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 and Innovation Policies.
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. If you wish to develop a new research project to be sponsored by UHSussex you need access to the SOP pack now please contact us [email protected]. We can provide access to up to date versions of SOPs, associated guidance and the templates required to manage your project.
All CIs and PIs who have received regulatory approvals for their research (whether sponsored or hosted by the Trust) will automatically be Given access to SOPs etc. by the Research Governance Team during study set up. This includes PDFs of the SOPs, guidance on which ones will be relevant to your research, and a template to record your training if this is required by the sponsoring organisation.
Investigators should read relevant SOPs before they start recruiting participants.
UHSussex research SOPs for researchers
Not all of these SOPs will be relevant to every study/ every investigator’s role. We provide an SOP matrix that indicates which SOPs should be followed for your study.
Designing and setting up a research study
- Writing a research protocol
- Informed consent for research
- Case Report Forms
- Data management for research
- Sponsorship approval
- GCP and mandatory training
- Delegation of roles and responsibilities
Conducting research
- Essential documents management
- Equipment maintenance and calibration
- Staffing in the Clinical Research Facility
- Clinical Research Facility management of acutely unwell patients
- Out of hours contact information
- Transport of Samples, Clinical Waste & Sharps
- Amendment approvals
- Amendment implementation
Safety, deviations and incident management
- Adverse Events and safety reporting
- Deviations and serious breaches
- Research misconduct and fraud
Closing down a study and sharing results
- End of a research study
- Publications and dissemination of study outputs