MRCS PART A · APPLIED BASIC SCIENCES
Audit design: classify the purpose, not the label
Two concept trees and two original five-option questions about fictional surgical-service projects. Not permission to start a real project or a complete audit course. Primary HRA sources checked and platform owner reviewed. Difficulty is not calibrated.
2 topics · 2 original SBAs
1 · Identify what the project is trying to establish
Your task: Distinguish comparison against a pre-existing standard from describing a service.
What makes the supplied first project an audit?
It checks current practice against a standard fixed before measurement. Describing a service without that comparison is a different task.
Does using a spreadsheet decide the category?
No. The same data tool can support different purposes; inspect the question and design instead.
Does calling a project an audit authorise access to records?
No. Discuss local review and data-use arrangements with the organisation. Non-research classification is not a blanket permission.
Who determines the project classification in practice?
The managing organisation is responsible. Use the HRA tools with accurate details and involve the local governance or R&D office where appropriate.
2 · Separate sampling records from allocating care
Your task: Recognise when the project changes care allocation rather than just selecting observations.
What is the important distinction between the two uses of randomness?
Randomly selecting records determines what is measured. Randomly assigning care according to a study protocol determines what people receive; it cannot retain an audit label.
Do routine options cease to be research when both are already used?
Not for that reason. Protocol-driven random allocation of routine care still requires the research pathway; the novelty of a drug is not the deciding test.
Can a planned journal submission settle the category?
Publication alone does not settle it. The underlying purpose and allocation design must be assessed.
Does research classification specify every approval by itself?
No. Work with the responsible organisation to establish the applicable approvals and data safeguards before beginning; do not infer a universal exemption or one-size-fits-all approval.