The three levels of quality assurance procedure for University-sponsored human-interventional studies
The quality assurance procedure for University-sponsored human-interventional studies involves three possible levels of assessment depending on the risk score that has been assigned to the study (it is anticipated that most studies will be potentially low risk):
1. Potentially HIGH RISK human-interventional studies
The procedure for these studies involves a meeting between the independent assessment (IA) team and the Chief/Principal Investigator (CI/PI) to discuss the trial management arrangements, and a check of essential documents in the master site file is carried out.
The IA team will consist of two academic members of staff with expertise in human-interventional studies and an administrator from R&IS.
2. Potentially MEDIUM RISK human-interventional studies
The procedure for these trials involves a meeting between the Independent Assessment team and the CI/PI, to discuss the study management arrangements.
The IA team will consist of two academic members of staff with expertise in human-interventional studies, and an administrator from R&IS.
3. Potentially LOW RISK human-interventional studies
The procedure for these studies does not include a meeting and will be monitored and managed within the Department. However the Principle Investigator will need to complete and submit a Self Certification Statement which is sent with the authorisation letter.
The CI/PI may invite another member(s) of the research team to be present at any meeting, and/or a representative(s) of a clincal trials research unit, if applicable. Members of the IA teams carrying out the assessments will be academics with expertise in human-interventional studies as nominated by the Health and Human-interventional studies research sub committee
The questions asked by the IA team will vary according by project and meeting purpose. A question guide has been produced by the Health and Human-Interventional Studies Research Sub Committee to assist Departments.
The template letter confirming the University's sponsorship of a study sets out the assessed level of risk and the responsiblities of the study team and the Head of Department