Policies and SOP's

Guidance for Research Applications Requiring NHS Ethical and/or HRA Approval

The policy describes the REIS process for granting SU sponsorship.

The following processes take place, defined as stages 1 – 4: 

• Stage 1: Obtain initial study information and determine pathway for appropriate regulatory framework and governance processes to be implemented.
• Stage 2: Conduct a full review of the study, including submission to the SUSOC, to ensure it meets appropriate standards, is scientifically sound and feasible in practice.
• Stage 3: Issue Sponsorship in Principle to allow further regulatory approvals to be gained.
• Stage 4: Issue full sponsorship upon all regulatory approvals and other required documentation being received

SU Research Governance Sponsorship Guidance Policy

The purpose of this document is to describe the quality management activities undertaken by Swansea University (SU) Research Governance in relation to SU sponsored studies, including personnel roles and responsibilities, training, quality assurance and audits, document management, record retention and reporting and corrective and preventative actions.

This policy applies to all activities conducted by SU Research Governance on research applications requiring NHS ethical and/or HRA approval.

To meet regulatory expectations and ensure best practice, SU Research Governance must have quality systems with specific standards for each study process. The quality systems include:

• personnel roles and responsibilities,
• learning and development, 
• risk management,
• quality assurance and auditing,
• document management,
• record retention, and reporting,
• corrective and preventive actions,
• Annual Reports
• Amendments
• End of Study closure 

SU Research Governance Quality Policy