How to conduct a clinical audit

Clinical audit is undergoing a process of reinvigoration and its profile has never been higher. What do you need to know to carry one out so that it achieves its aim of improving patient care?

This content was published in 2011. We do not recommend that you take any clinical decisions based on this information without first ensuring you have checked the latest guidance.

In short

When designing your audit, keep it simple and focus on a specific aspect of care that is considered a priority. Develop audit criteria that allow you to measure whether or not you meet expected standards.

When designing your audit pro forma, try to avoid collecting more data than you need, and always pilot the data collection to identify any flaws. Once you have completed your audit, report the findings in a clear and meaningful way and be sure to repeat the exercise to complete the audit cycle.

Many clinical staff feel a degree of trepidation about undertaking a clinical audit. This may be because they have never conducted an audit before, or because they have not had a good experience with auditing in the past.

Being aware of potential obstacles when carrying out a clinical audit can help to ensure the exercise brings about real improvements in patient care. Obstacles can include insufficient time allocated to the audit, limited availability of patient records, unclear objectives and a lack of education in audit methodology. Importantly, if compliance with clear standards is not used to measure performance, the audit report can be left without recommendations that lead to improvement — the very purpose of clinical audit.1 Finally when you have reached the stage of planning for improvement, failure is virtually assured if you do not have the necessary clinical and managerial buy-in to make changes happen.

So you want to conduct an effective audit that really makes a difference — where do you start?

Choose a topic

The key to choosing an appropriate topic is to ensure it is simple and focused on a specific aspect of care that is considered a priority for assurance or improvement. As demand for quality data increases, it is vital that scarce resources are directed towards audit topics that are considered interesting and important to as many stakeholders as possible. Stakeholders can include members of the multidisciplinary team, heads of the department or service, trust managers and, of course, the patients or carers themselves.

Ensuring your audit is linked to organisational and service objectives and risks will gain you valuable managerial support for your audit, and also enables the use of “organisational levers” when it comes to changing practice. Consider whether there are areas of practice with known risks or concerns, perhaps from clinical incidents or complaints. For example, medicines audits will often be a priority due to the associated high risks, volumes of usage and costs.

Since clinical audit requires evaluation against explicit criteria, it is helpful if there are existing guidelines or standards available — so research those in your area of practice. Demonstration of compliance with national guidance is often an organisational objective, but auditing regional or local policies and protocols can also provide vital assurance on the quality of care. You should also remember to bear practicalities in mind when choosing a topic; data need to be accessible using available resources and the feasibility of making improvements should not be beyond the realms of possibility.


Talking to colleagues and involving them from the outset is essential if you want to avoid an uphill struggle when it comes to making recommendations and implementing change. It is less onerous if you identify a small group to support you in carrying out the audit.

Anyone involved in the aspect of care to be audited is a stakeholder whose awareness, support and advice may be invaluable throughout the process.

Do not forget the practical support of non-clinical staff as well as clinicians from other professions. Make senior staff and management aware of the work, particularly if there might be resource implications as a result of the audit. If you can include the views of patients or carers in your audit this will increase its value and often provide a different perspective.

If you have access to a clinical audit department, its staff are best involved at the outset since they usually have a wealth of experience to draw on and can be a valuable source of advice and practical support.

Set measurable standards

Develop audit criteria that allow you to measure whether or not you meet expected standards for the aspect of care you have chosen, for example, “allergy status is documented on all inpatient drug charts”. Do check whether the audit has been done before since this can save you time in developing tools and standards and allow you to benchmark your results.

Look at what nationally agreed best practice exists around your topic, for example recommendations from the National Institute for Health and Clinical Excellence, National Patient Safety Agency, confidential inquiries (eg, National Confidential Enquiry into Patient Outcome and Death), royal colleges and the Department of Health. Compare these with local and regional guidance. If no guidance is available, the clinical team can agree consensus standards for the audit; these may lead to the production of guidelines in the future.

You do not need many standards but they do need to be SMART: ie, “specific”, “measurable”, “achievable”, “relevant” and “time-bound”. They should also be theoretically sound (that is, based on the best evidence available). You may need to identify exclusions to the standards or reduce the expected level of compliance if they are not achievable for all patients.

