Once approved, the Trust has an obligation under the DH 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.
However during the course of a project, it is likely that unforeseen issues will arise. It is therefore important that researchers are alert to these unforeseen issues, maintain protocol compliance, if necessary through a protocol amendment.
Our quality management and protocol compliance web page provides researchers with guidance as 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 audit of research projects being conducted at the Trust.
In line with regulatory requirements, researchers should follow the links for the following procedures if they arise during the course of a research project.
Other practical guidance and help in the conduct of research studies is also available in our suite of policies, procedures and guidance documents drafted by the Research Office and include: