Study Initiation and Management: Audit and inspection

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Introduction

Audit
Under the UK policy framework for health and social care research, sponsors of research are required to audit compliance with legislative and governance requirements. This process is separate from routine monitoring.

Due to resource constraints, most organisations audit according to risk, selecting programmes of work or individual projects that are required to meet strict legislative requirements, or where there is suspicion of reduced research governance standards.  

The Greater Manchester Research Alliance has developed two research management tools for help with monitoring, audit and risk assessment (1st resource below).

Researchers should permit access to study documentation to help with this process.

The Information Commissioner's Office has produced a guide to Data Protection Audit (2nd resource below).

The Information Governance Toolkit (3rd resource below) is a tool which the NHS uses to assess compliance with information governance standards.  Completion of the toolkit may be required when obtaining data from the NHS for secondary use in research.  The toolkit is completed at an organisational level, so you should discuss any requirements for completion with your local research and development department or research office.

Inspection
Certain regulatory agencies will carry out inspections as part of their regulatory functions. From the regulatory authorities listed in Seeking Approvals, the Human Tissue Authority (HTA) and Human Fertilisation and Embryology Authority (HFEA) have this function.

The HTA carry out inspections of licensed establishments. Under the Human Tissue Act 2004 the HTA has a statutory responsibility to make judgements about the suitability of the Designated Individual, Licence Applicant (Licence Holder), premises and practices in relation to the licensed activities. More information can be found on the HTA Inspections webpage (4th resource below).

You can find reports from HTA inspections which have taken place after 1 November 2010 on the HTA website (see 5th resource below).

The HFEA has a programme of clinic inspections, aspects of the research project taking place in the clinic will also be inspected. For more information see 'Inspections' in the 6th resource below.

For information on MHRA inspections under the Clinical Trials Regulations, please visit the Clinical Trials Toolkit, MHRA Inspection station.

Resources

  • 1. Greater Manchester Research Alliance Management Tools

    MAJIK Monitoring and Audit; and MIRRA Risk Assessment tools (username: gmrarg; password: tools).

    Good practice for all research Date added: 22 September 2007
  • 2. ICO Guidance on Data Protection Audits

    Information Commissioner's Office (ICO) guidance on Data Protection Audits for all organisations holding identifiable personal data.

    Legal requirement for data Date added: 7 September 2007
  • 3. NHS Information Governance Toolkit

    An online system which allows NHS organisations and partners to assess themselves against Department of Health Information Governance policies and standards.

    Good practice for data Date added: 6 September 2007
  • 4. HTA Inspections

    HTA web page on Inspections.

    Legal requirement for tissues Date added: 7 September 2007
  • 5. HTA Inspection Reports

    To access individual inspection reports select a link from 'Licensed premises.'

    Legal requirement for tissues Date added: 10 November 2008
  • 6. HFEA Inspections

    Information on HFEA research inspections.

    Legal requirement for specific research projects Date added: 7 September 2007