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D5 Roles and responsibilities.

Roles are the positions filled by your team members, while responsibilities are the day-to-day tasks and functions of each role in your project. To understand the difference between roles and responsibilities, think of a role as a job title e.g., Clinical Trial Associate (CRA) and what they do each day on the job becomes their responsibilities, e.g., source document verification (SDV).

At the top level there is a requirement to divide responsibilities between different organisations and departments. If you interrogate the project deliverables it might be that the pharmaceutical company (Pharma) has responsibility for project design and the writing of the project protocol whereas the Clinical Research Organisation has responsibility for monitoring and cleaning of the data. At a simple level this is like a tick box exercise e.g., Pharma writes the protocol and CRO monitors and cleans the data. The situation becomes more complex where tasks are shared e.g., investigator site selection.

The next level down is defining the roles required to complete the task e.g., CRA are responsible for site monitoring. The final level is allocating tasks to an individual i.e.

defining who is responsible for monitoring which sites.

At the individual level there is also a definition of what constitutes the task. Using the monitoring example above, the monitoring plan will specify the level of source documentation verification (SDV), time-on-site, compared to remote monitoring etc. As each project is unique there need to be a minimum level of education on what is expected of the individual, taking into account their levels of experience and motivation.

If you are working with an experienced team, then techniques like Kanban boards are useful ways of getting individuals to take responsibility for delivery.

Why is it in the Lab?

People need to know what they supposed to do and what they are supposed to deliver, the alternative is confusion and repetition, leading to wasteful use of resource and a worst-case scenario of chaos. A clear definition of roles and responsibilities reduces the relational risks associated with opportunistic behaviour, the defence of “I did not know I was supposed to do this” is then no longer valid



“I love the idea of Kanban boards where team members select their own tasks from a to do list and therefore take personal responsibility for completing the task. This is empowering and motivating. Why is motivation so important? Because performance is a function of both ability and motivation.”


“Over and over I have seen a lack of awareness on roles and responsibilities cause huge confusion, overlap of decision making and delay to inefficient delivery. Being clear and understood on this cannot be understated.”


“Yes, it seems such an obvious thing to get right, but how often is it overlooked or it is erroneously assumed that someone already understands their role and their responsibilities!”

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