including the Trust’s Research Policy.
This section provides a list of SOPs that are relevant to Chief and/or Principal Investigators (CIs and PIs) and their study teams conducting research within the Trust.
There are additional SOPs for activities managed directly by the Research & Innovation (R&I) 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 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&I 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&I Office. If you need access to the SOP pack now please contact us. 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&I Office.
Please note that, in line with the Trust merger, all R&I SOPs are currently under review and will be updated shortly to reflect the new Trust identity, any changes to governance arrangements, new locations where research may take place etc. SOPs will be available below in due course.
UHSussex research SOPs for researchers
Designing and setting up a research study
- writing a research protocol
- sponsorship approval
- delegation of roles and responsibilities
- GCP and mandatory training for research
- informed consent for research
- clinical trial contracts
- essential documentation management
- data management
- equipment maintenance and calibration
- EJC management of acutely unwell patients
- CIRU management of acutely unwell patients
- out of hours contact information
- study amendments
Safety, deviations and incident management
- managing adverse events in research other than CTIMPs
- amendments, urgent safety measures and temporary halt of study
- deviations and serious breaches of GCP or the study protocol
- managing research participant complaints
- research misconduct and fraud
- serious incidents in research
Closing down a study and sharing results
- End of a research study
- Publications and dissemination of study outputs