Project governance

What does good project governance involve?

Good project governance in a clinical trial involves clear leadership, transparent decision making, communication, effective risk management and ethical oversight. It involves establishing who will be the sponsor (the organisation that provides overall oversight), setting up your trial team, establishing a Trial Steering Committee (TSC), and where applicable a Data Safety Monitoring Board (DSMB).

Why is establishing a good trial team important?

By assembling a diverse team with the right composition and defining the role and contribution of each team member, you will ensure your clinical trial runs smoothly and efficiently. This approach leverages the strengths and expertise of each team member. As a result, your trial will likely adhere to ethical guidelines, meet regulatory requirements and achieve its objectives.

The TSC is an important part of a clinical trial’s project governance. A TSC provides independent oversight and reviews the trial’s progress. A TSC will make decisions on whether to continue, modify or stop a trial.

Similarly, a Data Safety Monitoring Board (DSMB) periodically reviews accumulating trial data and provides advice on safety and trial conduct issues by making recommendations to the TSC and sponsor.

What does this involve?

• Engage with your organisation's research office early with your clinical trial idea. They will need to know information on aspects such as your project plan and who you will be collaborating with to evaluate whether or not this is a study they will sponsor.
• Consider and establish the roles required for your clinical trial team.
• Ensure your trial team have done the relevant required training.
• Set up your independent Trial Steering Committee.
• Establish a Data Safety Monitoring Board (where applicable).