The three levels of quality assurance procedure for University-sponsored clinical trials
The quality assurance procedure for University-sponsored clinical trials involves three possible levels of assessment depending on the risk score that has been assigned to the trial (it is anticipated that most trials will be potentially low risk):
1. Potentially HIGH RISK clinical trials
The procedure for these trials involves a meeting between the independent clinical trial assessment (ICTA) 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 ICTA team will consist of two academic members of staff with expertise in clinical trials and an administrator from R&IS.
2. Potentially MEDIUM RISK clinical trials
The procedure for these trials involves a meeting between the ICTA team and the CI/PI, to discuss the trial management arrangements.
The ICTA team will consist of two academic members of staff with expertise in clinical trials, and an administrator from R&IS.
3. Potentially LOW RISK clinical trials
The procedure for these trials involves a meeting between the ICTA team and the relevant Head of Department/School to discuss the trial management arrangements.
The ICTA team will consist of one academic member of staff with expertise in clinical trials, and an administrator from R&IS.
Please note: 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 ITCA teams carrying out the assessments will be academics with expertise in clinical trials; a list of those who have agreed to participate is available in the following document:
The University's approach to University-sponsored clinical trials