Once approved, the Trust has an obligation under the Department of Health’s Research Governance Framework (RGF) to ensure that research projects continue to be conducted in line with regulatory requirements.
The Trust’s responsibilities for ensuring compliance with the RGF are set out in its Research Governance Policy.
Following the approved protocol is key to maintaining regulatory compliance and reducing risks related to patient safety and/or the quality of study data.
During a project, unforeseen issues can possibly arise, therefore it is important that researchers are made aware of unforeseen issues, so they can maintain protocol compliance, if necessary through a protocol amendment.
Our quality management and protocol compliance page gives researchers guidance to the type of unforeseen issues that might arise during a study and the process for dealing with these.
The Trust also has in place a programme for monitoring and auditing research projects being conducted at the Trust.
In line with regulatory requirements, researchers should follow these procedures if needed during the course of a research project.
- Study amendments including the process for reporting Urgent Safety Measures
- Safety Reporting
- Serious breaches (CTIMP studies only)
- End of study processes
Other practical guidance and help in the conduct of research studies are also available in our suite of policies, procedures and guidance documents drafted by the Research Office, including:
- Study Management Logs - for patient screening, ID and withdrawal; adverse events, protocol deviations and delegation of staff responsibilities.
- Recruitment and Contingency Planning for Increasing recruitment and delivery of clinical research guidance.