Is it Research?

When people talk about clinical audit, most healthcare professionals immediately think of research. It is true that research and audit share similarities. They both involve answering specific questions which relate to the quality of care. They can both be carried out either prospectively or retrospectively. It is also true that both audit and research involve careful sampling, questionnaire design principles, and data collection and analysis. The truth is that there are more differences between them as they work towards different goals.

So, what is research, and what is clinical audit?


“a structured activity which is intended to provide new knowledge which is generalisable (i.e. of value to others in a similar situation) and intended for wider dissemination” (Department of Health, 2002)

Clinical Audit

‘ …a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery. ‘ (Principles for Best Practice in Clinical Audit, NICE, 2002)

Two Simple Definitions

Did that help? If not, then here are a couple of simpler definitions put into context:

  • Research is about creating new knowledge, about whether new treatments work or whether some treatments are better than others. It determines what is best practice.
  • Clinical audit is a way of finding out if we are doing what we should be doing. Are we following guidelines, and are we using best practice?

The Similarities

Clinical audit and research are similar in the following ways:

  • audit and research involve answering a specific question relating to quality of care
  • both can be carried out either prospectively or retrospectively
  • both involve careful sampling, questionnaire design and analysis of findings
  • both activities should be professionally led

The Differences

Ok, so now we know what research and clinical audit are, and what their similarities are; but what are the differences between them?

The following 12 points should help you decide if your project is clinical audit or if it is research:

  • Research creates new knowledge about what works and what is best; clinical audit tells us if we are following best practice.
  • Research is based on a hypothesis; clinical audit measures against standards.
  • Research can involve patients trying an untested treatment method; clinical audit never involves patients trying new treatment methods.
  • Research may involve a degree of experimentation on patients; clinical audit never involves anything happening to the patient which is different to their normal treatment.
  • Research may involve allocating patients to different treatment groups; clinical audit never involves allocating patients to different treatment groups.
  • Research may be based on a scientifically valid sample size; clinical audit sample sizes don’t need to be scientifically valid.
  • Research may involve some detailed statistical analysis of the collected data; clinical audit requires only basic statistic analyses.
  • The results from research are generalisable; clinical audit results are applicable within local settings only.
  • Research findings can have a wide reaching influence on clinical practice; clinical audit has a local influence on clinical practice but can be shared widely
  • Research involving NHS staff, patients, their tissue or data, or facilities and equipment requires ethics committee approval; clinical audit rarely requires ethics approval

The two are complementary

One can’t survive without the other. To be completely effective research can’t survive without audit as we wouldn’t know whether best practice was being carried out, and audit can’t survive without research as without research we wouldn’t know what best practice was! Research identifies areas for clinical audit and clinical audit identifies areas for research.

Still undecided?

Still can’t decide if your project is audit or research? Try answering honestly to the three questions below.

  1. Is the aim of your project to improve the quality of care for a particular patient group in the local setting (i.e. within the Trust)?
  2. Will the project involve measuring practice against a set of standards?
  3. Does your project involve anything being done to patients which is beyond what can be described as normal clinical management?

If you have answered yes to questions 1 and 2 and no to question 3, then it is fairly safe to say that you are thinking of doing a clinical audit. If you can’t then you are probably doing a form of research.

More information

For a summary please see the NRES definitions in their Defining Research pdf leaflet.

Our explanatory page is entirely drawn from . Grateful thanks to them for preparing such a clear description of the distinctions between audit and research.