Medical Chart Review (MCR) Studies Checklist

Medical chart reviews can deliver powerful insights but only when the methodology stands up to scrutiny. Without careful planning, studies risk selection bias, inconsistent documentation, or analysis that won’t meet HTA or publication standards.

This checklist highlights key design and operational considerations to help your team identify potential gaps early and align internal stakeholders before study initiation.

It covers considerations such as:

• Defining a clinically relevant and well-scoped research question

• Setting inclusion/exclusion criteria that reflect real-world clinical practice

• Assessing site feasibility and representativeness

• Documenting data sources, patient selection, and patient flow clearly

• Managing inter-rater variability with standardised codebooks

• Handling missing data and defining cleaning procedures

• Planning for bias mitigation (e.g. PSM, IPW, multivariate adjustment)

• Ensuring oversight by an independent steering board

• Aligning observation periods, censoring rules, and follow-up duration

  The checklist is not a shortcut. It’s a structured tool to help you ask the right questions and to make your collaboration with external partners more efficient and impactful.