Role definitions and workflow allocation: who does what, and how decisions about delegation are made
Translate a staffing structure into operational role definitions that satisfy ICH E6(R3) Annex 1 delegation documentation requirements while preventing tasks from falling through the cracks.
Role definitions and workflow allocation: who does what, and how decisions about delegation are made
In nearly thirty years of advising regulatory operations teams, I have noticed that when a coordinator tells me a task fell through the cracks, the conversation almost always pivots toward personalities. Someone forgot. Someone was overwhelmed. Someone was new and did not know any better. The instinct, both organizationally and humanly, is to look for the person who failed. Yet when I ask to see the written role definition for the position involved, what I find — far more often than not — is a paragraph that sounds reasonable on the page but does not actually say who does what. A document that lists "submits regulatory documents to the IRB" without specifying which submissions, under whose review, and with which signatures verified by whom. The task did not fall through the cracks. The cracks were drawn into the role definition itself.
Once a staffing structure has been designed — the FTEs allocated, the centralization model chosen, the institutional context accommodated — role definitions translate that structure into operational reality. They are the document that sits between the organizational chart and the work. And under ICH E6(R3) Annex 1, they are not merely a managerial nicety. They are the substrate of the delegation documentation that the guideline requires you to maintain.
What you will learn
By the end of this lesson, you will be able to: