Quality assuring University-sponsored human-interventional studies - the procedure

What does the procedure involve and what do I need to do as the Chief/Principal Investigator of a proposed human-interventional study?

Before the study 'goes live':

The project will need to go through the University's Research Governance Procedure; this includes deciding who the project's 'research governance sponsor' is, registering the project on the University's Research Management System (URMS) and obtaining scientific and ethical approval. 

The following only applies if the University of Sheffield is the sponsor:

Once you have obtained ethical approval, you will need to complete and return a brief questionnaire, the 'Risk Assessment Checklist' for University-Sponsored Human-Interventional Studies'. The aim of this questionnaire is to assess the potential risk posed by each study, in order to apply a quality assurance process that will be appropriate to that risk.

The answers provided on the Risk Assessment Checklist will be used to calculate a risk score, from which a risk level will be assigned to the study (potentially high risk, potentially medium risk, or potentially low risk). It is expected that the majority of studies will be assessed as low risk. Some studies may at first appear to be high risk, but a high risk score may not be applied if there are appropriate controls and procedures in place.

A sponsor authorisation letter will then be sent to you by R&IS, stating the risk level that has been assigned; for potentially medium or high risk trials, the letter will also confirm that the trial can 'go live'. For potentially low risk trials, you will additionally be asked to sign and return a self-certification statement, which your Head of Department also signs, in order for the study to go ahead.

After the study 'goes live':

The appropriate quality assurance procedure will be implemented according to the risk score; for potentially low risk projects, you will no longer need to be involved and your Head of Department will be contacted to make arrangements for a meeting to discuss the management of the trial; if your project is confirmed to be potentially medium or high risk, you will be contacted by R&IS to make appropriate arrangements for a meeting to discuss the management of the trial at the most suitable time. For example, this could be soon after a report to the project's funder is required, so that the information provided in the report can also be fed into the quality assurance process to avoid additional work. For further information on the procedures for each risk level, click on the link below:

The three levels of quality assurance procedure