Risk-adopted approaches to clinical trial monitoring

Is a risk-adapted monitoring plan, an effective approach to monitor academic clinical trials in Ireland?

Background: In 2012, the Health Research Board (HRB) established a number of Clinical Research Facilities (CRF) in Irish universities. Since then, Irish universities such as University College Cork (UCC) has assumed the role of study sponsor for academic clinical trials. Under the EU’s Clinical Trial Directive 2001/20/EC, study sponsors such as UCC must ensure that trials are adequately monitored.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) released guidance documents in 2013, which encouraged clinical researchers to move away from traditional monitoring to a system of risk -based monitoring. Despite this recommendation the effectiveness of risk-based monitoring has not been confirmed.

Aim:  To develop and evaluate a risk-based monitoring plan for academic clinical trials in Ireland

Methods: The project will based in Clinical Research Facility- Cork (CRF-C) and UCC’s Department of Epidemiology and Public Health. It will run from October 2014 to October 2017.

The project will employ a quantitative research design implemented through four packages (WP) as follows: •WP1: Systematic review of risk-based monitoring •WP2: Six months placement in a UK Hub for Trials Methodology Research to study and implement a risk-based monitoring system •WP3: Survey of monitoring methods, currently used by Irish academic clinical researchers •WP4: Development and implementation of a risk-based monitoring plan for a trial run through the Clinical Research Facility Cork

Result: Development of a risk based monitoring template and a manual to aid risk assessment in academic clinical trials.

Conducted by: Caroline Hurley carolinehurley@ucc.ie / @CarolineHur1


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