ICH E8(R1), adopted in late 2021 and taking effect across ICH regions in 2022, is the first revision of the General Considerations for Clinical Studies since 1997. It reads as a preface to the later rewrite of Good Clinical Practice: studies should be designed so that quality is built in, rather than inspected in after the fact.
Critical-to-quality factors
The central idea is that every study has a small number of factors whose integrity is essential to participant protection and to the reliability of results. E8(R1) asks sponsors to identify those factors during design, involve stakeholders including patients in that process, and focus resources on them.
What sponsors are doing
Our clinical consultants are seeing protocol development teams add a documented risk-assessment step before protocol finalisation, and monitoring plans that reference the critical factors explicitly. For CRAs and study managers the practical change is that the monitoring plan now has a rationale that can be explained to an inspector.
Why it matters for staffing
Sponsors need people who can run the risk assessment as well as execute the plan. Demand for clinical operations leads with risk-based monitoring experience has been strong through the first quarter of 2022, and we expect it to continue as E6 is revised along the same lines.