​Why is a formal, documented risk assessment proposed?

A risk assessment is an integral part of the sponsor’s responsibility to ensure the rights and safety of subjects are protected and is a standard component of a trial set-up across the world.

Risk Assessment Form for Investigator-Initiated Research


​Risk-based classification of trials

The Organisation for Economic Co-operation and Development (OECD) has published Recommendation on the Governance of Clinical Trials which promotes the use of a simple risk categorisation process to help investigators and sponsors develop proportionate systems for managing and monitoring their trials.

Documentation of the risk assessment process is valuable for the following reasons:

  • Speeding up ethics/governance review - It allows oversight bodies to quickly assess the adequacy of the proposed systems to mitigate additional risks to subjects posed by trials and where there are no additional risks, to be reassured of that fact.
  • It provides documented evidence to support a ‘defence of due diligence’ in the event of a claim for damages by a trial subject.
  • It provides investigators with a framework to develop proportionate trial management and monitoring strategies (the guidance supports training in the area of risk assessment and trial management).