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Compliance with the regulations | Audit

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Audit

 Guidelines for audit of Good Clinical Practice and research governance adherence

With the introduction of the Medicines for Human Use (Clinical Trials) Regulations 2004, it is necessary to audit Trust and QMUL research practice against the quality system of Good Clinical Practice intrinsic to the Regulations and encompassed in the Research Governance Framework. As Sponsor the Trust and Queen Mary University of London (QMUL) are responsible for auditing research practice and adherence to current legislation and guidelines.

This page contains guidance to assist researchers in understanding the processes of audit, so that they are prepared should they be selected for internal audit.

The purpose of internal audit of research is to:

  • Protect the reputation of the researcher, the Trust and QMUL.
  • To protect current and future funding opportunities
  • Measure compliance with regulatory requirements
  • Measure compliance with Trust policy
  • Maintain patient and staff safety
  • Improve data quality
  • Improve performance
  • Prepare for external audit processes

 Audit requirement

The Research Governance Framework requires that all NHS Organisations, where research is being conducted, will initiate formal audit of a selection of research projects and activities. The minimum standard in the Framework states that at least 10% of projects should be routinely audited.

A project should be audited:

  • As a result of a risk graded assessment
  • If there is suspicion of non-compliance to regulation
  • On a voluntary basis.

A written report on study progression does not constitute audit and should be submitted for every study in addition to audit requirements.

 Role of the auditor

It is the auditor’s primary role to collect evidence of research practice and compare it against the requirements of Good Clinical Practice and Research Governance. The auditor is responsible for documenting observations and conclusions, safeguarding audit documents, records and reports, assessing whether requirements are being met, and developing reports incorporating recommendations for change or adherence.

 Audit processes

A number of processes are required to compile a complete sample of available data. These are:

1. Audit plan
2. Open meeting
3. Physical audit processes
4. Develop conclusions
5. Discuss results
6. Final audit report
7. Follow-up actions
 
1. Audit plan

An audit plan should be developed by the auditor and agreed by the Joint Research Department prior to the audit beginning.

The plan should:

  • Define scope and objectives for audit
  • Provide timelines for audit conduct
  • Identify where and when the audit will take place
  • Identify requirements to be audited against
  • Identify groups and areas to be audited
  • List documents and records to be studied
  • List responsible people whose functions will be audited
  • Clarify who will get the final report and when it will be ready
 
2. Open meeting

An open meeting will be arranged to introduce the auditor to the team and area to be audited.

During this meeting the auditor will:

  • Define scope, objectives and schedule
  • Explain how the audit will be carried out
  • Confirm that the team are ready to support the audit process
 
3. Physical Audit Processes

This is the most intensive part of any audit process as it is the period where information is assessed and recorded.

This will be done by:

  • Interviewing personnel
  • Reading documents
  • Reviewing manuals
  • Studying records
  • Reading reports
  • Analysing data
  • Observing activity
  • Examining conditions
  • Confirming interview evidence
  • Documenting observations
 
4. Develop conclusions

Once the review and observational components have been completed the auditor processes the data to define conclusions and preliminary recommendations.

The auditor will:

  • List nonconformities supported by evidence
  • Cross-reference with regulatory requirements
 
5. Discuss results

The auditor will arrange a closing meeting to discuss the compiled evidence, observations, conclusions, recommendations or nonconformities. This is an interim measure to suggest an outcome but should not be viewed as the final and complete results of the audit.

 
6. Final audit report

Over the following 2 weeks from initial audit, the auditor will review the gathered information and compile a final report, which will be disseminated to Senior Research and Development staff, the Medical Director and the Chief/Principal Investigator.

The report will include:

  • The detailed audit plan
  • A review of the evidence collected
  • A discussion of any conclusions drawn from the audit
  • A list of identified nonconformities
  • An assessment of how well regulatory requirements have been met
  • Recommendations for change in practice to conform to regulation
  • A timescale for corrective action
  • A date for recommended review
 
7. Follow-up actions

It is the auditor’s responsibility to identify necessary action has been carried out to correct and prevent nonconformities. This will be in the form of a re-audit of the identified nonconformities and will occur no later than 6 months after the final report is issued. In this way the Trust can ensure appropriate corrective action has been taken.

 More information

Find more information on how to prepare for audit in our leaflet below.

Download Preparing for audit leaflet.

Alternatively, for more information about the audit process, please contact the GCP team.