Top tips for auditing

The following tips can help you get the most out of your audit:

  • Engage others involved in the aspect of care to be audited
  • Develop your standards from best available evidence
  • Pilot your methodology
  • Keep it simple at all stages
  • Allow sufficient time for planning and implementation of change
  • Measure practice against the standards and draw conclusions
  • Develop recommendations and an action plan
  • Follow through the actions to completion
  • After implementation of action, reaudit to close the audit loop
  • Share the learning through presentations, reports, newsletters, bulletins and posters
  • If you have access to a clinical audit team — use it

Agree data-collection methodology

Your audit sample should help you draw conclusions about the whole population, but will be influenced by the size of the population of your patient group and resource constraints.

Try to avoid bias in your selection of cases (eg, seasonal variations) and ensure you have sufficient cases to be meaningful. Depending on the topic and population size, 50 to 100 cases over a reasonable period may be a practicable solution if you are not able to meet the numbers needed for optimal confidence intervals. Clinical audit resources, including tools for calculating samples size, can be found at

Although ethics approval is not normally required for auditing, the audit design should be within ethical principles.2,3

Data can be collected either retrospectively or concurrently with care. The most common method is retrospective because it is usually quicker, but it might be necessary to commit the additional time and effort to concurrent data collection if the information required is not routinely recorded. Increasingly data may be available from electronic sources. It is particularly important to strive for consistency if more than one person is collecting data, for example, by meeting to agree how cases will be selected, when and from where data will be collected and how to interpret questions. Wherever possible, agreements reached should be included as guidance on the audit pro forma or in supporting documents.

Design the pro forma

When designing your audit pro forma, try to avoid collecting more data than you need. Word your audit questions in a way that will explicity provide the information you require and order them logically for the data collector, making use of tick boxes wherever possible.

Consider capturing data electronically, eg, using web-based tools, which can save time over a paper-based approach. Ensure that confidentiality is maintained by avoiding the use of patient identifiable information and storing pro formas securely after completion.


Save yourself from finding out too late that your audit is flawed by carrying out a pilot. Auditing just a few cases can allow you to rectify the following kinds of issues:

  • Data are difficult to obtain
  • Order of questions hampers data collection
  • Inconsistent responses obtained due to ambiguous questions
  • Data do not allow you to measure the identified standards

Your pilot results can be discussed with the audit group to ensure nothing important has been missed.

Conduct the audit

Once you have taken the opportunity to test the methodology, check everyone involved is aware of the process and timescales and you are ready to go.

Many audits benefit from checking the data at interim periods to ensure the work is on track. Once data collection is complete the data can be analysed to allow conclusions to be drawn about practice. There are various software packages to help with analysis; your clinical audit department may also assist.

Report the key messages

The results of your audit should be reported simply enough to allow your key messages to be understood readily — use of graphs and tables for presenting data can be highly effective. Ideally the report will provide sufficient information for someone wishing to duplicate the audit elsewhere. Limitations of the findings should be acknowledged and compliance with the standards stated clearly.

Comment on the findings with a view to agree a set of recommendations to improve care where required. The recommendations should be linked to an action plan that identifies responsibilities and timescales; do not underestimate the effort required to change practice. Audit results should be presented and disseminated wherever possible to share learning, support change and celebrate good practice.

Reaudit to complete the cycle

To ensure that any actions implemented lead to the planned outcomes, a reaudit should be carried out after a suitable period. The timescale will depend on the level of concern around the changes and need for assurance — as well as resources — but should allow time for changes to embed.

Wider dissemination of the results can be considered once reaudit data are obtained. Abstract and poster presentations at local, regional and national symposia are options, as well as submitting a write-up of the work for publication in a journal.


Joanne Woolley is clinical audit manager at the Centre for Cancer Epidemiology, The Christie NHS Foundation Trust. E:


1 National Institute for Clinical Excellence. Principles for best practice in clinical audit. 2002. (accessed 12 April 2011).

2 Healthcare Quality Improvement Partnership. Ethics and clinical audit and quality improvement (QI) — a guide for NHS organisations. 2010. (accessed 12 April 2011).

3 National Research Ethics Service. (accessed 12 April 2011).

Last updated
Clinical Pharmacist, CP, 2011;()::DOI:10.1211/PJ.2021.1.64700

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