Risk Assessment

This section contains the following:

Introduction
Things to consider
Additional resources

Introduction

It is important that before the commencement of any clinical trial that a risk assessment is carried out and documented . This will identify any hazards (anything that could cause harm) and the risks (chance that harm will be caused by the hazard) in order to propose ways of minimising the risks. The Chief Investigator has overall responsiblity for the documentation but this can be reviewed by the organisations and centers involved in the trial in order that they can carry out their own local assessments.

The risk assessment can be useful for planning the details of trial management and monitoring and can be helpful for preparing for internal audit and external inspection if the trial is evaluating a medicinal product (Farrell B, 2006).

Back to top

Things to consider

Three areas which should be considered when looking at the potential hazards in a trial:

the trial participants, their rights and safety,
the completion of the trial, such as recruitment and follow-up,
the reliability of the results.

For each of these hazards you should consider:

the associated risks to the particular trial;
the potential consequences;
steps that can reduce the risk such as, reductions in the probability of the hazard occurring or minimising its adverse consequences.

If a hazard does occur how will this be reported. The reporting framework should consider

what is required?
how will it be reported?
who will review/sign off the reports?
the plans required for this to be put into practice in other areas.

Additional resources

Checklist of things to consider when assessing risk for trial participants

This is helpful summary of the hazards which may be involved for participants participating in a trial and what should be considered to minimise the risk from the MRC/DH joint project to codify good practice in publicly-funded UK clinical trials with medicines.

Clinical trials tool kit

The clinical trials tool kit is a guide to setting up a publicly funded trial in accordance with the EU Clinical Trials Directive and gives guidance on management and monitoring and risk assessment within clinical trials.